Journalists Stay on Top of Rocky Vaccine Rollout

California Healthline senior correspondent Anna Maria Barry-Jester discussed California’s rocky covid-19 vaccine rollout with KALW’s “Your Call” on Wednesday.

• Click here to hear Barry-Jester on KALW

KHN data reporter Hannah Recht discussed covid vaccination gaps by race with Newsy’s “Morning Rush” on Thursday.

• Click here to watch a clip on Recht on Newsy
• Read “Black Americans Are Getting Vaccinated at Lower Rates Than White Americans” by Recht and KHN Midwest correspondent Lauren Weber

California Healthline reporter and producer Heidi de Marco spoke with Radio Bilingüe’s “Linea Abierta” about vaccine hesitancy among farmworkers on Monday.

• Click here to hear de Marco on Radio Bilingüe

KHN chief Washington correspondent Julie Rovner discussed President Joe Biden’s covid-19 strategy with BBC’s “World Business Report” on Jan. 21 and WAMU’s “1A” on Jan. 22.

• Click here to hear Rovner on BBC
• Click here to hear Rovner on WAMU
• Read Rovner’s “Biden Takes the Reins, Calls for a United Front Against Covid and Other Threats“

KHN freelance reporter Melissa Bailey discussed death certificates and covid with WITF’s “Smart Talk” on Wednesday and with Newsy’s “Morning Rush” on Tuesday.

• Click here to hear Bailey on WITF
• Click here to watch a clip of Bailey on Newsy
• Read “When Covid Deaths Aren’t Counted, Families Pay the Price” by Bailey and Eli Cahan

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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If This Self-Sufficient Hospital Cannot Stand Alone, Can Any Public Hospital Survive?

In America’s health care system, dominated by hospital chain leviathans, New Hanover Regional Medical Center in Wilmington, North Carolina, is an anomaly. It is a publicly owned hospital that boasts good care at lower prices than most and still flourishes financially.

Nonetheless, New Hanover County is selling the hospital to one of the state’s biggest health care systems. The sale has stoked concerns locally that the change in ownership will raise fees, which would not only leave patients with bigger bills but also eventually filter down into higher health insurance premiums for Wilmington workers.

Hospital consolidation has been a consistent trend unabated by recessions, bountiful times or even a pandemic. The New Hanover sale, which requires only the approval of the state attorney general for completion, prompts the question: If Wilmington’s self-sufficient medical center cannot stand alone, can any public hospital avoid being subsumed into the large systems that economists say are helping propel the cost of American health care ever upward?

“We project the prices will go up, they’ll probably lay off employees after a couple of years, and the hospital will decline in terms of its quality,” said Dale Smith, a retired Wilmington businessman who opposed the sale. Applying his professional experience buying chemical companies to the hospital industry, Smith said: “A very large percentage of mergers and acquisitions, like 90%, never succeed in fulfilling their initial goals.”

The public hospital — those owned by counties, cities or other local government entities — is an increasingly endangered species, numbering 965 out of 5,198, according to the American Hospital Association. While the total number of hospitals in the nation dropped by 4% between 2008 and 2018, the number of state or local hospitals decreased by 14%.

Many have been absorbed by large systems. Over the previous 14 years, the percentage of markets where one health care system treats more than half the cases grew from 47% to 57%. In 2017, nine out of 10 hospital markets met the federal definition for being highly concentrated.

While the industry says larger systems allow hospitals to run more efficiently, numerous studies have found that charges to insurers and patients are higher from hospitals with more market power. One study calculated the premium to be 7% to 9%; another study found 12%.

“There is a growing consensus that hospital mergers do lead to higher prices,” said Christopher Whaley, a policy researcher at the Rand Corp., a research organization.

Novant and backers of the sale disagree that prices will increase more than they would have otherwise. “We looked into the future and we felt we needed more resources,” said Spence Broadhurst, who was the co-chair of the committee the county created to evaluate the medical center’s future. “We were pretty convinced that the risk of doing nothing was significant.”

While the coronavirus inflicted serious financial damage on many hospitals by forcing them to postpone elective surgeries and improve infection control, the outbreak has not stymied mergers and acquisitions. In the third quarter of 2020, Kaufman Hall, a Chicago firm that advises companies on such deals, identified four substantial health care transactions, tying the highest number the firm has seen in a single quarter.

“In 2021 and beyond, even more activity in M&A is expected,” said Anu Singh, a managing director at Kaufman Hall.

Consolidation has been marching rigorously through North Carolina. Seventy-four percent of North Carolina general hospitals belong to systems, more than any other state except Hawaii, Maine and Rhode Island, according to a KHN analysis of 2018 data from the federal Agency for Healthcare Research and Quality. Since then, in the western part of the state, the investor-owned chain HCA purchased the nonprofit Mission Hospital in Asheville; in the middle, Greensboro-based Cone Health merged with Sentara Healthcare into a 17-hospital system; and on the coast, Novant Health is buying New Hanover.

Both the Mission and New Hanover sales provoked substantial community blowback. New Hanover opened its doors in 1967, in the midst of the civil rights movement, as Wilmington’s first integrated hospital. It grew to become the nation’s third-largest county-owned hospital, serving seven counties in southeastern North Carolina.

But unlike many public hospitals, the medical center makes money: $110 million in the fiscal year ending in September 2019, which translated to an enviable 10% surplus. It is the largest county-owned system that does not require taxpayer subsidies.

Despite its market leverage as the only general hospital in Wilmington, New Hanover charged private insurers less than did the 24 other North Carolina hospitals for which Whaley and his Rand colleagues could assess inpatient and outpatient prices from 2016 through 2018. New Hanover’s prices were 13% lower than UNC Health’s, 15% lower than Novant Health’s and 32% lower than Atrium Health’s, according to the Rand data.

New Hanover has also demonstrated its ability to provide care to Medicare beneficiaries thriftily without sacrificing quality: In the first six months of 2019, its accountable care organization, or ACO, earned a $3 million bonus from Medicare for saving more money than the government expected, according to federal data. Novant’s ACO did not reduce costs enough to earn a bonus.

“This is not your typical county hospital. This is a fairly high-functioning hospital with high-quality care and reasonable prices,” said Barak Richman, a professor of business administration at Duke Law School.

But leaders in New Hanover County and the medical center announced in 2019 they were exploring either selling the hospital or joining a larger health care system. They said they feared the hospital needed more capital and help to keep up with the surging population growth in the region and medical advances, including costly technologies.

The county’s request for proposals drew many suitors, including Novant and Atrium, which had been battling for dominance throughout North Carolina’s regional health care markets. Novant’s winning bid, which the county accepted last October, will pay the county $1.5 billion. The county will use most of the money to fund a new nonprofit endowment to bolster community health but will keep $350 million. Novant pledged to invest an additional $3.1 billion to build and upgrade medical facilities and equipment in the region, and it said it would create a branch of the University of North Carolina School of Medicine at New Hanover.

“We knew we wanted more,” said John Gizdic, president and CEO of New Hanover. “We wanted to do more; we wanted to be more.”

Along with the hospital, the sale includes other medical facilities the county owns under the medical center’s umbrella: smaller hospitals for children, rehabilitation and mental health on the medical center’s campus; a nearby orthopedic hospital, a physicians’ group and outpatient centers; and its contract to manage Pender Memorial Hospital, owned by an adjacent county.

Carl Armato, Novant’s president and chief executive, noted in an interview that Novant already owns the nearby Brunswick Medical Center, which refers some patients to New Hanover and, he said, provides affordable health care. “The two organizations have a unique cultural alignment,” he said.

Even some opponents of the deal acknowledged that New Hanover was not guaranteed to remain financially strong. “Owning and running a hospital has got some serious wind in its face,” said Bertram Williams III, an investment adviser whose father was a surgeon who helped found New Hanover. “There’s a lot of things coming down the pike making it more and more complicated to manage a hospital and keep it above water.”

Williams said he expected Novant would need to recoup the money it is spending on the deal. “That money’s got to be repaid,” he said. “It’s going to come from local payers. We know it’s going to be higher costs, there’s no question about that. Might there be higher costs anyway? Probably.”

