Category: From California Healthline.org

Millions of Americans are counting on a COVID-19 vaccine to curb the global pandemic and return life to normal.

While one or more options could be available toward the end of this year or early next, the path to delivering vaccines to 330 million people remains unclear for the local health officials expected to carry out the work.

“We haven’t gotten a lot of information about how this is going to roll out,” said Dr. Umair Shah, executive director of Texas’ Harris County Public Health department, which includes Houston.

In a four-page memo this summer, the federal Centers for Disease Control and Prevention told health departments across the country to draft vaccination plans by Oct. 1 “to coincide with the earliest possible release of COVID-19 vaccine.”

But health departments that have been underfunded for decades say they currently lack the staff, money and tools to educate people about vaccines and then to distribute, administer and track hundreds of millions of doses. Nor do they know when, or if, they’ll get federal aid to do that.

Dozens of doctors, nurses and health officials interviewed by KHN and The Associated Press expressed concern about the country’s readiness to conduct mass vaccinations, as well as frustration with months of inconsistent information from the federal government.

The gaps include figuring out how officials will keep track of who has gotten which doses and how they’ll keep the workers who give the shots safe, with enough protective gear and syringes to do their jobs.

With only about half of Americans saying they would get vaccinated, according to a poll from AP-NORC Center for Public Affairs Research, it also will be crucial to educate people about the benefits of vaccination, said Molly Howell, who manages the North Dakota Department of Health’s immunization program.

The unprecedented pace of vaccine development has left many Americans skeptical about the safety of COVID-19 immunizations; others simply don’t trust the federal government.

“We’re in a very deep-red state,” said Ann Lewis, CEO of CareSouth Carolina, a group of community health centers that serve mostly low-income people in five rural counties in South Carolina. “The message that is coming out is not a message of trust and confidence in medical or scientific evidence.”

Paying for the Rollout 

The U.S. has committed more than $10 billion to develop new coronavirus vaccines but hasn’t allocated money specifically for distributing and administering vaccines.

And while states, territories and 154 large cities and counties received billions in congressional emergency funding, that money can be used for a variety of purposes, including testing and overtime pay.

An ongoing investigation by KHN and the AP has detailed how state and local public health departments across the U.S. have been starved for decades, leaving them underfunded and without adequate resources to confront the coronavirus pandemic. The investigation further found that federal coronavirus funds have been slow to reach public health departments, forcing some communities to cancel non-coronavirus vaccine clinics and other essential services.

States are allowed to use some of the federal money they’ve already received to prepare for immunizations. But KHN and the AP found that many health departments are so overwhelmed with the current costs of the pandemic — such as testing and contact tracing — that they can’t reserve money for the vaccine work to come. Health departments will need to hire people to administer the vaccines and systems to track them, and pay for supplies such as protective medical masks, gowns and gloves, as well as warehouses and refrigerator space.

CareSouth Carolina is collaborating with the state health department on testing and the pandemic response. They used federal funding to purchase $140,000 retrofitted vans for mobile testing that they plan to continue to use to keep vaccines cold and deliver them to residents when the time comes, said Lewis.

But most vaccine costs will be new.

Pima County, Arizona, for example, is already at least $30 million short of what health officials need to fight the pandemic, let alone plan for vaccines, said Dr. Francisco Garcia, deputy county administrator and chief medical officer.

Some federal funds will expire soon. The $150 billion that states and local governments received from a fund in the CARES Act, for example, covers only expenses made through the end of the year, said Gretchen Musicant, health commissioner in Minneapolis. That’s a problem, given vaccine distribution may not have even begun.

Although public health officials say they need more money, Congress left Washington for its summer recess without passing a new pandemic relief bill that would include additional funding for vaccine distribution.

“States are anxious to receive those funds as soon as possible, so they can do what they need to be prepared,” said Dr. Kelly Moore, associate director of immunization education at the Immunization Action Coalition, a national vaccine education and advocacy organization based in St. Paul, Minnesota. “We can’t assume they can take existing funding and attempt the largest vaccination campaign in history.”

What’s the Plan?

Then there’s the basic question of scale. The federally funded Vaccines for Children program immunizes 40 million children each year. In 2009 and 2010, the CDC scaled up to vaccinate 81 million people against pandemic H1N1 influenza. And last winter, the country distributed 175 million vaccines for seasonal influenza vaccine, according to the CDC.

But for the U.S. to reach herd immunity against the coronavirus, most experts say, the nation would likely need to vaccinate roughly 70% of Americans, which translates to 200 million people and — because the first vaccines will require two doses to be effective — 400 million shots.

Although the CDC has overseen immunization campaigns in the past, the Trump administration created a new program, Operation Warp Speed, to facilitate vaccine development and distribution. In August, the administration announced that McKesson Corp., which distributed H1N1 vaccines during that pandemic, will also distribute COVID-19 vaccines to doctors’ offices and clinics.

“With few exceptions, our commercial distribution partners will be responsible for handling all the vaccines,” Operation Warp Speed’s Paul Mango said in an email.

“We’re not going to have 300 million doses all at once,” said Mango, deputy chief of staff for policy at the Health and Human Services Department, despite earlier government pledges to have that many doses ready by the new year. “We believe we are maximizing our probability of success of having tens of millions of doses of vaccines by January 2021, which is our goal.”

Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, said it will take time for the vaccines to be widespread enough for life to return to what’s considered normal. “We have to be prepared to deal with this virus in the absence of significant vaccine-induced immunity for a period of maybe a year or longer,” Adalja said in August.

In preliminary guidance for state vaccine managers, the CDC said doses will be distributed free of charge from a central location. Health departments’ local vaccination plans may be reviewed by both the CDC and Operation Warp Speed.

The CDC has vetted state and federal vaccination plans in five locations: North Dakota, Florida, California, Minnesota and Philadelphia. No actual vaccines were distributed during the “microplanning” sessions, which focused on how to get vaccines to people in places as different as urban Philadelphia, where pharmacies abound, and rural North Dakota, which has few chain drugstores but many clinics run by the federal Indian Health Service, said Kris Ehresmann, who directs infectious disease control at the Minnesota Department of Health.

Those planning sessions have made Ehresmann feel more confident about who’s in charge of distributing vaccines. “We are getting more specific guidance from CDC on planning now,” she said. “We feel better about the process, though there are still a lot of unknowns.”

Outdated Technology Could Hamper Response

Still, many public health departments will struggle to adequately track who has been vaccinated and when, because a lack of funding in recent decades has left them in the technological dark ages, said Dr. Marcus Plescia, chief medical officer at the Association of State and Territorial Health Officials.

In Mississippi, for example, health officials still rely on faxes, said the state’s health officer, Dr. Thomas Dobbs. “You can’t manually handle 1,200 faxes a day and expect anything efficient to happen,” he said.

When COVID-19 vaccines become available, health providers will need to track where and when patients receive their vaccines, said Moore, the medical director of Tennessee’s immunization plan during the H1N1 influenza pandemic in 2009 and 2010. And with many different shots in the works, they will need to know exactly which one each patient got, she said.

People will need to receive their second COVID-19 dose 21 or 28 days after the first, so health providers will need to remind patients to receive their second shot, Moore said, and ensure that the second dose is the same brand as the first.

The CDC will require vaccinators to provide “dose-level accounting and reporting” for immunizations, so that the agency knows where every dose of COVID-19 vaccine is “at any point in time,” Moore said. Although “the sophistication of these systems has improved dramatically” in the past decade, she said, “many states will still face major challenges meeting data tracking and reporting expectations.”

