Tagged NIH

Voz de un experto: los niveles de seguridad que propone Fauci durante COVID

Como periodista de salud, médica y ex corresponsal que vivió el SARS en Beijing, recibo preguntas de amigos, colegas y personas que ni siquiera conozco sobre cómo vivir durante una pandemia. ¿Creo que es seguro planear una boda en persona el próximo junio? ¿Enviaría a mis hijos a la escuela con las precauciones adecuadas? ¿Cuándo confiaré en una vacuna?

A la última pregunta, siempre respondo: vuando vea a Anthony Fauci recibir una.

Como muchos estadounidenses, sigo la palabra del doctor Fauci, el principal experto en enfermedades infecciosas del país y miembro del grupo de trabajo de la Casa Blanca sobre el coronavirus.

Cuando le dijo a The Washington Post que no estaba limpiando los paquetes sino que los dejaba reposar durante un par de días, comencé a hacer lo mismo. En octubre, comentó que ya entraba las bolsas del mercado a su casa. Simplemente se lava las manos después de sacar los productos. (¡Yo también!)

Ahora nos encontramos en una peligrosa transición política, con casos que se disparan alrededor del país, y Fauci y el grupo de trabajo original, en gran parte marginado.

El presidente electo Joe Biden ha designado a su equipo, pero no puede hacer mucho hasta que la Administración de Servicios Generales (GSA) acepte los resultados de las elecciones. Y Fauci me dijo que aún no ha hablado con el grupo de trabajo de Biden.

El presidente Donald Trump se ha resistido a las normas sobre la transición del gobierno, en las que los equipos nuevos y los salientes se coordinan entre sí.

Los tumultuosos meses pasados ​​se han llenado de brechas de información (todavía estamos aprendiendo sobre el nuevo coronavirus), datos erróneos (a menudo de boca del presidente) y una serie de “expertos”: personal de salud pública, matemáticos, cardiólogos y médicos de emergencias, como yo, ofreciendo opiniones en la televisión.

Pero todo este tiempo, la persona de la que más he querido saber es Fauci. Es directo, sin aparentes conflictos de intereses, políticos o financieros, o, a los 79 años, ambiciones profesionales. Al parecer, no tiene otros intereses más que los tuyos y los míos.

Así que le pregunté cómo podrían esperar vivir los estadounidenses en los próximos seis a nueve meses. ¿Cómo debemos comportarnos? ¿Y qué debería hacer la próxima administración? Algunas respuestas se han editado para mayor claridad y brevedad.

¿Qué dos o tres cosas cree que la administración Biden debería hacer el primer día de gobierno?

Algunos estados regiones parecen no haber aprendido las lecciones que podrían o deberían haberse aprendido cuando la ciudad de Nueva York y otras grandes ciudades fueron afectadas. Como implementar algunas medidas básicas de salud pública.

Quiero ser realmente explícito sobre esto, porque siempre que hablo de cosas simples como el uso consistente de máscaras faciales, mantener la distancia física, evitar las multitudes (particularmente en interiores), hacer cosas al aire libre si el clima lo permite, y lavarse las manos con frecuencia, eso no significa cerrar el país.

Aún puedes tener un margen considerable para los negocios, para la recuperación económica, si haces esas cosas simples. Pero lo que estamos viendo, desafortunadamente, es una respuesta muy dispar. Y eso conduce inevitablemente al tipo de olas [de nuevos casos] que vemos ahora.

¿Cree que necesitamos una norma como un mandato de máscara nacional? La administración actual ha delegado gran parte de la gestión de COVID-19 a los estados.

Creo que debería haber un uso universal de cubrebocas. Es ideal lograrlo con los alcaldes, gobernadores, autoridades locales. Si no, deberíamos considerar seriamente la norma nacional. La única razón por la que evito hacer una recomendación fuerte en ese sentido es que las cosas que vienen del nivel nacional hacia abajo generalmente generan un poco de rechazo por parte de una población ya reacia a que le digan qué hacer. Por lo tanto, podría terminar teniendo el efecto contrario: que se retroceda aún más.

¿Cómo sería un uso mandatorio de máscaras a nivel nacional? Significaría diferentes cosas en diferentes estados. Muchos estados requieren que la persona se cubra la cara, pero no específicamenteque que use cubrebocas. Muchos veinteañeros usan solo un pañuelo.

