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Covid Politics and Fatigue Work Against Contact-Tracing Foot Soldiers

Thu, 08/19/2021 - 5:00am

Health departments nationwide scaled back their contact tracing in late spring or early summer when covid-19 cases started to decrease as vaccination efforts took center stage.

Then delta hit.

Now state and local health departments are trying to build back operations with depleted resources, as covid fatigue among their workers and the public alike complicate those efforts.

“Contact tracing from the start of this pandemic provided us with really kind of invaluable information,” said Dr. Amanda Castel, a professor of epidemiology at George Washington University. Castel said it’s still “a fundamental part of our response.” As is covid testing, especially for those who are vulnerable or unvaccinated, such as children under age 12. Yet numerous departments now find themselves with fewer contact tracers and less robust programs. Like testing, contact tracing seems to have fallen by the wayside.

Contact tracing is a resource-intensive operation, requiring workers to quickly call people who test positive for a disease and offer medical advice, and then to identify and reach out to anyone with whom the infected people came in close contact. The hope during the pandemic is to prevent spread of the covid virus, and to observe how the virus is changing. The process has been used for decades by public health officials to stop disease transmission.

But many public health departments were overwhelmed by the onslaught of covid. Last winter — before vaccines provided relief — they were unable to stay ahead of the virus through contact tracing. And as case counts dropped by virtue of increased vaccination rates in the spring and early summer, more than a dozen state health departments scaled back the workforce, said Crystal Watson, a senior scholar and assistant professor at the Johns Hopkins Center for Health Security. The resources were needed for vaccination initiatives and to restart other public health programs.

The situation has grown critical in a number of states during the past month or so as local health officials find themselves once again behind the curve as the delta variant drives up case counts. Resources are already stretched, and the politicization of covid-19 has left these local officials making tough calls regarding whom to trace in places like Missouri and Texas. And some states just don’t have enough personnel to do the job. The army of disease detectives more often than not included temporary staff or civil servants from outside the health department. In Kentucky, the former contact-tracing director is now the aviation department commissioner. The state health department said he has a successor but declined to name them.

The highly contagious delta variant makes the job harder. Cases can stack up quickly. Public health departments, which are chronically understaffed and underfunded, must pick and choose which tools will serve them the best.

“Some places have done a good job at retaining a kind of reserve workforce that they could call back up. And I’m sure that’s coming in handy right now. Other places did not. And they’re probably going to be quickly overwhelmed,” Watson said. “It’s also hard to say because there’s not a lot of public reporting.”

Arkansas, where Republican Gov. Asa Hutchison now says it was an error to sign a law in April banning mask mandates, is averaging around 2,000 new cases a day, one of the steepest upsurges among states. But the state health department has significantly fewer contact tracers now — 192 compared with 840 in December, when case counts were at the same level, according to the department and data collected by Johns Hopkins.

Danyelle McNeill, an Arkansas health department public information officer, said contractors performing this work have been authorized to increase their staff size. She also said that the agency is triaging cases, prioritizing those who tested positive for or were diagnosed with covid within six days of specimen collection or symptom onset, which the Centers for Disease Control and Prevention has recommended when capacity is limited, and that its vendors are not calling all positive cases the same day they receive lists when infections near 2,000.

In states that have opted to downplay contact tracing, county and city health officials are left to fend for themselves. In hard-hit southwestern Missouri, the flood of cases has overwhelmed a staff already stretched thin, said Springfield-Greene County Health Department Director Katie Towns, so the department pivoted to conducting contact tracing only in cases involving children younger than 12, who aren’t eligible for vaccination, Towns said.

Lisa Cox, a spokesperson for the state health department, said that “local health departments will work to triage and prioritize case investigations and will work with them if assistance is needed.” Her department expects financial support through the federal American Rescue Plan, but funds have yet to be appropriated. Ultimately, local strategies will come down to priorities. “We’ve made it clear that local jurisdictions need to make decisions locally based on their unique situation.”

The Springfield-Greene County Health Department’s surge capacity has diminished as team members have been redeployed to other health programs, which had been neglected during the pandemic. But even if Towns had unlimited resources, she said, she questions how effective investing it all in contact tracing would be: Covid is rampant and compliance with public health measures has waned. She would likely deploy more people to perform vaccine outreach and distribution.

Kelley Vollmar, executive director of the Jefferson County Health Department in eastern Missouri, said the delta surge is hitting a community polarized against public health efforts. “You have a public who is really not supportive of contact tracing and quarantine, as well as the funding for contact tracing and infrastructure is not there like it was last year,” she said.

In Texas, the Department of State Health Services is “winding down” the contact-tracing program to meet the requirements of the budget. In the new budget, which takes effect Sept. 1, taxpayer dollars are expressly banned from being used for covid contact tracing. “We will still be doing case investigations and other public health follow up,” said Chris Van Deusen, the state health department’s director of media relations, via email, “but won’t be providing contact tracing for local health departments.” The Texas Education Agency, which oversees primary and secondary education, also said earlier this month that schools are not required to conduct contact tracing.

Contact tracing has been clouded by controversy in Texas. Five legislators sued Republican Gov. Greg Abbott and the health department in August 2020 for awarding a contract to conduct the program. “The contract tracing policy has never been established as a policy accepted or supported by the Texas Legislature,” the suit said. Another lawsuit filed the same month by dozens of Texans alleges that the adoption of contact tracing violates their constitutional right to privacy.

In Texas’ Williamson and Bexar counties, where community covid transmission is high, local health officials are troubled by the lack of statewide tracing.

Williamson County turned to the state health department for help in contact tracing and case investigation as 50 to 100 new cases per day were being reported.

The county health department, which is separate from the county government, also trained more than half its staff to do contact tracing, everyone from clinical staff to press, said Allison Stewart, lead epidemiologist at Williamson County and Cities Health District, but the 65 people, including external staff and volunteers, couldn’t keep up with cases. Some worked seven days a week or 12-hour days, but now the county relies on the state for that work. “We can’t return to those days now, because all the people that we used actually are doing their real jobs,” she said. “We’re trying to figure out right now what the plan is come Sept 1. And it may mean the plan is that we don’t do case investigation or contact tracing.”

“Honestly, we don’t know,” she said.

San Antonio, one of the country’s largest cities and located in Bexar County, has its own contact tracers but leans on the state whenever there is a surge, said Rita Espinoza, the city’s chief of epidemiology. San Antonio is currently relying on the state and thus able to handle the load without backlogs, Espinoza said. She worries about what will happen in the fall, after school starts and there are more opportunities for transmission. The staff is already operating at a reduced capacity of 80 people.

“The specific impacts are unknown, but it may impact efforts to enhance other infectious disease investigations,” said Espinoza.

Florida, where covid has become a political buzzword, is another state where this tension is playing out. Broward County Mayor Steve Geller said he’s asked about contact-tracing capabilities, including how many investigators the state health department has, but he said he’s only ever told, “We’re working on it. It’s under control.” Contact-tracing data is not publicly available, but Republican Gov. Ron DeSantis once told local reporters contact tracing “has just not worked.”

Geller has not pushed health officials for information, given that “contact tracing doesn’t work well when everyone has covid” and that covid data has become contentious in Florida. “I’m not looking to create any new martyrs,” he said.

Midwest correspondent Lauren Weber contributed to this story.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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If the Unvaccinated Want to Work, They Face a Series of Hurdles

Thu, 08/19/2021 - 5:00am

With the delta variant surging, a growing number of employers are tiring of merely cajoling workers to get vaccinated against covid-19 and are following President Joe Biden’s protocol for federal workers: Either show proof of vaccination, or mask up and get regular testing if you want to work on-site.

The federal government — the nation’s largest employer — will require unvaccinated employees to wear masks while working, get regular testing and take other precautions, like maintaining physical distance from co-workers and restricting work travel. Several states, including California, Hawaii, Maryland, Virginia and Washington, also say unvaccinated state workers must get regular tests.

On Wednesday, California Gov. Gavin Newsom broadly extended such a mandate to teachers and all school employees, the first state to do so.

Those programs, with their testing alternative, differ from outright mandates to get vaccinated, as some health care organizations — including the health care workforce of the Department of Health and Human Services, hospitals and the U.S. military — are requiring.

Employers, fearing a backlash, frame the policy as a choice, with both sides of the equation seen as effective in reducing the spread of covid. Do public health experts think this approach will help?

All agreed the best solution is universal vaccination. Short of that, many said, the moves by employers will add a layer of protection — although how much remains to be seen.

Test results are “really only a snapshot in time,” said Dr. Gigi Kwik Gronvall, an associate professor at Johns Hopkins’ Bloomberg School of Public Health. Even testing every day, as was the standard in the Trump White House — without other measures like masking — didn’t prevent staffers from falling ill last fall.

And daily testing is cumbersome and costly.

Employers hope the hassles required to remain unvaccinated in the workplace will encourage the reluctant to just get a vaccine. “It’s a forceful nudge,” said Dr. Georges Benjamin, executive director of the American Public Health Association.

But there are challenges, too. Here’s what several experts had to say:

Universal Vaccination Remains the Gold Standard

Getting all eligible people vaccinated is “the perfect way out of this whole situation,” said Dr. Marcus Plescia, chief medical officer at the Association of State and Territorial Health Officers. “But, given the realities of the current situation, I think it’s reasonable that employers and others who are setting up vaccine requirements offer some accommodations.”

But much depends, he and others said, on how well the rules are enforced.

“If [unvaccinated] people are wearing masks all day at work, even in the break room, that alone is pretty strong,” he said. “When you add in the testing, it’s an alternative that is going to have some value.”

Some employers, he noted, are reluctant to set such edicts because they fear losing employees, particularly in areas already suffering shortages, such as nursing homes.

This Approach Relies Somewhat on the Honor System

Some states, health care organizations and New York City say they’ll require proof of vaccination — a copy of an employee’s vaccination certificate or a version uploaded into an app on a person’s phone. But other employers say they will allow workers to self-attest that they’ve had the vaccine.

“There will be some folks who fib, no doubt about that,” said Dr. William Schaffner, professor of medicine in the division of infectious diseases at Vanderbilt University School of Medicine, in Nashville.

“That will raise the issue of annoyance and concern by the vaccinated people,” said Schaffner. “They will say, ‘Wait a minute. Charlie is here and he’s not wearing a mask and we know he’s not vaccinated.’ People know that sort of stuff about their co-workers.”

There are other consequences.

There is online traffic in buying forged vaccination cards, designed to look like the real thing from the Centers for Disease Control and Prevention — even though that is illegal and can lead to fines or even jail time, the FBI has warned. Employers could also discipline workers who falsely state they’ve been vaccinated.

As for test results, it’s less clear how the honor system will apply. Some workers — especially those in health care organizations — may well be able to get their tests done in-house. Other companies may allow workers to find (and pay for) outside testing. It isn’t known whether employers will allow the use of self-administered home tests. And what kind of test companies require matters, since the rapid antigen tests are not as reliable as the standard PCR versions. To complicate matters, rising demand for tests during the surge has led to long lines for both kinds of tests in some parts of the country, and results for the more accurate PCR version may take days.

Frequency of Testing Will Vary and May Not Be Ideal

Many of the workplace edicts — including the one for federal workers — call for weekly or twice-a-week testing. Is that enough? It’s hard to give an exact answer.

Dr. Robert Wachter, professor and chair of the department of medicine at the University of California-San Francisco, prefers tests be performed twice a week, especially given the explosion of cases in many parts of the country.

“If you’re only testing once a week, there will be some cases that slip through,” said Wachter. “You could get tested on a Monday, infected on Tuesday and could infect someone else that Friday or Saturday.”

Who’s Paying?

While some employers may pick up the cost, at least initially, not all will. And workers should not count on testing being fully covered by their health insurers, either. They may well have to pay out-of-pocket for employer-required tests.

“Generally, health insurance providers are covering covid tests that are taken for diagnosing or treating a patient — if they are displaying symptoms or have had contact with someone who has been diagnosed with covid,” said Kristine Grow, a spokesperson for AHIP, the industry’s lobbying group.

But, she noted, guidance issued last year by several federal agencies said insurers don’t have to cover testing “conducted to screen for general workplace health and safety, for public health surveillance, or for any other purpose not primarily intended for diagnosis or treatment.”

Bottom line: Employees could have to go through a lot of hoops to remain unvaccinated in the workplace. “That will get old very quickly for a lot of people,” Schaffner said. “That will push a lot of people off the fence and onto the vaccination side.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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To Stoke Rural Vaccination Rates, Trusted Farmers Are Asked to Spread Word

Thu, 08/19/2021 - 5:00am

When he became eligible for the coronavirus vaccine in Illinois, Tom Arnold, 68, said he didn’t need any convincing. He raises cattle, hogs and chickens in Elizabeth, a small town in the state’s northwestern corner.

After all, who better to understand why herd immunity matters than a herdsman?

“Being a livestock producer, I’m well aware of vaccinations and vaccines,” he said. “That’s how we develop immunity in our animals. We’re always vaccinating the breeding stock to pass on immunity to the little ones.”

Boosting covid-19 vaccination rates in rural America is now less a problem of access and more an issue of trust. Only about 40% of people in Jo Daviess County, where Arnold lives, are fully vaccinated. Arnold said he doesn’t get why people are acting as if the pandemic were over. Scientists say those under-vaccinated parts of the country like Jo Daviess are at serious risk, especially as the highly contagious delta variant spreads rapidly.

It’s why farmers and ranchers need to speak openly about why they’ve chosen to be vaccinated, said Carrie Cochran-McClain, chief policy officer with the National Rural Health Association.

“One of the hardest things about the vaccination effort is that it really, at this point, is almost down to those one-on-one kinds of conversations,” she said.

Cochran-McClain’s association has teamed up with the National Farmers Union to try to get more farmers to promote the vaccine in their communities. They’ve created an online toolkit for farmers with information and talking points for starting conversations.

Ryan Goodman, 32, is giving it a try. He’s a cattle rancher in Virginia and self-described “agriculture advocate.” On Instagram and Twitter, he’s known as “Beef Runner.”

Goodman, who lived in Colorado until recently, has been using his social media accounts to promote the vaccine, as part of a paid content partnership with the Colorado Department of Public Health and Environment.

The agency provides him with information about the vaccines to share online, and he responds to questions with support from the department’s public health experts.

He said he’s not sure he’s changed any minds, but he’s encouraged when skeptics return to chat more.

“I’m a fan of saying no one conversation changes someone’s mind, especially when you disagree on a topic that might be as hot or as political as vaccines,” Goodman said.

He’d like to see more farmers speak up, because in rural towns farmers have long roots, extending back generations — making them more trusted than even health experts, he said.

“Everybody looks at Joe down the road and thinks, ‘Hey, you know, what might be his experiences on this topic or this issue?'” Goodman said. “[And they] listen to what he or she may say.”

Larry Lieb farms 92 acres of soybeans and timber in central Illinois and also raises a few cows and pigs.

He said he wondered whether the vaccine could be safe, given how quickly it came to market — and he got it for only one reason.

“My daughter’s a respiratory therapist, and she told me I was gonna get it,” Lieb said. “Plain and simple.”

Unlike some of his relatives, Lieb said, he does not buy into conspiracy theories about the vaccine. But he said he avoids those conversations altogether.

“It’s their own personal choice,” he said. “On issues where they’re set in their ways, you know, it’s futile to try.”

The pandemic has had a huge economic impact on farmers, said Mike Stranz, vice president of advocacy for the National Farmers Union.

“There’s been so much upheaval in the agricultural economy and in our communities,” Stranz said. “We need to start moving past that, and vaccines are the way towards that [goal].”

Vaccination rates have consistently lagged in rural communities, and an analysis from NPR and Johns Hopkins University in June found new covid hot spots are cropping up in areas with dangerously low vaccination rates — especially in the South, Midwest and West.

Urban and rural areas have been seeing similar rates of new covid cases lately, according to an analysis from the University of Iowa. But some states — including Illinois, Missouri and Utah — are seeing higher rates in nonmetropolitan areas.

Recent polls suggest most unvaccinated people don’t want the vaccine.

But Cochran-McClain said she hopes farmers don’t get discouraged, and she has this message for people like Lieb: “He may not feel like his voice is much, but we believe it’s very strong and important.”

Arnold said he believes the vaccine saves lives, but he doesn’t think it’s his job to try to convince his neighbors or friends. And, he said, he has limited capacity for new challenges.

“I’m already overworked and underpaid,” Arnold said. The vaccine rollout, so far, has coincided with some of the busiest times of the year for farmers.

If he gets into a conversation with someone about the vaccine, he said, he’ll express to them that he’s a livestock producer and understands how they work.

“But I don’t elaborate,” Arnold said. “Unless people are asking me. And usually they don’t.”

This story is part of a reporting partnership that includes Illinois Public Media, Side Effects Public Media, NPR and KHN.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Lo que debes saber sobre el refuerzo de la vacuna contra covid

Wed, 08/18/2021 - 4:02pm

La administración Biden anunció el miércoles 18 de agosto planes para ofrecer refuerzos de la vacuna contra covid-19 a todos los adultos estadounidenses a partir del próximo mes, y dijo que los datos recientes, incluidos algunos disponibles solo en los últimos días, jugaron un papel en esa decisión.

“Si esperan a que suceda algo malo antes de responder, se quedarán atrás”, dijo el doctor Anthony Fauci durante una sesión informativa en la Casa Blanca. “Y siemre quieres estar por delante del virus”.