The CDC is developing an app called the Vaccine Administration Monitoring System for health departments whose data systems don’t meet standards for COVID-19 response, said Claire Hannan, executive director of the Association of Immunization Managers, a nonprofit based in Rockville, Maryland.

“Those standards haven’t been released,” Hannan said, “so health departments are waiting to invest in necessary IT enhancements.” The CDC needs to release standards and data expectations as quickly as possible, she added.

Meanwhile, health departments are dealing with what Minnesota’s Ehresmann described as “legacy” vaccine registries, sometimes dating to the late 1980s.

A Historic Task

Overwhelmed public health teams are already working long hours to test patients and trace their contacts, a time-consuming process that will need to continue even after vaccines become available.

When vaccines are ready, health departments will need more staffers to identify people at high risk for COVID-19, who should get the vaccine first, Moore said. Public health staff also will be needed to educate the public about the importance of vaccines and to administer shots, she said, as well as monitor patients and report serious side effects.

At an August meeting about vaccine distribution, Dr. Ngozi Ezike, director of Illinois’ health department, said her state will need to recruit additional health professionals to administer the shots, including nursing students, medical students, dentists, dental hygienists and even veterinarians. Such vaccinators will need medical-grade masks, gowns and gloves to keep those workers safe as they handle needles amid the contagious coronavirus.

Many health officials say they feel burned by the country’s struggle to provide hospitals with ventilators last spring, when states found themselves bidding against one another for a limited supply. Those concerns are amplified by the country’s continuing difficulties providing enough testing kits; supplying health workers with personal protective equipment; allocating drugs such as remdesivir; and recruiting contact tracers — who track down everyone with whom people diagnosed with COVID-19 have been in contact.

Although Ehresmann said she’s concerned Minnesota could run out of syringes, she said the CDC has assured her they will provide them.

Given that vaccines are far more complex than personal protective equipment and other medical supplies — one vaccine candidate must be stored at minus 94 degrees Fahrenheit — Plescia said people should be prepared for shortages, delays and mix-ups.

“It’s probably going to be even worse than the problems with testing and PPE,” Plescia said.

Associated Press writer Michelle R. Smith and KHN Midwest correspondent Lauren Weber contributed to this report.

This story is a collaboration between The Associated Press and KHN, an editorially independent program of the Kaiser Family Foundation.

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

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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NEW YORK — Evaristo “Risto” Grant counted down from 10 as his clients held their plank positions and shook with the effort. Michael Jackson’s “Wanna Be Startin’ Somethin’” blared in the background. Grant paced around his clients on their yoga mats, shouting words of encouragement.

It looked and sounded like any normal gym session. Except it wasn’t. Grant’s gym consisted of a few yoga mats and equipment underneath a strip of scaffolding in Carl Schurz Park, which borders the East River in Manhattan. People on their evening quarantine walks strolled by, many glancing with amusement at the signs Grant had taped to the scaffolding: “Get your sexy back … no more cookies!” and “Come for the party, stay for the workout!”

Grant, 57, was despondent for the first few weeks of quarantine last spring. New York City was quickly becoming the epicenter of the coronavirus pandemic, and everyone hunkered down at home. As a personal trainer who works for himself, Grant watched his income crumble.

Then, a lightbulb went off. Grant used some savings to buy face shields, disinfectant, hand sanitizer and some additional equipment. He set up shop in the park, which is just a few blocks from his house, and started to attract new clients.

“This is an opportunity to meet people and get prospective clients for the future,” Grant said. “I just talk to people, connect, share and inspire, hopefully.”

One new client is Elizabeth Pompa, a 53-year-old real estate agent living on the Upper East Side. Pompa, who used to teach Lotte Berk Technique dance-based exercise classes, has always valued fitness and personal training. Her husband struck up a conversation with Grant while working out next to him and later suggested Pompa give Grant a try. Since then, she’s seen Grant once a week.

“He pushes me, but in a great way,” Pompa said. “I know I’m not going to get hurt with him. For that hour, I forget everything that’s going on around me.”

Casey Grillo, a 40-year-old nurse practitioner, comes to Grant’s sessions twice a week. At the start of the pandemic, she would not have considered working out with others in person. But she said now that she and others know how to take the appropriate measures to stay safe, she’s comfortable at Grant’s sessions.

Grant holds small classes Sunday through Thursday, charging his clients $25 per session. And he teaches private clients on Fridays for $85. At every session, he wears a face shield and reminds clients to stay 6 feet apart. He disinfects equipment after every use and offers hand sanitizer to those who want it.

Grillo said she’s noticed a larger community of fitness enthusiasts getting their exercise outside. She admires everyone’s creativity.

“I’ve seen people use canned goods and water bottles and gallon jugs for weights,” Grillo said. “It’s really encouraging to see people still staying active.”

Grant is not the only personal trainer using Carl Schurz as gym space. Patrick Narain, a 36-year-old trainer and martial arts instructor, has been teaching classes in Carl Schurz, Astoria Park and Central Park. At the beginning of the pandemic, he mostly did virtual classes from home without charging people. It was tough, he said, staying financially afloat on solely the tips he got from online clients. Now he’s getting $15 from each class participant.

As for many people, Narain said the pandemic and subsequent quarantine have caused him anxiety.

“I find myself worrying too much about others and not really paying attention to taking care of myself,” Narain said. “It really caused me a lot of stress, to the point where I couldn’t really feel my right side.”

His stress slowly improved as he worked with another instructor to teach small classes in the park. He’s enjoying the fresh air and open space, though he’s careful not to push clients too hard in the heat.

Devin Paul, another trainer, also transitioned his business smoothly to the outdoors. He’d worked with a gym until the quarantine started, and now he’s training his own clients in Carl Schurz and in Jackie Robinson Park in Harlem.

Paul, 46, has found that since he’s working for himself, he’s making more money and working fewer hours. He said his minimum fee for a private lesson is $100.

“I’m at a point in my life where I don’t think I’m going to go back when the gyms open,” Paul said. “I can have a better peace of mind just doing everything on my own.”

Paul plans to rent a training studio when the weather turns too cold to work outside.

Grant said the personal trainer community has had one another’s backs through it all. He’s been a part of the industry for 17 years, ever since a fellow fitness enthusiast told him he’d be a “natural.” He’s seeing trainers he’s known for a long time using parks to their advantage, being creative and making things work.

“We just try to help each other out and stand for each other,” Grant said.

Pre-pandemic, Grant had been doing well financially with his model of meeting up with clients at gyms and getting new ones through referrals. Still, he’s taking the pandemic as an opportunity to reevaluate his operation.

“We have to really think about how to create something for the future and see the glass as half full and be optimistic because you’ll never know what you create when you put your mind to it,” he said.

For the foreseeable future, he’s sticking around at his makeshift gym throughout the week, hoping to entice people to “get your sexy back.”

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

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Millones de estadounidenses esperan una vacuna contra COVID-19 para frenar la pandemia y volver a la normalidad.

Pero el camino para entregar vacunas a 330 millones de personas sigue sin estar claro para los funcionarios de salud locales que, se espera, sean los que realicen el trabajo.

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“No hemos recibido mucha información sobre cómo se implementará”, dijo el doctor Umair Shah, director ejecutivo del Departamento de Salud Pública del condado de Harris, en Texas, que incluye a Houston.

Los Centros para el Control y Prevención de Enfermedades (CDC) han dicho a los departamentos de salud locales a lo largo del país que diseñen planes de vacunación antes del primero de octubre, para una posible distribución de una vacuna contra COVID-19 tan pronto como el primero de noviembre.