The sale of the medical center removes the direct leverage local consumers had in influencing the hospitals’ prices. Novant agreed to create a local hospital board, with a majority of members living in the service areas, but the board’s role will not extend to setting prices.

“Novant Health, what they’re proposing to do sounds just too good to be true,” said Howard Loving, a retired naval officer who questioned the sale. “To my mind, the first thing that’s going to unravel is there’s two years with the doctors who are there now, [and then] Novant will have the ability to decide who gets to stay and who gets to go.”

State Treasurer Dale Folwell said he expects that, as part of Novant, New Hanover will press for higher rates from the health care fund that covers state employees and teachers, which Folwell’s office oversees. “I’m their largest customer,” he said. “I know we should expect quality to go down, access to go down, prices to go up. And when that happens, public service workers get hit the worst.”

Novant disputed that its takeover would lead to higher costs. “Novant Health has a track record of lowering the cost of care to patients compared to other healthcare systems in North Carolina,” the organization said in a statement. Novant also noted that more low-income people will qualify for free or lower-cost care under Novant’s charity care rules than under New Hanover’s.

Unpersuaded, opponents of the sale said the county did not take a serious enough look at finding other ways to raise capital without losing control of the hospital.

“They said the future is scary and unknown,” Smith, the retired businessman, said. “The counterargument is, Why don’t we wait and see what the future holds?”

“Once this is done,” he added, “you can never go back.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Por qué ni siquiera la presión presidencial podría acelerar las vacunas contra covid

Miles de estadounidenses están muriendo a causa de covid-19, pero los esfuerzos para aumentar la producción de vacunas que potencialmente salvan vidas están en un callejón sin salida.

Moderna y Pfizer-BioNTech, los fabricantes de las dos vacunas disponibles hasta el momento, están operando al máximo, bajo una enorme presión por expandir la producción o colaborar con otras farmacéuticas para establecer líneas de ensamblaje adicionales.

Esta presión crece a medida que las nuevas cepas del virus amenazan con poner al país ante una ola pandémica más letal.

El presidente Joe Biden ha dicho que planea invocar la Ley de Producción de Defensa, una norma de la era de la Guerra Fría, para proporcionar más vacunas a millones de estadounidenses.

Los defensores de los consumidores, que habían pedido a Donald Trump que usara esta ley de manera más agresiva como presidente, ahora le piden a Biden que haga lo mismo.

Pero incluso obligar a las empresas a acelerar la producción no proporcionará las dosis tan necesarias en el corto plazo. Ampliar las líneas de producción lleva tiempo, meses.

“El gran problema es que incluso si se puede obtener la materia prima y configurar la infraestructura, ¿cómo se consigue que una empresa que ya está produciendo a su máxima capacidad supere ese límite?”, dijo Lawrence Gostin, profesor de leyes de salud global en la Universidad de Georgetown.

Ordenar a las empresas que trabajen las 24 horas del día, los 7 días de la semana “sería una solución ingenua”, dijo la doctora Nicole Lurie, asesora principal de la Coalition for Epidemic Preparedness Innovations, un grupo internacional que financia vacunas para enfermedades emergentes. “Probablemente ya lo estén haciendo en la medida en que tengan materias primas”.

Lurie agregó: “Si desgastas por completo a la gente, ocurren errores. Tienes que equilibrar la velocidad con la calidad y la seguridad”.

Los desafíos tecnológicos involucrados son abrumadores, y las empresas no han comunicado bien lo que se necesita para superar la escasez de suministro.

“No sabemos cuál es la causa del atraso. ¿Es capacidad? ¿Materias primas? ¿Personas? ¿Frascos de vidrio? Simplemente no sabemos cuál es el cuello de botella”, dijo Erin Fox, directora senior de información sobre medicamentos y servicios de apoyo en la red de hospitales de la Universidad de Utah.

Tampoco podría funcionar obligar a otras compañías a comenzar a fabricar vacunas, dijo Gostin.

“No estoy seguro de si Biden podría exigir a una empresa privada que transfiera su tecnología a otra empresa”, dijo Gostin. “Es muy cuestionable legalmente… El espacio de maniobra del presidente no es tan grande como la gente piensa”.

Las compañías farmacéuticas definen los “secretos comerciales” de manera amplia, dijo Fox. “En general, no tienen que decirme quién fabrica su producto, dónde se fabrica, la ubicación de la fábrica. Eso se considera propiedad”.

Parte del desafío se relaciona con cómo se producen estas vacunas. Las dos primeras autorizadas utilizan nanopartículas de lípidos para insertar un fragmento del material genético del coronavirus, llamado ARN mensajero o ARNm, en las células.

Los genes virales enseñan a nuestras células cómo producir proteínas que estimulan una respuesta inmune ante el nuevo coronavirus.

El ARN mensajero es frágil y se descompone fácilmente, por lo que debe manipularse con cuidado, con temperaturas y niveles de humedad específicos.

Las vacunas “no son dispositivos”, dijo Lurie, quien se desempeñó como secretaria adjunta de preparación y respuesta en el Departamento de Salud y Servicios Humanos durante la administración Obama.

Expertos explican que cada paso para llevar las vacunas al mercado tiene sus complejidades: obtener materias primas; construir instalaciones especiales; comprar productos que se usan una sola vez, como tubos y bolsas de plástico para revestir biorreactores de acero inoxidable; y contratar empleados con la formación y la experiencia necesarias.

Las empresas también deben pasar inspecciones de seguridad y calidad y organizar el transporte.

La Ley de Producción de Defensa, por ejemplo, permitiría al gobierno tomar posesión de una planta que ya tiene un fermentador (hay muchos en la industria biotecnológica) para expandir la producción.

Pero esa es solo la primera etapa en la fabricación de una vacuna de ARNm e, incluso entonces, tomaría alrededor de un año comenzar, explicó el doctor George Siber, experto en vacunas que forma parte del consejo asesor de CureVac, una compañía alemana de vacunas de ARNm.

Las empresas primero tendrían que hacer una limpieza increíblemente profunda para evitar la contaminación cruzada, dijo Siber. Luego, tendrían que configurar, calibrar y probar equipos, y capacitar a científicos e ingenieros para usarlos.

Finalmente, Siber dijo que, a diferencia de un medicamento cuyos componentes pueden probarse para determinar su pureza, no hay forma de estar seguro de que una vacuna producida en una nueva instalación sea lo que dice ser sin probarla en animales y personas.

“Fabricar vacunas no es como fabricar coches, y el control de calidad es primordial”, dijo el doctor Stanley Plotkin, consultor de la industria de vacunas al que se le atribuye la invención de la vacuna contra la rubeola.

Johnson & Johnson, que se espera que anuncie los resultados de los ensayos clínicos este mes, ha dicho que no podrá administrar tantas inyecciones como estaba previsto debido a retrasos en la producción. La compañía se negó a responder preguntas.

La vacuna de AstraZeneca, también financiada en parte por los contribuyentes estadounidenses, ya está en uso en el Reino Unido y la India, pero la Administración de Alimentos y Medicamentos (FDA) ha planteado dudas sobre su ensayo en fase 3, por lo que es posible que no esté disponible aquí hasta la primavera.

Novavax, otro fabricante de vacunas financiado por Estados Unidos, se ha visto afectado por retrasos y solo recientemente comenzó a reclutar voluntarios para su ensayo a gran escala. Merck, la compañía más reciente en obtener apoyo federal para las vacunas de covid, anunció el lunes 25 de enero que descartaba a sus dos candidatos después de que no lograron producir una respuesta inmune adecuada en las primeras pruebas.

“Ninguno de los fabricantes de vacunas está fabricando al volumen que en última instancia desea tener”, dijo Lurie. “Todos tienen retrasos en la fabricación”.

Pfizer, que ha comprometido 200 millones de dosis para el gobierno de los Estados Unidos para fines de julio, dijo que no esperaba “interrupciones” en los envíos desde su principal planta de fabricación de covid en Estados Unidos, en Kalamazoo, Michigan.

Sharon Castillo, vocera de Pfizer, dijo que la compañía ha ampliado las instalaciones de fabricación y ha sumado más proveedores y fabricantes contratistas. Esos esfuerzos, y el anuncio de la compañía de que sus viales de cinco dosis en realidad contienen una dosis adicional, significan que “potencialmente podemos administrar aproximadamente 2 mil millones de dosis en todo el mundo para fines de 2021”.