Los funcionarios de la Casa Blanca enfatizaron que el lanzamiento de refuerzos estaba pendiente de la revisión que deben hacer funcionarios de la Administración de Alimentos y Medicamentos (FDA), así como del comité asesor de los Centros para el Control y Prevención de Enfermedades (CDC).

El lanzamiento comenzaría la semana del 20 de septiembre. Los residentes de Estados Unidos de 18 años y más que recibieron las vacunas de Moderna o de Pfizer-BioNTech serían elegibles para una tercera dosis ocho meses después de su segunda dosis. Los primeros en la fila serían las personas que viven en centros de atención de largo plazo y los adultos mayores en general.

“Si está completamente vacunado, aún tiene un alto grado de protección contra las peores complicaciones; no recomendamos que salga a recibir una dosis de refuerzo hoy”, dijo el cirujano general, el doctor Vivek Murthy.

Las vacunas de Johnson & Johnson no se distribuyeron hasta marzo y un plan para esas vacunas de refuerzo vendrá más tarde, dijeron las autoridades. La presión política y corporativa para ofrecer un refuerzo a los ciudadanos estadounidenses ha aumentado durante los meses de verano, ya que la contagiosa variante delta se ha extendido a nivel nacional y ha llenado las camas de los hospitales.

El miércoles, los funcionarios de Biden ofrecieron diapositivas llenas de gráficos de datos recientes, hablaron sobre la respuesta de anticuerpos y señalaron que la investigación que muestra la disminución de la fuerza de la vacuna en Israel jugó un papel clave en su decisión, al igual que un estudio de la Clínica Mayo que aún no ha sido revisado por pares.

“Siga los consejos de los CDC y la FDA, porque están haciendo todo lo posible para garantizar la máxima protección y seguridad”, dijo el doctor Cody Meissner, especialista en enfermedades infecciosas pediátricas que forma parte del panel asesor de vacunas de la FDA. “La gente debe tener mucho cuidado con las declaraciones que provienen de las grandes farmacéuticas. Tienen un objetivo muy diferente”.

El doctor Sadiya Khan, epidemiólogo y cardiólogo de la Escuela de Medicina Feinberg de la Universidad Northwestern, dijo que tomar cualquier medicamento tiene riesgos y que agregar una dosis adicional de la vacuna podría causar efectos secundarios innecesarios. “Lo que necesitamos son datos”, dijo. “No hubo discusión el miércoles sobre los posibles efectos secundarios de una tercera dosis”.

Entonces, ¿qué sabemos sobre si una persona saludable, y completamente vacunada, debería recibir el refuerzo? Las siguientes son respuestas clave.

  1. ¿Qué pruebas aportan los fabricantes de vacunas a los reguladores federales para apoyar la idea de que es necesaria una inyección adicional?

No está claro cómo los reguladores pueden autorizar el refuerzo. El martes 17, Abby Capobianco, vocera de la FDA, dijo que las agencias federales están revisando los datos de los ensayos clínicos y de laboratorio, así como los datos del mundo real. Algunos serán de empresas farmacéuticas concretas, pero el análisis de la agencia “no se basa exclusivamente en esos datos”, señaló.

Las empresas, por su parte, se apresuran a ofrecer información. El lunes 16, Pfizer y BioNTech presentaron resultados iniciales, pero prometedores, de un estudio de fase 1 sobre la seguridad y la respuesta inmunitaria de una dosis de refuerzo administrada al menos seis meses después de la segunda dosis. Los resultados de los ensayos de última fase que evalúan la eficacia de una tercera dosis se “esperan en breve”, dijo Jerica Pitts, vocera de Pfizer.

Stephen Hoge, presidente de Moderna, dijo que es “probable que sea necesaria” una tercera dosis en el otoño debido a delta. Ray Jordan, vocero de Moderna, dijo el martes 17, que la empresa está en conversaciones con los organismos reguladores, pero no facilitó fechas concretas.

Johnson & Johnson, cuya vacuna se administra en una sola inyección, espera compartir pronto los resultados de un ensayo clínico en fase avanzada que estudia la seguridad y eficacia de un régimen de dos dosis en 30,000 adultos. El estudio está analizando los “potenciales beneficios” de una segunda dosis, escribió en un correo electrónico el Richard Ferreira, vocero de la farmacéutica.

2. ¿Por qué es posible que las personas sanas todavía no necesiten un refuerzo?

El doctor Paul Offit, director del Centro de Educación sobre Vacunas del Hospital Infantil de Philadelphia y asesor de los Institutos Nacionales de Salud (NIH) y de la FDA, dijo que las directrices federales actuales no recomiendan un refuerzo y que no hay ninguna razón “con base científica” para recibir una inyección adicional en este momento, incluso después de recibir la vacuna de J&J.

Las actuales vacunas de ARNm funcionan induciendo un cierto nivel de anticuerpos neutralizantes y específicos del virus con la primera dosis. Después, la segunda dosis provoca un aumento exponencial del nivel medible de anticuerpos neutralizantes específicos y, lo que es más importante, hay pruebas de que la segunda dosis de la vacuna de ARNm también proporciona inmunidad celular, señaló Offit.

“Eso predice una protección relativamente más prolongada contra la enfermedad crítica grave”, indicó. Se ha demostrado que una sola dosis de la vacuna de J&J —que utiliza una tecnología diferente, llamada vectores de adenovirus— proporciona la respuesta equivalente a la segunda dosis de una vacuna de ARNm, añadió.

3. ¿Cómo se comparan las tres vacunas autorizadas en Estados Unidos?

Una preimpresión reciente (un borrador de un artículo científico que no ha sido revisado por pares) de la Clínica Mayo sugiere que la vacuna de Moderna puede proteger más contra la variante delta que la vacuna de Pfizer-BioNTech. Sin embargo, esa investigación se basa en el examen del historial de vacunación de miles de personas que se vacunaron contra covid, y no en una comparación directa de las vacunas, explicó la doctora Catherine Blish, especialista en enfermedades infecciosas de Stanford Medicine.

“Yo dudaría en alterar cualquier práctica o cambiar el comportamiento de alguna manera basándome en esos datos”, dijo.

Las vacunas de Moderna y de Pfizer-BioNTech se administran de forma diferente, lo que podría influir en la cantidad de ARNm que el organismo recibe para codificar la proteína, indicó la doctora Monica Gandhi, especialista en enfermedades infecciosas de la Universidad de California-San Francisco. La dosis de Moderna consiste en dos inyecciones de 100 microgramos administradas con un intervalo de cuatro semanas, mientras que las dos dosis de 30 microgramos de la vacuna de Pfizer-BioNTech se administran con un intervalo de tres semanas.

A finales de julio, Pfizer y BioNTech anunciaron que, entre cuatro y seis meses después de la segunda dosis, la eficacia de su vacuna había descendido del 96% al 84%. Con sus propios datos sobre la disminución de la eficacia, el gobierno israelí lanzó este mes una campaña de vacunación animando a más de un millón de residentes mayores de 50 años a recibir una tercera dosis.

En cuanto a la vacuna de una sola dosis de J&J, no hay pruebas de que los receptores estén siendo hospitalizados con infecciones posvacunación a una tasa más alta que si hubieran recibido otras vacunas, señaló el doctor Amesh Adalja, especialista en enfermedades infecciosas del Centro para la Seguridad de la Salud de Johns Hopkins.

4. ¿Puede un refuerzo perjudicar a una persona sana y totalmente vacunada?

No está claro. Offit dijo que un refuerzo es seguro y puede llegar a ser importante; pero “simplemente no es donde debemos centrarnos en este país en este momento.” La mejor defensa contra delta y otras variantes, aseguró, es vacunar primero a tantas personas como sea posible.

Otros, sin embargo, opinaron que la investigación disponible indicaba que la precaución está justificada. Durante una sesión informativa para los medios de comunicación, recogida por Reuters el mes pasado, Jay Butler, subdirector de enfermedades infecciosas de los CDC, dijo que la agencia estaba “muy interesada en saber si una tercera dosis podía estar asociada a un mayor riesgo de reacciones adversas, en particular a algunos de los efectos secundarios más graves, aunque raros”.

Los CDC no respondieron a las preguntas sobre su posición ante posibles riesgos. Se han notificado casos de coágulos sanguíneos y reacciones alérgicas tras la administración regular. Khan, de Northwestern, dijo que también le preocupan los informes de miocarditis, inflamación del corazón, que es más común después de la segunda inyección. Señaló que no está claro que el beneficio de recibir un refuerzo supere al riesgo para las personas jóvenes y sanas.

5. ¿Limitaría un refuerzo la capacidad de una persona vacunada para propagar el virus?

El doctor William Moss, profesor de epidemiología de la Escuela de Salud Pública Bloomberg de Johns Hopkins, explicó que la protección inmunitaria que confieren las vacunas opera a lo largo de un espectro, desde la limitación severa de la replicación inicial del virus hasta la prevención de la diseminación y replicación generalizada del virus en nuestro organismo.

“Las dosis de refuerzo, al aumentar los niveles de anticuerpos y potenciar otros componentes de nuestra respuesta inmunitaria, hacen más probable que se impida rápidamente la replicación del virus”, dijo Moss. “Esto hace entonces que sea menos probable que un individuo vacunado pueda transmitir el virus”.

Moss también afirmó que hay beneficios potenciales en las combinaciones de vacunas como las que se están administrando en San Francisco y en algunos países europeos. La canciller alemana, Angela Merkel, reforzó su vacuna de AstraZeneca con la de Moderna en junio.

Otro posible paso para las farmacéuticas es reformular sus vacunas contra covid para que se ajusten más a las nuevas variantes. Pfizer ha anunciado que podría hacerlo en los 100 días siguientes al descubrimiento de una variante.

Es de esperar que el proceso regulatorio pueda acelerarse para estas vacunas reformuladas, dijo Moss, que trabaja en el Centro Internacional de Acceso a las Vacunas de Johns Hopkins.

6. ¿Habrá que pagar por la dosis de refuerzo o será gratuita, como las anteriores?

Se espera que sea gratuita. Según Pfizer y la Casa Blanca, el gobierno federal compró 200 millones de dosis adicionales de la vacuna de Pfizer-BioNTech para eventualmente inocular a niños menores de 12 años y para posibles refuerzos.

7. ¿Es posible que en un futuro nos tengamos que vacunar anualmente contra covid?

El doctor Vincent Rajkumar, hematólogo de la Clínica Mayo que estudia los cánceres que afectan al sistema inmunitario, dijo hace un año que creía que las respuestas inmunitarias a covid podrían ser similares a las del sarampión, que crean “una memoria muy larga que nos protege”.

Pero covid mutó. “La India lo cambió todo para mí”, expresó, refiriéndose a la segunda oleada masiva tras el descubrimiento de delta. Muchos de los infectados ya habían tenido covid, recordó.

Ahora Rajkumar cree que “podríamos necesitar refuerzos anuales, y estaría bien que esos refuerzos pudieran combinarse con la vacuna de la gripe”.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Science Shows Mask-Wearing Is Largely Safe for Children

Wed, 08/18/2021 - 5:00am

Florida Gov. Ron DeSantis is one of a handful of Republican governors trying to block school districts from requiring masks in the classroom. 

Under DeSantis’ direction, the state health department adopted a rule that lets families opt out of locally ordered school mask mandates. The State Board of Education approved another rule that allows parents to secure vouchers for their children to attend a different school if they encounter pushback on their refusal to use masks. The DeSantis administration threatened to penalize school officials financially if they bucked the rules. 

Much of DeSantis’ argument was based on his belief that parents have a right to determine what’s best for their child, as well as his doubts about whether mask mandates are effective at curbing the covid virus in a school setting. (When PolitiFact looked into the latter argument, multiple experts pointed to research showing that mask-wearing is effective at protecting children from covid-19 and preventing covid transmission in schools.)

But DeSantis also cited specific negatives for mask wearers’ health.

In an executive order, DeSantis wrote that “masking children may lead to negative health and societal ramifications” and that “forcing children to wear masks could inhibit breathing, lead to the collection of dangerous impurities including bacteria parasites, fungi, and other contaminants, and adversely affect communications in the classroom and student performance.”

DeSantis’ press secretary, Christina Pushaw, told PolitiFact that “there are potential downsides to masking children for eight hours per day, from a developmental, emotional, academic, and medical perspective. These potential downsides are largely unexplored.”

She cited concerns raised in an op-ed by Dr. Marty Makary, a professor at the Johns Hopkins School of Medicine, and Dr. Cody Meissner, chief of pediatric infectious diseases at Tufts Children’s Hospital, that said that “masks can lead to increased levels of carbon dioxide in the blood” and that they “can be vectors for pathogens if they become moist or are used for too long.” Makary and Meissner also warned of impacts on verbal and nonverbal communication.

Other people aligned with DeSantis’ view have put the harm of kids wearing masks in even starker terms.

During a panel discussion convened by DeSantis, clinical psychiatrist Dr. Mark McDonald said, “My position is simple: Masking children is child abuse,” according to the Miami Herald. (Meissner was also on the panel.)

Rep. Madison Cawthorn (R-N.C.) spoke out against a proposed school mask mandate by the Buncombe County Board of Education, saying a mandate is “nothing short of psychological child abuse.”

And on the July 27 edition of his Fox News show, Tucker Carlson asserted that it’s a “scientifically established fact that masks pose a far greater threat to children than covid does. So, strictly speaking as a scientific matter, this is lunacy.”

What does science say about whether masks can harm the wearer?

Generally, we found that concerns about significant negative effects on breathing aren’t well supported. Worries about masks interfering with communication and serving as a barrier to social connection in the classroom may be more reasonable, experts say.

Breathing Concerns

The first thing to note is that masks aren’t recommended for everyone. The American Lung Association cautions people with lung disease, for instance, to consult their doctor before wearing a mask regularly. In addition, the CDC does not recommend that children under 2 years old wear masks. Masks are also generally not recommended during heavy exercise.

But what about people who do not fall into these categories? Could they be hurt by wearing a mask? 

Some of the most common concerns raised involve a lack of oxygen, or a buildup in carbon dioxide. We have previously found such concerns to be oversold, as have other fact-checkers

The issue “has been convincingly debunked,” said Babak Javid, a professor of medicine at the University of California-San Francisco.

We should note that studies specific to children have been rare, so most of the scientific literature has involved research on adults. Two studies on children used N95 masks, which are more sophisticated than the masks most schoolchildren will use, but even these found no significant effect on breathing. Other peer-reviewed studies of adults have produced similar results.

A mask “will add some resistance to the breathing process, meaning it may feel like it takes a bit more work to take a breath, but it won’t materially change the makeup of air that comes through the mask,” said Benjamin Neuman, a biology professor at Texas A&M University and chief virologist of the university’s Global Health Research Complex.

paper published in February looked at 10 previous studies of adults or children that addressed questions of breathing while wearing a mask. The authors expressed disappointment at how few studies looked specifically at the impacts on children, and they urged that more research is needed on that specific question.

However, the paper found little reason for worry.

“The eight adult studies, including four prompted by the pandemic and one on surgeons, reported that face masks commonly used during the pandemic did not impair gas exchange during rest or mild exercise,” the authors wrote.

A June study that seemed to indicate breathing challenges for masked children was retracted by the journal JAMA Pediatrics 16 days after publication because of methodological shortcomings and other concerns.

Dr. David Hill, an American Lung Association board member, has written that masks “absolutely” do not cause low oxygen levels.

“We wear masks all day long in the hospital,” Hill wrote. “The masks are designed to be breathed through and there is no evidence that low oxygen levels occur.”

Another reason medical experts aren’t too worried is that “the world has engaged in a massive study — observational, but literally billions of people — on mass mask-wearing, and people are not dropping dead left, right and center,” Javid said.  

Other Possible Risks

A few other complaints about masks sometimes surface, such as fear that they could concentrate toxins or harm the immune system. But these aren’t well supported either, experts say.

As long as masks are regularly replaced or laundered, “there’s no reason to worry about toxins,’’ said Columbia University virologist Angela Rasmussen. And there’s “no evidence that masks have any effect on the immune system or immune function,” she said.

Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, told PolitiFact that swabbing a student’s backpack would probably generate as many (or more) pathogens as swabbing their mask.

And Nicole Gatto, an associate professor of public health at Claremont Graduate University, said pathogens on masks may be evidence that they’re being kept “out of the mouths and noses of those who wore them, preventing people from potentially getting ill.”

While the scientific evidence for specific ills such as low oxygen or high carbon dioxide is weak, experts say it’s more plausible that the annoyances of masking could distract from in-class lessons and make it harder to hear other students or the teacher.

In a September 2020 paper in the International Journal of Environmental Research and Public Health, the authors wrote that “while there are minimal physiological impacts on wearing a mask … there may be consequential psychological impacts of mask wearing on the basic psychological needs of competence, autonomy, and relatedness.”

Such downsides may be especially acute for students who are English-language learners, or those who are deaf or hard of hearing.

“Masks interfere with lip-reading, which has a major impact on communication,” Javid said.

The reality is that “there is minimal evidence” on how severe these sorts of impacts could be for most children. “This is the first time in most of our lifetimes we have faced the prospect of continued isolation and masking, so it is not surprising we have insufficient evidence to guide us,” said Amy Price, a senior research scientist at Stanford University.

Still, there is evidence that children are adaptable. In a December 2020 study of children’s ability to read the facial expressions of masked people, researchers at the University of Wisconsin-Madison found that “while there may be some challenges for children incurred by others wearing masks, in combination with other contextual cues, masks are unlikely to dramatically impair children’s social interactions in their everyday lives.”

And child-development experts caution against assuming that any deficits from masks will linger over the long term.