Pero los departamentos de salud, que han carecido de fondos suficientes durante décadas, dicen que no tienen personal, dinero ni herramientas para educar a las personas sobre las vacunas; y luego para distribuir, administrar y rastrear cientos de millones de dosis. Tampoco saben cuándo, o si obtendrán ayuda federal para lograrlo.

Docenas de médicos, enfermeras y funcionarios de salud entrevistados por KHN y The Associated Press expresaron preocupación por la disposición del país para realizar vacunaciones masivas, y frustración por meses de información inconsistente por parte del gobierno federal.

Las brechas incluyen cómo se hará el seguimiento de los vacunados, y cómo mantendrán a los trabajadores que administran las vacunas seguros, con suficiente equipo de protección y jeringas.

Con solo la mitad de los estadounidenses diciendo que se vacunarán, según una encuesta del Centro de Investigación de Asuntos Públicos de AP-NORC, también será crucial educar a las personas sobre los beneficios de la vacunación, dijo Molly Howell, quien administra el programa de inmunizaciones del Departamento de Salud de Dakota del Norte.

Estados Unidos ha comprometido más de $10 mil millones para desarrollar nuevas vacunas contra el coronavirus, pero no ha asignado dinero específico para distribuirlas y administrarlas.

Y aunque los gobiernos locales recibieron miles de millones en fondos de emergencia del Congreso, ese dinero no está destinado a distribuir una vacuna.

Una investigación en curso de KHN y AP ha detallado cómo los departamentos de salud pública estatales y locales han sufrido décadas de desmantelamiento, lo que los ha dejado sin fondos suficientes para realizar servicios básicos, y enfrentar al coronavirus

Los estados pueden usar parte del dinero federal que ya han recibido para prepararse para las vacunas. Pero AP y KHN descubrieron que muchos departamentos de salud están tan abrumados con los costos actuales de la pandemia, como las pruebas y el rastreo de contactos, que no pueden reservar dinero para el proceso con las vacunas.

Los departamentos de salud deberán contratar personas para administrarlas y sistemas para rastrearlas, y pagar por suministros como máscaras médicas protectoras, batas y guantes, espacios para almacenarlas, y refrigeradores.

Por ejemplo, el presupuesto del condado de Pima, en Arizona, ya está unos $30 millones por debajo de lo que los funcionarios de salud necesitan para combatir la pandemia, y mucho menos planificar la vacunación, expresó el doctor Francisco García, administrador adjunto y director médico del condado.

Algunos fondos federales vencerán pronto. Por ejemplo, los $150 mil millones que los gobiernos estatales y locales recibieron de un fondo en la Ley CARES, cubren solo los gastos que se realicen hasta fin de año, dijo Gretchen Musicant, comisionada de salud en Minneapolis. Un problema, dado que la distribución de la vacuna puede que ni siquiera haya comenzado para ese momento.

Aunque funcionarios de salud pública dicen que necesitan ayuda, el Congreso dejó Washington para su receso de verano sin aprobar un nuevo proyecto de ley de ayuda para COVID, que hubiera incluido fondos adicionales para la distribución de vacunas.

Los estados no pueden simplemente tomar las fuentes de financiamiento existentes y utilizarlas para intentar la campaña de vacunación más grande de la historia, dijo la doctora Kelly Moore, de la Coalición de Acción de Inmunización, una organización nacional de educación y defensa de las vacunas.

Luego está la cuestión básica de la escala. El invierno pasado, el país distribuyó 175 millones de vacunas contra la influenza estacional, según los CDC.

Pero expertos dicen que, para que los Estados Unidos alcancen la inmunidad colectiva contra el coronavirus, es probable que se deba vacunar a aproximadamente el 70% de los estadounidenses, o 200 millones de personas. Las primeras vacunas requerirán dos dosis para ser efectivas: 400 millones de inyecciones.

Los mismos expertos auguran que muchos departamentos de salud pública tendrán dificultades para realizar un seguimiento adecuado de quién se ha vacunado y cuándo, porque la falta de fondos en las últimas décadas los ha dejado con tecnología obsoleta.

Moore, quien fue directora médica del plan de inmunización de Tennessee durante la pandemia de influenza H1N1, dijo que las personas necesitarán recibir su segunda dosis de COVID-19 21 o 28 días después de la primera, por lo que los proveedores de salud deberán recordarles a los pacientes que deben recibir su segunda vacuna.

También deben asegurarse que la segunda dosis sea de la misma marca que la primera.

Los CDC están desarrollando una aplicación llamada Sistema de Monitoreo de la Administración de Vacunas para los departamentos de salud cuyos sistemas de datos están rezagados, dijo Claire Hannan, directora ejecutiva de la Asociación de Administradores de Inmunización. Los departamentos están esperando saber más sobre esta tecnología.

Mientras tanto, se ocupan de los registros de vacunas que a veces datan de finales de la década de 1980.

Los abrumados equipos de salud pública ya están trabajando largas horas para hacer pruebas a los pacientes y rastrear sus contactos, un proceso que requiere mucho tiempo y que deberá continuar incluso después que las vacunas estén disponibles.

Cuando eso suceda, los departamentos necesitarán más personal para una variedad de trabajos, incluida la educación del público, el seguimiento de los pacientes y la notificación de efectos secundarios graves.

En una reunión de agosto sobre la distribución de vacunas, la doctora Ngozi Ezike, directora del departamento de salud de Illinois, dijo que su estado necesitará contratar profesionales de salud adicionales para administrar las vacunas, incluidos estudiantes de enfermería, estudiantes de medicina, dentistas, higienistas dentales e incluso veterinarios.

Todos necesitarán máscaras, batas y guantes de grado médico para seguridad mientras manipulan agujas en medio del contagioso coronavirus.

Dado que las vacunas son mucho más complejas que el equipo de protección personal y otros suministros médicos (una vacuna candidata debe almacenarse a menos de 94 grados Fahrenheit), el doctor Marcus Plescia, director médico de la Asociación de Funcionarios de Salud Estatales y Territoriales, dijo que las personas deben estar preparadas para escasez, retrasos y confusión.

“Probablemente será incluso peor que los problemas con las pruebas y los equipos de protección personal”, dijo Plescia.

La escritora de Associated Press Michelle R. Smith y la corresponsal de KHN en el Medio Oeste Lauren Weber colaboraron con este informe.

Esta historia es una colaboración entre The Associated Press y KHN.

A COVID-19 vaccine could be available earlier than expected if ongoing clinical trials produce overwhelmingly positive results, said Dr. Anthony Fauci, the nation’s top infectious disease official, in an interview Tuesday with KHN.

Although two ongoing clinical trials of 30,000 volunteers are expected to conclude by the end of the year, Fauci said an independent board has the authority to end the trials weeks early if interim results are overwhelmingly positive or negative.

The Data and Safety Monitoring Board could say, “‘The data is so good right now that you can say it’s safe and effective,’” Fauci said. In that case, researchers would have “a moral obligation” to end the trial early and make the active vaccine available to everyone in the study, including those who had been given placebos — and accelerate the process to give the vaccine to millions.

Fauci’s comments come at a time of growing concern about whether political pressure from the Trump administration could influence federal regulators and scientists overseeing the nation’s response to the novel coronavirus pandemic, and erode shaky public confidence in vaccines. Prominent vaccine experts have said they fear Trump is pushing for an early vaccine approval to help win reelection.