El gobierno de los Estados Unidos también tiene la opción de adquirir otras 400 millones de dosis de la vacuna Pfizer-BioNTech, aunque la compañía se negó a proporcionar detalles sobre esa opción.

Pero todos los países compiten por los mismos suministros y materias primas, apuntó Gostin.

Biden podría usar la Ley de Producción de Defensa “para obligar a Pfizer a priorizar los contratos estadounidenses, pero eso sería políticamente arriesgado”, dado que otros países podrían tomar represalias acumulando suministros.

Aunque Pfizer es una empresa estadounidense, se ha asociado con BioNTech, de Alemania, para fabricar la vacuna. “Eso conduciría a un desastre global”.

Intentar acaparar el mercado mundial de ingredientes o suministros de vacunas se vería mal, dicen expertos, más ahora que Estados Unidos se acaba de unir a Covax, una empresa internacional para obtener y distribuir vacunas, en un esfuerzo por garantizar que los países pobres no se queden atrás.

Paradójicamente, la prisa por llevar las vacunas al mercado puede haber resultado en un proceso de fabricación menos eficiente.

Las compañías de vacunas suelen pasar meses haciendo que sus fábricas funcionen de la manera más eficiente posible, además de encontrar una dosis ideal y el intervalo más eficaz entre dosis, explicó Lurie.

Sin embargo, dada la urgencia de la pandemia, retrasaron partes de este proceso y se lanzaron directamente a la producción en masa.

Hace pocos días, Pfizer enfureció a los países europeos cuando detuvo la producción de vacunas en una planta belga para mejorar su capacidad. Pfizer dijo que el cierre de una semana reduciría las entregas de vacunas a Europa durante tres o cuatro semanas antes de aumentar los suministros en febrero. La medida no afecta los suministros de vacunas en los Estados Unidos.

“Estados Unidos no puede acceder fácilmente a las cosas que se guardan para vacunas en otros países”, dijo Lurie.

Y obligar a otras compañías a fabricar vacunas contra covid podría poner en peligro la producción de otras vacunas importantes, como la del sarampión, dijo el doctor Amesh Adalja, investigador principal del Johns Hopkins Center for Health Security.

Las tasas de vacunación infantil de rutina han disminuido durante la pandemia, lo que aumenta el riesgo de epidemias.

Usar la ley para priorizar la fabricación de vacunas ya ha interrumpido los suministros de al menos un medicamento, señaló Fox. En diciembre, Horizon Therapeutics advirtió a los médicos y pacientes que esperaran una escasez de un medicamento llamado Tepezza, que se usa para tratar la enfermedad ocular relacionada con la tiroides, porque su fabricante recibió la orden de priorizar las vacunas de covid.

Legisladores y defensores de los consumidores como Public Citizen pidieron al gobierno que use la Ley de Producción de Defensa de manera más agresiva.

En una carta enviada a principios de este mes, la senadora Elizabeth Warren (demócrata de Massachusetts) y la representante Katie Porter (demócrata de California) dijeron que Moderna debería compartir su técnica para estabilizar su vacuna en un refrigerador a temperaturas normales, sin congeladores “ultrafríos”.

Los funcionarios de Moderna han dicho que las diferencias intrínsecas en el material de ARNm de las dos compañías hacen que esa tecnología sea difícil de compartir. Además, dicen, Pfizer se ha negado a compartir datos con Moderna. Pfizer se ha negado a comentar sobre el tema.

Dado que el esfuerzo de Moderna está financiado con fondos federales, el gobierno presumiblemente tiene derecho de acceso y podría hacerse cargo de la producción, dijo Mike Watson, ex presidente de la subsidiaria de Moderna, Valera, en un correo electrónico.

“La realidad es que, por mucho que se impulse la capacidad de producción, tarde o temprano se llega a un cuello de botella”, agregó.

Los expertos dicen que no es tan simple como pedirle al fabricante de vidrio Corning que haga viales (tubos de vidrio). Por supuesto, los tubos deberán cumplir requisitos rigurosos. Pero hay otro problema: Estados Unidos enfrenta una escasez de arena minada, el principal componente necesario para fabricar estos tubos.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Why Even Presidential Pressure Might Not Get More Vaccine to Market Faster

Americans are dying of covid-19 by the thousands, but efforts to ramp up production of potentially lifesaving vaccines are hitting a brick wall.

Vaccine makers Moderna and Pfizer-BioNTech are running their factories full tilt and are under enormous pressure to expand production or collaborate with other drug companies to set up additional assembly lines. That pressure is only growing as new viral variants of the virus threaten to launch the country into a deadlier phase of the pandemic.

President Joe Biden has said he plans to invoke the Cold War-era authority of the Defense Production Act to provide more vaccines to millions of Americans. Consumer advocates — who had called for Donald Trump to use the Defense Production Act more aggressively as president — are now asking Biden to do the same.

But even forcing companies to gear up production won’t provide much-needed doses anytime soon. Expanding production lines takes time. Establishing lines in repurposed facilities can take months.

“The big problem is that even if you can get the raw material and get the infrastructure set up, how do you get a company that is already producing at maximum capacity to go beyond that maximum capacity?” said Lawrence Gostin, a professor of global health law at Georgetown University.

Ordering the companies to work 24/7 “would be a naïve solution,” said Dr. Nicole Lurie, a senior adviser to the CEO of the Coalition for Epidemic Preparedness Innovations, an international group that finances vaccines for emerging diseases. “They’re probably already doing that to the extent they have the raw materials.”

Lurie added, “If you completely wear people out, mistakes happen. You have to balance speed with quality and safety.”

The technological challenges involved are daunting, and the companies haven’t been forthcoming about what’s needed to overcome any supply shortfalls.

“We don’t know what the holdup is. Is it capacity? Raw materials? People? Glass vials? We just don’t know what the bottleneck is,” said Erin Fox, senior director of drug information and support services at the University of Utah Health Hospitals.

Forcing other companies to start making the vaccines might not work either, Gostin said.

“I’m not sure if Biden could require a private company to transfer its technology to another company,” Gostin said. “That is highly questionable legally. … President Biden’s room for maneuvering isn’t as great as people think.”

Drug companies define “trade secrets” broadly, Fox said. “In general, drug companies don’t have to tell me who is making their product, where it’s made, the location of the factory. … That’s considered proprietary.”

Part of the challenge relates to how these vaccines are made. The first two authorized products use lipid nanoparticles to deliver a snippet of the coronavirus’s genetic material — called messenger RNA, or mRNA — into cells. The viral genes teach our cells how to make proteins that stimulate an immune response to the novel coronavirus.

Messenger RNA is fragile and breaks down easily, so it needs to be handled with care, with specific temperatures and humidity levels.

The vaccines “are not widgets,” said Lurie, who served as assistant secretary for preparedness and response at the Department of Health and Human Services during the Obama administration.

Every step, experts say, to get vaccines to market has its complexities: obtaining raw materials; building facilities to precise specifications; buying single-use products, such as tubing and plastic bags to line stainless steel bioreactors; and hiring employees with the requisite training and expertise. Companies also must pass safety and quality inspections and arrange for transportation.

The Defense Production Act, for instance, would allow the government to commandeer a plant that already has a fermenter — there are plenty in the biotech industry — to expand production. But that’s just the first stage in making an mRNA vaccine and, even then, it would take about a year to get going, said Dr. George Siber, a vaccine expert who is on the advisory board of CureVac, a German mRNA vaccine company.

Companies would first have to do a breathtakingly thorough cleaning to prevent cross-contamination, Siber said. Next, they would need to set up, calibrate and test equipment, and train scientists and engineers to run it. Finally, Siber said, unlike a drug, whose components can be tested for purity, there’s no way to be sure a vaccine produced in a new facility is what it claims to be without testing it on animals and people.

“Making vaccines is not like making cars, and quality control is paramount,” said Dr. Stanley Plotkin, a vaccine industry consultant credited with inventing the rubella vaccine. “We are expecting other vaccines in a matter of weeks, so it might be faster to bring them into use.”