Creo que es poco probable que exista una diferencia sustancial. Quiero decir, el tipo común de máscara es la máscara quirúrgica. No es una máscara N95. Una tela gruesa puede ser igualmente efectiva. Creemos que puede haber algunas pequeñas diferencias, pero el objetivo principal es evitar infectar a otros. Estudios recientes han demostrado que [usar una máscara] también tiene el buen efecto de protegerte parcialmente. Por lo tanto, el beneficios es en ambas direcciones.

Muchos lugares que tienen mandatos de uso de cubrebocas han tenido problemas para hacerlos cumplir.

Esa es realmente una de las razones por las que hay una reticencia de parte de muchas personas, incluido yo mismo [a apoyar un mandato nacional]. Si tienes un mandato, debes hacerlo cumplir. Y, con suerte, podemos convencer a la gente cuando vean lo que está sucediendo en el país. Pero tengo que decirte que me sorprendió el hecho de que en ciertas áreas del país, aunque la devastación del brote es clara, algunas personas todavía dicen que son noticias falsas. Eso es algo muy difícil de superar: por qué la gente todavía insiste en que algo que tiene bajo sus narices no es real.

La gente suele pensar en los cierres como blanco o negro. Estás abierto o estás cerrado. Me gustaría escuchar la jerarquía del doctor Fauci de “es seguro e importante mantenerse abierto con precauciones” y “cosas que no son seguras bajo ninguna circunstancia”.

La razón por la que respondo con cierto grado de inquietud es porque las personas que son propietarias de estos negocios se enojan mucho conmigo. Hay algunos negocios esenciales que quieres mantener abiertos. Quieres mantener abiertos los supermercados, cosas que la gente necesita para su subsistencia. Si se hace correctamente, es posible que puedas mantener abiertos algunos negocios no esenciales, como tiendas de ropa, grandes almacenes.

Se acerca el invierno. Se podría mantener la distancia social en un restaurante o reunión en interiores. ¿Pero se sentiría bien estando ahí sin una máscara?

Si estamos en la zona caliente como estamos ahora, donde hay tantas infecciones alrededor, me sentiría bastante incómodo incluso solo estando en un restaurante. Sobre todo si está funcionando a capacidad completa.

Veo que te has cortado el cabello. ¿Qué opinas de las barberías y salones?

De nuevo, depende. Solía ​​cortarme el cabello cada cinco semanas. Ahora me lo corto cada 12, usando un cubrebocas, yo y el peluquero, claro.

¿Transporte? ¿Trenes? ¿Aviones? ¿Metro? ¿Cuál es la situación?

Depende de tus circunstancias individuales. Si eres alguien que se encuentra en la categoría de mayor riesgo, lo mejor es no viajar a ningún lado. O si tienes un automóvil, mejor que subirse a un metro, un autobús o un avión lleno de gente. Ahora, si tienes 25 años y no tienes condiciones subyacentes, es muy diferente.

¿Bares?

Las barras son realmente problemáticas. Si miras algunos de los brotes, ocurren cuando la gente entra en bares abarrotados. Yo mismo solía ir a un bar. Me gustaba sentarme en la barra, tomar una cerveza y comerme una hamburguesa. Pero cuando estás en un bar, la gente se inclina sobre tu hombro para pedir una copa, están pegados unos a otros. Es divertido porque es social, pero no es divertido cuando este virus está en el aire. Así que creo que si hay algo para evitar, por el momento, son los bares.

Algunas aerolíneas y algunos estados le dicen a la gente que debe hacerse una prueba de coronavirus antes de subir al avión o visitar otro estado. ¿Tiene eso algún sentido médico?

Si eres negativo cuando subes al avión, excepto en la rara circunstancia de que estés en esa pequeña ventana de incubación antes de volverte positivo, es algo bueno.

Si tuviera un plan nacional de pruebas, ¿cuál sería?