Fauci, director of the National Institute of Allergy and Infectious Diseases, said he trusts the independent members of the DSMB — who are not government employees — to hold vaccines to high standards without being politically influenced. Members of the board are typically experts in vaccine science and biostatistics who teach at major medical schools.

“If you are making a decision about the vaccine, you’d better be sure you have very good evidence that it is both safe and effective,” Fauci said. “I’m not concerned about political pressure.”

The safety board periodically looks at data from a clinical trial to determine if it’s ethical to continue enrolling volunteers, who are randomly assigned to receive either an experimental vaccine or a placebo shot. Neither the volunteers nor the health workers who vaccinate them know which shot they’re receiving.

Manufacturers are now testing three COVID vaccines in large-scale U.S. trials. The first two studies — one led by Moderna and the National Institutes of Health and the other led by Pfizer and BioNTech — began in late July. Each study was designed to enroll 30,000 participants. Company officials have said both trials have enrolled about half that total. AstraZeneca , which has been running large-scale clinical trials in Great Britain, Brazil and South Africa, launched another large-scale vaccine study this week in the U.S., involving 30,000 volunteers. Additional vaccine trials are expected to begin this month.

In trials of this size, researchers will know if a vaccine is effective after as few as 150 to 175 infections, said Dr. Robert Redfield, director of the Centers for Disease Control and Prevention, in a call with reporters Friday.

“It may be surprising, but the number of events that need to occur is relatively small,” Redfield said.

Right now, only the safety board has access to the trial data, said Paul Mango, deputy chief of staff for policy at the Department of Health and Human Services. As for when trial results will be available, “we cannot determine if it will be the middle of October or December.”

Safety boards set “stopping rules” at the beginning of a study, making their criteria for ending a trial very clear, said Dr. Eric Topol, executive vice president for research at Scripps Research in San Diego and an expert on the use of data in medical research.

Although the safety board can recommend stopping a trial, the ultimate decision to halt a study is made by the scientists running the trial, Topol said.

A vaccine manufacturer could then apply to the Food and Drug Administration for an emergency use authorization, which can be granted quickly, or continue through the regular drug approval process, which requires more time and evidence.

Safety monitors also can stop a trial because of safety concerns, “if it looks like it’s actually harming people in the vaccine arm, due to a lot of adverse events,” Fauci said.

Fauci said people can trust the process, because all the data that outside monitors used to make their decisions would be made public.

“All of that has to be transparent,” Fauci said. “The only time you get concerned is if there is any pressure to terminate the trial before you have enough data on safety and efficacy.”

Topol and other scientists have sharply criticized the FDA in recent weeks, accusing Commissioner Stephen Hahn of bowing to political pressure from the Trump administration, which has pushed the agency to approve COVID treatments faster.

Stopping trials early poses a number of risks, such as making a vaccine look more effective than it really is, Topol said.

“If you stop something early, you can get an exaggerated benefit that isn’t real,” because less positive evidence only emerges later, Topol said.

Stopping the studies early also could prevent researchers from recruiting more minority volunteers. So far, only about 1 in 5 trial participants is Black or Hispanic. Given that Blacks and Hispanics have been hit harder than other groups by the pandemic, Topol said, it’s important that they make up a larger part of vaccine trials.

Ending vaccine trials early also carries safety risks, said Dr. Paul Offit, a vaccine developer who serves on an NIH advisory panel on COVID vaccines and treatments.

A smaller, shorter trial could fail to detect important vaccine side effects, which could become apparent only after millions of people have been immunized, said Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.

Researchers will continue to follow vaccinated volunteers for a full year to look for long-term side effects, Redfield said.

And Fauci acknowledged that cutting a trial short could undermine public confidence in COVID vaccines. One in three Americans is unwilling to get a COVID vaccine, according to a recent Gallup Poll.

This story was produced by Kaiser Health News, an editorially independent program of the Kaiser Family Foundation.

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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Una vacuna contra COVID-19 podría estar disponible antes de lo esperado si los ensayos clínicos en curso producen resultados abrumadoramente positivos, dijo el doctor Anthony Fauci, funcionario de enfermedades infecciosas de más alto rango del país, en una entrevista con KHN.

Aunque se espera que dos ensayos clínicos en curso con 30,000 voluntarios terminen para fin de año, Fauci dijo que una junta independiente tiene la autoridad para finalizarlos semanas antes si los resultados provisionales son abrumadoramente positivos o, por el contrario, negativos.

La Junta de Monitoreo de Datos y Seguridad (DSMB) podría decir: “al momento, los datos son tan buenos que se puede decir que son seguros y efectivos”, explicó Fauci. En ese caso, los investigadores tendrían “la obligación moral” de finalizar el ensayo antes de tiempo y hacer que la vacuna esté disponible para todos en el estudio, incluidos los que recibieron placebos, y acelerar el proceso para administrarla a millones.

Los comentarios de Fauci, quien es director del Instituto Nacional de Alergias y Enfermedades Infecciosas, ocurren en un momento de creciente preocupación sobre si la presión política de la administración Trump podría influir en los reguladores federales y los científicos que supervisan la respuesta de la nación a la pandemia del nuevo coronavirus. Y erosionar la débil confianza del público en las vacunas.

Destacados expertos en vacunas han dicho que temen que Trump esté presionando por una aprobación temprana de una vacuna para ayudar a ganar la reelección.

Fauci dijo que confía en los miembros independientes del DSMB, que no son empleados del gobierno, para mantener las vacunas a altos estándares sin influencias políticas. Los miembros de la junta suelen ser expertos en inmunización y bioestadística, y suelen dar cátedra en las principales escuelas de medicina.

“Si estás tomando una decisión sobre la vacuna, es mejor asegurarse de tener muy buena evidencia de que es segura y efectiva”, dijo Fauci. “No me preocupa la presión política”.

La junta de seguridad analiza periódicamente los datos de un ensayo clínico para determinar si es ético continuar inscribiendo voluntarios, que se asignan al azar para recibir una vacuna experimental o una inyección de placebo (que no contiene la dosis de la vacuna). Ni los voluntarios ni los trabajadores sanitarios que los inyectan saben qué vacuna están recibiendo.

Los fabricantes ahora están probando tres vacunas contra COVID en ensayos a gran escala en los Estados Unidos. Los dos primeros estudios, uno dirigido por Moderna y los Institutos Nacionales de Salud y el otro dirigido por Pfizer y BioNTech, comenzaron a fines de julio.

Cada estudio fue diseñado para inscribir a 30,000 participantes. Los funcionarios de la compañía han dicho que ambos ensayos han inscrito aproximadamente la mitad de ese total. AstraZeneca, que ha estado ejecutando ensayos clínicos a gran escala en Gran Bretaña, Brasil y Sudáfrica, lanzó otro gran estudio con una vacuna en los Estados Unidos la primera semana de septiembre, en el que participan 30,000 voluntarios. Se espera que comiencen ensayos adicionales de vacunas este mes.

En ensayos de este tamaño, los investigadores sabrán si una vacuna es efectiva después de tan solo 150 a 175 infecciones, dijo el doctor Robert Redfield, director de los Centros para el Control y Prevención de Enfermedades (CDC), en una llamada con periodistas el viernes 28 de agosto.

“Puede ser sorprendente, pero el número de eventos que deben ocurrir es relativamente pequeño”, dijo Redfield.

En este momento, la junta de seguridad sólo tiene acceso a los datos del ensayo, dijo Paul Mango, subdirector de personal para Normas del Departamento de Salud y Servicios Humanos (HHS). En cuanto a cuándo estarán disponibles los resultados de la prueba, “no podemos determinar si será a mediados de octubre o diciembre”.

