Tagged Trump Administration

After Billions of Dollars and Dozens of Wartime Declarations, Why Are Vaccines Still in Short Supply?

The U.S. government has invested billions of dollars in manufacturing, used a wartime act dozens of times to boost supplies and yet there’s still not enough covid vaccine on the way to meet demand — or even the government’s own goals for national immunization.

President Joe Biden, in remarks at the National Institutes of Health this month, said the nation is “now on track to have enough supply for 300 million Americans by the end of July.” But at the current rate of production, Pfizer and Moderna will miss their targets of providing at least 100 million doses each by the end of March, let alone 200 million more doses each has promised by July.

Moderna would need to more than double its vaccine production rate from January — when it made roughly 19 million doses — to meet its contractual obligations. Pfizer supplied 40 million vaccine doses by Feb. 17. It has roughly six weeks left to deliver the first 120 million doses it has promised.

Biden and officials from the two companies say they are rapidly expanding production capacity. But critics are lining up. They want to know whether the government did enough, fast enough, to guarantee that companies would meet the urgent challenges of the pandemic. As for the manufacturers bolstered by extraordinary sums of taxpayer money, why did they not share technology and know-how sooner, or move more quickly into strategic production partnerships?

Experts say it’s complicated, noting that the output of raw materials and assembly lines can’t be ratcheted up 10,000-fold at the push of a button — and that the effort thus far has been close to miraculous. They cite bottlenecks in at least three areas: the production of specialty lipids, fatty materials that are a primary component of the Moderna and Pfizer-BioNTech vaccines; the hundreds of millions of glass vials that hold the vaccine; and the sterile automated assembly lines where vaccine moves from bulk containers into vials before shipment.

U.S. officials have run headlong into the limits of the Defense Production Act, a Korean War-era law that allows the federal government to ramp up supplies of critical materials in times of national emergency. The vaccine manufacturing process relies on a complex supply chain, from sourcing raw materials and equipment to designing chemical processes, building production lines and hiring and training workers.

Also, experts note, no one knew which vaccines would prove effective.

“A year ago there was no commercial market for mRNA product. There was scientific research and pharma making small-volume clinical lots. Now we need billions of doses, in the space of a year. That’s overloading the supply infrastructure,” said Kevin Gilligan, a senior consultant with Biologics Consulting and a former official with the Biomedical Advanced Research and Development Authority, or BARDA, a federal agency created in 2006 to deal with pandemics and bioterrorism.

As of December, the Trump administration through its Operation Warp Speed initiative had obligated nearly $14 billion for vaccine development and manufacturing, including investments to expand U.S. capacity, according to a Government Accountability Office report in January. The administration invoked the Defense Production Act on at least 23 vaccine-related contracts, in part to prioritize the government’s contracts over others, according to a KHN review of the federal contracts database, contracts obtained by the nonprofit group Knowledge Ecology International, GAO and government news releases.

They include the December contract that the Department of Health and Human Services signed with Pfizer for another 100 million doses, on top of the initial 100 million it committed to last summer. That contract, worth $1.95 billion, included DPA provisions to give the company priority access to raw materials and spare parts for factories, according to a former administration official.

The DPA has also been used in vaccine contracts with Moderna, Johnson & Johnson and other drug companies for hundreds of millions of doses. On top of that, the law has been invoked for at least 10 contracts with companies making needles or syringes. It’s been used to require glass makers Corning and SiO2 Materials Science to prioritize vial production for vaccine production, and in contracts for aspects of manufacturing with companies like Emergent BioSolutions, Fujifilm Diosynth Biotechnologies and Grand River Aseptic Manufacturing.

Operation Warp Speed awarded Emergent BioSolutions $648 million last year to boost the manufacturing capacity it needed to enter agreements with Johnson & Johnson and AstraZeneca — worth at least $615 million and $261 million, respectively — to help make their vaccines. Grand River Aseptic Manufacturing won a $160 million award from BARDA and has contracted with Johnson & Johnson to fill vials and finish packaging of its single-shot covid vaccine, which is expected to get emergency authorization from the Food and Drug Administration as soon as this month but will only have a few million doses available initially.

The Biden administration has expanded its use of the wartime act to prioritize equipment like filling pumps and filtration systems for Pfizer. “We told you that when we heard of a bottleneck on needed equipment, supplies or technology related to vaccine supply, that we would step in and help,” Tim Manning, the White House official leading the administration’s covid supply efforts, said during a February press briefing.

Yet it can do only so much, according to medical supply chain experts. Prashant Yadav, a senior fellow at the Center for Global Development at Harvard University, said it could take months for the impact of that DPA action to be felt because of the time it takes to procure equipment and get it installed, with each step tightly regulated.