Most children “don’t like wearing pants or shoes at first, but they adjust, like they do for all the other things we require of them,” said A.E. Learmonth, a professor with the cognition, memory and development lab at William Paterson University. “In many ways, a mask is just another article of clothing. In the beginning it could be distracting and uncomfortable, but like shoes, they will get used to it.”

Meanwhile, polling suggests that parents are open to masks in schools. A KFF survey taken in July and August found that 63% of parents wanted masks required in schools for people who are unvaccinated.

PolitiFact’s Gabrielle Settles and Jason Asenso contributed to this article.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Federal Vaccine Program Hasn’t Helped Those Whose Lives Were Altered by Covid Shot

Wed, 08/18/2021 - 5:00am

Angela Marie Wulbrecht jumped at the first chance to get a covid-19 vaccine, driving three hours from her Santa Rosa, California, home to a mass-vaccination site on Jan. 19. Twelve minutes after her Moderna shot, she stumbled into the paramedic tent with soaring blood pressure and a racing heartbeat. And so began a calvary of severe fatigue, brain fog, imbalance and other symptoms that are still with her eight months later.

Wulbrecht, 46, had been a nurse for 23 years before the shot. She was healthy, ate a vegan diet and was an accomplished salsa dancer. Since January she’s had to leave her job and missed out on many activities with her husband and 12-year-old daughter, Gabriella. She has spent about $35,000 on out-of-pocket medical bills, despite having insurance.

“I wanted to get vaccinated as soon as I could to help fight the pandemic,” said Wulbrecht, who still supports the vaccination campaign. Her husband got his shots despite her reaction, and Gabriella was scheduled to get her first dose Wednesday. “But it would help those who are hesitant if they took care of those of us who got injured.”

The options are slim for people who suffer rare life-altering injuries after a covid shot — a problem whose significance has grown as states and the federal government increasingly ponder vaccination mandates.

A federal program compensates people experiencing vaccine injuries, but not injuries from covid vaccines — not yet, anyway.

Such injuries are rare, but “if you’re going to take one for the team, the team has to have your back,” said Katharine Van Tassel, a vaccine law expert at the Case Western Reserve University School of Law in Cleveland. “That’s a moral imperative.”

Thirty-five years ago, Congress created the National Vaccine Injury Compensation Program, known as the vaccine court, for children hurt by routine immunizations administered as a condition of school entry — “injured recruits in the war on infectious disease,” as Georgetown University bioethicist Leroy Walters once described them.

Since it began operations in 1988, the vaccine court has paid more than $4 billion to over 8,000 families who could provide a “preponderance of evidence” that vaccines against diseases like measles and pertussis hurt their kids. The court also covers vaccine injuries in pregnant women, and from the flu vaccine. But it does not cover aftereffects from covid vaccines.

A smaller federal program, the Countermeasures Injury Compensation Program, addresses illnesses resulting from drugs or vaccines administered during a public health emergency, such as the covid pandemic.

But that program requires evidence that’s harder to pin down, does not pay attorney fees and rules by administrative fiat, while the vaccine court has judges. The countermeasures program has yet to pay a cent to anyone hurt by a covid vaccine, and its largely invisible decisions are “an inscrutable enigma,” said Brian Abramson, an expert on vaccine law.

David Bowman, a spokesperson for the Health and Human Services Department’s Health Resources & Services Administration, said the countermeasures program had a total of seven staff members and contractors and was seeking to hire more. He declined to answer questions about how covid vaccine claims could be handled in the future.

In June, a bipartisan group of lawmakers led by Reps. Lloyd Doggett (D-Texas) and Fred Upton (R-Mich.) introduced legislation to address problems with the original vaccine court, including a two-year backlog of cases. That bill would also increase the pain and suffering or death payments to people who can prove an injury, from $250,000 to $600,000.

A spokesperson for Doggett said he hopes the bill — not currently attached to a larger package moving through Congress — would eventually allow covid vaccine-injured patients to get compensation through the vaccine court. But that’s far from guaranteed.

In general, it is very difficult to prove a vaccine caused an injury that appears post-vaccination, since the ailments can be coincidental. But the rare vaccine injury can devastate a person’s health and financial resources.

Wulbrecht, whose care has included five ambulance trips, each billed for $3,000, filed a claim in February with the Countermeasures Injury Compensation Program. She got a note acknowledging her claim but hasn’t heard further from the program.

She’s in a Facebook group created for people reporting grievous covid vaccine-related neurological issues. It was launched by Dr. Danice Hertz, a retired gastroenterologist in Santa Monica, California, who has been diagnosed post-vaccination with mast cell activation syndrome, a rare condition in which part of the immune system goes haywire.

Hertz got her first Pfizer-BioNTech shot on Dec. 23, shortly after the Food and Drug Administration authorized the vaccine. Within 30 minutes she suffered terrible numbness and pain in her face and tongue and “felt vibrations going through my whole body,” she said.

More than 90% of the 150 people in the Facebook group are women, Hertz said. She is careful to keep what she terms anti-vaccine “riffraff” off the list, but she said many of the injured people have been frustrated at being unable to get a diagnosis or find doctors who understand the nature of their injuries.

Talk of vaccine injuries is sometimes muted in public health circles because of reluctance to feed the anti-vaccine movement and its bogus claims of vaccine injury ranging from infertility to magnetism to microchips secretly implanted by Microsoft founder Bill Gates.

But rare reactions like the ones Hertz and Wulbrecht report are scattered through the vaccine literature and often attributed to a phenomenon called “molecular mimicry,” in which the immune system responds to an element in the vaccine by attacking similar-looking human proteins. Guillain-Barré syndrome, or GBS, is caused by an immune attack on the nervous system in reaction to a vaccination — and to viral infections. It has been reported after influenza shots, and the single-dose Johnson & Johnson covid vaccine.

Hertz and others have been in contact with Dr. Avindra Nath, chief of clinical medicine at the National Institute of Neurological Disorders and Stroke, whose specialty is the study of immune-modulated neurological illness. Nath told KHN he was studying some of the patients but hadn’t confirmed their illnesses were caused by a covid vaccine.

“We have to find these answers, but they aren’t easy to come by,” Nath said. “I know these reactions are rare, because there were 36,000 NIH employees vaccinated against covid and, if it was common, I could study it here. But I don’t have a single NIH employee” who experienced it.

Regardless of how common the reactions are, vaccine law specialists worry about the impact of a failure to help those hurt by shots administered before the products gain full FDA approval, which could come this fall.

Congress created the vaccine court to keep pharmaceutical companies from abandoning production of common childhood vaccines by protecting them from damaging lawsuits, while at the same time offering support for kids hurt by a vaccine.

The Countermeasures Injury Compensation Program, however, arose as part of the 2005 Public Readiness and Emergency Preparedness Act, and was pushed through to shield drug companies from lawsuits over products like the anthrax and smallpox vaccines, which had a relatively high rate of dangerous side effects. Covid vaccines shouldn’t be in the same category, Van Tassel said.

The PREP Act is likely to set an almost insurmountable burden of proof for injury compensation, she said. Rewards depend on “compelling, reliable, valid medical and scientific evidence,” which doesn’t exist for covid vaccines because they are so new.

But cause and effect appear clear to women like Brianne Dressen, a Saratoga Springs, Utah, preschool teacher who was bedridden for months with neurological symptoms that began after she got an AstraZeneca shot in a clinical trial last November.

“Vaccines are an important piece of the puzzle to get us through the pandemic,” she told KHN. “But some people are going to draw the short straw with any drug or vaccine, and we need to take care of them.

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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The White House Says Boosters for All. Here’s What You Need to Know.

Wed, 08/18/2021 - 5:00am

The Biden administration announced plans Wednesday to offer boosters to all U.S. adults as soon as next month, saying that recent data, including some made available only in the past few days, played a role in that decision.

“If you wait for something bad to happen before you respond to it, you find yourselves considerably behind,” Dr. Anthony Fauci said during a White House briefing. “You want to stay ahead of the virus.”

White House officials emphasized that the rollout of boosters was pending review of evidence by officials at the Food and Drug Administration as well as the advisory committee to the Centers for Disease Control and Prevention.

The rollout would begin the week of Sept. 20. U.S. residents 18 and older who received the Moderna or Pfizer-BioNTech vaccines would be eligible for a third shot eight months after their second dose. The timing would mean that health care workers, long-term care residents and older residents would be first in line for boosters.

“If you are fully vaccinated, you still have a high degree of protection from the worst outcomes — we are not recommending you go out and get a booster today,” U.S. Surgeon General Vivek Murthy said. Johnson & Johnson vaccines were not distributed until March and a plan for those booster shots will come later, officials said.

Political and corporate pressure to offer a booster to U.S. citizens has been mounting over the summer months, as the highly contagious delta variant has spread nationally and filled hospital beds. On Wednesday, Biden officials offered slides filled with charts of recent data, talked about antibody response, and noted that research showing waning vaccine strength in Israel played a key role in their decision as did a study from Mayo Clinic that is not yet peer-reviewed.

“Stick to the advice from the CDC and the FDA, because they are doing their very best to ensure maximum protection and safety,” said Dr. Cody Meissner, a specialist in pediatric infectious diseases who sits on the FDA’s vaccine advisory panel. “People have to be very careful about statements that come from Big Pharma. They have a very different goal.”

Dr. Sadiya Khan, an epidemiologist and cardiologist at Northwestern University’s Feinberg School of Medicine, said that taking any medication has risks and that adding an additional dose of vaccine might cause unnecessary side effects. “What we need is data,” she said.

There was no discussion Wednesday of any potential side effects of a third dose.

So what do we know about whether healthy, fully vaccinated people should get a booster? Here are answers to seven key questions.

1. What evidence are vaccine makers giving federal regulators to support the idea that an additional shot is needed?

It’s unclear how the booster may be authorized by regulators. On Tuesday, FDA spokesperson Abby Capobianco said federal agencies are reviewing laboratory and clinical trial data as well as data from the real world. Some data will come from specific pharmaceutical companies, but the agency’s analysis “does not rely on those data exclusively,” she said.

The companies, for their part, are racing to produce data. On Monday, Pfizer and BioNTech submitted initial but promising results from a phase 1 study of the safety and immune response from a booster dose given at least six months after the second dose. Late-stage trial results that evaluate the effectiveness of a third dose are “expected shortly,” Pfizer spokesperson Jerica Pitts confirmed this week.

Moderna President Stephen Hoge said during his company’s earnings call this month that a third dose is “likely to be necessary” this fall because of the highly contagious delta variant. Moderna spokesperson Ray Jordan said Tuesday the company is in talks with regulators but hasn’t provided an estimated timeline.

Johnson & Johnson, whose vaccine is administered in a single shot, hopes to share results soon from a late-stage clinical trial studying the safety and efficacy of a two-dose regimen in 30,000 adults. The study is looking at “potential incremental benefits” with a second dose, company spokesperson Richard Ferreira wrote in a Tuesday email.

2. Why might healthy people not need a booster yet?

Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and an adviser to the National Institutes of Health and FDA, said current federal guidance does not recommend a booster and there’s no “science-based” reason to get an additional shot at this time — even after receiving the J&J vaccine.

The current mRNA vaccines work by inducing a certain level of neutralizing, virus-specific antibodies with the first dose. Then the second dose brings on an exponential increase in the measurable level of specific neutralizing antibodies — and, more important, there’s evidence that the second dose of mRNA vaccine also gives cellular immunity, Offit said.

“That predicts relatively longer-term protection against severe critical disease,” he said. A single dose of the J&J vaccine — which uses a different technology, called an adenovirus vector — has been shown to provide the equivalent response to the second dose of an mRNA vaccine, he said.

3. How do the three vaccines authorized in the U.S. compare?

A recent preprint — a paper that has not been peer-reviewed — from the Mayo Clinic suggests that the Moderna vaccine may be more protective against the delta variant than the Pfizer-BioNTech vaccine. However, that research is based on examining the vaccination history of thousands of people who got covid, rather than a direct comparison of the vaccines, said Dr. Catherine Blish, a specialist in infectious diseases at Stanford Medicine.

“I would be hesitant to alter any practices or change behavior in any way based on that data,” she said.

The Moderna and Pfizer-BioNTech vaccines are administered differently, which could factor into how much mRNA the body receives to code into protein, said Dr. Monica Gandhi, a specialist in infectious diseases at the University of California-San Francisco. Moderna’s dosing is two shots of 100 micrograms delivered four weeks apart, while the Pfizer-BioNTech vaccine’s two 30-microgram doses are delivered three weeks apart.

At the end of July, Pfizer and BioNTech announced findings that four to six months after a second dose their vaccine’s efficacy dropped from a peak of 96% to about 84%. With its own data of fading efficacy, the Israeli government launched a vaccination campaign this month encouraging more than 1 million residents over age 50 to get a third shot.

As for J&J’s one-shot vaccine, there’s no evidence that recipients are being hospitalized with breakthrough infections at a higher rate than if they had received other vaccines, said Dr. Amesh Adalja, a specialist in infectious diseases at Johns Hopkins Center for Health Security.

4. Could a booster harm a healthy, fully vaccinated person?

It’s unclear. Offit said he believes a booster is safe and may well become important — but “it’s just not where we should be in this country right now.” The best defense against delta and other variants, he said, is to first vaccinate as many people as possible.

Others, though, said the available research signaled that caution is warranted. During a media briefing reported by Reuters last month, Jay Butler, the CDC’s deputy director for infectious diseases, said the agency was “keenly interested in knowing whether or not a third dose may be associated with any higher risk of adverse reactions, particularly some of those more severe — although very rare — side effects.”

The CDC did not respond to questions this week about its stance on potential risks. There have been reports of blood clots and allergic reactions after regular dosing. Khan, at Northwestern, said she is also concerned about reports of myocarditis, inflammation of the heart — which is more common after the second shot than the first. She said it’s not clear that the benefit of taking a booster would outweigh the risk for young, healthy people.

5. Would a booster limit a vaccinated person’s ability to spread the virus?

Dr. William Moss, a professor of epidemiology at Johns Hopkins’ Bloomberg School of Public Health, explained that the immune protection conferred by vaccines operates along a spectrum, from severely limiting initial virus replication to preventing widespread virus dissemination and replication within our bodies.

“Booster doses, by increasing antibody levels and enhancing other components of our immune responses, make it more likely virus replication will be rapidly prevented,” Moss said. “This then makes it less likely a vaccinated individual will be able to transmit the virus.”

Moss also said there are potential benefits to combinations of vaccines like those being administered in San Francisco and some European countries. German Chancellor Angela Merkel boosted her adenovirus-vectored AstraZeneca shot with Moderna in June.

Another possible step for pharmaceutical companies is to reformulate their covid vaccines to more closely match newer variants. Pfizer has announced it could do so within 100 days of the discovery of a variant.

Hopefully, the regulatory process could be expedited for such reformulated vaccines, said Moss, who works within Johns Hopkins’ International Vaccine Access Center.

6. Would we have to pay for the booster dose, or would it be free, like the previous shots?

It will be free regardless of immigration or health insurance status, according to White House officials. No identification or insurance will be required.

In July, White House press secretary Jen Psaki announced that the federal government bought an additional 200 million doses of the Pfizer-BioNTech vaccine for inoculating children under 12 and for possible boosters.

7. Is there a future in which we take an annual covid shot?

Dr. Vincent Rajkumar, a hematologist at the Mayo Clinic who studies cancers involving the immune system, said a year ago he believed immune responses to covid may be similar to those of the measles, which create “a very long memory that protects us.”

Then covid mutated. “India changed everything for me,” he said, referring to its massive second wave after delta was discovered. Many of those who were infected had already had covid, he said.

Rajkumar now believes “we might need annual boosters — and it would be nice if such boosters can be combined with the flu vaccine.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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‘Tainted’ Blood: Covid Skeptics Request Blood Transfusions From Unvaccinated Donors

Tue, 08/17/2021 - 5:00am

The nation’s roiling tensions over vaccination against covid-19 have spilled into an unexpected arena: lifesaving blood transfusions.

With nearly 60% of the eligible U.S. population fully vaccinated, most of the nation’s blood supply is now coming from donors who have been inoculated, experts said. That’s led some patients who are skeptical of the shots to demand transfusions only from the unvaccinated, an option blood centers insist is neither medically sound nor operationally feasible.

“We are definitely aware of patients who have refused blood products from vaccinated donors,” said Dr. Julie Katz Karp, who directs the blood bank and transfusion medicine program at Thomas Jefferson University Hospitals in Philadelphia.

Emily Osment, an American Red Cross spokesperson, said her organization has fielded questions from clients worried that vaccinated blood would be “tainted,” capable of transmitting components from the covid vaccines. Red Cross officials said they’ve had to reassure clients that a covid vaccine, which is injected into muscle or the layer of skin below, doesn’t circulate in the blood.

“While the antibodies that are produced by the stimulated immune system in response to vaccination are found throughout the bloodstream, the actual vaccine components are not,” Jessa Merrill, the Red Cross director of biomedical communications, said in an email.

So far, such demands have been rare, industry officials said. Dr. Louis Katz, chief medical officer for ImpactLife, an Iowa-based blood center, said he’s heard from “a small handful” of patients asking for blood from unvaccinated donors. And the resounding answer from centers and hospitals, he added, has been “no.”

“I know of no one who has acceded to such a request, which would be an operational can of worms for a medically unjustifiable request,” Katz wrote in an email.

In practical terms, blood centers have only limited access to donated blood that has not in some way been affected by covid. Based on samples, Katz estimated that as much as 60% to 70% of the blood currently being donated is coming from vaccinated donors. Overall, more than 90% of current donors have either been infected with covid or vaccinated against it, said Dr. Michael Busch, director of the Vitalant Research Institute, who is monitoring antibody levels in samples from the U.S. blood supply.