Las juntas de seguridad establecen “reglas de detención” al comienzo de un estudio, lo que deja muy claro sus criterios para finalizar un ensayo, dijo el doctor Eric Topol, vicepresidente ejecutivo de investigación de Scripps Research en San Diego y experto en el uso de datos en investigación médica.

Aunque la junta de seguridad puede recomendar detener un ensayo, la decisión final la toman los científicos que lo está realizando, dijo Topol.

Luego, un fabricante de vacunas podría solicitar a la Administración de Alimentos y Medicamentos (FDA) una autorización de uso de emergencia, que se puede otorgar rápidamente, o continuar a través del proceso regular de aprobación de medicamentos, que requiere más tiempo y evidencia.

Los que monitorean la seguridad también pueden detener un ensayo debido a preocupaciones de seguridad, “si parece que realmente está dañando a las personas en el brazo, o por una una gran cantidad de efectos secundarios”, dijo Fauci.

Fauci dijo que la gente puede confiar en el proceso, porque todos los datos que los monitores externos usaron para tomar sus decisiones se hacen públicos.

“Todo eso tiene que ser transparente”, dijo Fauci. “El único momento preocupante es si existe alguna presión para terminar el ensayo antes de tener suficientes datos sobre seguridad y eficacia”.

En las últimas semanas, Topol y otros científicos han criticado duramente a la FDA, acusando al comisionado Stephen Hahn de ceder ante la presión política de la administración Trump, que ha empujado a la agencia a aprobar los tratamientos para COVID más rápido.

Frenar los ensayos antes de tiempo plantea una serie de riesgos, por ejemplo,  hacer que una vacuna parezca más eficaz de lo que realmente es, dijo Topol.

“Si detienes algo antes, puedes obtener un beneficio exagerado que no es real, porque la evidencia menos positiva solo surge más tarde”, dijo Topol.

Detener los estudios antes de tiempo también podría evitar que los investigadores recluten más voluntarios de minorías. Hasta ahora, solo 1 de cada 5 participantes del ensayo son personas de raza negra o hispanos (de todas las razas). Dado que esos grupos se han visto más afectados por la pandemia que otros, es importante que constituyan una parte más importante de los ensayos de vacunas, agrego Topol.

La finalización temprana de los ensayos de vacunas también conlleva riesgos de seguridad, expresó el doctor Paul Offit, desarrollador de vacunas que forma parte de un panel asesor de los NIH sobre vacunas y tratamientos para COVID.

Un ensayo más pequeño y más corto podría no detectar efectos secundarios importantes de la vacuna, que podrían hacerse evidentes solo después de que millones de personas hayan sido inmunizadas, dijo Offit, director del Centro de Educación sobre Vacunas del Hospital de Niños de Philadelphia.

Los investigadores continuarán siguiendo a los voluntarios vacunados durante un año completo para detectar efectos secundarios a largo plazo, dijo Redfield.

Y Fauci reconoció que acortar un ensayo podría socavar la confianza del público en las vacunas contra COVID. Uno de cada tres estadounidenses no está dispuesto a recibir una vacuna contra el nuevo coronavirus, según una encuesta reciente de Gallup.

Esta historia fue producida por Kaiser Health News, un programa editorial independiente de la Kaiser Family Foundation.

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 senior correspondent Markian Hawryluk joined KUNC’s Erin O’Toole on “Colorado Edition” to discuss his recent story about how the Affordable Care Act is affecting the close Colorado Senate race between incumbent Republican Sen. Cory Gardner and Democratic former Gov. John Hickenlooper. That race and five others involving vulnerable Republican incumbents who sought to repeal the health care law could determine which party controls the U.S. Senate in 2021.

Public sentiment about the health care law, also known as Obamacare, has shifted. What was a political liability in 2014 for candidates has become a selling point amid the loss of jobs and health insurance for millions of people during the coronavirus pandemic.

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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SACRAMENTO — After years of failed attempts and vociferous opposition, California lawmakers on Monday adopted a measure to grant nurse practitioners the ability to practice without doctor supervision — but only after making big concessions to the powerful doctors’ lobby, which nonetheless remains opposed.

The bill now heads to Gov. Gavin Newsom for consideration, fenced in by amendments that would stringently limit how much independence nurse practitioners — nurses with advanced training and degrees — can have to practice medicine.

Lawmakers credit these compromises, like them or not, for finally allowing them to push the issue over the finish line, capping years of political scrapping and perhaps one day altering the delivery of health care in California.

“This is not an intrusion on a hallowed profession, it’s a relief,” said state Sen. John Moorlach (R-Costa Mesa), one of four Republican senators who voted for the bill. Moorlach said the measure would get more practitioners into underserved areas that don’t have enough doctors.

“It’s like the cavalry coming up over the hill to provide reinforcements to a tired army of wonderful and overworked doctors,” he said.

California is behind most other states in empowering nurse practitioners. If the bill becomes law, the state would join nearly 40 others to grant some level of independence to nurse practitioners; 22 grant full independence, according to the American Association of Nurse Practitioners. California would have among the most restrictive policies on nurse practitioner independence in the country.

“I’m not going to say I regret any of these changes,” said Assembly member Jim Wood (D-Santa Rosa), who chairs the Assembly Health Committee and authored the bill, AB-890.

Wood opposed previous attempts to remove supervision requirements.

“I wish it could be a little less strict, quite frankly,” he said, adding that this was a reasonable compromise informed by his experiences as a dentist and what he learned from other providers.

Today, nurse practitioners must enter into a written agreement with a physician to oversee their work with patients. In exchange, physicians bill them between $5,000 and $15,000 per year, according to a report by the California Health Care Foundation and the University of California-San Francisco. (California Healthline is an editorially independent service of the California Health Care Foundation.)

“Where we are with the pandemic and the craziness of the world today, it highlights why there’s a need for this,” said Andrew Acosta, a spokesperson for the California Association for Nurse Practitioners. “The doctor shortage isn’t going away anytime soon.”

Under Wood’s measure, nurse practitioners would be able to see patients in their own practice, but only after working under physician supervision for at least three years. The bill also contains many other restrictions.

Nurse practitioners argue that the measure, even with its limitations, would ease primary care shortages, especially in rural areas — a problem the pandemic has made more stark.

Opponents, primarily the powerful California Medical Association, which is the doctors’ lobbying group, counter that stripping nurse practitioners of physician oversight would lead to a lower standard of care, and that nurse practitioners wouldn’t necessarily flock to rural areas once they’re free of physician supervision.

These arguments aren’t new in Sacramento, but lawmakers and lobbyists say this version of the bill succeeded because there are new leaders at the helm of influential legislative committees who were willing to make changes, and because the pandemic has changed health care.

“I think the legislature is starting to realize decades of evidence that nurse practitioners are safe, productive providers,” said Ed Hernandez, a former legislator who was termed out in 2018 and authored the last two failed bills. “I think the policy is finally overshadowing the politics” of the California Medical Association.

Still, the biggest difference this year is the bill itself. Hernandez’s bills, introduced in 2013 and 2015, were “clean” bills that granted independence to nurse practitioners without many requirements.

There’s nothing clean about Wood’s bill, which was heavily amended in the state Senate. Instead of simply lifting the supervision requirements on nurse practitioners, the measure imposes several hoops for nurse practitioners to jump through. Before they could practice independently, nurse practitioners would have to be certified by preapproved national nursing boards, and possibly complete additional California-specific testing if accredited out of state.

Once certified, they would have to practice under physician supervision for at least three years — up to six in some cases — before they could strike out on their own. And they would have to disclose to patients that they aren’t doctors.