The U.S. is unlikely to get a meaningful bump in capacity “unless we think about co-production deals,” in which a drug company agrees to manufacture a competitor’s vaccine, said Tinglong Dai, an associate professor at Johns Hopkins University’s Carey Business School.

So far, such arrangements have proliferated in Europe — which has less capacity to produce drugs than the United States does. Deals with other major vaccine manufacturers have been less common on the U.S. side of the pond.

“Though we have not partnered with, say, another large pharma for production, we have built strategic partnerships with a number of organizations that have been instrumental to our scaling up and meeting supply and commercialization plans,” Moderna spokesperson Ray Jordan said in an email.

Moderna this month said that its manufacturing process would scale up rapidly in the coming weeks, that it would provide the U.S. between 30 million and 35 million doses in February and March and between 40 million and 50 million doses monthly from April to July. The company declined to elaborate on what made the boost possible.

Vaccine manufacturers long ago should have been sharing technology and expertise to boost production in the U.S. and Europe, and especially in developing countries, said James Love, director of Knowledge Ecology International, a nonprofit focused on patent rights.

“We’ve wasted about a year by not doing some of the obvious things,” he said. “The rhetoric is that it’s an emergency. But on the scale-up of manufacturing, you just don’t see it.”

It’s not that simple, others say. “There wasn’t any excess capacity available in the United States a year ago. Zero,” Paul Mango, a former HHS official heavily involved in Operation Warp Speed, said regarding vaccines. “It’s getting the equipment. It’s quality control. It’s getting the employees. People make it sound like this is easy. You can’t just push 400 workers and say, go at it.”

Each Pfizer-BioNTech or Moderna shot contains billions of lipid nanoparticles, each particle containing four lipids and a strand of the nucleic acid RNA, the five pieces assembled in a way that allows the RNA to enter our cells and create a particle that stimulates the immune system to defend against the covid virus.

The lipids, which are made only in a handful of factories, have been a major supply problem. “No one has ever thought of a scenario where we would use lipid nanoparticle formulation for [billions of] doses,” Yadav said. “We have not invented a process for doing lipid nanoparticles at scale.”

Two of the lipids in the vaccine, cholesterol and DSCP, have long been used in industry to shape and buffer chemical formulations. A third lipid prevents the particles from clumping together. A fourth enables the lipid shell of the vaccine to fuse with human cells and, once inside the cell, to crack open so the RNA can move to a structure called a ribosome and make proteins that stimulate immunity.

All of these raw materials are produced under regulated conditions — in Massachusetts, Missouri, Colorado and Alabama by companies under license with Moderna, Pfizer or Acuitas Therapeutics, which was co-founded by Pieter Cullis, a University of British Columbia professor who is considered the grandfather of lipid nanoparticle technology.

Before the pandemic, these companies produced meager amounts for use in small clinical trials, laboratory experiments or in one licensed drug, patisiran, which is used to treat a rare genetic disease in about a thousand people worldwide. Now they are producing thousands of kilograms of the stuff, said Stefan Randl, a vice president at Evonik, a lipid maker. Evonik recently announced it would scale up production at two German sites, possibly in the second half of the year, to be used in the Pfizer-BioNTech vaccine. The company last year bought a U.S. lipid manufacturer in Alabama.

“All of a sudden the quantities had to be ramped up a thousand-fold or more,” Randl said. “This is the biggest bottleneck.”

Several elements of the vaccine, including lipids and enzymes used in making the mRNA, until recently were produced using animal products such as sheep’s wool, said Andrew Geall, chief scientific officer at Precision NanoSystems, which designs equipment for mixing the mRNA and lipids. Animal products could cause contamination or disease, even in minute quantities, so manufacturers now use synthetic chemicals.

Luckily, the cosmetic industry — a major user of some of the same lipids used in the vaccines — has been switching from animal products in recent decades, noted Julia Born, an Evonik spokesperson.

Still, only a limited number of companies globally have expertise and facilities to make the lipids, said Thomas Madden, CEO and a co-founder of Acuitas, and they’ve all struggled to move from quantities produced in a laboratory to industrial-scale production. For instance, he said, hazardous solvents and chemicals used in laboratory procedures need to be avoided in industrial processes, where they could give rise to workplace safety issues.

“This is a hugely complex supply chain,” Madden said. “Once you address a bottleneck at one point, you identify the next bottleneck in the process. It’s a bit of a game of whack-a-mole.”