“Less than 10% of the blood we collect does not have antibodies,” Busch noted.

In addition, outside of research studies, blood centers in the U.S. don’t retain data noting whether donors have been infected with or vaccinated against covid, and there’s no federal requirement that collected blood products be identified in that manner.

“The Food and Drug Administration has determined there’s no safety risk, so there’s no reason to label the units,” said Dr. Claudia Cohn, chief medical officer for AABB, a nonprofit focused on transfusion medicine and cellular therapies.

Indeed, the FDA does not recommend routine screening of blood donors for covid. Respiratory viruses, in general, aren’t known to spread by blood transfusion and, worldwide, there have been no reported cases of SARS-CoV-2, the virus that causes the disease, being transmitted via blood. One study identified the risk as “negligible.”

All donors are supposed to be healthy when they give blood and answer basic questions about potential risks. Collected units of blood are tested for transmissible infectious diseases before they’re distributed to hospitals.

But that hasn’t quelled concerns for some people skeptical of covid vaccines.

In Bedford, Texas, the father of a boy scheduled for surgery recently asked that his son get blood exclusively from unvaccinated donors, said Dr. Geeta Paranjape, medical director at Carter BloodCare. Separately, a young mother fretted about transfusions from vaccinated donors to her newborn.

Many patients expressing concerns have been influenced by rampant misinformation about vaccines and the blood supply, said Paranjape. “A lot of people think there’s some kind of microchip or they’re going to be cloned,” she said.

Other patients have balked at getting blood from people previously infected with covid, even though federal guidance greenlights donations two weeks after a positive test or the last symptom fades.

Last month, a woman facing a cesarean section for a high-risk pregnancy said she didn’t want blood from a donor who had had covid, recalled Cohn with AABB. “I said, ‘Listen, the alternative is you don’t get the blood and that’s what will affect you,’” Cohn said.

Some industry experts were hesitant to discuss the vaccine-free blood requests, for fear it would fuel more such demands. But Cohn and others said correcting widely spread misinformation outweighed the risk.

Patients are free to refuse transfusions for any reason, industry officials said. But in dire situations — trauma, emergency surgery — saving lives often requires using the available blood. For patients with chronic conditions requiring transfusion, alternative treatments such as medication or certain equipment may not be as efficient or effective.

People who require transfusions also may donate their own blood in advance or request donations from designated friends and family members. But there’s no evidence that the blood is safer when patients select donors than that provided by the volunteer blood system, according to the Red Cross.

Earlier in the pandemic, many blood donations were tested to see whether they contained antibodies to the covid virus. The hope was that blood from previously infected people who had recovered from covid could be used to treat those who were very sick with the disease. Tens of thousands of patients were treated with so-called convalescent plasma under a Mayo Clinic-led program and through authorization from the FDA.

But the much-hyped use of convalescent plasma largely fell flat after studies showed no clear-cut benefits for the broad swath of covid patients. (Research continues into the potential benefits of treating narrowly targeted patient groups with high-potency plasma.) Most hospitals stopped testing blood and labeling units with high levels of antibodies this spring, said Busch. “It’s really no longer a germane issue because we’re not testing anymore,” he said. “There’s no way we can inform recipients.”

Busch stressed that the studies also have shown no harm associated with infusing antibody-containing blood plasma into covid patients.

Past health crises have raised similar concerns about sources of donor blood. In the mid-1980s, recipients scared by the AIDS epidemic didn’t want blood donated from cities such as San Francisco with large gay populations, Busch recalled. Even now, some recipients demand not to receive blood from people of certain races or ethnicities.

Such requests, like those for vaccine-free blood, have no medical or scientific basis and are soundly refused, blood center officials said.

The most pressing issue for blood centers remains the ongoing shortage of willing donors. As of the second week of August, the national blood supply was down to two days’ worth or less at a third of sites affiliated with America’s Blood Centers. That can limit the blood available for trauma victims, surgery patients and others who rely on transfusions to survive.

“If for some reason we didn’t want vaccinated people to donate blood, we’d be in a real problem, wouldn’t we?” Karp said. “Please believe us when we tell you it’s fine.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Have Vaccines, Will Travel: On the Road With a Covid Entrepreneur

Tue, 08/17/2021 - 5:00am

VIRGINIA CITY, Mont. — While many businesses in this southwestern Montana “ghost town” reel in tourists with its mining and Wild West vigilante past, one businessman arrived offering a modern product: covid-19 vaccines.

Kyle Austin, a traveling pharmacist, set up his mobile clinic in Virginia City on a recent Saturday, the latest stop on his circuit of Montana’s vaccine deserts.

“In any business, going to the people is better than waiting for the people to come to you,” the 38-year-old pharmacist said.

While many businesses scaled back at the height of the pandemic, Austin saw covid as an opportunity. He opened his own shop, Pharm406, in Billings — a nod to Montana’s lone area code. Then when the covid vaccine became available, and thousands of people across Montana were stuck on waitlists, he hit cities large and small in a school bus turned vaccine clinic, offering shots with no appointment needed.

“When they started talking about covid coming out I was like, ‘All right, we’re gonna create a vaccine, there’s gonna be a big demand for it, and Montana doesn’t have a lot of access,’” he said. “I hate to say it, but I literally took advantage of covid-19 to open up and push forward.”

Now, with demand at a trickle and the nation grappling with how to finish distributing vaccines, collecting stragglers is part of Austin’s business model as he rotates among towns. He sees it as a service to rural Montana that could also pay off for him.

In some parts of the state, Austin is the only person administering Pfizer-BioNTech vaccines, the sole shot approved for those ages 12 to 17. When the mobile clinic leaves, local leaders must figure out how to fill the gaps between his visits.

Dressed in blue scrubs, Austin talks like a businessman who knows rural Montana. He’s from Havre, a Montana town about 35 miles south of the U.S.-Canada border, population roughly 9,000. For years, he traveled across the state as a relief pharmacist for drugstores. That work stalled when covid arrived.

Austin then wanted to create a mobile pharmacy, but a brick-and-mortar base was required to obtain a state pharmacy license. So, in July 2020, he opened his own shop in Billings, Montana’s largest city.

There he offered rapid covid tests, which had been in short supply. He also expanded beyond what’s found in typical drugstores: After trying cryotherapy once himself, he bought a machine to add to his pharmacy’s list of services. When he noticed people could rent electric scooters in town, he began selling them. Then he used flu shots to conduct a test run of his vaccine tour last fall on the slogan “Get a brew, not the flu,” partnering with breweries to give a free drink to anyone getting a shot. In April, he hit the road with covid vaccines, leaving his team of seven employees to keep his Billings drugstore running.

His mobile clinics have been the easiest way to turn a profit. He doesn’t have to rent space or staff an entire pharmacy for the trips. Health departments advertise the clinics for him, and locals provide space for him to park and patients to wait. When the weather is nice, he keeps costs low by camping along the way.

And covid vaccines have had more demand and higher reimbursement rates than any other vaccine he could have used to propel his business. In most cases, Austin said, he can break even by giving as few as 20 doses a day. So far, the government has supplied the shots for free, and he estimated he gets paid roughly $30 on average to administer a dose between payments from insurance companies and federal reimbursements — as opposed to the $17 he said he saw last year for flu vaccines.

Some days he gives out 200 shots, other days five, but said that adds up. He said it’s financially possible because he doesn’t pay another pharmacist to do the work.

“If I paid someone to do it, I would probably be upside down,” Austin said.

Austin’s recent trip to Virginia City to offer a second round of doses came at the request of the town and local health department. This time he drove a Jeep, leaving his school bus behind, because he expected only about 15 customers.

But in a town of 120 year-round residents, in a county of fewer than 9,000, a few shots can make a difference. “Even an incremental increase in uptake could have a big effect on our statistics,” said Emilie Sayler, county health director.

Virginia City is at the center of Madison County, where 43% of those eligible for the covid shot are fully vaccinated — compared with 49% statewide and 59% nationally.

Teenagers remain the county’s age group with the biggest vaccine shortfall.

Virginia City doesn’t have a pharmacy. The county’s vaccine providers are two hospitals that don’t stock Pfizer doses. At the beginning of the rollout, Sayler said, the one-nurse health department couldn’t handle both vaccines and contact tracing. And as demand dwindled, she worried they wouldn’t be able to use up doses — especially Pfizer’s. That brand comes in shipments so large that most rural towns can’t or won’t offer it.

Now the department is balancing educating people about vaccines without coming off as aggressive. It’s a county where many locals call incentives — like a free beer or ice cream cone for a jab — a bribe.

Brothers Nicholas and Jacob Johnson, 17 and 16, showed up first to Austin’s recent clinic, coming for their second shots. Their next option was going to Bozeman, at least a 100-mile round trip.

“And we would have needed to do it for two shots,” Nicholas said, adding he has a summer job and is busy with football and lacrosse.

“I just wanted to get it over with,” Jacob added. “I trust the science.”

Some of the county’s vaccination gap can be attributed to lack of time. Dr. Douglas Young, chair on the county’s Board of Health and a veterinarian, came for his shot straight from tending to a sick mule. Young said he always planned to get vaccinated but held off in case it triggered a reaction that knocked him out of work for a few days during the busy spring.

“I didn’t want to be down and out during calving season,” Young said.

Virginia City Mayor Justin Gatewood, a 44-year-old farmer in a pink pearl-snap shirt and work-stained jeans, stood outside the Pharm406 tent and greeted locals by name and occasionally answered questions for tourists, such as where to find Wi-Fi.

The season of visitors is booming, Gatewood said. That’s a relief for the town that survives on tourism. But that traffic is also a concern as the delta variant sparks new covid surges nationwide.

“Now we’re dealing with this pandemic of the unvaccinated,” said Gatewood, before nodding toward the clinic. “This brings it back into the consciousness of folks, just makes them aware and, hopefully, maybe, minds are changing.”

About a block from the covid vaccine clinic, Adam Root, 41, said he hadn’t known about the clinic but wouldn’t have gone anyway. He hasn’t liked the federal pressure to get vaccinated.

“I’m not vaccine-hesitant, it’s just a hard ‘no’ for me,” Root said. “I don’t like being told what to do, for one thing, and, two, I believe health comes from how you take care of your body.”

By the time Austin headed back to his campsite along the Madison River, he had vaccinated 20 people — adding five people who got first doses. He planned to return to give them their second shots and pick up any new takers.

He’s already booked for much of the fall and expects to see an uptick as schools start.

In the meantime, Gatewood said, he can direct adults in Virginia City to the county’s hospitals and families with teens to locations outside the county. Otherwise, he hopes he can get people to show up when Austin returns.

“I can’t stab people myself,” Gatewood said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Heces: la nueva herramienta de detección de covid y otras enfermedades

Mon, 08/16/2021 - 2:21pm

Desde la reapertura del campus de la Universidad de California-San Diego, el pasado verano, la institución ha recurrido a estrategias de salud pública de probada eficacia, como las pruebas y el rastreo de contactos. Pero también ha añadido una herramienta a su arsenal: excrementos.

Esta herramienta alertó a los investigadores de un 85% de los casos de covid-19 en las residencias universitarias antes de que fueran diagnosticados, según un estudio que se publicará próximamente, dijo Rob Knight, profesor de pediatría y ciencias e ingeniería informática que ayudó a crear el programa de análisis de aguas residuales del campus.

Cuando se detecta la presencia de covid en las aguas residuales, se realizan pruebas a los estudiantes, al personal y a los profesores, lo que ha permitido a la universidad identificar y aislar a los individuos infectados que aún no muestran síntomas. Esto podría evitar brotes antes de que se produzcan.

El programa de pruebas de la UC-San Diego es uno de los cientos de esfuerzos realizados en California, y en el país, para convertir los residuos en valiosos datos sanitarios. Desde Fresno hasta Portland, Maine, universidades, comunidades y empresas monitorean los excrementos humanos en busca de signos de covid.

Los investigadores han depositado grandes esperanzas en este nuevo flujo de datos que, según aseguran, alertaría a los funcionarios de salud pública sobre las tendencias de las infecciones sin tener que depender de que las personas se hagan las pruebas. Y como las personas excretan el virus en las heces antes de mostrar síntomas, serviría de alerta temprana para los brotes.

Los Centros para el Control y la Prevención de Enfermedades (CDC) consideran esta práctica tan prometedora que han creado una base de datos federal de muestras de aguas residuales, transformando los datos en información valiosa para los departamentos de salud locales.

Según expertos, el programa genera una herramienta de salud pública en tiempo real, que podría tener una serie de usos más allá de la actual pandemia, incluyendo el seguimiento de otras enfermedades infecciosas y la resistencia de los gérmenes a los antibióticos.

“Creemos que esto puede proporcionar datos muy valiosos, no sólo para covid, sino para muchas enfermedades”, afirmó Amy Kirby, una microbióloga que dirige la iniciativa de los CDC.

El virus que causa covid infecta muchos tipos de células, incluidas las del tracto respiratorio y el intestino. La firma genética del virus, el ARN viral, llega a las heces y suele aparecer en ellas días antes de que aparezcan los síntomas.

En la UC-San Diego y otros campus, los investigadores toman muestras de los edificios, capturando datos tan específicos que a menudo pueden deducir el número de personas infectadas que viven o trabajan allí. Pero en la mayoría de los entornos, debido a la preocupación por la privacidad y la limitación de recursos, las pruebas se realizan a una escala mucho mayor, con el objetivo de seguir las tendencias a lo largo del tiempo.

Las muestras se extraen de las aguas residuales, que es lo que sale de tuberías de alcantarillado, los sólidos que se han sedimentado en las aguas residuales. Suelen extraerse mecánicamente o una persona toma una muestra usando una vara larga.

Cuando investigadores en Davis, California, observaron el aumento de la carga viral en las aguas residuales de varios vecindarios, en julio, enviaron alertas por mensajes de texto y colgaron carteles en las puertas de 3,000 hogares recomendando que la gente se hiciera la prueba de covid.

Antes de la pandemia, el análisis de aguas residuales para identificar y prevenir enfermedades en Estados Unidos se limitaba, en gran medida, al uso académico. Israel lo utilizó para evitar un brote de poliomielitis en 2013, y algunas comunidades estadounidenses tomaron en el pasado muestras de aguas residuales para averiguar qué tipo de opioides consumían los residentes, un servicio ofrecido por la empresa Biobot.

Pero cuando covid llegó a Estados Unidos, en medio del caos político y la escasez de pruebas, los gobiernos locales se apresuraron a buscar cualquier información que pudieran obtener sobre el virus.

En el condado rural de Lake, California, las autoridades sanitarias identificaron un puñado de casos enviando a enfermeras en busca de personas infectadas. Estaban seguros de que había más, pero no podían conseguir pruebas que lo demostraran, así que en la primavera de 2020 se apuntaron a un programa gratuito de análisis de aguas residuales gestionado por Biobot.

Se realizaron pruebas de covid cuando la pandemia despegó y ahora se cobra por realizar pruebas en escuelas de primaria y secundaria, edificios de oficinas y residencias de mayores, además de en gobiernos locales y universidades, explicó Mariana Matus, CEO y cofundadora de la empresa.

El virus de covid apareció en muestras de cuatro instalaciones de tratamiento de aguas residuales en el condado de Lake.

“Es una forma de obtener más información porque no podemos hacer esas pruebas”, dijo entonces a KHN Gary Pace, responsable de salud del condado.

A medida que el muestreo de aguas residuales se generalizaba en todo el mundo, el Departamento de Salud y Servicios Humanos de los Estados Unidos (DHHS) comenzó a otorgar subvenciones, en el otoño de 2020, a las plantas de tratamiento de aguas residuales. Biobot ganó una licitación para ejecutar una segunda ronda de ese programa, actualmente en curso hasta finales de agosto, analizando las aguas residuales de hasta el 30% de la población estadounidense.

Al menos 25 plantas de tratamiento de aguas residuales de California participan en el programa, y muchas otras reciben dinero de los CDC, trabajan con universidades locales o pagan por sus propias pruebas. Mientras que estados como Ohio y Missouri han creado paneles públicos para mostrar sus datos, los esfuerzos de California siguen siendo inconsistentes.

Los datos de las pruebas, por sí solos, no aportan mucho valor a los funcionarios de la salud: es necesario traducirlos para que sean útiles. Los científicos todavía están aprendiendo a leer los datos, un proceso complicado que implica comprender las relaciones entre la cantidad de virus que excreta la gente, cuántas personas utilizan un sistema de aguas residuales y cuánta agua de lluvia corre por el sistema, diluyendo potencialmente las aguas residuales, entre otros muchos factores.

Dado que el uso de las aguas residuales para el rastreo de enfermedades no era habitual antes de la pandemia, ha habido una curva de aprendizaje constante.

Bajo presión, los funcionarios de salud pública han tenido dificultades para incorporar los nuevos datos a su ya abrumadora carga de trabajo, pero los CDC esperan poder resolver esos problemas con un nuevo sistema nacional que rastrea y traduce los datos de las aguas residuales para los gobiernos locales.

A lo largo de 2020, Kirby, la microbióloga de los CDC, y la ingeniera Mia Mattioli formaron un equipo de dos personas para las aguas residuales, entre las 7,000 personas que componen el grupo de respuesta covid de la agencia. Durante ese tiempo, las colegas compartieron generosamente lo que sabían sobre la epidemiología de las aguas residuales, contó Kirby.