The bill even prescribes a Spanish phrase for “nurse practitioner”: enfermera especializada. (Technically, this refers to a female nurse. The bill doesn’t provide the equivalent phrase for a male nurse.)

That’s not even all the amendments — and the measure wouldn’t take effect until 2023.

The requirements were inserted in response to criticism from the California Medical Association that nurse practitioners are not qualified to provide patient care without physician oversight, and that patients wouldn’t understand that they’re seeing someone with less training than a doctor, lawmakers said.

Despite the numerous amendments, the association remains opposed, saying the changes don’t address their fundamental concerns.

“We’ve increased the training required for physicians over the last couple years and now all of a sudden we’re allowing unsupervised providers to treat patients who have even less training,” said association spokesperson Anthony York.

Rounds of negotiations, major concessions and hourslong Zoom calls still could not get the doctors’ group on board, Wood said.

He said it was like chasing “goalposts that continue to move.”

“It’s very disappointing when you work with opposition and nothing is ever good enough,” Wood said. “CMA will never support this bill. They’ll never go neutral on it.”

York said that characterization is not accurate. He pointed to a different bill — SB-1237 — that would allow certified nurse midwives to attend to low-risk pregnancies without physician supervision. The association was initially opposed, but after negotiations and amendments to the bill, it changed its position to neutral. That bill is also headed to Newsom.

“You don’t have to look too far to find a case where we were willing to engage on a scope-of-practice issue,” York said.

David McCuan, a political science professor at Sonoma State University, called the association’s inability to kill Wood’s bill a political “watershed moment” for the group.

“Their M.O. for 70 years has been about blocking, stunting and preventing change,” McCuan said. “The deference toward the medical profession has changed. In that sense, it would be a momentous event if this is signed.”

Though the California Association for Nurse Practitioners is celebrating legislative passage of the measure, even in its amended form, it’s a different story at the national level. Sophia Thomas, president of the American Association of Nurse Practitioners, said in a statement that the bill is choked by too much red tape to provide any meaningful change.

“California’s so-called ‘solution,’ the flawed AB-890, would establish a cascading set of new restrictions on NP practice that would maintain California’s position among the most heavily regulated and restrictive in the nation,” Thomas said.

State Sen. Richard Pan (D-Sacramento), a pediatrician who chairs the Senate Health Committee, said he also opposed the bill, but not simply because he is a doctor or a member of the California Medical Association.

Yet many of his objections reflect those of the association, such as concerns about training and access to care in rural areas.

He also believes independence for nurse practitioners could exacerbate inequalities in the health care system, as people with less means see providers with less training.

“People with more resources are going to go with the person they think is more qualified. That’s just the way it tends to happen,” Pan said.

California Healthline’s Angela Hart contributed to this report.

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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SACRAMENTO — California is poised to become the first state to develop its own line of generic drugs, targeting soaring drug prices and stepping into a fiercely competitive drug market dominated by deep-pocketed pharmaceutical companies.

The Democratic-controlled legislature overwhelmingly approved a measure Monday that would direct the state’s top health agency to partner with one or more drug companies by January to make or distribute a broad range of generic or biosimilar drugs — including the diabetes medicine insulin — that are cheaper than brand-name products.

The bill, SB-852, also opens the door for California to make its own generic drugs in the future.

Gov. Gavin Newsom will have until Sept. 30 to sign or veto the measure.

“People need these drugs, but prices are through the roof, so we’re saying there’s a role for the state to bring prices down,” said the bill’s author, state Sen. Richard Pan (D-Sacramento).

He argued the measure is more important than ever because COVID-19 has exposed “glaring gaps” in the ability of public and private entities — from major hospitals to government drug purchasers — to maintain adequate supplies of drugs, medical equipment and devices.

“This also creates a model to address drug shortages and other supply chain issues during COVID and future pandemics,” he said.

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Newsom, a Democrat, floated his own generic drug proposal in January as part of his broader drug agenda to reduce pharmaceutical costs, but was forced to abandon his plan in May as he and lawmakers sought to address a pandemic-induced $54 billion budget deficit.

Though it could take years to successfully bring a new California generic product to the market, the move would put the nation’s most populous state in direct competition with major generic and brand-name drug manufacturers that dominate the market, and potentially allow California to use its massive purchasing power to drive down drug prices.

“Other legislative efforts in Congress and in other states have focused on government negotiating with pharmaceutical companies to lower prices on generic drugs,” said Edwin Park, research professor at the Health Policy Institute at Georgetown University.

The Pharmaceutical Research and Manufacturers of America, which represents brand-name drugmakers, has taken a neutral position on the bill and declined to comment.

But Brett Michelin, lead lobbyist for the Washington, D.C.-based trade group that represents generic drugmakers, the Association for Accessible Medicines, said generic companies aren’t threatened by the possibility of California entering the market — and even welcome it.

“Generic manufacturers are more than open to doing this kind of partnership,” Michelin said. “I think having a fair and open process to sell drugs and compete for customers is what the generic industry is very used to and comfortable with.”

Under the measure, state-developed generics would be “widely” available to public and private purchasers within California. Taxpayers would pick up the costs, roughly $1 million to $2 million in startup funding, plus ongoing staff costs estimated in the low hundreds of thousands of dollars annually, according to a state fiscal analysis.

It’s unclear which drugs the state would make or procure, though it would target drugs that could produce the biggest cost savings for the state and consumers.

But the bill specifically calls for the production of “at least one form of insulin, provided that a viable pathway for manufacturing a more affordable form of insulin exists at a price that results in savings.”

Insulin is a biologic drug, made with living cells. Once a biologic hits the market, rival copycat products that follow are called biosimilars.

Three major drug companies — Eli Lilly and Co., Sanofi and Novo Nordisk — have long controlled the lucrative insulin market in the U.S. The state of California would be the first entity to produce a biosimilar version of one of the newer, fast- and long-acting insulins on a not-for-profit basis, said Jane Horvath, a health policy consultant in Washington, D.C.

Although it would be costly and could take years, the Utah-based nonprofit drug company Civica Rx, which has consulted with Pan on his bill, is discussing partnering with California to produce generic or biosimilar drugs. It has already hammered out deals with major health systems running short on critical drugs, including the Department of Veterans Affairs, and is producing lower-cost generics for insurers, including Blue Shield of California.

“There’s no doubt insulin would be a more complex and expensive drug to develop, but it’s certainly possible,” said Allan Coukell, the company’s senior vice president of public policy. “We are watching how the biosimilar market develops.”

Patients who need insulin have faced huge cost spikes. A 2019 report by the Health Care Cost Institute concluded that average prices for insulin doubled from 2012 to 2016. And California health insurance regulators found last year that diabetes medications accounted for nine of the 25 costliest brand-name drugs sold in the state.

“It’s a big deal — diabetes affects a lot of people who rely on insulin for their very lives,” said Larry Levitt, executive vice president for health policy at the Kaiser Family Foundation. “And insulin has probably been the poster child for unreasonable drug pricing.” (Kaiser Health News, which produces California Healthline, is an editorially independent program of the foundation.)

Laura Marston, a Washington, D.C.-based lawyer and diabetic who advocates for lower insulin prices, said she’s excited about California’s idea.

Marston has been on the same insulin, Humalog, since 1996. At that time, the price was $21 a vial, but has since ballooned to more than $275 a vial, she said.

“If there was a lower-cost option and the price wasn’t going to be raised, I would absolutely switch from Humalog,” she said. “I feel held totally hostage to these pharmaceutical companies.”