Although it’s not particularly difficult to make the lipids used in vaccines, it takes time to get FDA authorization of a facility that can make them in high quantities, said Cullis, the UBC professor. It would take two to three years to start such a factory from scratch, so instead, Moderna and Pfizer-BioNTech have been hooking up with existing manufacturers and getting them to convert to lipid production, he said.

Another bottleneck is “fill/finish” — getting the finished vaccine into vials or syringes so the shots can be shipped to customers. Vaccine filling lines require extremely high levels of efficiency and sterility, and few companies in the world have this capacity, said Mike Watson, former president of Valera, a Moderna subsidiary. Moderna has hired Catalent, a contract manufacturer that recently experienced delays that slowed the release of some doses, to fill and finish U.S. doses at its facility in Bloomington, Indiana. At least two other companies will do the same for Moderna’s vaccine supply abroad.

In January, the French multinational Sanofi — whose own covid vaccine has been delayed by poor performance in producing immunity — agreed to offer its fill/finish line in Germany for the Pfizer-BioNTech vaccine. That line isn’t expected to be running until July.

In the U.S., the number of vaccine doses shipped to states has ticked up in recent weeks, partly because Pfizer said its five-dose vials actually provide six shots. Moderna is seeking FDA permission to add up to five doses to its 10-dose vials.

Pfizer has said it is manufacturing raw materials in St. Louis, the active ingredients for the vaccine in Andover, Massachusetts, and filling vials in Kalamazoo, Michigan.

CEO Albert Bourla, with Biden at his side in Kalamazoo on Friday, said the company added lipid production capabilities at plants in Michigan and Connecticut, as well as fill/finish lines in Kansas. He said it has significantly cut the average time it takes to make doses — from 110 days to 60 days.

“Today, during this meeting, the president challenged us to identify additional ways in which his administration could help us potentially accelerate even further the delivery of the full 300 million doses earlier than July,” Bourla said. “The challenge is accepted, and we will try to do our best.”

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

Feds OK’d Export of Millions of N95 Masks as U.S. Workers Cried for More

In the midst of a national shortage of N95 masks, the U.S. government quietly granted an exception to its export ban on protective gear, allowing as many as 5 million of the masks per month to be shipped overseas.

The Federal Emergency Management Agency issued the waiver in the final moments of Donald Trump’s presidency last month, allowing a Texas company to export its products after it failed to secure U.S. customers, according to the FEMA letter obtained by KHN.

National Nurses United president Zenei Triunfo-Cortez called the export waiver “unconscionable” and said N95s remain under lock and key in many hospitals. She said she still has to “beg” for a new N95 if hers gets soiled during a shift caring for covid-19 patients.

Health care employers “and a federal agency that is supposed to be protecting the people of America are not doing their jobs,” she said. “They have no regard for our safety.”

The disconnect between front-line workers going without better protection and federal officials suddenly exporting masks boils down to one thing, workplace-safety experts say: The government has not pivoted quickly enough to lift supply chain crisis-mode guidelines and force employers to take costly and sometimes cumbersome steps to better protect workers with top-quality gear.

The FEMA letter references the challenge that Fort Worth-based Prestige Ameritech faced in finding customers for its government-approved, high-end respirators: Hospitals did not want to “fit test” employees to its N95s, a 15-minute process per employee to ensure that a new N95 model seals to the face, according to company president Mike Bowen.

Prestige Ameritech’s Mike Bowen testifies before the House Energy and Commerce Subcommittee on Health hearing to discuss protecting scientific integrity in response to the covid pandemic on May 14, 2020. (Shaw Thew/AFP / Getty Images)

Bowen said he ramped up N95 production during the pandemic from 75,000 to 9.6 million per month. Lately, he said, he can’t sell them to major buyers, does not have the infrastructure to sell them to small buyers and has so many in storage that he may need to lay off workers and wind down production.

The FEMA letter references those challenges and says the waiver was granted in the “national defense interest” to ensure he keeps production running at pace. The letter was transmitted to Border Patrol officials who oversee exports 103 minutes before Joe Biden was sworn into office.

Yet even with the waiver, Bowen said, he hasn’t been able to find an overseas buyer. He said he can’t understand the contradictory information he’s getting: Front-line workers say they need more N95s, but hospitals say they don’t.

“There is a disconnect someplace, and I don’t know where it is,” Bowen said. “Why aren’t my phones ringing off the hook if there’s a shortage?”

A FEMA official said by email that the waiver could be revoked at any time if U.S. demand increases and that the agency could require the company to “satisfy domestic demand” before exporting N95s.

Although prices fall considerably for those buying in bulk, prices for smaller lots of N95s have reached $4 to $7 each, according to Get Us PPE, a nonprofit meant to match front-line workers with needed gear.