However, even that will require patience. Johnson & Johnson, expected to announce clinical trial results this month, has said that it won’t be able to deliver as many shots as planned because of manufacturing delays. The company did not confirm a manufacturing delay and declined to respond to questions.

AstraZeneca’s vaccine, also funded in part by U.S. taxpayers, is in use already in the United Kingdom and India, but the Food and Drug Administration has raised questions about its late-stage trial, so it may not be available here until the spring.

Novavax, another U.S.-funded vaccine maker, has been plagued by delays and only recently began recruiting volunteers for its big trial. Merck, the most recent company to get federal support for covid vaccines, announced Monday it was scrapping its two candidates after they failed to produce adequate immune response in early tests.

“None of the vaccine makers are manufacturing at the volume they ultimately want to be at,” Lurie said. “They all have manufacturing delays.”

Pfizer, which has committed 200 million doses to the U.S. government by the end of July, said last week it expected “no interruptions” in shipments from its primary U.S. covid manufacturing plant in Kalamazoo, Michigan. Pfizer spokesperson Sharon Castillo said the company has expanded manufacturing facilities and added more suppliers and contract manufacturers. Those efforts, and the company’s announcement that its five-dose vials actually contain an extra dose, mean “we can potentially deliver approximately 2 billion doses worldwide by the end of 2021.”

The U.S. government also has an option to acquire another 400 million doses of the Pfizer-BioNTech vaccine, though the company declined to provide details on that option when asked.

But countries around the world are competing for the same supplies and raw materials, Gostin said.

Biden could use the Defense Production Act “to force Pfizer to prioritize U.S. contracts, but that would be politically risky,” given that other countries could retaliate by hoarding supplies. Although Pfizer is an American company, it has partnered with BioNTech, of Germany, to make covid its vaccine. “That would lead to a global mess.”

Trying to corner the world market on vaccine ingredients or supplies would look bad, experts say, given that the United States just this week joined Covax, an international venture to source and distribute vaccines, in an effort to ensure poor countries aren’t left behind.

Paradoxically, the rush to get vaccines to market may have resulted in a less efficient manufacturing process.

Vaccine companies typically spend months making their factories run as efficiently as possible, as well as finding an ideal dose and the most effective interval between doses, Lurie said. Given the urgency of the pandemic, however, they delayed parts of this process and launched straight into mass production.

Pfizer angered European countries last week when it paused vaccine production at a Belgian plant to upgrade its capacity. Pfizer said the weeklong closure would decrease vaccine deliveries to Europe for three to four weeks before boosting supplies in February. The move doesn’t affect U.S. vaccine supplies.

“The U.S can’t necessarily readily access stuff that’s being held for vaccines in other countries,” Lurie said.

And forcing other companies to make covid vaccines could jeopardize production of other important shots, such as measles, said Dr. Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security. Routine childhood immunization rates have fallen during the pandemic, raising the risk of epidemics.

Using the act to prioritize covid vaccine manufacturing has already disrupted supplies of at least one drug, Fox noted. In December, Horizon Therapeutics warned doctors and patients to expect a shortage of a drug called Tepezza, used to treat thyroid-related eye disease, because its manufacturer was ordered to prioritize covid shots.

Lawmakers and consumer advocates such as Public Citizen called on the government to use the Defense Production Act more aggressively. In a letter sent earlier this month, Sen. Elizabeth Warren (D-Mass.) and Rep. Katie Porter (D-Calif.) said Moderna should share its technique for stabilizing its vaccine at normal refrigerator temperatures, without “ultracold” freezers.

Moderna officials have said the intrinsic differences in the two companies’ mRNA material make that technology hard to share. Besides, they say, Pfizer has declined to share data with Moderna. Pfizer has declined to comment on the issue.

Since Moderna’s effort is federally funded, the government presumably has march-in rights and could take over production, said Mike Watson, former president of Moderna subsidiary Valera, in an email. “The reality is that however far you push production capacity, you sooner or later reach a bottleneck.”

Experts say it’s not as simple as demanding that glassmaker Corning step up and make glass vials, for example. Of course, the vials will need to meet rigorous requirements. But there’s also this: The U.S. is facing a shortage of mined sand, the main component needed to make glass vials.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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California Is Overriding Its Limits on Nurse Workloads as Covid Surges

This story is from a reporting partnership that includes KQED, NPR and KHN. It can be republished for free.

California’s telemetry nurses, who specialize in the electronic monitoring of critically ill patients, normally take care of four patients at once. But ever since the state relaxed California’s mandatory nurse-to-patient ratios in mid-December, Nerissa Black has had to keep track of six.

And these six patients are really sick: Many of them are being treated simultaneously for a stroke and covid-19, or a heart attack and covid. With more patients than usual needing more complex care, Black said she’s worried she’ll miss something or make a mistake.

“We are given 50% more patients and we’re expected to do 50% more things with the same amount of time,” said Black, who has worked at the Henry Mayo Newhall Hospital in Valencia, California, for seven years. “I go home and I feel like I could have done more. I don’t feel like I’m giving the care to my patients like a human being deserves.”

As covid patients continue to flood California emergency rooms, hospitals are increasingly desperate to find enough staffers to care for them all. The state is asking nurses to tend to more patients simultaneously than they typically would, watering down what many nurses and their unions consider their most sacrosanct job protection: a law existing only in California that puts legal restrictions on the nurse-to-patient ratio.

“We need to temporarily — very short-term, temporarily — look a little bit differently in terms of our staffing needs,” said Gov. Gavin Newsom, after he quietly allowed hospitals to adjust their nurse-to-patient ratios on Dec. 11. Usually, California law requires a hospital to first get approval from the state before tinkering with those ratios; Newsom’s move gave hospitals presumptive approval to work outside the ratio rules immediately.

Since then, 188 hospitals, mainly in Southern California, have been operating under the new pandemic ratios: They can require ICU nurses to care for three patients instead of two. Emergency room and telemetry nurses may now be asked to care for six patients instead of four. Medical-surgical nurses are looking after seven patients instead of five.

Nurses have taken to the streets in protest, holding physically distanced demonstrations across the state, shouting and carrying posters that read: “Ratios Save Lives.” The union, the California Nurses Association, says the staffing shortage is a result of bad hospital management, of taking a reactive approach to staffing rather than proactive — laying nurses off over the summer, then not hiring or training enough for winter.

“What we’re seeing in these hospitals is their just-in-time response to a pandemic that they never prepared for — just-in-time staffing, just-in-time resources, not staffing up, calling nurses in on a shift at the very last minute — to boost profits,” said Stephanie Roberson, government relations director for the California Nurses Association. “And we’re seeing how nurses are being stretched even thinner.”

But hospitals say this is an unprecedented crisis that has spiraled beyond their control. In the current surge, four times as many Californians are testing positive for the coronavirus compared with the summer’s peak. As many as 7,000 new patients could soon be coming to California hospitals every day, according to Carmela Coyle, who heads the California Hospital Association.

“This is catastrophic and we cannot dodge this math,” she said. “We are simply out of nurses, out of doctors, out of respiratory therapists.”

The state has asked the federal government for staff, including 200 medical personnel from the Department of Defense, and it’s tried to reactivate the California Health Corps, an initiative to recruit retired health workers to come back to work. But that has yielded few people with the qualifications needed to care for hospitalized covid patients.

Hiring contract nurses from temporary staffing agencies or other states is all but impossible right now, Coyle said.

“Because California surged early during the summer and other parts of the United States then surged afterward,” she said, “those travel nurses are taken.“

The next step for hospitals is to try “team nursing,” Coyle said — pulling nurses from other departments, like the operating room, for example, and partnering them with experienced critical care nurses to help care for covid patients.

Joanne Spetz, an economics professor who studies health care workforce issues at the University of California-San Francisco, said hospitals should have started training nurses for team care over the summer, in anticipation of a winter surge, but they didn’t, either because of costs — hospitals lost a lot of revenue from canceled elective surgeries that could have paid for that training — or because of excessive optimism.

“California was doing so well,” she said. “It was easy for all of us to believe that we kind of got it under control, and I think there was a lot of belief that we would be able to maintain that.”