Marston said she’d like the federal government to do the same thing, “so it could apply to all patients.”

Congressional efforts to tackle rising prices for insulin and other drugs fizzled last year in the face of opposition from the influential pharmaceutical lobby. So states have increasingly sought ways to regulate a for-profit industry in which brand-name manufacturers hold near-monopoly power.

Colorado last year became the first state to cap out-of-pocket insulin costs at $100 for a 30-day supply. It was followed by at least nine other states, from New Mexico to New York, whose cost-sharing caps vary.

California had already capped out-of-pocket drug costs at $250 to $500 for a 30-day supply, but a measure that would have lowered the cap for insulin to $100 a month stalled this year — a casualty of a pandemic-shortened legislative calendar.

Newsom’s office declined to comment on the generic drug legislation. But recent changes to the proposal reflect direct negotiations with the administration, Pan’s office said.

Newsom spokesperson Jesse Melgar said in a statement that “the governor’s goal of a sustainable system of universal coverage has not changed and making prescription drugs affordable is one more step toward that goal.”

Should Newsom sign the bill into law, the state Health and Human Services Agency would have 18 months to identify a list of drugs the state could manufacture, with a report due to the legislature by July 2022. By July the following year, the state would be required to assess whether it can manufacture its own generics and biosimilars.

The bill calls for state health officials to prioritize development of generics for chronic and high-cost health conditions, and urges production of those that can be delivered through mail order.

California could emerge as a leader in the national drug debate, Levitt said.

“If California can pull it off, it would be a model for other states and federally,” he said. “For it to pull this off means it can be done at scale.”

“What activities are open to do next week? Zip-lining? Jet ski? Anyone have recommendations on things still open?” a Facebook user asks.

“Stay home!” another user replies.

The Facebook group called “What’s Going on St. Thomas?” has been flooded with pointed, exasperated comments urging travelers to stay away. This is a marked change. Before the pandemic, the exchanges between vacationers and island residents resonated with promises of excitement and fun. Now, tour operators from the mainland who administer the Facebook page quickly try to delete any expressions of anger.

In nearby Puerto Rico, the friction has spilled into real life. Media reports have detailed multiple episodes in which tourists, having escaped pandemic restrictions back home, became violent and destroyed store merchandise after being asked to wear a mask.

The COVID-19 pandemic has pitted economic interests against public health guidance all across the United States. Puerto Rico and the Virgin Islands feel this tension acutely, as both U.S. territories rely on tourism to generate revenue and provide jobs. Increasingly, locals have begun to wonder now if welcoming visitors to these islands is worth the risk.

Tourism represents more than half of the Virgin Islands’ gross domestic product. In Puerto Rico, the industry accounts for 80,000 jobs and about 6.5% of the island’s total economy.

But islanders are not only vulnerable to COVID-19’s economic disruptions. Residents of both Puerto Rico and the Virgin Islands are diagnosed with chronic health conditions like diabetes and cardiovascular illness at higher rates than in most U.S. states, which puts them at higher risk for the virus’s complications.

In short, the very industry that represents an economic lifeline for islanders threatens their ability to protect their health.

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One Step Forward

When COVID-19 triggered alarms in late winter, Puerto Rico and the USVI adopted strong COVID prevention strategies before most U.S. states did.

In Puerto Rico, Gov. Wanda Vázquez issued an executive order March 15, effectively locking down the island by imposing a curfew, a stay-at-home order and business closures. The first coronavirus cases on the island were reported March 13.

Similarly, Virgin Islands Gov. Albert Bryan Jr. issued executive orders prohibiting hotels, villas and other accommodations from accepting leisure guests between March 25 and June 1. The area remained open to business travelers, flight crews, health officials, emergency personnel, government guests and residents. According to a March 20 Department of Health update, the territory had — at that time — six confirmed COVID cases and 43 pending test results.

Neither territory, however, was able to close its airports. Local officials do not have the authority to do so because the federal government regulates aviation.

“Part of the challenge of being a U.S. colony, in particular, is that, you know, we don’t have control over our borders,” said Hadiya Sewer, president and co-founder of St. JanCo: the St John Heritage Collective, a cultural heritage preservation and land rights organization on the small island of St. John, U.S. Virgin Islands.

Still, the aggressive measures — while effective — came at a price for residents like Melina Aguilar.

Before the lockdown, the 31-year-old entrepreneur worked as a tour guide for Isla Caribe, a company she founded that offers historical walking tours of Ponce, Puerto Rico. The stay-at-home order in March shut down Aguilar’s business for three months and sequestered her in her house.

Aguilar said the sacrifice would have been worth it if the island could have maintained control of the spread by closing the border and enforcing the 14-day quarantine for travelers. It didn’t work out that way. According to data from The New York Times, the seven-day average for cases on May 1 — while Puerto Rico was still in lockdown — was 42 cases per day. On July 1, the seven-day average was 102 cases. By July 15, the average was 233.

“We could’ve basically had the fruits of being locked up for three months,” Aguilar said. “But now we’re stuck.”

Reopening the Gateway

By summer, both territories were itching to get back to business. With many overseas vacation destinations banning U.S. travelers, it seemed like the nearby mainland would be full of beachgoers, who, after living under stay-at-home orders for months, would be ready to travel — no passport required — to the sun and sand.

The U.S. Virgin Islands formally welcomed tourists back to its shores on June 1 — with caveats. Travelers from coronavirus hot spots needed to submit COVID-19 test information through an online portal to receive a negative result “certification code.” Those who didn’t were required to quarantine for 14 days or until they had documentation of a negative test result.

But locals and tourists alike said COVID enforcement measures haven’t been consistent. Capt. Matthias Bitterwolf, owner of Antillean Yacht Charters on St. Thomas, said he delivered a boat to Puerto Rico and was not allowed off the vessel until local police could verify his COVID paperwork. His COVID status was not checked upon returning to St. Thomas.

The Virgin Islands’ case counts soon began ticking up. Between June and mid-July, the case count increased by more than 3,500%, according to one NBC news report.

Gov. Bryan responded by issuing other executive orders to regain control of the outbreak, including prohibiting beach visits after 4 p.m. and not allowing patrons to stand or eat at bars located in restaurants. As of Aug. 24, the USVI had a total of 984 positive COVID-19 cases and 11 deaths.

Puerto Rico formally welcomed tourists on July 15 while still imposing some COVID-related restrictions. As in the Virgin Islands, officials required travelers to present documentation of a negative COVID test result upon arrival.

Dr. Victor Ramos, president of the island’s medical association who is involved with the island’s medical task force, said these decisions tended to expose the rift “between the medical task force that favors closing things and the economic task force that wants to leave everything open.”

By July, the local economy was in shambles. The Department of Labor reported over 21% of the island’s workforce was receiving unemployment assistance related to the pandemic in the week ending Aug. 1.

But rising case counts attributed to travel prompted local officials to encourage that only essential travel be allowed. As of Aug. 24, the island had recorded over 30,700 COVID cases and at least 395 deaths, according to the New York Times database.

Government data, though, indicated Puerto Rico’s climbing case numbers were not being triggered by tourists. They are not the culprits, insisted Leah Chandler, chief marketing officer of Discover Puerto Rico, the island’s official tourism website. Rather, the spread was linked to island residents coming home after visiting COVID hot spots like Texas and Florida.

Life on the Ground

Despite the global pandemic and the restrictions, both territories have experienced no shortage of vacationers. “We would have expected this to be a slow moment for us in terms of tourism,” said Sewer. “It’s very busy.”