The requirement for employers to perform fit tests annually was set aside amid the public health emergency, giving employers little incentive to veer from the industry-standard models like 3M that were used for years. And the Centers for Disease Control and Prevention has left guidelines in place that say a limited cadre of health care workers should get N95s, which can be reused and rationed.

That adds up to an unusual situation in which U.S. mask supplies have surged, but employers’ motivation to buy the best protective gear has not, said Peg Seminario, a former union health and safety official who recently signed a letter urging the CDC to update its guidelines to reflect the risk of inhaling the virus.

“This is crazy,” she said. “We could … crush this pandemic where the biggest risks of infection are and we’re not doing it.”

Started by a group of emergency room doctors in March, Get Us PPE said it gets 89% of requests for gear — often N95s — from health workers outside of hospitals, like community clinics, covid testing sites and psychiatric care facilities. Demand rose throughout January, with 28% of front-line workers seeking N95s reporting that their site had none.

Yet the volunteer-run group has been able to fulfill only about 15% of the requests it receives. Dr. Ali Raja, a founder of the group and executive vice chair of the emergency department at Massachusetts General Hospital, said the need is vast outside of hospitals, but small facilities scrambling for gear are not connecting to bulk sellers like Bowen’s firm.

“There was nothing out there — no centralized place for all facilities to report PPE needs,” Raja said. “We don’t want to be the website with the best data on this. We want that to be the federal government.”

On the last day of 2020, FEMA extended its rule prohibiting anyone from exporting PPE, including N95s, without first getting express approval from the agency. The rule says the fall and winter surge in covid cases meant “domestic supply of the allocated PPE has not kept pace with demand and is not anticipated to do so.”

The U.S. Strategic National Stockpile has not yet met its goal for N95 respirators, according to a U.S. Government Accountability Office report. The report said that as of Dec. 18, there were 190 million N95 respirators in storage — well short of its goal of 300 million.

“GAO remains deeply troubled that agencies have not acted on recommendations to more fully address critical gaps in the medical supply chain,” the government watchdog report says.

Another twist to the saga is that millions of counterfeit N95s stamped “3M,” an industry standard that has long been used in previously required annual fit tests, have flooded hospital shelves even as federal agents rush to seize them at U.S. ports.

A prominent group of scientists wrote to the CDC on Monday to point out guidelines that urgently need to be changed to protect workers from inhaling tiny airborne virus particles. Their letter noted that the “CDC does not recommend the use of N95 respirators” outside health care settings, even though outsize risks are documented for bus drivers, prison guards and meatpacking staffers.

CDC guidelines also allow hospitals to limit which workers get the N95s, leaving out those in community settings and lower-level workers who typically spend the most time next to patients.

In the Lost on the Frontline project, KHN and The Guardian have documented the deaths of hundreds of more than 3,440 front-line health workers, of whom 2 in 3 were workers of color and 56% worked outside of hospitals. For more than 120 who died, family members had concerns about PPE, including the extensive reuse of N95s or the use of surgical masks for direct care of covid patients.

KHN senior correspondent JoNel Aleccia contributed to this report.

El discurso anti inmigrante complica la vacunación contra covid en estados del sur

En el este de Tennessee, los médicos han visto de primera mano cómo una política de inmigración dura puede afectar la salud y el bienestar de una comunidad.

En 2018, agentes federales allanaron una planta empacadora de carne en Morristown, en el Valle de Tennessee, y detuvieron a unos 100 trabajadores sospechosos de ser indocumentados.

En las semanas siguientes, decenas de familias inmigrantes que habían encontrado trabajo en esas plantas buscaron santuario en las iglesias y dejaron de ir a las citas médicas.

¿La razón? Los agentes de inmigración estaban vigilando las clínicas.

“No queríamos que la gente viniera a recibir atención porque había oficiales de ICE en nuestro estacionamiento”, dijo Parinda Khatri, directora clínica de Cherokee Health Systems, un proveedor sin fines de lucro en el condado de Hamblen.

Mientras Tennessee, al igual que otros estados, se embarca en la abrumadora tarea de vacunar a millones de residentes contra covid-19, a muchos funcionarios de salud se les dificulta la tarea, por una desconfianza generalizada en el gobierno y las fuerzas del orden entre los inmigrantes sin papeles, una población estimada en 11 millones en todo el país.

Los desafíos son particularmente críticos en el sur, donde grandes poblaciones de inmigrantes indocumentados ayudan a mantener las prósperas industrias agrícola y de procesamiento de alimentos, incluso cuando muchos líderes republicanos estatales y locales, empoderados por la retórica antiinmigrante de la administración Trump, los denuncian como criminales y piden limitar su camino a la ciudadanía.