The California Nurses Association has good reason to be defensive regarding the integrity of the patient-ratio law, Spetz said. It took 10 years of lobbying and activism before the bill passed the state legislature in 1999, then several more years to overcome multiple court challenges, including one from then-Gov. Arnold Schwarzenegger.

“I’m always kicking their butt, that’s why they don’t like me,” Schwarzenegger famously said of nurses, drawing broad ire from the nurses union and its allies.

Nurses prevailed in the court of public opinion and in law; rules that put a legal cap on the number of patients per nurse finally took effect in 2004. But the long battle made nurses fiercely protective of their win. They’ve even accused hospitals of using the pandemic to try to roll back ratios for good.

“This is the exercise of disaster capitalism at its finest, where [hospital administrators] are completely maximizing their opportunity to take advantage of this crisis,” Roberson said.

Hospitals deny they want to change the ratio law permanently, and Spetz said it’s unlikely they’d succeed if they tried. The public can see that nurses are overworked and burned out by the pandemic, she said, so there would be little support for cutting back their job protections once it’s over.

“To go in and say, ‘Oh, you clearly did so well without ratios when we let you waive them, so let’s just eliminate them entirely,’ I think, would be just adding insult to moral injury,” Spetz said.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Patients Fend for Themselves to Access Highly Touted Covid Antibody Treatments

By the time he tested positive for covid-19 on Jan. 12, Gary Herritz was feeling pretty sick. He suspects he was infected a week earlier, during a medical appointment in which he saw health workers who were wearing masks beneath their noses or who had removed them entirely.

His scratchy throat had turned to a dry cough, headache, joint pain and fever — all warning signs to Herritz, who underwent liver transplant surgery in 2012, followed by a rejection scare in 2018. He knew his compromised immune system left him especially vulnerable to a potentially deadly case of covid.

“The thing with transplant patients is we can crash in a heartbeat,” said Herritz, 39. “The outcome for transplant patients [with covid] is not good.”

On Twitter, Herritz had read about monoclonal antibody therapy, the treatment famously given to President Donald Trump and other high-profile politicians and authorized by the Food and Drug Administration for emergency use in high-risk covid patients. But as his symptoms worsened, Herritz found himself very much on his own as he scrambled for access.

His primary care doctor wasn’t sure he qualified for treatment. His transplant team in Wisconsin, where he’d had the liver surgery, wasn’t calling back. No one was sure exactly where he should go to get it. From bed in Pascagoula, Mississippi, he spent two days punching in phone numbers, reaching out to health officials in four states, before he finally landed an appointment to receive a treatment aimed at keeping patients like him out of the hospital — and, perhaps, the morgue.

“I am not rich, I am not special, I am not a political figure,” Herritz, a former community service officer, wrote on Twitter. “I just called until someone would listen.”

Months after Trump emphatically credited an experimental antibody therapy for his quick recovery from covid and even as drugmakers ramp up supplies, only a trickle of the product has found its way into regular people. While hundreds of thousands of vials sit unused, sick patients who, research indicates, could benefit from early treatment — available for free — have largely been fending for themselves.

Federal officials have allocated more than 785,000 doses of two antibody treatments authorized for emergency use during the pandemic, and more than 550,000 doses have been delivered to sites across the nation. The federal government has contracted for nearly 2.5 million doses of the products from drugmakers Eli Lilly and Co. and Regeneron Pharmaceuticals at a cost of more than $4.4 billion.

So far, however, only about 30% of the available doses have been administered to patients, federal Department of Health and Human Services officials said.

Scores of high-risk covid patients who are eligible remain unaware or have not been offered the option. Research has shown the therapy is most effective if given early in the illness, within 10 days of a positive covid test. But many would-be recipients have missed this crucial window because of a patchwork system in the U.S. that can delay testing and diagnosis.

“The bottleneck here in the funnel is administration, not availability of the product,” said Dr. Janet Woodcock, a veteran FDA official in charge of therapeutics for the federal Operation Warp Speed effort.

Among the daunting hurdles: Until this week, there has been no nationwide system to tell people where they could obtain the drugs, which are delivered through IV infusions that require hours to administer and monitor. Finding space to keep covid-infected patients separate from others has been difficult in some health centers slammed by the pandemic.

“The health care system is crashing,” Woodcock told reporters. “What we’ve heard around the country is the No. 1 barrier is staffing.”

At the same time, many hospitals have refused to offer the therapy because doctors were unimpressed with the research federal officials used to justify its use.

Monoclonal antibodies are lab-produced molecules that act as substitutes for the body’s own antibodies that fight infection. The covid treatments are designed to block the SARS-CoV-2 virus that causes infection from attaching to and entering human cells. Such treatments are usually prohibitively expensive, but for the time being the federal government is footing the bulk of the bill, though patients likely will be charged administrative fees.

Nationwide, nearly 4,000 sites offer the infusion therapies. But for patients and families of people most at risk — those 65 and older or with underlying health conditions — finding the sites and gaining access has been almost impossible, said Brian Nyquist, chief executive officer of the National Infusion Center Association, which is tracking supplies of the antibody products. Like Herritz, many seeking information about monoclonals find themselves on a lone crusade.

“If they’re not hammering the phones and advocating for access for their loved ones, others often won’t,” he said. “Tenacity is critical.”

Regeneron officials said they’re fielding calls about covid treatments daily to the company’s medical information line. More than 3,500 people have flooded Eli Lilly’s covid hotline with questions about access.

As of this week, all states are required to list on a federal locator map sites that have received the monoclonal antibody products, HHS officials said. The updated map shows wide distribution, but a listing doesn’t guarantee availability or access; patients still need to check. It’s best to confer with a primary care provider before reaching out to the centers. For best results, treatment should occur as soon as possible after a positive covid test.

Some health systems have refused to offer the monoclonal antibody therapies because of doubts about the data used to authorize them. Early studies suggested that Lilly’s therapy, bamlanivimab, reduced the need for hospitalization or emergency treatment in outpatient covid cases by about 70%, while Regeneron’s antibody cocktail of casirivimab plus imdevimab reduced the need by about 50%.

But those studies were small, just a few hundred subjects, and the results were limited. “A lot of doctors, actually, they’re not impressed with the data,” said Dr. Daniel Griffin, an infectious disease expert at Columbia University who co-hosts the podcast “This Week in Virology.” “There really is still that question of, ‘Does this stuff really work?’”

As more patients are treated, however, there’s growing evidence that the therapies can keep high-risk patients out of the hospital, not only easing their recovery but also decreasing the burden on health systems struggling with record numbers of patients.

Dr. Raymund Razonable, an infectious disease expert at the Mayo Clinic in Minnesota, said he has treated more than 2,500 covid patients with monoclonal antibody therapy with promising results. “It’s looking good,” he said, declining to provide details because they’re embargoed for publication. “We are seeing reductions in hospitalizations; we’re seeing reductions in ICU care; we’re also seeing reductions in mortality.”

Banking on observations from Mayo experts and others, federal officials have been pushing for wider use of antibody therapies. HHS officials have partnered with hospitals in three hard-hit states — California, Arizona and Nevada — to set up infusion centers that are treating dozens of covid patients each day.

One of those sites went up in late December at El Centro Regional Medical Center in California’s Imperial County, an impoverished farming region on the state’s southern border that has recorded among the highest covid infection rates in the state. For months, the medical center strained to absorb the overwhelming influx of patients, but chief executive Dr. Adolphe Edward said a new walk-up infusion site has already put a dent in the covid load.

More than 130 people have been treated, all patients who were able to get the two-hour infusions and then recuperate at home. “If those folks would not have had the treatment, they would have come through the emergency department and we would have had to admit the lion’s share of them,” he said.

It’s important to make sure people in high-risk groups know to seek out the therapy and to get it early, Edward said. He and his staff have been working with area doctors’ offices and nonprofit groups and relying on word-of-mouth.

“On multiple levels, we’re saying, ‘If you’ve tested positive for the virus, come and let us see if you are eligible,’” Edward said.

Greater awareness is a goal of the HHS effort, said Dr. John Redd, chief medical officer for the assistant secretary for preparedness and response. “These antibodies are meant for everyone,” he said. “Everyone across the country should have equal access to these products.”