En septiembre de 2020, el dúo había puesto en marcha el Sistema Nacional de Vigilancia de Aguas Residuales, que interpreta los datos de muestreo para los gobiernos estatales y locales. En la actualidad, dirigen un equipo de seis personas y tienen un puesto permanente en uno de los departamentos de los CDC.

“Cada pieza de este sistema tuvo que construirse en gran parte desde cero”, expresó Kirby. “Cuando lo pienso, realmente me sorprende dónde estamos ahora”.

En los meses transcurridos desde el debut del sistema, éste ha sido capaz de detectar un aumento de casos, entre cuatro y seis días antes de que las pruebas de diagnóstico muestren un incremento, añadió Kirby.

Espera que a finales del año que viene el programa federal de vigilancia se utilice para detectar una serie de enfermedades, como E. coli, salmonela, norovirus y un hongo mortal resistente a los medicamentos llamado Candida auris, que se ha convertido en una amenaza mundial y ha causado estragos en hospitales y residencias de mayores.

Cuanto más tiempo estén en marcha estos programas, más útiles resultarán, afirmó Colleen Naughton, profesora e ingeniera civil de la Universidad de California-Merced que dirige COVIDPoops19, un seguimiento de los esfuerzos de vigilancia de las aguas residuales a nivel mundial.

Naughton trabaja con sus colegas de la Universidad de California-Davis para poner en marcha programas de control cerca de donde ella trabaja, en el Valle Central, pero se ha encontrado con que algunas comunidades no tienen los recursos necesarios para llevar a cabo las pruebas, ni suficiente personal sanitario para analizar o utilizar los datos.

Es en estas comunidades más pequeñas con acceso limitado a las pruebas y a los médicos donde la práctica puede ser más prometedora, aseguró Naughton. Covid puso de manifiesto las desigualdades que existen, desde hace tiempo, entre las comunidades y Naughton teme que se perpetúen con el uso de esta nueva herramienta de salud pública.

Los expertos señalan que también hay que tener en cuenta el tema de la privacidad. Los datos de las aguas residuales no se han considerado, tradicionalmente, información sanitaria personal protegida, como lo son las pruebas de diagnóstico. Las autoridades sanitarias ya habían respondido a las preocupaciones sobre el rastreo del consumo de drogas ilícitas en aguas residuales, tomando muestras lo suficientemente grandes como para ofrecer anonimato. Pero las pruebas para detectar determinados problemas de salud exigen examinar el ADN.

“Creo que va a ser un reto para la comunicación pública”, dijo Knight, “asegurarse de que no se perciba como un espionaje de los secretos genéticos de cada individuo”.

Funcionarios de salud pública y aguas residuales afirmaron que están entusiasmados con el potencial de esta nueva herramienta, y trabajan para abordar las preocupaciones sobre la privacidad mientras la utilizan. Greg Kester, director de programas de recursos renovables de la Asociación de Agencias de Saneamiento de California, escribió a los funcionarios de los CDC, en junio de 2020, pidiendo una red de vigilancia federal. Le sorprendió la rapidez con que esa petición se hizo realidad. Y espera que esté aquí para quedarse, tanto para la pandemia en curso, como para el inevitable próximo brote.

“A medida que aumenten las tasas de vacunación y lleguen las variantes, seguirá siendo importante porque las pruebas clínicas disminuyen”, dijo Kester. “Lo que queremos es que esto forme parte de la infraestructura”.

Esta historia fue producida por KHN, que publica California Healthline, un servicio editorialmente independiente de la California Health Care Foundation.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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In Rural America, Twisting Arms to Take a Covid Vaccine First Takes Trust

Mon, 08/16/2021 - 5:00am

CAIRO, Ill. — Lee Wright was hard at work, constructing a nail salon near the city’s abandoned hospital, when Jody Johnson stopped by to introduce himself on a recent afternoon.

Johnson, who works for the University of Illinois Extension program, chatted with Wright casually in the summertime heat. For Johnson, it was the first step to building trust in this city of fewer than 2,200 people as extension programs across the U.S — long valued in many rural communities for helping farmers and supporting 4-H clubs — expand their service to include educating the public about covid-19 vaccines.

Wright, 68, was unvaccinated and planned to remain so, even though he’d followed other public health guidelines during the pandemic. When it came to getting the shots, he decided to leave his fate to his faith.

“Doctors are good. Don’t get me wrong,” Wright said. “But we got to have something that we can really depend on.”

Johnson didn’t talk to Wright about the vaccines that day. He just listened instead. “No one wants to feel ashamed or belittled because they’re not doing something,” Johnson said later.

Only 16% of residents here in Alexander County are fully vaccinated against covid-19, the lowest rate in Illinois, according to the state health department. And case counts of coronavirus infections are rising. So the Cooperative Extension System, which is tied to a network of land-grant universities, plans to spend the next two years talking about vaccines in this community and elsewhere. It may take that long or more to persuade enough people to get vaccinated.

The extension system has a tradition of bringing research-based information to communities on a wide variety of topics, including water quality, food safety and disaster preparedness. With its roots sunk deep in rural America, where vaccines have been slow to catch on, the system is now using state and federal funding to pay for immunization education efforts tailored to specific communities.

Already 4-H clubs have been making masks and face shields. In Illinois, the agency has a covid resource guide for families, business owners and farmers. The office covering the southern portion of the state is now looking to hire someone in the community to help get out the word on why vaccinations matter. Johnson also wants to team up with local churches, civic groups and business owners to get the job done.

“This is not our first global pandemic,” said Carissa Nelson, a spokesperson for 4-H programs in Illinois. The organization’s agents and club members nursed patients during the 1918 flu pandemic that devastated the world.

This time around, the extension service’s strategy could also help in these rural communities and the urban areas it serves. But local leaders say there’s no quick solution for improving vaccination rates in Cairo or across the country. Getting people vaccinated is a nuanced challenge in every community. In Cairo, a long history of racial tension dating to the Civil War still stings. Like many rural towns across the U.S., the community also feels underappreciated and misunderstood.

Vaccine apathy is common here, where infection rates remained low until recently.

“We haven’t had great turnouts,” said Tyrone Coleman, president and co-founder of the Alexander and Pulaski NAACP chapter, which has helped organize vaccine clinics in Cairo.

In June, he invited the health department to the city’s Juneteenth celebration at St. Mary’s Park. More than 300 people attended. But the event’s pop-up clinic hosted by the state didn’t have many seeking vaccinations during its six hours of operation.

“We only had two,” Coleman said.

More than 15,000 people lived in Cairo in the early 20th century, helping it earn the nicknames “Little Chicago” and “the Gateway to the South.” Old factories, antebellum homes, an ornate library and a vacant hospital remain as reminders of the city’s majestic past. The city’s library prominently displays the work of Samuel Clemens, the American writer best known as Mark Twain. After traveling through Cairo, Twain wrote about the city in his 1884 novel “The Adventures of Huckleberry Finn.”

In the novel, Cairo represents freedom and the chance for a better life.

But the hospital shut down in 1987. The only grocery store in town closed years ago, public housing was torn down in recent years, and the only nursing home closed during the pandemic, forcing residents to find a new place to live without much notice. On top of all that, flooding has threatened to wipe the city out more than once.

Today, fewer than 2,200 people, the majority of them Black, live here. And locals say the population has continued to drop with all the closures. The city is often mislabeled by the press and travel guides as abandoned.

“Cairo is not a ghost town,” said Ronnie Woods, a local pastor and retired schoolteacher. “It’s not dead at all.”

Tourists still stop by to see the confluence of the Mississippi and Ohio rivers. But they don’t typically see the rocky riverbank where residents fish for their dinner. Beverly Davis, 60, heads there often with rod in hand and gives much of her catch away to other members of the community. The scenic waterfront, though, is carpeted with driftwood and dead fish that washed ashore.

“I guess it’s meant to be like this,” Davis said, standing on the riverbanks among the fish carcasses. “’Cause if not, it would be better.”

But many residents continue to believe their city will return to its past glory. “The world hears that this is a negative part of the country, and it’s not,” Johnson said. “We’ve got too many good things and people here.”

On this day, the only outdoor basketball court in the city, anchored by a single hoop, was busy in a rural community that was fighting to stay alive long before the pandemic hit. The men on the court didn’t seem worried about catching covid.

“I haven’t had covid, so I feel like I don’t need to get vaccinated right now,” said Jeffery DeWitt, 24. “I’ll just take it as it goes.”

Wright’s son, Roman Wright, 36, said much the same thing while helping his dad build the nail salon across town. He works for the prison system, and one of its facilities nearby reported covid cases. But he hadn’t contracted the disease. Like his father, he said he didn’t plan on getting the shots.

“I’m like my dad,” Roman Wright said. “I was born and raised in church all my life. So I say we believe in God. I know my parents pray for me. We pray for each other and we just believe in God.”

Woods, the pastor, has a different point of view. He keeps his vaccination card in a plastic sheath and carries it with him wherever he goes.

“I have strong faith,” said Woods, 66. “And at my age, my risk factors, I just felt that God placed science there to help us.”

But Woods said it’s going to take work to persuade others in Cairo to get vaccinated, even if they know someone who died of covid. A prominent doctor was among the dead in the community. “It’s going to take more than explaining, it is going to take a cultural shift because people are just not trusting,” he said.

That’s one reason Johnson is searching for a local voice to lead the extension service’s vaccine education program over the next year. As a 51-year-old white man who grew up in a predominantly white community 45 miles outside of Cairo, he recognizes that local residents would be more likely to share their thoughts with someone who lives here. Plus, he spends most of his time talking with community leaders and public officials. He is searching for someone who will spend time with locals who don’t hold titles and positions.

“Everybody doesn’t think like me,” Johnson said. “So we need to take that into consideration.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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The Newest Disease Detection Tool for Covid and Beyond: Poop

Mon, 08/16/2021 - 5:00am

Since reopening campus at the University of California-San Diego last summer, university officials have relied on the tried-and-true public health strategies of testing and contact tracing. But they have also added a new tool to their arsenal: excrement.

That tool alerted researchers to about 85% of cases in dorms before they were diagnosed, according to a soon-to-be published study, said Rob Knight, a professor of pediatrics and computer science and engineering who helped create the campus’s wastewater testing program.

When covid is detected in sewage, students, staffers and faculty members are tested, which has allowed the school to identify and isolate infected individuals who aren’t yet showing symptoms — potentially stopping outbreaks in their tracks.

UC-San Diego’s testing program is among hundreds of efforts around California and the nation to turn waste into valuable health data. From Fresno, California, to Portland, Maine, universities, communities and businesses are monitoring human excrement for signs of covid.

Researchers have high hopes for this sludgy new data stream, which they say can alert public health officials to trends in infections and doesn’t depend on individuals getting tested. And because people excrete virus in feces before they show symptoms, it can serve as an early warning system for outbreaks.

The Centers for Disease Control and Prevention finds the practice so promising that it has created a federal database of wastewater samples, transforming raw data into valuable information for local health departments. The program is essentially creating a public health tool in real time, experts say, one that could have a range of uses beyond the current global pandemic, including tracking other infectious diseases and germs’ resistance to antibiotics.

“We think this can really provide valuable data, not just for covid, but for a lot of diseases,” said Amy Kirby, a microbiologist leading the CDC effort.

The virus that causes covid infects many types of cells in the body, including those in the respiratory tract and gut. The virus’s genetic signature, viral RNA, makes its way into feces, and typically shows up in poop days before symptoms start.

At UC-San Diego and other campuses, researchers take samples flowing from individual buildings, capturing such granular data that they can often deduce the number of infected people living or working there. But in most other settings, because of privacy concerns and resource constraints, testing is done on a much larger scale, with the goal of tracking trends over time.

Samples are drawn from wastewater, which is what comes out of our sewer pipes, or sludge, the solids that have settled out of the wastewater. They are typically extracted mechanically or by a human with a dipper on the end of a rod.

When researchers in Davis, California, saw the viral load rise in several neighborhood sewage streams in July, they sent out text message alerts and hung signs on the doors of 3,000 homes recommending that people get tested.

Before the pandemic, testing sewage to identify and ward off illness in the U.S. was largely limited to academic use. Israel used it to stave off a polio outbreak in 2013, and some communities in the U.S. were sampling sewage before the pandemic to figure out what kinds of opioids people in their communities were using, a service offered by the company Biobot.

But when covid hit the U.S. amid political chaos and a shortage of tests, local governments scrambled for any information they could get on the virus.

In rural Lake County, California, health officials had identified a handful of cases by sending nurses out to look for infected people. They were sure there were more but couldn’t get their hands on tests to prove it, so in spring 2020 they signed up for a free sewage testing program run by Biobot, which pivoted to covid testing as the pandemic took off and now is charging to test in K-12 schools, office buildings and nursing homes, in addition to local governments and universities, said Mariana Matus, CEO and co-founder of the company.

The covid virus turned up in samples at four wastewater treatment facilities in Lake County.

“It is a way to just get more information because we can’t do testing,” Gary Pace, then the county’s health officer, told KHN at the time.

As sewage sampling took off around the world, the U.S. Department of Health and Human Services began awarding grants in fall 2020 to wastewater treatment plants. Biobot won a bid to run a second round of that program, currently underway through late August, testing the sewage of up to 30% of the U.S. population.

At least 25 California wastewater treatment plants are participating in the program, and numerous others are getting money from the CDC, working with local universities or paying for their own testing. While such states as Ohio and Missouri have created public dashboards to show their data, California’s efforts remain scattershot.

The test data alone doesn’t provide much value to health officials — it needs to be translated to be useful. Scientists are still learning how to read the data, a complicated process that involves understanding the relationships between how much virus people excrete, how many people are using a wastewater system and how much rainwater is running into the system, potentially diluting the sewage, among many other factors. Since using wastewater to track diseases was not widespread before the pandemic, there’s been a steep and ongoing learning curve.

Beleaguered public health officials have struggled to incorporate the new data into their already overwhelming workloads, but the CDC hopes it can address those issues with its new national system that tracks and translates wastewater data for local governments.

Throughout 2020, Kirby, the CDC microbiologist, and engineer Mia Mattioli were a two-person wastewater team inside the agency’s larger 7,000-person covid response. During that time, academic colleagues generously shared what they knew about wastewater epidemiology, Kirby said. By September 2020, the pair had launched the National Wastewater Surveillance System, which interprets sampling data for state and local governments. Today, they lead a team of six and have a permanent place in one of the CDC’s departments.

“Every piece of this system had to be built largely from scratch,” Kirby said. “When I look at that, it really amazes me where we are now.”

In the months since the system debuted, it has been able to detect an uptick in cases anywhere from four to six days before diagnostic testing shows an increase, Kirby said.

She hopes that by the end of next year the federal monitoring program will be used to check for a range of diseases, including E. coli, salmonella, norovirus and a deadly drug-resistant fungus called Candida auris, which has become a global threat and wreaked havoc in hospitals and nursing homes.

The longer these programs are up and running, the more useful they become, said Colleen Naughton, a professor and civil engineer at the University of California-Merced who leads COVIDPoops19, which tracks wastewater monitoring efforts globally. Naughton is working with colleagues at the University of California-Davis to launch monitoring programs near where she works in the Central Valley but is finding that some smaller communities don’t have the resources to conduct testing or sufficient health personnel to analyze or use the data.

It’s in these smaller communities with limited access to testing and doctors where the practice may hold the most promise, Naughton said. Covid laid bare long-standing inequities among communities that she fears will be perpetuated by the use of this new public health tool.

Privacy concerns also need to be addressed, experts said. Wastewater data hasn’t traditionally been considered protected personal health information the way diagnostic tests are. Health officials have managed earlier concerns about wastewater tracking of illicit drug use by sampling from large enough sewage streams to offer anonymity. But testing for certain health problems requires looking at DNA. “I think that’s going to be a challenge for public communication,” Knight said, “to make sure that’s not perceived as essentially spying on every individual’s genetic secrets.”

Public health and wastewater officials said they are thrilled by the potential of this new tool and are working on ways to address privacy concerns while taking advantage of it. Greg Kester, director of renewable resource programs at the California Association of Sanitation Agencies, wrote to CDC officials in June 2020 asking for a federal surveillance network. He can hardly believe how quickly that call became a reality. And he hopes it is here to stay, both for the ongoing pandemic and for the inevitable next outbreak.

“As vaccination rates increase and we get the variants, it’s still going to be important because clinical testing is decreasing,” Kester said. “We really want to make this part of the infrastructure.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Mensaje del CEO de Pfizer al público: confíen en nosotros con el refuerzo de la vacuna contra covid

Fri, 08/13/2021 - 1:47pm

El CEO de Pfizer, Albert Bourla, confiaba en junio en la capacidad de la vacuna de su empresa para proteger contra la variante delta, altamente contagiosa, mientras se diseminaba por el mundo y llenaba de pacientes los hospitales estadounidenses.

Apenas unas semanas después, Pfizer comunicó que solicitaría autorización para una vacuna de refuerzo, después que los primeros resultados de los ensayos mostraran que una tercera dosis aumentaba potencialmente la protección. A finales de julio, Pfizer y BioNTech anunciaron que, entre cuatro y seis meses después de la segunda dosis, la eficacia de su vacuna se reducía a cerca del 84%.

Bourla se apresuró a promover una tercera dosis tras las desalentadoras noticias, diciendo que estaba “muy, muy seguro” de que un refuerzo aumentaría los niveles de inmunidad en los vacunados.

Hay un problema: Pfizer aún no ha aportado pruebas concluyentes que respalden esa confianza. La empresa carece de resultados de ensayos clínicos de última fase que confirmen que el refuerzo funcionará contra las variantes de covid, incluida delta, que actualmente representa el 93% de las nuevas infecciones en los Estados Unidos.