La confluencia de esas actitudes agresivas y un virus altamente contagioso ha generado preocupación en algunos estados: temen que la baja vacunación de indocumentados ponga en riesgo los esfuerzos para lograr la inmunidad colectiva.

“Nunca podremos superar esta pandemia si los indocumentados se quedan fuera”, dijo la doctora Sharon Davis, directora médica de la clínica comunitaria Los Barrios Unidos en Dallas, que atiende a 28,000 pacientes, la mayoría sin papeles.

Davis reconoció el desafío que plantea esto en un estado como Texas, donde la plataforma estatal del Partido Republicano pide la expulsión inmediata de todos los “extranjeros ilegales”. Como otros directores de clínicas en muchos estados del sur, Davis dijo que implementar planes de vacunación en las comunidades inmigrantes es una política de “don’t ask, don’t tell (“no preguntar, no decir”).

“Vivimos en Texas, así que ni lo mencionas”, agregó. “Hablamos de los que no tienen seguro, y hablamos de la población latina con la mayor morbilidad y mortalidad, es a quien estamos tratando de atender”.

En el área de Dallas-Fort Worth, hogar de una de las poblaciones más grandes de inmigrantes sin papeles de la nación, la tasa de muerte de los hombres latinos de mediana edad es ocho veces mayor que la de sus homólogos blancos no latinos.

Los epidemiólogos dicen que la disparidad no es sorprendente, dado que un gran número de trabajadores centro y sudamericanos indocumentados están en empleos considerados esenciales en la pandemia, incluido el trabajo agrícola, procesamiento de carne y servicio de alimentos, y la mayoría no tiene seguro médico.

Para agravar los riesgos, muchos trabajan en condiciones propicias para la propagación viral, parados hombro con hombro a lo largo de las cintas transportadoras en las empacadoras de verduras, lavando platos en las cocinas de los restaurantes, abasteciendo los estantes de los supermercados y limpiando habitaciones de hoteles.

Al final del día, muchos regresan a barracas o casas pequeñas que albergan a varias generaciones de familias.

“Si no trabajan, no comen”, dijo Davis. “Hemos tenido pacientes que nos suplican que no les hagamos la prueba, porque entonces no pueden ir a trabajar”.

Davis fue uno de los directores médicos que dijo que los sitios de vacunación masiva que muchos estados están usando (carpas gigantes con personal uniformado de la Guardia Nacional y personal médico con iPads) asustan a las familias inmigrantes.

“Preguntan ‘¿qué documentos tenemos que mostrar?’”, dijo Davis. “El miedo a la deportación es enorme y muy real”.

Y no es infundado, señalaron defensores, después de cuatro años en los que el ex presidente Donald Trump redujo drásticamente la inmigración legal e ilegal a través de detenciones y deportaciones masivas, prohibiciones de viaje y restricciones severas de asilo.

El presidente Joe Biden se ha comprometido a anular muchas de esas normas, pero defensores dicen que el apoyo a medidas más drásticas es fuerte entre algunos agentes de inmigración y agentes locales, lo que podría complicar la vida de muchos inmigrantes.

Davis agregó que, más allá del miedo al hostigamiento o al arresto, los funcionarios de salud pública están lidiando con información errónea. “Están escuchando historias horribles en las redes sociales”, dijo. “Creen que hay un microchip en la vacuna y que serán rastreados”.

Incluso algunos inmigrantes con papeles tienen reservas sobre recibir una vacuna proporcionada por el gobierno. La administración Trump presionó para descarrilar la ciudadanía de cualquier inmigrante que usara servicios públicos financiados por los contribuyentes, incluida la atención médica.

En diciembre, el Departamento de Justicia retiró la regla, pero hay confusión y los directores de las clínicas dicen que los pacientes darán prioridad a sus tarjetas de residencia por encima de casi todo.

Las bajas tasas de vacunación entre las poblaciones inmigrantes ya son evidentes. En Mississippi, por ejemplo, el Departamento de Salud informó que la semana del 8 de febrero se habían vacunado menos de 2,800 latinos, aproximadamente el 1% de todas las vacunas administradas hasta ahora.

Tennessee ofrece un excelente ejemplo de las tensiones que subyacen al lanzamiento de la vacuna.

El gobernador republicano, Bill Lee, fue noticia en mayo cuando permitió que el Departamento de Salud estatal compartiera con la policía los nombres y direcciones de quienes daban positivo para covid.

Por separado, el departamento de salud de la ciudad de Nashville proporcionó a la policía local las direcciones de las personas que daban positivo o que estaban en cuarentena.