For now, patients like Herritz, the Mississippi liver transplant recipient, say reality is falling well short of that goal. If he hadn’t continued to call in search of a referral, he wouldn’t have been treated. And without the therapy, Herritz believes, he was just days away from hospitalization.

“I think it’s horrible that if I didn’t have Twitter, I wouldn’t know anything about this,” he said. “I think about all the people who have died not knowing this was an option for high-risk individuals.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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KHN’s ‘What the Health?’: On Capitol Hill, Actions Have Consequences

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The reverberations from the Jan. 6 storming of the U.S. Capitol by supporters of President Donald Trump continue. A broad array of business groups, including many from the health industry, are halting contributions to Republicans in the House and Senate who voted against certifying the victory of President-elect Joe Biden. Meanwhile, Republicans in the House who have refused to wear masks or insisted on carrying weapons are being subjected to greater enforcement, including significant fines.

Away from the Capitol, the Trump administration has granted a first-in-the-nation waiver to Tennessee to turn its Medicaid program into a block grant, which would give the state potentially less federal money but more flexibility to structure the federal-state health program for those with low incomes. And in its waning days, the administration is moving to make its last-minute policies harder for Biden to undo.

This week’s panelists are Julie Rovner of KHN, Joanne Kenen of Politico, Margot Sanger-Katz of The New York Times and Kimberly Leonard of Business Insider.

Among the takeaways from this week’s podcast:

• The decision by industry groups to cut their political contributions to some Republican lawmakers could reshape businesses’ relationships on Capitol Hill. But it’s still not clear if this announcement will affect the vast sums of political contributions that come through PACs and other unnamed sources, as well as individual contributions from corporate officials.
• The slow start of the covid vaccination campaign points to the tension between the need to steer the vaccine to people at high risk of contracting the disease and the concerns about wasting the precious medicine. Because the vaccines that have been approved for emergency use have a relatively short shelf life, some doses may go to waste if they are reserved for specific populations.
• The response to the vaccine among health care workers varies widely. In some areas, staffers are eager to get the shots, while in other places, some workers have been hesitant and the shots are going unused. And the federal government has not provided a strong public messaging campaign about the vaccines.
• The Trump administration’s announcement last week that it would move to convert Tennessee’s Medicaid program to a block grant program is raising concerns among advocates for the poor, who fear that the flexibility the state is gaining could lead to enrollees getting less care, especially since the state will get a hefty portion of any savings it finds in running the program.
• It may not be easy for the Biden administration to change this decision. Federal officials in recent weeks have been sending states, including Tennessee, letters to sign that could protect the Medicaid waivers they have received from the Trump administration and could serve as a legal guarantee that would require a long, difficult process to unwind.
• Mental health care may be a casualty of the coronavirus pandemic. As states look to balance their budgets after a year in which revenues were slashed, they may turn to cutting mental health care services provided through Medicaid and other programs.

Also this week, Rovner interviews KHN’s Victoria Knight, who wrote the latest KHN-NPR “Bill of the Month” feature — about an unusually large bill for in-network care. If you have an outrageous medical bill you’d like to share with us, you can do that here.

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

Julie Rovner: The Washington Post’s “Young ER doctors Risk Their Lives on the Pandemic’s Front Line. But They Struggle to Find Jobs,” by Ben Guarino

Margot Sanger-Katz: The New York Times’ “Why You’re Probably Not So Great at Risk Assessment,” by AC Shilton

Joanne Kenen: The Atlantic’s “Why Aren’t We Wearing Better Masks?” by Zeynep Tufekci and Jeremy Howard

Kimberly Leonard: Business Insider’s “I Was Offered a Covid Vaccine Even Though I’m Young and Healthy. Here’s How I Did It,” by Kimberly Leonard

To hear all our podcasts, click here.

And subscribe to What the Health? on iTunes, Stitcher, Google Play, Spotify, or Pocket Casts.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Feeling Left Out: Private Practice Doctors, Patients Wonder When It’s Their Turn for Vaccine

Dr. Andrew Carroll — a family doctor in Chandler, Arizona — wants to help his patients get immunized against covid, so he paid more than $4,000 to buy an ultra-low-temperature freezer from eBay needed to store the Pfizer vaccine.

But he’s not sure he’ll get a chance to use it, given health officials have so far not said when private doctor’s offices will get vaccine.

“I’m really angry,” said Carroll.

Not only are doctors having trouble getting vaccine for patients, but many of the community-based physicians and medical staff that aren’t employed by hospitals or health systems also report mixed results in getting inoculated. Some have had their shots, yet others are still waiting, even though health workers providing direct care to patients are in the Centers for Disease Control and Prevention’s top-priority group.

Many of these doctors say they don’t know when — or if — they will get doses for their patients, which will soon become a bigger issue as states attempt to vaccinate more people.

“The reason that’s important is patients trust their doctors when it comes to the vaccine,” said Carroll, who has complained on social media that his county hasn’t yet released plans on how primary care doctors will be brought into the loop.

Collectively, physicians in the county could vaccinate thousands of patients a day, he said, and might draw some who would otherwise be hesitant if they had to go to a large hospital, a fairground or another central site.

His concern comes as, nationally, the rollout of the vaccine is off to a slower start than expected, lagging far behind the initial goal of giving 20 million doses before the new year.

But Dr. Jen Brull, a family practice doctor in Plainville, Kansas, said her rural area has made good progress on the first phase of vaccinations, crediting close working relationships formed well before the pandemic.

This fall, before any doses became available, the local hospital, the health department and physician offices coordinated a sign-up list for medical workers who wanted the vaccine. So, when their county, with a population of 5,000, got its first 70 doses, they were ready to go. Another 80 doses came a week later.

“We’ll be able to vaccinate almost all the health care-associated folks who wanted it in the county” Brull said recently

Gaps in the Rollout

But that’s not the case everywhere.

Dr. Jason Goldman, a family doctor in Coral Gables, Florida, said he was able to get vaccinated at a local hospital that received the bulk of vaccines in his county and oversaw distribution.

In the weeks since, however, he said several of his front-line staff members still “don’t have access to the vaccine.”

Additionally, “a tremendous number” of patients are calling his office because Florida has relaxed distribution guidelines to include anyone over age 65, Goldman said, asking when they can get the vaccine. He’s applied to officials about distributing the vaccines through his practice but has heard nothing back.

Patients “are frustrated that they do not have clear answers and that I am not being given clear answers to provide them,” he said. “We have no choice but to direct them to the health department and some of the hospital systems.”

Another troubling point for Goldman, who served as a liaison between the American Academy of Family Physicians and the expert panel drawing up the CDC distribution guidelines, is the tremendous variation in how those recommendations are being implemented in the states.

The CDC recommends several phases, with front-line health care workers and nursing home residents and staff in the initial group. Then, in the second part of that phase, come people over 75 and non-health care front-line workers, which could include first responders, teachers and other designated essential workers.

States have the flexibility to design their own rollout schedule and priority groups. Florida, for example, is offering doses to anyone 65 and up. In some counties, older folks were told vaccines were available on a first-come, first-served basis, a move that has resulted in long lines.

“To say right now, 65-plus, when you haven’t even appropriately vaccinated all the health care workers, is negating the phasing,” said Goldman. “There needs to be a national standard. We have those guidelines. We need to come up with some oversight.”

On Thursday, the American Hospital Association echoed that concern in a letter to Health and Human Services Secretary Alex Azar. Hospitals — along with health departments and large pharmacy chains — are doing the bulk of the vaccinations.

Calling for additional coordination by federal officials, the letter outlined what it would take to reach the goal of vaccinating 75% of Americans by the end of May: 1.8 million vaccinations every day. Noting there are 64 different rollout plans from states, cities and other jurisdictions, the letter asked whether HHS has “assessed whether these plans, taken as a whole, are capable of achieving this level of vaccination?”

Making It Work

Lack of direct national support or strategy means each county is essentially on its own, with success or failure affected by available resources and the experience of local officials. Most state and local health departments are underfunded and are under intense pressure because of the surging pandemic.

Still, the success of vaccination efforts depends on planning, preparation and clear communication.