Pfizer anunció su ensayo global de fase 3 sobre una tercera dosis a mediados de julio. La fecha de finalización de ese ensayo es en 2022. Los resultados de la fase 3 suelen ser necesarios antes de la aprobación reglamentaria.

“Confiamos en esta vacuna y en la tercera dosis, pero hay que recordar que el estudio sobre la eficacia de la vacuna sigue en marcha, por lo que necesitamos todas las pruebas que lo respalden”, dijo, el 9 de agosto, Jerica Pitts, directora de relaciones con los medios a nivel mundial de Pfizer.

Lo que está en juego es enorme: Pfizer anunció, en julio, que espera obtener $33,500 millones en ingresos por la vacuna contra covid-19 este año.

Mientras, Pfizer comunicó recientemente que, si una tercera dosis no podía combatir la variante delta u otras, la farmacéutica está preparada para presentar una vacuna “a medida” en un plazo de 100 días.

Todo esto ha sembrado confusión sobre qué funcionará exactamente, y cuándo.

La prisa de la industria farmacéutica por recomendar refuerzos es “un poco frustrante”, señaló el doctor Paul Offit, director del Centro de Educación sobre Vacunas del Hospital Infantil de Philadelphia y asesor de los Institutos Nacionales de Salud y de la Administración de Alimentos y Medicamentos (FDA). Incluso si se comprueba que un refuerzo es seguro, el esfuerzo de Estados Unidos debería centrarse en “vacunar a quienes que no están vacunados”, puntualizó Offit.

En cualquier caso, las decisiones sobre los refuerzos no dependen de los fabricantes de vacunas, añadió.

“Las farmacéuticas no son organismos de salud pública, y no les corresponde determinar cuándo o si debe haber dosis de refuerzo”, explicó Offit. “Eso es competencia de los Centros para el Control y la Prevención de Enfermedades (CDC)”.

De hecho, los CDC y la FDA —las agencias federales que supervisan la autorización de las vacunas contra covid— comunicaron en julio que los estadounidenses totalmente vacunados no necesitan una dosis de refuerzo.

Las vacunas actualmente autorizadas —Pfizer, Moderna y Johnson & Johnson— funcionan como deberían: las tres reducen el riesgo de covid lo suficiente como para desarrollar una forma grave, hospitalizar o matar a una persona.

Si las tasas de hospitalización y muerte aumentan entre los vacunados, entonces sería el momento de hablar de refuerzos, dijo Offit, pero “no estamos ahí, todavía”.

La Casa Blanca se ha sumado a los mensajes contradictorios: la vocera Jan Psaki confirmó que Estados Unidos comprará 200 millones de dosis adicionales de la vacuna de Pfizer-BioNTech para inocular a los menores de 12 años (en el futuro) y para posibles refuerzos.

Natalie Dean, especialista en bioestadística de la Universidad de Emory en Atlanta, indicó que la confusión no es necesariamente culpa de ninguna institución, sino que “existe una auténtica incertidumbre científica sobre la eficacia de las vacunas [existentes] contra la nueva variante”.

Los científicos están reuniendo información de estudios observacionales, investigaciones de brotes y análisis de las respuestas de los anticuerpos.

Para muchos estadounidenses —especialmente para quienes hace seis meses se esforzaron por encontrar alguna dosis, contratando frenéticamente a cazadores de vacunas y viajando varias horas para recibir su primera inyección— la confusión ha desencadenado una búsqueda febril de una tercera dosis ilícita, por si fuera necesaria.

Angie Melton, de Kensington, Maryland, recibió la vacuna de Johnson & Johnson de una sola dosis, en abril. Pero desde entonces le preocupó que la contagiosa variante delta pudiera infectarla a ella y a su hijo de 10 años no vacunado. “Conseguí que me pusieran una dosis de Pfizer la semana pasada”, dijo Melton, quien también ha programado su segunda dosis.

Tras consultar a amigos y médicos y ver informes sobre las combinaciones que se hacen en Europa, Melton se inscribió en el sitio de una farmacia local y pidió una cita para vacunarse con Pfizer. También tiene programada una segunda inyección.

“Intento mantener a mi familia a salvo”, explicó Melton.

El panel asesor de los CDC tenía previsto reunirse hoy, 13 de agosto, para considerar si son necesarias dosis adicionales de vacunas para las personas inmunodeprimidas. También está en la agenda una presentación sobre los refuerzos.

Pacientes inmunodeprimidos, como Sarah Keitt, que padece esclerosis múltiple y la enfermedad de Crohn, expresaron su alivio por el hecho de que los reguladores federales consideren recomendar una tercera dosis. Keitt, una activista por los derechos de los discapacitados que vive en Connecticut contó que su neurólogo le recomendó un refuerzo incluso después de haber recibido dos dosis de Moderna. Dijo que estaba ansiosa por recibir otra dosis, pero que seguía frustrada por la falta de confianza en el grado de protección que ofrecería.

“Si alguien pudiera decirme definitivamente que hay un 95% de posibilidades de estar protegido” con un refuerzo, expresó Keitt, “me encantaría”.

A pesar de los reportes en los medios de comunicación sobre “casos de infección entre vacunados”, un reciente análisis de datos realizado por la KFF constató que las hospitalizaciones y las muertes son extremadamente raras entre las personas totalmente vacunadas, muy por debajo del 1%.

Offit habló sobre un brote reciente en Provincetown, Massachusetts, en el que sólo cuatro de las 346 personas totalmente vacunadas, e infectadas por covid, fueron hospitalizadas, dos de las cuales tenían afecciones médicas subyacentes. Y nadie murió. “Esta vacuna sigue haciendo un excelente trabajo frente a la variante delta para proteger a las personas contra la enfermedad grave y crítica”, señaló.

Sin embargo, la eficacia de la vacuna de Pfizer contra las variantes sigue siendo objeto de debate. Este mes, un nuevo estudio previo realizado por la Clínica Mayo indicó que la eficacia del producto contra la infección se redujo al 42% de enero a julio, a medida que la prevalencia de la variante delta aumentaba notablemente.

Pfizer, y su socio BioNTech, anunciaron que están desarrollando una versión actualizada de su vacuna en Alemania para atacar las características genómicas de la variante delta.

Sin embargo, la idea de que una nueva formulación pueda funcionar mejor es “hipotética en este momento”, afirmó Vaughn Cooper, profesor de microbiología y genética molecular de la Universidad de Pittsburgh.

El doctor Vincent Ajumar, hematólogo de la Clínica Mayo que estudia de cerca las respuestas inmunitarias y los niveles de anticuerpos de sus pacientes, dijo que intentar las dos estrategias, utilizar la vacuna actual y probar una nueva versión, parece razonable.

Existe la hipótesis de que, si las infecciones “en vacunados” se deben a un descenso de los niveles de anticuerpos, bastará con aumentar esos niveles, apuntó Rajkumar. Pero la hipótesis más preocupante es que la variante delta, o cualquier otra variante, podría responder de forma considerablemente diferente, y estar menos amenazada, por los anticuerpos que genera la vacuna actual.

“Así que, a menos que se refuercen [los anticuerpos] con una vacuna que sea específica para la delta, no funcionará”, dijo Rajkumar y añadió que probar ambas hipótesis es lo “correcto por cuestión de tiempo”.

Sin embargo, promover vacunas de refuerzo en poblaciones sanas es prematuro, advirtió la doctora Sadiya Khan, epidemióloga y cardióloga de la Facultad de Medicina Feinberg de la Universidad Northwestern. Esto se debe a que, incluso si los que ya están totalmente vacunados reciben una tercera dosis o refuerzo, el virus sigue circulando entre millones de personas no vacunadas.

“La abrumadora mayoría de las infecciones, hospitalizaciones y muertes se producen entre quienes no están vacunados”, aseguró Khan.

“Renunciar a la estrategia principal de vacunar a la población va a conducir a continuos repuntes”, señaló. “El daño potencial es enorme”.

El editor de KHN, Arthur Allen, colaboró con esta historia.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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‘I Don’t Want to Risk My Life for a Paycheck’: Immunosuppressed People Grapple With Returning to Work

Fri, 08/13/2021 - 1:25pm

Elizabeth Groenweghe got a kidney transplant 14 years ago. She now takes several medications to prevent her body from rejecting her transplant organ. But these medications also weaken her immune system, putting her at higher risk of becoming seriously ill if she catches covid-19.

When the pandemic began last year, Groenweghe, 29, worked from home for the first month and a half. But then in May 2020, as the chief epidemiologist for the public health department in Wyandotte County, Kansas, she returned to the office.

“Obviously, I was nervous about it because I’m so immunosuppressed,” said Groenweghe.

She felt relatively safe because her co-workers wore masks and strictly followed infection control protocols. But now that vaccinations have become widely available, her workplace has stopped requiring or enforcing mask use. There is no vaccine mandate for her office, and she knows some co-workers are unvaccinated. She feels uncomfortable working around them.

“I am debating putting a sign on my door that says ‘Please do not enter if you are unvaccinated,’ because I am really concerned about getting covid … and have even had a couple co-workers test positive recently,” said Groenweghe.

“Knowing that I don’t have any protection against covid, I’m still wearing a mask and I’m trying to avoid in-person meetings,” she added. “It has been frustrating because, at home, my bubble of protection is great; all of my family and friends are vaccinated. At work I don’t have as much control.”

While the emergence of the delta variant in the U.S. has made many companies delay the return to in-person work or mandate vaccinations, in other offices, immunosuppressed people like Groenweghe are left to cobble together their own strategies to minimize their risks. The delta variant raises the stakes for many who were already concerned about catching covid when they return. Those who have the option to keep working remotely have done so — but worry about what it means for their careers as their colleagues return to the workplace.

Research showing how well vaccines protect those with weakened immune systems is limited. In part that’s because immunosuppressed people, who make up at least 3% of the U.S. population and include people with cancer, HIV and many chronic health conditions, were not included in the original clinical trials for the three covid vaccines authorized for emergency use.

Scientists didn’t include them because they needed to conduct the clinical trials quickly and were concerned that this group’s immunosuppressive medicines and increased likelihood of developing infections in general would complicate interpreting the study results.

Research does show that those who are immunosuppressed are at higher risk of becoming severely ill from covid, passing the virus to others in their household and getting infected even if vaccinated. A recent study reported that 44% of hospitalized “breakthrough” cases in the U.S. were in immunosuppressed people.

Concerns about her elevated covid risk led Groenweghe to obtain a third dose of the Moderna vaccine on her own — and participate in a Johns Hopkins University research study that involved measuring transplant recipients’ immune response to an extra vaccine dose. Hopkins recently told her she hadn’t produced any antibodies.

But, while the third dose might not have helped Groenweghe, early research shows that a booster shot seems to strengthen the immune response for some with weakened immune systems. Israel began distributing additional doses to the immunosuppressed in July. Britain and France have said they plan to start distributing booster doses to high-risk groups in September. However, the World Health Organization recently called for a moratorium on booster shots until more vaccine could be distributed globally to countries with low vaccination rates.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said in a July Senate hearing that immunosuppressed people “may actually need a boost as part of their initial regimen in the sense of getting them up to the point where they are protected.”

And soon, third doses may indeed become part of the regimen. The Food and Drug Administration reportedly is closing in on amending the emergency use authorization requests for the Pfizer-BioNTech and Moderna vaccines to allow third doses of those shots to be given to those with weakened immune systems. The vaccine advisory committee of the Centers for Disease Control and Prevention was set to meet Friday and is expected to vote on whether to officially recommend that doctors can prescribe third doses to immunocompromised people. Still, federal officials said these third doses would be recommended only for a small number of immunocompromised people, and it’s not yet clear who will be included.

Well in advance of this green light, patients were asking their doctors about additional shots.

Andrew Clifford is one such patient. (KHN is identifying him by his first and middle names because he fears retaliation from his workplace.) Andrew, a marketing manager from Missouri, is working from home indefinitely and worries about what he might be missing. The 40-year-old has multiple sclerosis and takes immunosuppressive medication.

“The fear of missing out is a tremendous anxiety,” he said. Recently his entire team went back to the office for two weeks to meet with an outside agency. While Andrew was able to go in for two days, he could tell he had missed out on things on the days he stayed home.

“I missed out on the lunchtime convos. When I did show up in the Zoom meetings, I was playing a lot of catch-up,” he said. “I was trying to figure out who I was actually talking to and what they did.”

Some patients, such as transplant recipient Elyse Thomas, aren’t waiting for new guidance from the U.S. government. (KHN is identifying her by her middle and last names because she is worried about pushback from her employer.) Instead, Elyse, a 30-year-old social worker for a high school district in the Bay Area of California, pursued third and fourth doses of a covid vaccine on her own since her school district had staff members return in person in early August.

“Some of us transplant patients have had to take matters into our own hands,” Thomas said. “We can’t wait for the recommendation while we could be dying.”

She asked for an accommodation to continue working remotely during the 2021-22 school year, as she did the year before, but was told all employees must return. Thomas was offered the option to take medical leave without pay if she didn’t want to come into the office, but that would strain her finances. Her workplace does have a mask mandate, but she’s not sure physical distancing will be enforced and she’s even more anxious now that the delta variant is circulating.

“I don’t feel safe and I don’t understand why I have to be there in person,” Thomas said. “I don’t want to risk my transplant for a paycheck. I don’t want to risk my life for a paycheck.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Veterans Push for Medical Marijuana in Conservative South

Fri, 08/13/2021 - 5:00am

RALEIGH, N.C. — Each time Chayse Roth drives home to North Carolina, he notices the highway welcome signs that declare: “Nation’s Most Military Friendly State.”

“That’s a powerful thing to claim,” said Roth, a former Marine Corps gunnery sergeant who served multiple deployments to Iraq, Afghanistan and Pakistan.

Now he says he’s calling on the state to live up to those words. A Wilmington resident, Roth is advocating for lawmakers to pass a bill that would legalize medical marijuana and allow veterans with post-traumatic stress disorder and other debilitating conditions to use it for treatment.

“I’ve lost more men to suicide since we went to Afghanistan in ’01 than I have in combat,” said Roth, who said he doesn’t use cannabis himself but wants others to have the option. “It’s just unacceptable for these guys to go overseas and win the battle and come home and lose the battle to themselves.”

He is among several veterans brought together by a recently formed advocacy group called NC Families for Medical Cannabis. These veterans have testified before the legislature and visited lawmakers individually.

In a state that’s home to eight military bases, one of the largest veteran populations in the country and a Republican-controlled legislature that prides itself on supporting the troops, they hope their voices will act as a crucial lever to push through a bill that has faced opposition in the past.

“If we really want to be the most veteran-friendly state in the union, this is just another thing we can do to solidify that statement,” Roth said.

From California to Massachusetts, veterans have been active in the push for medical marijuana legalization for decades. But now, as the movement focuses on the remaining 14 states that have not enacted comprehensive medical marijuana programs or full marijuana legalization, their voices may have outsize influence, experts say.

Many of these remaining states are in the traditionally conservative South and dominated by Republican legislatures. “The group carrying the message here makes a huge difference,” said Julius Hobson Jr., a former lobbyist for the American Medical Association who now teaches lobbying at George Washington University. “When you’ve got veterans coming in advocating for that, and they’re considered to be a more conservative bunch of folks, that has more impact.”

Veterans also have the power of numbers in many of these states, Hobson said. “That’s what gives them clout.”

Successes are already evident. In Texas and Louisiana, veterans played a key role in the recent expansion of medical marijuana programs. In Mississippi, they supported a successful ballot initiative for medical cannabis in 2020, though the result was later overturned by the state Supreme Court. And in Alabama, the case of an out-of-state veteran arrested and jailed for possession of medical marijuana incited national outrage and calls for legalization. The state legalized medical marijuana earlier this year.

To be sure, not every veteran supports these efforts, and the developments in red states have been influenced by other factors: advocacy from cancer patients and parents whose children have epilepsy, lawmakers who see this as a states’ rights issue, a search for alternative pain relief amid the opioid epidemic and a push from industries seeking economic gains.

But the attention to the addiction and suicide epidemics among veterans, and calls to give them more treatment options, are also powerful forces.

In states like North Carolina, where statewide ballot initiatives are banned, veterans can kick-start a conversation with lawmakers who hold the power to make change, said Garrett Perdue, the son of former North Carolina Gov. Beverly Perdue and a spokesperson for NC Families for Medical Cannabis and CEO of Root Bioscience, a company that makes hemp products.

“It fits right in with the general assembly’s historical support of those communities,” Perdue said. “For [lawmakers] to hear stories of those people that are trusted to protect us and enforce the right of law” and see them as advocates for this policy “is pretty compelling.”

Gary Hess, a Marine Corps veteran from Louisiana, said he first realized the power of his platform in 2019, when he testified in front of the state legislature about seeing friends decapitated by explosions, reliving the trauma day-to-day, taking a cocktail of prescription medications that did little to help his symptoms and finally finding relief with cannabis. His story resonated with lawmakers who had served in the military themselves, Hess said.

He recalled one former colonel serving in the Louisiana House telling him: “They’re not going to say no to a veteran because of the crisis you’re all in. As someone who is put together well and can tell the story of marijuana’s efficacy, you have a powerful platform.”

Hess has since started his own nonprofit to advocate for medical marijuana legalization and has traveled to other state and national events, including hearings before the North Carolina legislature.

“Once I saw the power my story had,” he said, “the goal became: How do I expedite this process for others?”

Experts trace the push for medical marijuana legalization back to the AIDS epidemic of the 1980s and ’90s, particularly in California’s Bay Area.