Ambas acciones fueron criticadas y finalmente terminaron, pero Lee las defendió, diciendo que las eran apropiadas “para proteger las vidas de las fuerzas del orden” y que cumplían con las reglas federales de privacidad de la salud. Posteriormente, la ciudad buscó tranquilizar a sus “comunidades de inmigrantes diversas” diciendo que la información no se compartiría con las autoridades federales de inmigración.

Alabama, como Tennessee, tiene un historial de reglas estrictas con respecto a la inmigración, como una ley de 2011 que prohíbe que los inmigrantes sin papeles reciban casi todos los beneficios públicos, incluida la mayoría de la atención médica que no es de emergencia.

Velvet Luna, enfermera registrada de 26 años, ha construido su vida en Ozark, Alabama, una pequeña ciudad en Wiregrass, una región conocida por sus instalaciones de procesamiento de aves de corral y grandes poblaciones de inmigrantes hispanos y vietnamitas.

Luna se inscribió en el programa de Acción Diferida para los Llegados en la Infancia (DACA) una iniciativa de la era Obama que otorga estatus temporal a jóvenes indocumentados a los que trajeron al país de niños. Según el Centro Nacional de Leyes de Inmigración, casi 500,000 inmigrantes elegibles para DACA son trabajadores esenciales.

Luna, que habla con un suave acento sureño, solía hablar de su estatus migratorio, pero dijo que, en los últimos años, hombres que coqueteaban con ella cambiaban inmediatamente de actitud si sabían su estatus migratorio. “Decían cosas feas, hirientes, ‘Ustedes son la razón por la que nuestro país está en declive. Tienes que irte’”.

Como enfermera en un hospital del área que se ofreció como voluntaria para la unidad de covid, Luna ha recibido las dos dosis de la vacuna, pero entiende los riesgos que sopesan las familias indocumentadas; ninguno de sus padres, que vive cerca, tiene papeles. “Está bien tener miedo, y es una decisión valiente ir a vacunarse y proteger a tu familia”, dijo.

Incluso los opositores a la inmigración reconocen que la pandemia ha unido el destino de todos los que viven en el país, independientemente de cómo hayan llegado.

“Lo principal es vacunar a tantas personas como sea posible”, dijo Mark Krikorian, director ejecutivo del Centro de Estudios de Inmigración, un grupo conservador que aboga enérgicamente por restringir la inmigración. “Tu inmigración puede alcanzarte algún día, pero no será hoy”.

La administración Biden ha dicho que ICE no realizará operaciones en o cerca de los sitios de vacunación. “ICE no realiza ni llevará a cabo operaciones en o cerca de las instalaciones de atención médica, como hospitales, consultorios médicos, clínicas de salud acreditadas e instalaciones de atención de emergencia o urgencias, excepto en las circunstancias más extraordinarias”, según una declaración del Departamento de Seguridad Nacional del 1 de febrero.

Los comisionados estatales de salud también han tratado de calmar los nervios. “No le negamos la vacuna a nadie que se presente en nuestros sitios y esté en la fase que se está vacunando”, dijo la doctora Lisa Piercey, comisionada del Departamento de Salud de Tennessee. “Este es un recurso federal, y si estás en este país, tienes una vacuna”.

Los defensores, sin embargo, dijeron que persisten obstáculos para convencer a los inmigrantes de que la información no se utilizará en su contra. Los Centros para el Control y la Prevención de Enfermedades (CDC) esperan que los proveedores que administran las vacunas carguen la información del paciente en los registros estatales, incluido TennISS en Tennessee o ImmTrac2 en Texas.

Los sistemas de seguimiento permiten a los proveedores asegurarse de que los pacientes regresen para su segunda dosis e identificar cualquier reacción adversa.

Los proveedores tratan de explicar que esta información se usa para iniciativas de salud, no para inmigración.

“Los pacientes, en particular los de origen inmigrante, son muy sensibles a compartir detalles familiares”, escribió Brian Haile, director ejecutivo de Neighborhood Health, una clínica comunitaria en Nashville, a funcionarios de salud de Tennessee en diciembre. “Si les pedimos que proporcionen esta información a proveedores que no conocen, serán aún más reticentes a vacunar a sus familias”.

En el condado de Hamblen, Khatri dijo que está tratando de persuadir a trabajadores en granjas de tomate y tabaco, y en plantas procesadoras de carne, zonas calientes de brotes de coronavirus, de que confíen en su clínica no solo para administrar la vacuna sino también para manejar datos confidenciales.

“Quieren acudir a un grupo de confianza”, dijo Khatri, cuyas clínicas tienen la aprobación para distribuir la vacuna, pero aún no han recibido ninguna dosis.