In Lorain County, Ohio, population 310,000, local officials started practicing in October, said Mark Adams, deputy health commissioner. They set up mass vaccination clinics for influenza to study what would be needed for a covid vaccination effort. How many staff? What would the traffic flow be like? Could patients be kept 6 feet apart?

“That gave us an idea of what is good, what is bad and what needs to change,” said Adams, who has had previous experience coordinating mass vaccination efforts at a county level.

So, when the county got its first shipment of 500 doses Dec. 21, Adams had his plan ready. He called the fire chiefs to invite all emergency medical technicians and affiliated personnel to an ad hoc vaccination center set up at a large entertainment venue staffed by his health department. Upon arrival, people were greeted at the door and directed to spaced-apart “lanes” where they would get their shots, then to a monitoring area where they could wait for 15 minutes to make sure they didn’t have a reaction.

Right after Christmas, another 400 doses arrived — and the makeshift clinic opened again. This time, doses went to community-based physicians, dentists and other hands-on medical practitioners, 600 of whom had previously signed up. (Hospital workers and nursing home staff and residents are getting their vaccinations through their own institutions.)

As they move into the next phase — recipients include residents over 80, people with developmental disorders and school staff — the challenges will grow, he said. The county plans a multipronged approach to notify people when it’s their turn, including use of a website, the local media, churches, other organizations and word-of-mouth.

Adams shares the concerns of medical providers nationwide: He gets only two days’ notice of how many doses he’s going to receive and, at the current pace of 400 or 500 doses a week, it’s going to take a while before most residents in the county have a chance to get a shot, including the estimated 33,000 people 65 and older.

With 10 nurses, his clinic can inject about 1,200 people a day. But many other health professionals have volunteered to administer the shots if he gets more doses.

“If I were to run three clinics, five days a week, I could do 15,000 vaccinations a week,” Adams said. “With all the volunteers, I could do almost six clinics, or 30,000 a week.”

Still, for those in the last public group, those age 18 and up without underlying medical conditions, “it could be summer,” Adams said.

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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Health Workers Unions See Surge in Interest Amid Covid

This story also ran on NPR. It can be republished for free.

The nurses at Mission Hospital in Asheville, North Carolina, declared on March 6 — by filing the official paperwork — that they were ready to vote on the prospect of joining a national union. At the time, they were motivated by the desire for more nurses and support staff, and to have a voice in hospital decisions.

A week later, as the covid-19 pandemic bore down on the state, the effort was put on hold, and everyone scrambled to respond to the coronavirus. But the nurses’ long-standing concerns only became heightened during the crisis, and new issues they’d never considered suddenly became urgent problems.

Staffers struggled to find masks and other protective equipment, said nurses interviewed for this story. The hospital discouraged them from wearing masks one day and required masks 10 days later. The staff wasn’t consistently tested for covid and often not even notified when exposed to covid-positive patients. According to the nurses and a review of safety complaints made to federal regulators, the concerns persisted for months. And some nurses said the situation fueled doubts about whether hospital executives were prioritizing staff and patients, or the bottom line.

By the time the nurses held their election in September — six months after they had filed paperwork to do so — 70% voted to unionize. In a historically anti-union state with right-to-work laws and the second-least unionized workforce in the country, that margin of victory is a significant feat, said academic experts who study labor movements.

That it occurred during the pandemic is no coincidence.

For months now, front-line health workers across the country have faced a perpetual lack of personal protective equipment, or PPE, and inconsistent safety measures. Studies show they’re more likely to be infected by the coronavirus than the general population, and hundreds have died, according to reporting by KHN and The Guardian.

Many workers say employers and government systems that are meant to protect them have failed.

Research shows that health facilities with unions have better patient outcomes and are more likely to have inspections that can find and correct workplace hazards. One study found New York nursing homes with unionized workers had lower covid mortality rates, as well as better access to PPE and stronger infection control measures, than nonunion facilities.

Recognizing that, some workers — like the nurses at Mission Hospital — are forming new unions or thinking about organizing for the first time. Others, who already belong to a union, are taking more active leadership roles, voting to strike, launching public information campaigns and filing lawsuits against employers.

“The urgency and desperation we’ve heard from workers is at a pitch I haven’t experienced before in 20 years of this work,” said Cass Gualvez, organizing director for Service Employees International Union-United Healthcare Workers West in California. “We’ve talked to workers who said, ‘I was dead set against a union five years ago, but covid has changed that.’”

In response to union actions, many hospitals across the country have said worker safety is already their top priority, and unions are taking advantage of a difficult situation to divide staff and management, rather than working together.

Labor experts say it’s too soon to know if the outrage over working conditions will translate into an increase in union membership, but early indications suggest a small uptick. Of the approximately 1,500 petitions for union representation posted on the National Labor Relations Board website in 2020, 16% appear related to the health care field, up from 14% the previous year.

In Colorado, SEIU Local 105 health care organizing director Stephanie Felix-Sowy said her team is fielding dozens of calls a month from nonunion workers interested in joining. Not only are nurses and respiratory therapists reaching out, but dietary workers and cleaning staff are as well, including several from rural parts of the state where union representation has traditionally been low.

“The pandemic didn’t create most of the root problems they’re concerned about,” she said. “But it amplified them and the need to address them.”

A nurse for 30 years, Amy Waters had always been aware of a mostly unspoken but widespread sentiment that talking about unions could endanger her job. But after HCA Healthcare took over Mission Health in 2019, she saw nurses and support staff members being cut and she worried about the effect on patient care. Joining National Nurses United could help, she thought. During the pandemic, her fears only worsened. At times, nurses cared for seven patients at once, despite research indicating four is a reasonable number.

In a statement, Mission Health said it has adequate staffing and is aggressively recruiting nurses. “We have the beds, staffing, PPE supplies and equipment we need at this time and we are well-equipped to handle any potential surge,” spokesperson Nancy Lindell wrote. The hospital has required universal masking since March and requires staff members who test positive to stay home, she added.

Although the nurses didn’t vote to unionize until September, Waters said, they began acting collectively from the early days of the pandemic. They drafted a petition and sent a letter to administrators together. When the hospital agreed to provide advanced training on how to use PPE to protect against covid transmission, it was a small but significant victory, Waters said.

“Seeing that change brought a fair number of nurses who had still been undecided about the union to feel like, ‘Yeah, if we work together, we can make change,’” she said.

Old Concerns Heightened, New Issues Arise

Even as union membership in most industries has declined in recent years, health workers unions have remained relatively stable. Experts say it’s partly because of the focus on patient care issues, like safe staffing ratios, which resonate widely and have only grown during the pandemic.

At St. Mary Medical Center outside Philadelphia, short staffing led nurses to strike in November. Donna Halpern, a nurse on the cardiovascular and critical care unit, said staffing had been a point of negotiation with the hospital since the nurses joined the Pennsylvania Association of Staff Nurses and Allied Professionals in 2019. But with another surge of covid cases approaching, the nurses decided not to wait any longer to take action, she said.

A month later, officials with Trinity Health Mid-Atlantic, which owns the hospital, announced a tentative labor agreement with the union. The contract “gives nurses a voice in discussions on staffing while preserving the hospital’s right and authority to make all staffing decisions,” the hospital said in a statement.

In Colorado, where state inspection reports show understaffing led to a patient death at a suburban Denver hospital, SEIU Local 105 has launched a media campaign about unsafe practices by the hospital’s parent company, HealthOne. The union doesn’t represent HealthOne employees, but union leaders said they felt compelled to act after repeatedly hearing concerns.

In a statement, HealthOne said staffing levels are appropriate across its hospitals and it is continuing to recruit and hire staff members.

Covid is also raising entirely new issues for workers to organize around. At the forefront is the lack of PPE, which was noted in one-third of the health worker deaths catalogued by KHN and The Guardian.

Nurses at Albany Medical Center in New York picketed on Dec. 1 with signs demanding PPE and spoke about having to reuse N95 masks up to 20 times.

The hospital told KHN it follows federal guidelines for reprocessing masks, but intensive care nurse Jennifer Bejo said it feels unsafe.