Still, the trend lines for COVID case counts weren’t moving in the right direction for either territory, so it was no surprise when Puerto Rico closed days after reopening and the USVI followed suit on Aug. 19.

The underlying socioeconomic and health issues put residents in both places at high risk. It’s not just the prevalence of chronic health conditions like diabetes and cardiovascular disease. The high number of multigenerational households in both areas complicates a family’s ability to socially distance from its most vulnerable members. Roughly a quarter of the population in Puerto Rico and the Virgin Islands is age 65 or older, and poverty is widespread.

At the same time, both territories have limited health care infrastructure — making it difficult to envision that they can care for their own populations in an emergency let alone visitors who could become ill and island-bound if the virus were to surge.

Currently, the USVI has two main hospitals — one in St. Thomas and one in St. Croix — and a health clinic in St. John. The territory has 20 intensive care unit beds and about 100 one-time-use ventilators for its 106,235 residents, said Justa Encarnacion, the USVI’s health commissioner. Each island has about 30 full-capacity ventilators.

In Puerto Rico, about 60% of the island’s ventilators for adults were available as of Aug. 24. However, ICU beds are harder to come by, said Ramos. They are filled with COVID patients and those whose conditions worsened after avoiding care out of fear of catching the virus, he said.

The string of problems that have besieged these islands magnifies the effects of the pandemic. That includes debt crises and infrastructure damage from hurricanes and earthquakes. Island residents also fear the possibility of battling a hurricane and a coronavirus outbreak at the same time — a reality that they’ve already confronted when COVID hampered the USVI’s emergency management agency’s ability to distribute sandbags ahead of a storm in late July.

Colorado State University hurricane researchers predict an “extremely active” 2020 Atlantic hurricane season.

“At this point, we literally have disasters layered on top of disasters,” said Sewer, of the St. John’s Collective.

Still, Joseph Boschulte, tourism commissioner for the Virgin Islands, is cautiously optimistic about finding a balance between health and economic interests.

“We appreciate the concerns of our tourism partners and stakeholders,” he said. But with the spike in cases, he said, “we must reset, take stock, safeguard human life and prepare for restarting our tourism economy at a later date.”

As a veteran who served back-to-back tours in Iraq, I initially cringed when commentators compared the COVID-19 crisis to wartime — no bullets, no blood and no one volunteered for this.

But after my months of reporting on the pandemic, it has become painfully clear this is like war. People are dying every day as a result of government decisions — and indecision — and the death toll is climbing with no end in sight.

Less than six months into the pandemic, COVID-19 has already killed at least 183,000 Americans, more than triple the number who died in the Vietnam War, and far more than the wars in Iraq and Afghanistan combined.

We are all being asked to make sacrifices for the good of our country. And we’re experiencing, as a nation, a deeply traumatic event. Like war, the toll will be felt for a long time.

In California, local public health officials are leading the front lines in this battle against COVID-19, dictating strategy, issuing orders and developing tactics to carry out that strategy. Every day, they make gut-wrenching calls to protect our health and livelihoods, even if those decisions may inflict initial harm on the economy or contradict politicians and popular opinion.

But instead of being celebrated for their difficult and dangerous work, as I was, they are now facing violent threats and political attacks from those who disagree with their tactics — such as requiring masks in public and ordering businesses and parks closed to prevent the spread of infection.

When I interview them, often late at night, I hear in their voices that familiar mix of emotions that often come with war: exhaustion, anxiety and devotion to duty.

“We’ve become easy scapegoats for people’s fear and anxiety during COVID-19,” said Dr. Gail Newel, the health officer for Santa Cruz County, who continues to face threats for issuing public health orders.

The latest — a menacing email sent to her in late July calling her a “communist bitch” — prompted local law enforcement to recommend she get a guard dog and firearm to protect herself. “That weighs very heavily,” she said.

I can’t imagine the burden. Although many of us serving in Iraq disagreed with the war, we remained dedicated to our mission and enjoyed broad support at home.

I joined the military as a U.S. Army reservist in 1999 and was deployed on active duty to Iraq in early 2003, when it truly was like the Wild West.

Serving first as logistics clerk and then the acting supply sergeant for a military police company out of San Jose, California, I helped ensure my military brothers and sisters had proper equipment. When the George W. Bush administration sent us to Iraq, for example, it did so without armoring our Humvees — a major failure that elevated our risk of being blown up by roadside explosives.

I returned home in July 2004 and spent years putting the battlefield behind me as I transitioned to a career in journalism. But living through COVID-19 has resurrected those feelings of being at war.

Now, just like then, there is an overall sense of fear and uncertainty because we don’t know when the crisis will end. We aren’t free to go about our lives as we once did and we yearn for the comforts we took for granted. We miss our loved ones we can’t see.

We must remain hyper-vigilant to potential threats, and even make sure to don our “armor” when we leave our homes, except now it’s masks and gloves instead of helmets and flak jackets.

There’s something that happens when you’re in a conflict zone — the air feels heavier. You can feel threats all around you, just waiting to strike. There’s deep anxiety for what the future holds, and you wonder whether you’ll be alive next week or next month.

Public health officers are shouldering the added anxiety that duty brings. For much of the pandemic, Gov. Gavin Newsom has pushed the responsibility — and blame — of reopening largely onto counties and the state’s 61 local health officers, who have worked for months without days off, giving up time with their families to attack this crisis head-on.

I have interviewed dozens of them. Some have broken into tears while talking with me, and worry chokes their voices as they lament problems with testing or explain how they don’t have enough supplies or contact tracers to safely reopen. They felt rushed into lifting stay-at-home restrictions in May and June, yet they had no choice in the face of pressure from politicians and suffering residents and businesses. After years of severe underfunding, public health agencies don’t have the money or resources to deploy an adequate response.

They’re also wrestling with the guilt and trauma that come with making decisions that affect people’s lives and livelihoods.

“It has been hard on all of us,” acknowledged Sacramento County’s health officer, Dr. Olivia Kasirye. “We’re getting phone calls daily from people saying they’re going bankrupt and they can’t pay their rent and they have loved ones who are dying that they can’t see.”

I know how that feels, having been conflicted about our long-term strategy in the Middle East and the harm we inadvertently inflicted on innocent civilians. But I can’t imagine being afraid of the people I signed up to protect.

Public health officials have become targets of aggressive and personal attacks. Some have seen their photos smeared with Hitler mustaches, while others have had their personal phone numbers and home addresses circulated publicly, prompting the need for round-the-clock security.

“Imagine treating American soldiers and military families with the kind of hatred and disrespect that local health officers are facing,” said Dr. Charity Dean, unprompted, a day after she left her job as one of the top public health officials in the Newsom administration. “They’re the ones taking all the risk, and it makes me angry to see how they’ve been treated.”

Since the start of the pandemic, at least eight career public health officials in California have resigned, and more are considering it. But most are soldiering on.

Mimi Hall, Newel’s boss and Santa Cruz County’s top public health official, told me law enforcement is investigating a threatening letter addressed to her that was allegedly signed by a far-right anti-government extremist group.

In response, Hall considered retiring early. But she didn’t want to abandon her troops and wasn’t going to let fear stop her from doing her job. So she had a perimeter fence and home security system installed over the weekend — and reported for work promptly Monday morning.

Yes, we are waging a life-or-death battle in which innocent people are hurt, but it’s these battle-scarred public health officers who are making deeply personal sacrifices to steer us to safety.

We commemorate military leaders with medals and parades. Why not treat our public health officials with the same level of appreciation?

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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