As the movement tried to expand, medical marijuana activists realized other regions were not as sympathetic to the LGBTQ community, said Lee Hannah, an associate professor of political science at Wright State University who is writing a book about the rise of legal marijuana in the U.S. They had to find “more target populations that evoke sympathy, understanding and support,” Hannah said.

Over time, the medical marijuana conversation grew from providing symptom relief for patients with AIDS to include such conditions as cancer, pediatric epilepsy and PTSD, Hannah and his colleagues noted in a 2020 research paper. With each condition added, the movement gained wider appeal.

“It helped change the view of who a marijuana user is,” said Daniel Mallinson, a co-author on the 2020 paper and the upcoming book with Hannah, and an assistant professor at the Penn State-Harrisburg School of Public Affairs. “That makes it more palatable in these legislatures where it wouldn’t have been before.”

In 2009, New Mexico became the first state to make PTSD patients eligible for medical marijuana. The condition has since been included in most state medical marijuana programs.

The movement got another boost in 2016 when the American Legion, a veterans organization with 1.8 million members known for its conservative politics, urged Congress to remove marijuana from its list of prohibited drugs and allow research into its medical uses.

“I think knowing an organization like the American Legion supports it frankly gives [lawmakers] a little bit of political cover to do something that they may have all along supported but had concerns about voter reaction,” said Lawrence Montreuil, the group’s legislative director.

In Texas, when the Republican governor recently approved a law expanding the state’s limited medical marijuana program, he tweeted: “Veterans could qualify for medical marijuana under new law. I will sign it.”

It’s smart political messaging, Hannah said. Elected officials “are always looking to paint laws they support in the most positive light, and the approval rate of veterans is universally high.”

Nationally, veteran-related marijuana bills seem to be among the few cannabis-related reforms that have gained bipartisan support. Bills with Democratic and Republican co-sponsors in Congress this session deal with promoting research into medical marijuana treatment for veterans, allowing Veterans Affairs doctors to discuss cannabis with patients in states where it is legal and protecting veterans from federal penalization for using state-legalized cannabis.

Rep. Dave Joyce (R-Ohio), who has co-sponsored two bipartisan bills concerning veterans and medical marijuana this session, said the interest of veterans is “what drew me to cannabis in the first place.”

In North Carolina, veterans like Roth and Hess, along with various advocacy groups, continue to drum up support for the medical marijuana bill. They know it’s a long battle. The bill must clear several Senate committees, a full Senate vote and then repeat the process in the House. But Roth said he’s optimistic “the veteran aspect of it will be heavily considered by lawmakers.”

An early indication of that came at a Senate committee hearing earlier this summer. Standing at the podium, Roth scrolled through his phone to show lawmakers how many of his veteran contacts were now dead due to suicide. Other veterans testified about the times they had contemplated suicide and how the dozens of prescription medications they had tried before cannabis had done little to quiet those thoughts.

The hearing room was silent as each person spoke. At the end, the lawmakers stood and gave a round of applause “for those veterans who are with us today and those who are not.”

The bill later passed that committee with a nearly unanimous vote.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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How a Hospital and a School District Teamed Up to Help Kids in Emotional Crisis

Fri, 08/13/2021 - 5:00am

In 2019, the Rockville Centre school district in Long Island, New York, was shaken by a string of student deaths, including the suicides of a recent graduate and a current student.

“When you get these losses, one after the other, you almost can’t get traction on normalcy,” said Noreen Leahy, an assistant superintendent at the school district.

To Leahy, the student suicides exposed a children’s mental health crisis brewing for years. She had observed a concerning uptick in depression, anxiety and suicidal ideation among students. Her school district had a team of mental health professionals, but Leahy said they couldn’t provide the kind of long-term care many students needed.

“Remember, psychologists and social workers and counselors in school districts are there to make sure kids are learning,” said Leahy. “We’re not hospital wards. We don’t do psychotherapy. So it’s very limited what we can do for these students.”

She said she saw an urgent need to connect students to mental health care quickly and easily, and the 2019 tragedies drove her to find a way.

Her vision ultimately led to the formation of a unique partnership between several Long Island school districts and the nearby children’s hospital, Cohen Children’s Medical Center, part of the Northwell Health system. That partnership provides prompt access to mental health services for students and includes ongoing support for school staff members in addressing kids’ mental health, creating a mental health safety net for children and families in the area that didn’t exist before.

At its heart is a new behavioral health center, which the hospital opened in January 2020. Students are evaluated by the center’s child psychiatrist and mental health counselor, who start and continue treatment until a child can be connected to long-term care in the community.

The concerning rise in mental health issues noticed by the Long Island school administrators mirrors national trends. Roughly 1 in 5 U.S. children meet the criteria for a mental health disorder, and the rate of suicide attempts among teens has risen over the past decade, according to the Centers for Disease Control and Prevention.

Around the country, most kids who have mental health issues don’t get treatment. There’s a shortage of providers who work with children and it can take months to get an appointment.

“The wait times on average to see a mental health specialist on an emergency basis is somewhere between two to three months, and for regular basis is up to 12 months, which is an unacceptable wait time,” said Dr. Ujjwal Ramtekkar, a child and adolescent psychiatrist at Nationwide Children’s Hospital.

Without timely access to care, many kids end up with worsening symptoms and eventually land in a hospital emergency department, “as the fastest way to either avert [a mental health] crisis, or as the fastest way to get some kind of mental health evaluation,” Ramtekkar said.

“It sort of creates this ping-pong effect,” said Tina Smith, executive director of special education at Oceanside School District in Long Island.

It’s common to see students go to the ER only to be discharged soon after and return to school without a plan for follow-up care, she said. “And then the problems start to spiral again out of control,” Smith said, “and then they’re sent back to the hospital [ER].”

It was with these worries in mind that, after the student suicides in 2019, Leahy began raising her concerns with colleagues, school board members and other parents, including Gina-Marie Bounds, a hospital administrator at Cohen Children’s.

Bounds took the idea to the head of emergency child psychiatry and other hospital officials at Cohen’s and they got to work. Leahy spread the word to neighboring school districts, who were dealing with similar problems, and persuaded them to come on board. Several months later, the mental health center opened its doors.

This couldn’t have come at a better time, said Leahy. As many large hospitals around the country saw a surge in the number of kids in mental health crises in their emergency departments, the new behavioral health center reports the opposite trend. The number of mental health visits to the emergency room by students from these school districts declined by at least 60% in 2020 compared with the previous year.

School administrators also say the health center has played a critical role in prevention by promoting the emotional well-being of students, families and school personnel. School and health center staffers meet twice a month via Zoom to check in and brainstorm ways to address emerging health and wellness concerns of staff members and families.

Getting Kids the Right Help at the Right Time

The goal of the new health center is to provide kids with care as soon as symptoms emerge.

The center is staffed by a child psychiatrist, a mental health counselor and a medical assistant. It’s located next to a pediatrician’s office and within a few miles of the school districts it serves.

When a child first arrives, the child is evaluated to determine whether they need to be hospitalized.

“Most kids don’t need that,” said Dr. Vera Feuer, Northwell Health’s associate vice president for school-based mental health, who helped create the center and now oversees it. “Most kids need outpatient care.”

And the center starts that care right away — medication and/or therapy, depending on what each child needs — to stabilize the child and prevent worsening of symptoms, and connect them to ongoing care with a provider in the community.

In January 2021, a local resident, Tara, found herself calling the health center to make an appointment for her 17-year-old sister, who had been struggling with irregular sleep patterns and panic attacks for months.

Tara had recently become her sister’s legal guardian. KHN is not using their last names and only using the sister’s middle name — Jasmine — to protect their privacy.

Jasmine said she felt suffocated during her panic attacks.

“It felt like I was running, like my heart got really fast, and like I was being put in a little tiny box,” she said.

Jasmine and Tara met with a mental health counselor at the behavioral health center. The follow-up sessions were helpful for Jasmine, who learned about the importance of speaking with a trusted friend or adult any time she felt triggered. And the clinic helped Jasmine get connected with a nearby psychologist whom she now sees for weekly therapy sessions, Tara said.

Removing Barriers for the Most Vulnerable

The new health center provides an important safety net for kids who might otherwise fall through the cracks, like 17-year-old Alyssa Gibaldi, who was refused care by other mental health providers because of a disability.

Alyssa attends Oceanside High School and is extremely social, said her mother, Jennifer.

“She’s like the mayor of the school; everybody knows her,” Jennifer said.

Alyssa has Down syndrome and the pandemic upped her anxiety. Last fall, she became catatonic and went into what Jennifer describes as a “zombie-like state.”

“She couldn’t talk. She couldn’t move. She couldn’t speak. She couldn’t feed herself,” Jennifer said.

On several occasions, Jennifer called 911. Alyssa was transported in an ambulance to the ER and hospitalized. After her neurologists ruled out seizures and other conditions, they suggested Alyssa see a psychiatrist.

But Jennifer said Alyssa was turned down repeatedly by providers saying they didn’t take her insurance or that they didn’t work with kids with disabilities.

That’s when Jennifer reached out to the school nurse, who referred the family to the new behavioral health center. The center’s child psychiatrist, Dr. Zoya Popivker, reviewed Alyssa’s medical records and prescribed medications for depression and anxiety.

Jennifer said they got the meds on a Saturday morning, “and by Saturday night, she was out of the catatonic state. Ever since then, she’s been coming back to us, like her personality came back.”

Alyssa continued to go to the behavioral health center for several months, until they were able to transition to a psychiatrist who works with kids with disabilities.

The Case for School-Hospital Partnerships

It makes sense for children’s hospitals to partner with schools because that’s where kids spend most of their day, said Ramtekkar, the psychiatrist at Nationwide Children’s Hospital.

School staffers often know their students well and can spot early signs. It’s why schools in many parts of the country have been working to forge partnerships with nearby mental health care providers.

But such partnerships still depend on mental health care resources in the communities they serve. A 2019 study found 70% of counties didn’t have a single practicing child psychiatrist.

Leahy, the assistant superintendent at Rockville Centre in Long Island, said sharing a behavioral health center across multiple school districts leads both to better collaboration and cost savings. The price her district pays for the services is less than the cost of one full-time staff member, and the state chips in to cover part of that.

Cohen Children’s will add a new behavioral health center this summer, expanding to 14 school districts. At that point, about 60,000 students in Long Island will have access to immediate mental health support should they need it.

This story is part of a reporting partnership that includes NPR, Illinois Public Media and KHN. Nationwide Children’s Hospital, mentioned in this story, is a financial supporter of NPR.

If you or someone you know may be considering suicide, contact the National Suicide Prevention Lifeline at 1-800-273-8255 (en español: 1-888-628-9454; deaf and hard of hearing: dial 711, then 1-800-273-8255) or the Crisis Text Line by texting HOME to 741741.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Pfizer CEO to Public: Just Trust Us on the Covid Booster

Fri, 08/13/2021 - 5:00am

Pfizer CEO Albert Bourla was confident in June about the ability of his company’s vaccine to protect against the highly contagious delta variant, as it marched across the globe and filled U.S. hospitals with patients.

“I feel quite comfortable that we cover it,” Bourla said.

Just weeks later, Pfizer said it would seek authorization for a booster shot, after early trial results showed a third dose potentially increased protection. At the end of July, Pfizer and BioNTech announced findings that four to six months after a second dose, their vaccine’s efficacy dropped to about 84%.

Bourla was quick to promote a third dose after the discouraging news, saying he was “very, very confident” that a booster would increase immunity levels in the vaccinated.

There’s one hitch: Pfizer has not yet delivered conclusive proof to back up that confidence. The company lacks late-stage clinical trial results to confirm a booster will work against covid variants including delta, which now accounts for 93% of new infections across the U.S.

Pfizer announced its global phase 3 trial on a third dose in mid-July. That trial’s completion date is in 2022. Phase 3 results generally are required before regulatory approval.

“We are confident in this vaccine and the third dose, but you have to remember the vaccine efficacy study is still going on, so we need all the evidence to back up that,” Jerica Pitts, Pfizer’s director of global media relations, said Monday. The financial stakes are enormous: Pfizer announced in July that it expects $33.5 billion in covid-19 vaccine revenue this year.

Meanwhile, Pfizer recently said that if a third dose couldn’t combat the delta or other variants, the drugmaker is poised to come up with a “tailor-made” vaccine within 100 days.

All of this has sown a sense of confusion about what exactly will work, and when. The pharmaceutical industry’s rush to recommend boosters for the public is “a little frustrating,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and an adviser to the National Institutes of Health and Food and Drug Administration. Even if a booster is found to be safe, he said, the U.S. effort should focus on “vaccinating people who are unvaccinated.”

In any case, decisions about boosters do not rest with vaccine makers, he said.

“Pharmaceutical companies aren’t public health agencies, it’s really not theirs to determine when or whether there should be booster dosing,” Offit said. “That is the purview of the CDC.”

Indeed, the Centers for Disease Control and Prevention and the FDA ― the federal agencies overseeing the authorization of covid vaccines ― said in July that fully vaccinated Americans do not need a booster shot. Currently authorized vaccines ― from Pfizer, Moderna and Johnson & Johnson ― are working as they should: All three lower the risk of covid severe enough to hospitalize or kill a person.

If hospitalization and death rates increase among the vaccinated, then it would be time to talk about boosters, Offit said, but “we’re not there, yet.”

The White House has added to the mixed messaging: Spokesperson Jen Psaki confirmed that the U.S. will buy an additional 200 million doses of the Pfizer-BioNTech vaccine for inoculating children under 12 and for possible boosters.

Natalie Dean, a biostatistician at Emory University in Atlanta, said the confusion is not necessarily the fault of any one institution but rather “there is genuine scientific uncertainty about how well [existing] vaccines work against the new variant.”

Scientists are piecing together information from observational studies, outbreak investigations and analyses of antibody responses.

For many Americans ― especially those who struggled six months ago to find any dose, frantically hiring vaccine hunters and driving hours-long distances for their first jab ― the confusion has set off a feverish search for an illicit third dose just in case it’s necessary.

“I snuck in a dose of Pfizer last week,” Angie Melton, a 50-year-old mother of four, shared on Facebook. Melton received the one-dose Johnson & Johnson shot at a mass vaccination site in April and feared the highly contagious delta variant could infect her and, then, her unvaccinated 10-year-old son, who has asthma.

After consulting friends and doctors and seeing reports about mix-and-match approaches in Europe, Melton signed onto a local pharmacy site and made an appointment to get a Pfizer shot. She’s scheduled for a second shot as well.

“I’m trying to keep my family safe,” Melton said.

The CDC advisory panel was set to meet Friday to consider updates on whether additional vaccine doses are necessary for immunocompromised people. A presentation about boosters is also on the agenda.

Immunocompromised patients like Sarah Keitt, who has multiple sclerosis and Crohn’s disease, expressed relief that federal regulators planned to recommend a third dose. Keitt, a disability rights activist who lives in Connecticut, said her neurologist told her to get a booster even after she had received two doses of Moderna. On Thursday, she said she was eager to get another dose but still frustrated about a lack of confidence in how much protection it would offer.

“If someone could definitely say there is a 95% chance you are protected” by a booster, Keitt said, “I would love it.”

Despite widespread media reports of “breakthrough cases,” a recent data analysis by KFF found that hospitalizations and deaths are extremely rare among the fully vaccinated ― well below 1%.

Offit points to a recent outbreak in Provincetown, Massachusetts, in which only four of the 346 fully vaccinated people infected with covid were hospitalized, two of whom had underlying medical conditions. And no one died. “This vaccine still does an excellent job in the face of the delta variant at protecting people against severe, critical disease,” he said.

Yet the effectiveness of the Pfizer vaccine against variants is still under debate. This month a new preprint study by the Mayo Clinic found that the product’s effectiveness against infection dropped to 42% from January to July ― as the delta variant’s prevalence markedly increased.

Pfizer and partner BioNTech announced they are developing an updated version of their vaccine in Germany to target the genomic features of the delta variant.

However, the idea that a new formulation could work better is “mostly hypothetical at this point,” said Vaughn Cooper, a professor of microbiology and molecular genetics at the University of Pittsburgh.

Dr. Vincent Rajkumar, a hematologist at the Mayo Clinic who closely studies his patients’ immune responses and antibody levels, said trying both strategies of using the current vaccine and testing a new version sounds reasonable.

There is one hypothesis that if “breakthrough” infections are due to a drop in antibody levels, boosting those levels will be enough, Rajkumar said. But the more worrisome hypothesis is that the delta variant, or any other variant, might respond considerably differently ― and be less threatened ― by the antibodies the current vaccine generates.

“So unless you boost [antibodies] with a vaccine that is specific to delta, it won’t work,” Rajkumar said. Rajkumar said testing both hypotheses is the “right thing to do in the interest of time.”

At the same time, though, the push for giving booster shots to healthy populations is premature, said Dr. Sadiya Khan, an epidemiologist and cardiologist at Northwestern University Feinberg School of Medicine. That’s because even if those already fully vaccinated do get a third dose or booster, the virus is still circulating among millions of unvaccinated people.

“The overwhelming majority of infections and hospitalizations and deaths are occurring among those who are unvaccinated,” Khan said.

“Giving up on that greater strategy of vaccinating the population is going to lead to continued surges,” she said. “The potential for harm is quite large.”

KHN editor Arthur Allen contributed to this report.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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KHN’s ‘What the Health?’: The Senate Acts

Thu, 08/12/2021 - 2:00pm

Can’t see the audio player? Click here to listen on SoundCloud. You can also listen on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts.