At MultiCare Indigo Urgent Care clinics in Washington state, staff members were provided only surgical masks and face shields for months, even when performing covid tests and seeing covid patients, said Dr. Brian Fox, who works at the clinics and is a member of the Union of American Physicians and Dentists. The company agreed to provide N95 masks after staffers went on a two-day strike in November.

MultiCare said it found another vendor for N95s in early December and is in the process of distributing them.

PPE has also become a rallying point for nonunion workers. At a November event handing out PPE in El Paso, Texas, more than 60 workers showed up in the first hour, said SEIU Texas President Elsa Caballero. Many were not union members, she said, but by the end of the day, dozens had signed membership cards to join.

Small Successes, Gradual Movement

Organized labor is not a panacea, union officials admit. Their members have faced PPE shortages and high infection rates throughout the pandemic, too. But collective action can help workers push for and achieve change, they said.

National Nurses United and the National Union of Healthcare Workers said they’ve each seen an influx in calls from nonmembers, but whether that results in more union elections is yet to be seen.

David Zonderman, an expert in labor history at North Carolina State University, said safety concerns like factory fires and mine collapses have often galvanized collective action in the past, as workers felt their lives were endangered. But labor laws can make it difficult to organize, he said, and many efforts to unionize are unsuccessful.

Health care employers, in particular, are known to launch aggressive and well-funded anti-union campaigns, said Rebecca Givan, a labor studies expert at Rutgers university. Still, workers might be more motivated by what they witnessed during the pandemic, she said.

“An experience like treating patients in this pandemic will change a health care worker forever,” Givan said, “and will have an impact on their willingness to speak out, to go on strike and to unionize if needed.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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An Urban Hospital on the Brink Vs. the Officials Sworn to Save It

Illinois and Chicago officials are trying to figure out how to stop a private company from closing a money-losing urban hospital in a poor, underserved Chicago neighborhood.

Trinity Health, a national Catholic tax-exempt chain, wants to close Mercy Hospital and Medical Center on Chicago’s Near South Side by May 31. Last month, in an unusual move, the Illinois Health Facilities & Services Review Board unanimously denied Trinity permission to close the 412-bed facility, which predominantly serves Black and other minority patients on Medicaid.

The board members said they feared the closure would limit access to care for nearly 60,000 South Side residents, forcing them to travel nearly 7 miles to the closest facility with an emergency room, intensive care unit and birthing center. It also would cost the community about 2,000 hospital jobs.

Urban hospitals in low-income areas of Los Angeles, Philadelphia, San Francisco, Washington, D.C., and other cities and suburbs face similar financial squeezes. Inner-city facilities like Mercy struggle to survive on lean payment rates from Medicaid and to compete with financially robust hospitals that mostly serve well-paying, privately insured patients.

So far, no one has come up with a politically and financially viable solution for strengthening safety-net health providers in low-income urban communities. “The sad fact is market location is everything,” said Lawton Robert Burns, a professor of health care management at the University of Pennsylvania, who studied the controversial closure of Hahnemann University Hospital in Philadelphia in 2019. “No offense to poor people, but there are economic factors that hospitals can’t control.”

But it is far from clear that a government board can stop a hospital from going out of business. “It’s really difficult in a capitalist country to tell a private company you have to continue to lose money,” said Dr. Linda Rae Murray, a member of the health facilities board and former Trinity Health board member who teaches health policy at the University of Illinois-Chicago.

Trinity, which operates 92 hospitals in 22 states, seems determined to push forward with its plans to close the hospital. It has deep pockets, with $31.9 billion in total assets. It reported revenue of $18.8 billion last year, and a profit of 2.3% in the most recent quarter. Trinity executives told the health facilities board in December that Mercy loses nearly $39 million a year and that they could not find any buyers for the hospital — Chicago’s oldest, chartered in 1852. They also reminded the board that state lawmakers rejected Mercy’s 2019 $1 billion proposal to merge with three other South Side hospitals and build a new hospital facility and several new clinics with $520 million in state aid.

Trinity declined to make anyone available for an interview for this article.

Trinity has said it will try again to get approval to shut Mercy at the facilities review board’s Jan. 26 meeting. It has offered to replace the hospital with a $13 million clinic offering just diagnostic and urgent care — but no primary care physician services. Critics of that proposal say the clinic, while helpful, would not be an adequate replacement for the hospital because it would not provide access to the full range of needed services.

“We can’t have these mega-hospital companies that are getting a property tax exemption for providing charity care closing a safety-net hospital in the middle of a pandemic,” said former Illinois Gov. Pat Quinn, a Democrat who spearheaded a 2013 deal to save Roseland Hospital, another embattled facility on Chicago’s South Side. “I’d tell the Trinity executives, ‘You’re not doing this to Chicago. We’ll work with you to put together a bigger deal.’”

The obvious long-term solution is richer Medicaid funding for safety-net hospitals, effective partnerships between public and private providers and firm commitments by financially strong hospital companies, including academic medical centers, to expand services in low-income communities. For instance, some say state and local officials should prod Trinity to use the resources of its Loyola University Medical Center in west suburban Chicago to bolster Mercy.

Hospitals are required to get a certificate of need for closure from the facilities review board, according to a new state law. But state officials’ actions are limited when seeking to enforce a decision to keep a facility open.

The state could levy a fine of up to $10,000 for not complying with the board’s decision, plus an additional $10,000 a month while the hospital continues to operate. But that’s a trivial amount for a big company like Trinity.

The state also could halt Medicaid and other public payments to Mercy. But that would be counterproductive, hastening the hospital’s demise since nearly half of Mercy’s inpatient revenue and 35% of its outpatient revenue comes from Medicaid, according to state data.

A final source of leverage is in Trinity’s ownership of three other hospitals in the Chicago area: Loyola, Gottlieb Memorial Hospital and MacNeal Hospital. The state could threaten Trinity’s property-tax exemption as a charitable organization. That’s an approach favored by Quinn, who cited a previous legal challenge to the tax-exempt status of the Carle Foundation Hospital in Urbana, Illinois.

No matter what the state does, Trinity can find ways to shut down Mercy. It could argue that even as Mercy is meeting the state requirement to continue to treat patients, it must close critical services like the emergency department or the birthing center because it lacks funding or staff to maintain adequate quality of care, said Juan Morado Jr., a Chicago health care lawyer who formerly served as general counsel for the facilities review board. The new law permits closing only one hospital department every six months.

While the state presses to keep the hospital open, Mercy also could suffer from attrition. When there’s talk of closing a hospital, physicians, nurses and other staffers may start leaving for other jobs. Whether Trinity seeks to refill positions is critical.

“There are things the owner can do to trickle the hospital down to nothing,” said Dr. David Ansell, senior vice president for community health equity at Rush University Medical Center in Chicago, who opposes shuttering Mercy. “There is a drip, drip, drip of negativity, and at some point people vote with their feet.”

The Chicago area has been through a similar battle recently. Pipeline Health, a private-equity investment firm, bought Westlake Hospital in suburban Melrose Park and two other local hospitals from hospital chain Tenet Healthcare in 2019. Pipeline quickly announced it was closing Westlake, a 230-bed hospital — even though it had promised the state it would keep it open for at least two years.

That controversial move prompted the Illinois legislature to give the facilities review board new authority to deny permission for future hospital closures, which the board lacked for Westlake.

Yet, the Westlake saga may point to a better solution for Mercy. In early 2020, the state and federal governments renovated the Westlake facility so it could be used as an overflow site for covid-19 patients. It wasn’t needed, but the updates led to strong interest from companies in purchasing and reopening the hospital, particularly for behavioral health inpatient services.

State Rep. Kathleen Willis, a Democrat who co-sponsored the 2019 bill to let the facilities review board say no to hospital closures, said a deal to buy and reopen Westlake likely will be announced within the next few weeks.

Any deal to save Mercy likely will require more money from Trinity, more commitment from other providers to offer a full range of hospital and medical services in the area, and significant increases in state and federal funding.

“Every hospital CEO has to worry about the bottom line of their business,” Ansell said. “But big organizations like Trinity need to come up with a better solution than the wholesale shutdown of an anchor institution that will leave communities bereft.”

Kaiser Health News (KHN) is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.

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