Helena Lobo, quien coordina el alcance hispano en Cherokee Health, dijo que, para algunos inmigrantes, la elección puede estar entre su salud o permanecer ocultos.

“Si tienen que arriesgar su estatus migratorio para recibir la vacuna contra covid, no la tendrán. No los culpo”, dijo Lobo. “Se preguntan: ‘¿Cuál es mi mayor riesgo? ¿Ser deportado o tener covid?’”.

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Anti-Immigrant Vitriol Complicates Vaccine Rollout in Southern States

In eastern Tennessee, doctors have seen firsthand how a hard-line immigration policy can affect the health and well-being of a community.

In 2018, federal agents raided a meatpacking plant in Morristown, a manufacturing hub in the Tennessee Valley, and detained nearly 100 workers they suspected of being in the country illegally. In the weeks that followed, scores of immigrant families who had found work in the meat-processing plants dotting broader Hamblen County scrambled to find sanctuary in churches — and scrupulously avoided seeking medical care.

The reason? Immigration agents were staking out clinics.

“We did not want people to come in for care because there were ICE officers in our parking lot,” said Parinda Khatri, chief clinical officer at Cherokee Health Systems, a nonprofit provider in Hamblen County.

As Tennessee, like other states, embarks on the daunting task of inoculating millions of residents against covid-19, many health officials find their mission complicated by a pervasive mistrust of government and law enforcement among unauthorized immigrants, a population estimated at 11 million across the U.S.

The challenges are particularly acute in the South, where large populations of immigrants living there illegally help maintain the region’s thriving agricultural and food-processing industries even as many state and local Republican leaders, emboldened by the Trump administration’s four years of anti-immigrant vitriol, denounce unauthorized residents as criminals and call for more limited paths to citizenship.

The confluence of those aggressive attitudes and a highly contagious virus has prompted concerns in some states that lackluster vaccination of people in the country without legal permission will short-circuit efforts to achieve herd immunity for the broader community.

“We will never get on top of this pandemic if the undocumented are left out,” said Dr. Sharon Davis, chief medical officer at Los Barrios Unidos Community Clinic in Dallas, which serves 28,000 patients, the majority of them in the country without authorization.

She acknowledged the challenge that poses in a state such as Texas, where the state Republican Party platform calls for the immediate expulsion of all “illegal aliens.” Echoing clinic directors in many Southern states, Davis said rolling out vaccination plans in immigrant communities is a “don’t ask, don’t tell” policy.

“We live in Texas, so you don’t bring it up. You don’t mention it,” she said. “We talk about the uninsured, and we talk about the Latinx population with the highest morbidity and mortality — that’s who we’re trying to serve.”

In the Dallas-Fort Worth area, home to one of the nation’s largest populations of unauthorized immigrants, the covid death rate for middle-aged Latino men is eight times higher than for their non-Latino white counterparts.

Epidemiologists say the disparity is not surprising, given vast numbers of Central and South American workers in the country illegally are doing jobs deemed essential in the pandemic, including farm labor, meat-processing and food service, and most have no health insurance.

Compounding the risks, many of these workers labor in conditions ripe for viral spread, standing shoulder to shoulder along conveyor belts in vegetable-packing houses, washing dishes in restaurant kitchens, stocking grocery shelves and cleaning hotel rooms. At day’s end, many return to bunkhouses or cramped homes housing multiple generations of family.

“It’s going through the whole house, and if the whole house doesn’t work, they don’t eat,” Davis said. “We’ve had patients begging us not to test them, because then they can’t go to work.”

Davis was among the medical directors who said the mass vaccination sites many states are using in the rollout — giant tents staffed by uniformed National Guard troops and iPad-toting medical personnel — have spooked immigrant families.

“They are asking, ‘What documentation do we have to show at the mass vaccination sites?’” said Davis. “Fear of deportation is just huge, and very real.”

And not unfounded, advocates noted, coming off four years in which former President Donald Trump sharply curtailed both legal and illegal immigration through mass detention and deportation, travel bans and severely restricting asylum. President Joe Biden has pledged to undo many of Trump’s policies, but immigrant advocates say support for more drastic measures runs strong among some immigration agents and local law enforcement officers, who could make life difficult for immigrants they suspect are in the country illegally.

Beyond fear of harassment or arrest, Davis said, public health officials are dealing with misinformation, including widespread rumors about government surveillance efforts secreted in the vaccine. “They are hearing horrible stories on social media,” she said. “They believed there was a microchip in the vaccine and they would be tracked.”

Even some immigrants living in the U.S. legally have reservations about receiving a government-provided vaccine. The Trump administration pushed to derail citizenship for any immigrant who used taxpayer-funded public services, including health care. In December, the Department of Justice withdrew the rule, but confusion abounds, and clinic directors say patients will prioritize their green cards above almost all else.