The Senate has set the stage for a busy fall that will include debate on a broad array of health issues, such as prescription drug prices, Medicare expansion and further expansion of the Affordable Care Act. Before leaving for a delayed August break, the chamber passed a bipartisan infrastructure bill and budget resolution with an outline of a $3.5 trillion measure to be crafted when lawmakers return. Whether any of those health issues can make it across the legislative finish line remains to be seen, and the path to success is a narrow one.

Meanwhile, covid’s delta variant is spreading rapidly around the U.S., particularly in states with large swaths of unvaccinated people. And the spike is happening just as schools around the country are opening, with children under 12 still unvaccinated.

This week’s panelists are Julie Rovner of KHN, Joanne Kenen of Politico, Mary Ellen McIntire of CQ Roll Call and Yasmeen Abutaleb of The Washington Post.

Among the takeaways from this week’s episode:

  • One funding mechanism senators used to pay for the bipartisan infrastructure bill was a temporary rollback of a Trump administration rule on prescription drug pricing designed to take money from the drug industry middlemen who broker prices for insurers and give consumers a discount. The rule has not yet been implemented, but federal auditors determined it would drive up insurance premiums and cost the government money. So, by rolling the rule back, senators say they are saving the government billions of dollars that they would now spend on bridges, mass transit and other projects.
  • After the Senate passed its infrastructure bill this week, it moved immediately to pass a budget resolution that could give Democrats just about everything on their social agenda wish list, including an expansion of Medicare benefits, a lower eligibility age for Medicare, extension of the tax credits that fund premium subsidies for plans purchased on the Affordable Care Act’s marketplaces, an expansion of home health care, lower drug prices and coverage for low-income people who live in states that did not expand Medicaid to adults. But wishing and receiving are very different things, and most observers think many of these items will not make it into the final spending bills.
  • The Senate’s budget resolution calls for those spending bills to be written and voted on by committees by Sept. 15. That seems highly unlikely.
  • President Joe Biden on Thursday reiterated his concerns about the high cost of prescription drugs. That is a potent political issue: Drug expenses generate a lot of consumer concerns, yet efforts to lower prices have run into trouble before on Capitol Hill because of drugmakers’ influence. Despite Biden’s speech, the White House has not shown any indication it is willing to expend serious political capital in trying to get a Medicare drug-pricing proposal through Congress.
  • Concerns about the effects of the delta variant on children has the potential to shake up current politics. Southern governors, especially Republican Govs. Ron DeSantis of Florida and Greg Abbott of Texas, have vowed to oppose any mandates on masks or covid vaccines. But some school districts in their states are defying the governors, saying they need masks to help keep kids — many of whom can’t be vaccinated because of their age — safe. The issue will likely play out in the courts.
  • While big-name employers are delaying the date for workers to return to the office, schools appear set to resume classes on time. Parents, doctors and educators have said that children need to be back in school and that last year’s widespread lockdowns were harmful, but the delta variant is causing concerns. It appears to be a bigger threat to students than last year’s version of the covid virus.
  • Vaccine mandates are still a hot topic, too. A Florida court said this week that DeSantis could not stop a cruise line from requiring that passengers be vaccinated. More employers are also requiring workers to get a shot before coming back to work. And as places like restaurants, theaters and gyms set vaccine requirements, people who have been reluctant to be inoculated might feel pressured to get a shot.

Plus, for extra credit, the panelists recommend their favorite health policy stories of the week they think you should read, too:

Julie Rovner: The Washington Post’s “Covid Killed Her Husband. Now It’s Taking the Only Home Her Kids Have Ever Known,” by William Wan

Joanne Kenen: Stat’s “A Snort or a Jab? Scientists Debate Potential Benefits of Intranasal Covid-19 Vaccines,” by Helen Branswell

Mary Ellen McIntire: Journal of the American Medical Association’s “Gun Violence Researchers Are Making Up for 20 Years of Lost Time,” by Alicia Ault

Yasmeen Abutaleb: The Atlantic’s “The Vaccine Cards Are the Wrong Size,” by Amanda Mull

To hear all our podcasts, click here.

And subscribe to KHN’s What the Health? on Spotify, Apple Podcasts, Stitcher, Pocket Casts or wherever you listen to podcasts.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Más embarazadas con covid en cuidados intensivos, expertos enfatizan que deben vacunarse

Thu, 08/12/2021 - 11:43am

Los Centros para el Control y Prevención de Enfermedades (CDC) están duplicando su recomendación de que las mujeres embarazadas reciban la vacuna contra covid-19, a la luz de nuevos datos que subrayan su seguridad y eficacia durante el embarazo.

Esta recomendación llega en un momento en que los médicos de todo el país informan de un aumento en el número de embarazadas no vacunadas que deben ser hospitalizadas con casos graves de covid.

La baja tasa de vacunación en este grupo es sorprendente, señalan médicos. Al 31 de julio, solo el 23% de las embarazadas habían recibido al menos una dosis de la vacuna contra el coronavirus, según estadísticas de los CDC.

“Los CDC recomiendan que las personas embarazadas se vacunen contra covid-19, basándose en nueva evidencia sobre la seguridad y efectividad de las vacunas”, dijo la agencia en una guía actualizada que se suma a la recomendación urgente de las principales sociedades médicas.

“La vacuna contra covid-19 se recomienda para todas las personas mayores de 12 años, incluidas las embarazadas, las que intentan estarlo o las que están amamantando”, indica la guía.

Según la agencia, las preocupaciones entre algunas personas de que las vacunas de ARN mensajero podrían aumentar el riesgo de aborto espontáneo cuando se administran al principio del embarazo no se confirman con los datos de las investigaciones.

Los oficiales de salud dijeron que las tasas de aborto espontáneo después de vacunarse eran similares a la tasa esperada de aborto espontáneo en cualquier grupo de personas embarazadas. Recibir una vacuna contra covid también es seguro más adelante en el embarazo y durante la lactancia, enfatiza el nuevo análisis de la agencia.

La doctora Alison Cahill, especialista en medicina materno-fetal y profesora de la Escuela de Medicina Dell de la Universidad de Texas-Austin, dijo que ha estado promoviendo la vacunación a todo el que quiera escuchar. Trabaja principalmente con personas embarazadas que están enfermas de covid y ve el daño que puede causar el coronavirus.

Cahill recordó haber tratado a una mujer no vacunada que llegó al hospital con dificultad para respirar. Contó que, en 24 horas, el cuadro empeoró mucho y la mujer necesitó una enorme cantidad de oxígeno para mantenerse con vida.

“Estaba en su segundo trimestre. Si hubiera tenido que dar a luz, habría tenido un bebé extremadamente prematuro con un alto riesgo de tener una discapacidad de por vida o incluso la muerte”, dijo Cahill.

Dijo que a los dos días de haber sido internada, la mujer ya no podía respirar por sí misma. La intubaron y luego le pusieron un ventilador.

Finalmente, la mujer necesitó ECMO, oxigenación por membrana extracorpórea, una máquina que “saltea” los pulmones oxigenando directamente la sangre. Cahill dijo que estuvo en ECMO, un proceso que a menudo es un puente hacia un trasplante de corazón o pulmón para personas en estado crítico, durante varias semanas.

“Eventualmente pudo salir adelante”, dijo Cahill. “Milagrosamente no requirió un parto prematuro. Permaneció embarazada y después de dos meses y medio en el hospital pudo irse a casa”.

El bebé nació sano, pero la mujer puede enfrentar toda una vida de discapacidades a causa de covid. Cahill dijo que todo podría haberse evitado si se hubiera vacunado.

“Creo que es una oportunidad increíble que tenemos en los Estados Unidos, y todos deberían aprovechar esta tremenda vacuna para evitar que sucedan ese tipo de cosas”, dijo. “Es realmente trágico”.

Estos casos son la razón por la que el Colegio Americano de Obstetras y Ginecólogos (ACOG), y la Sociedad de Medicina Materno-Fetal, las dos organizaciones líderes que representan a médicos y científicos que se especializan en atención obstétrica, recomendaron el 30 de julio que todas las embarazadas reciban la vacuna contra covid.

“Es una ‘tormenta perfecta’”, dijo el doctor Mark Turrentine, profesor de obstetricia en Baylor College of Medicine, quien también es copresidente de un grupo de trabajo sobre covid para ACOG. “Tenemos una variante altamente infecciosa del virus que causa covid-19 en un grupo en el que la mayoría no está inmunizada. Así que sí, estamos viendo mucha gente enferma”.

“ACOG anima a sus miembros a recomendar enfáticamente la vacunación a sus pacientes“, dijo el doctor J. Martin Tucker, presidente de ACOG, en una declaración escrita. “Esto significa enfatizar la seguridad conocida de las vacunas y el mayor riesgo de complicaciones graves asociadas con la infección por covid-19, incluida la muerte, durante el embarazo”.

Vacunar a las embarazadas se ha vuelto especialmente urgente en estados como Texas, donde la variante delta altamente contagiosa representa actualmente más del 75% de los casos nuevos. El porcentaje de personas en Texas que están completamente vacunadas es del 44,6%, en comparación con el 50,3% de toda la población del país.

A medida que aumentan las tasas de infección en el estado, la doctora Jessica Ehrig, jefa de obstetricia del Centro Médico Baylor Scott & White en Temple, Texas, dijo que ha visto un aumento significativo en la cantidad de embarazadas hospitalizadas e intubadas; con algunas muertes. Y esos casos graves de covid también son peligrosos para el feto, remarcó.

“Las complicaciones incluyen el parto prematuro y un mayor riesgo de preeclampsia para estas mamás, lo que también puede requerir un parto prematuro”, dijo Ehrig recientemente en una conferencia de prensa en Austin sobre el tema. “Y, desafortunadamente, también aumenta el riesgo de muerte fetal”.

Es una situación especialmente peligrosa cuando una mujer embarazada tiene un caso sintomático de covid, anotó Turrentine.

“Hay un aumento de tres veces en la admisión a la unidad de cuidados intensivos”, dijo, “un aumento de dos veces y medio en el riesgo de recibir ventilación mecánica o soporte de bypass, e incluso hay un aumento en el riesgo de muerte”.

Los profesionales médicos y los científicos no saben exactamente por qué las embarazadas corren un riesgo tan alto cuando se infectan con el virus, pero les preocupa que esta población sea especialmente vulnerable porque muchas de ellas siguen sin vacunarse.

Los CDC han recomendado las vacunas para las embarazadas como la mejor manera de protegerlas a ellas y a sus bebés del coronavirus, desde abril. Aunque las embarazadas no fueron parte de los ensayos clínicos iniciales de las tres vacunas contra covid autorizadas para uso de emergencia en los Estados Unidos, los datos recopilados desde entonces han demostrado que son seguras y efectivas para este grupo.

Turrentine dijo que es importante enfatizar que los beneficios de vacunarse superan con creces cualquier tipo de riesgo. Especialmente para una mujer embarazada, dijo, los costos de no vacunarse son demasiado altos.

“He visto a algunas mujeres embarazadas muy enfermas. He visto a algunas morir”, dijo. “Y, ya sabes, entras en este negocio como obstetra-ginecólogo porque las pacientes son jóvenes y están sanas. Y la mayoría de las veces tienes excelentes resultados. Este es un virus muy malo”.

Esta historia es de una asociación de informes entre KUT, NPR y KHN.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Apple Aims to Push More Patient Data to Doctors. But Who Can Gauge Its Impact on Health?

Thu, 08/12/2021 - 5:00am

Soon, Apple announced recently, it will enable doctors to monitor health data from their patients’ phones and watches between visits, part of the push into health care that Tim Cook, Apple’s CEO, has declared will constitute the company’s greatest contribution to mankind.

Since 2014, health systems around the country have partnered with Apple to tap into the mountains of data the company’s devices generate from patients. But most are still experimenting with these tools. While some doctors appreciate seeing records of home-monitored blood pressure, exercise and the like between visits, for others the data is more of a burden than an asset.

Over 100 types of data are available in Apple’s health app through iPhone, Apple Watch and third-party apps. In June, Apple said patients whose doctors work with one of the six electronic medical record companies participating in the new feature will be able to send them tracked data like heart rate, sleep hours, exercise minutes, steps, falls or menstrual cycle history.

Some see great promise in building “pipes” between a patient’s phone and the health records viewed by their clinicians. Apple is “democratizing the flow of health data” between doctors and patients, said Anil Sethi, a former Apple health director and current CEO of Ciitizen, a startup that manages health data for cancer patients.

But Apple’s announcement was shrouded in ambiguity and short on particulars. The company would not provide a complete list of the data patients can share with doctors and declined to comment for this article. Previous Apple moves to get more data into the hands of doctors have been announced with great fanfare, but questions remain as to how many health care providers are using the data and to what effect, and whether success stories are the norm or outliers. To date, rigorous studies showing clear health benefits from monitoring these types of data remain limited.

Although Apple has built pipes enabling patients to share growing amounts of data with medical professionals, it’s unclear how much data flows through them.

In 2014, Apple released HealthKit, a tool enabling health systems to pull in patients’ health data, with their permission, from their iPhones. At the time, then-Mayo Clinic CEO John Noseworthy said this would “revolutionize how the health industry interacts with people.” But a Mayo spokesperson told KHN the system’s use of HealthKit is now limited.

Cedars-Sinai Medical Center said in 2015 that, through HealthKit, more than 87,000 patients had been able to share their data, an arrangement Cook touted on a quarterly earnings call. A Cedars-Sinai spokesperson declined to comment on what became of this project.

Even Apple’s attempts to use its own employees’ app data to improve their medical care have yet to pan out. The Wall Street Journal reported that an Apple initiative testing a new primary care service for doctors to monitor Apple employees’ health through their devices had stalled. The company said many of the story’s assertions were inaccurate.

There have been a few reports of success. Ochsner Health in Louisiana reported that patients in a hypertension management program that provided health coaching while monitoring blood pressure data from mobile phones were more likely than a control group to get their blood pressure under control, follow their medication regimen and feel satisfied with their care. The health system now also has remote monitoring programs for diabetes, chronic obstructive pulmonary disease and expectant mothers, an Ochsner spokesperson said.

And Epic, the nation’s largest health records company, said that over 100 of its large health system clients are using Apple HealthKit to capture data from home monitoring devices like blood pressure cuffs.

But patient-generated data has not been widely adopted in health care, said Dr. Benjamin Rosner, an associate professor of medicine at the University of California-San Francisco. He and others point out major hurdles.

One, Rosner said, is that evidence is mixed that monitoring such data improves health.

Another is that doctors generally aren’t reimbursed by health insurers for reviewing data that patients collect at home.

“In America, we generally pay doctors and health systems to see patients in front of them and do things to them when they show up,” said Matthew Holt, a health technology startup adviser.

In instances in which doctors can be reimbursed for remotely monitoring patients, like those with certain chronic conditions, the payment is usually low, Rosner said.

And many doctors already feel inundated with patient health information and electronic health record tasks.

“Primary care doctors are overwhelmed by their inboxes,” said Dr. Rebekah Gardner, an associate professor of medicine at Brown University. “Before people start buying Apple Watches and sending all their sleep hours, let’s show that this improves health.”

She said she wants to see more rigorous, independently funded studies showing that monitoring data from wearable devices makes people healthier or improves their care.

Liability concerns weigh on some doctors’ minds. Dr. Oguchi Nkwocha, a community health center physician-executive in Salinas, California, worries he could be held liable if he missed something in “a diary of data,” but said he might be more open to data that was analyzed and presented with predictive insights.

Apple isn’t the only tech company that has struggled to make health app data-sharing mainstream. Both Google and Microsoft enabled patients to share their data in their personal health record products over a decade ago but shut down these businesses because of limited user adoption, Holt noted.

Optimists believe that, eventually, research will show that more forms of data monitoring lead to better health and that technology could help make the data more digestible for doctors. Then, Apple might succeed in making its apps part of medicine — assuming the payment system changes in a way that gives providers more incentives to identify problems early and intervene before people get critically ill, Holt said.

“This is exciting for the future of chronic care management,” Dr. David Cho, a UCLA Health cardiologist, said of the new feature. With data at his fingertips on risk factors like exercise, diet and blood pressure, he believes he could help his patients manage chronic conditions more easily. That data, combined with virtual visits, could mean fewer office visits.

Apple’s announcement that it can integrate patient-generated data into the electronic medical record could be critical for doctors who want to see their patients’ self-collected information but don’t have time to hunt for it, said Dr. Seth Berkowitz, who leads a remote monitoring app pilot program at Beth Israel Deaconess Medical Center in Boston.

Some patients welcome a feature that would make it easy to share data with their doctors. Jen Horonjeff, a New York City-based autoimmune disorder patient and health care startup CEO, recently discovered by using an Apple Watch tracker that her heart rate, which doctors had described as irregular, registered as normal.

“I would absolutely send this to my physicians,” Horonjeff said, noting that her data would give doctors an accurate baseline of her heart rate if she were hospitalized.

But Gary Wolf of Berkeley, California, co-founder of the Quantified Self, a movement of people who track their health and other personal data, said that finding a doctor trained to make decisions with “fine-resolution data” is impossible.

Without more evidence that getting health app data to doctors is clinically beneficial, it will be hard to assess whether Apple is succeeding, said Neil Sehgal, assistant professor of health policy at the University of Maryland.

“Right now, we don’t know if there are consequences if you don’t put your Apple Watch data into your electronic medical record,” he said.

If evidence ultimately shows a benefit to sharing this information with doctors, he said, “that benefit will be concentrated among people who can buy the $1,000 phone and $400 watch.”

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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