Sluggish vaccination rates among immigrant populations are already apparent. In Mississippi, for example, the Department of Health reported last week that fewer than 2,800 Latinos have been vaccinated — about 1% of all vaccinations administered so far.

Tennessee offers a prime example of the tensions underlying the vaccine rollout.

The Republican governor, Bill Lee, made headlines in May when he allowed the state Department of Health to share the names and addresses of those who tested positive for the virus with police. The city of Nashville’s health department separately provided local police with the addresses of people who tested positive or were quarantining.

Both efforts came under criticism and eventually ended, but Lee defended the effort, saying the information was “appropriate to protect the lives of law enforcement” and permitted by federal health privacy laws. The city later sought to reassure its “diverse immigrant communities” that the information would not be shared with federal immigration authorities.

Alabama, like Tennessee, has a history of tough rules regarding immigration, including a sweeping 2011 law that bars unauthorized immigrants from receiving nearly all public benefits, including most nonemergency medical care.

Velvet Luna, a 26-year-old registered nurse, has built her life in Ozark, Alabama, a small city in the Wiregrass, a region known for its poultry-processing facilities and large populations of Hispanic and Vietnamese immigrants. Luna enrolled in Deferred Action for Childhood Arrivals, or DACA, an Obama-era program that granted temporary status to unauthorized immigrants brought across the border as children. According to the National Immigration Law Center, nearly 500,000 DACA-eligible immigrants are essential workers.

Luna, who speaks with a soft Southern accent, once freely shared her immigration status, she said, but in recent years men who flirted with her “would find out my status and they would immediately change their attitude toward me. They would say ugly, ugly, hurtful things. ‘You are the reason our country is declining. You need to get out of here.’”

As a nurse at an area hospital who volunteered in the covid unit, she has received both doses of vaccine, but she understands the risks undocumented families weigh; neither of her parents, who live close by, are authorized to be in the U.S. “It’s OK to be scared, and it’s a courageous move to go get the vaccine and protect your family,” she said.

Even hard-line immigration opponents acknowledge the pandemic has tied together the fates of everyone living in the U.S., regardless of how they arrived.

“The main thing is to get shots into as many people’s arms as possible,” said Mark Krikorian, executive director of the Center for Immigration Studies, a conservative think tank that strenuously advocates for restricting immigration. “Your immigration may catch up with you someday, but that’s not today.”

The Biden administration has said U.S. Immigration and Customs Enforcement will not conduct enforcement operations at or near vaccine distribution sites. “ICE does not and will not carry out enforcement operations at or near health care facilities, such as hospitals, doctors’ offices, accredited health clinics, and emergent or urgent care facilities, except in the most extraordinary of circumstances,” according to a Feb. 1 statement issued by the Department of Homeland Security.

State health commissioners also have tried to calm rattled nerves. “We are not denying vaccine to anyone who shows up at our sites and is in a phase,” said Dr. Lisa Piercey, commissioner of the Tennessee Department of Health. “This is a federal resource, and if you’re in this country, then you get a vaccine.”

Advocates, however, said hurdles remain in convincing wary emigres that the personnel information collected as part of the vaccination process will not be used against them. The Centers for Disease Control and Prevention expects providers administering covid vaccines to upload patient information to state registries, including TennISS in Tennessee or ImmTrac2 in Texas. The tracking systems allow providers to ensure patients return for their second dose, and to identify any adverse reactions.

The use of such information for health initiatives, not immigration crackdowns, is a nuance that providers struggle to explain.

“Patients, particularly those of immigrant origin, are highly sensitive to sharing family details,” Brian Haile, executive director of Neighborhood Health, a community clinic in Nashville, wrote to Tennessee health officials in December. “If we ask them to provide this information to providers they do not know, they will be even more reticent to have their families get vaccinated.”

In Hamblen County, Khatri said she’s trying to persuade those laboring on tomato and tobacco farms and in meat-processing plants — hot zones of coronavirus outbreaks — to trust her clinic not only to administer the vaccine but also to handle sensitive data.

“They want to go to a trusted group,” said Khatri, whose clinics have received approval to distribute the vaccine but have not yet received any doses.

Helena Lobo, who coordinates Hispanic outreach at Cherokee Health, echoed that, saying, for some immigrants, the choice may come down to choosing their health or choosing to remain hidden.

“If they have to risk their immigration status to have the covid vaccine, they will not have it. I don’t blame them,” said Lobo. “They go by risk: ‘What is my biggest risk? Being deported or to have covid?’”