Pruebas de vigilancia. Inundando literalmente el sistema con pruebas. Obtener una prueba casera que puedas hacerte tú mismo, que sea muy sensible y específica. ¿Sabes por qué sería fantástico? Porque si decidiste que quieres tener una pequeña reunión con tus suegros y un par de niños, puedes hacerte la prueba en ese momento. No es 100%. No dejes que lo perfecto sea enemigo de lo bueno. Pero el riesgo que tienes disminuye dramáticamente si todos se hacen la prueba antes de reunirse para cena. Puede que nunca sea cero, pero, ya sabes, no vivimos en una sociedad completamente libre de riesgos.

Hay varias vacunas candidatas que son prometedoras. Pero también hay mucho escepticismo porque hemos visto a la FDA estar bajo presión tanto comercial como, cada vez más, política. ¿Cuándo sabremos que está bien recibir una vacuna? ¿Y cuál?

Es bastante fácil cuando hay vacunas que tienen un 95% de efectividad. No hay nada mejor que eso. Creo que lo que la gente debe apreciar, y es por eso que lo he dicho tal vez 100 veces en las últimas semanas, es el proceso mediante el cual se toma una decisión. La empresa analiza los datos. Observo los datos. Luego, se envían a la FDA. La FDA tomará la decisión de realizar una autorización de uso de emergencia o una aprobación de solicitud de licencia. Y tienen científicos de carrera que son realmente independientes. No le deben nada a nadie. Luego está otro grupo independiente, el Comité Asesor de Vacunas y Productos Biológicos Relacionados. El comisionado de la FDA ha prometido públicamente que actuará de acuerdo con la opinión de los científicos de carrera y del consejo asesor.

¿Cree que los científicos profesionales tendrán la última palabra?

Sí. Sí.

¿Y las decisiones que se están tomando en este período de transición, como el plan de distribución de vacunas, limitarán de alguna manera las opciones de una nueva administración?

No, no lo creo. Creo que una nueva administración tendrá la opción de hacer lo que sienta. Pero puedo decirles lo que va a pasar, independientemente de la transición o no, porque tenemos personas totalmente comprometidas con hacer esto bien que van a estar involucradas en el proceso. Tengo confianza.

¿Cuándo cree que todos podremos tirar nuestras máscaras?

Creo que vamos a tener algún grado de medidas de salud pública junto con la vacuna durante un período de tiempo considerable. Pero comenzaremos a acercarnos a lo normal, si la gran mayoría de las personas se vacuna, a medida que nos adentremos en el tercer o cuarto trimestre [de 2021].

Rosenthal es editora jefe de KHN

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Noticias En Español Public Health

Take It From an Expert: Fauci’s Hierarchy of Safety During COVID

As a health journalist, a physician and a former foreign correspondent who lived through SARS in Beijing, I often get questions from friends, colleagues and people I don’t even know about how to live during the pandemic. Do I think it’s safe to plan a real wedding next June? Would I send my kids to school, with appropriate precautions? When will I trust a vaccine?

To the last question, I always answer: When I see Anthony Fauci take one.

Like many Americans, I take my signals from Dr. Fauci, the country’s top infectious disease expert and a member of the White House task force on the coronavirus. When he told The Washington Post that he was not wiping down packages but just letting them sit for a couple of days, I started doing the same. In October, he remarked that he was bringing shopping bags into the house. He merely washes his hands after unpacking them. (Me too!)

Now we are in a dangerous political transition, with cases spiking in much of the country and Fauci and the original task force largely sidelined. President-elect Joe Biden has appointed his own, but it can’t do much until the General Services Administration signals that it accepts the results of the election. And Fauci told me he has not yet spoken with the Biden task force. President Donald Trump has resisted the norms on government transition, in which the old and new teams brief each other and coordinate.

The past tumultuous months have been filled with information gaps (we’re still learning about the novel coronavirus), misinformation (often from the president) and a host of “experts” — public health folks, mathematical modelers, cardiologists and emergency room doctors like me — offering opinions on TV. But all this time, the person I’ve most wanted to hear from is Fauci. He’s a straight shooter, with no apparent conflicts of interest — political or financial — or, at 79, career ambition. He seemingly has no interests other than yours and mine.

So I asked him how Americans might expect to live in the next six to nine months. How should we behave? And what should the next administration do? Some answers have been edited for clarity and brevity.

Q: Are there two or three things you think a Biden administration should do on Day One?

There were some states in some regions of the country that somehow didn’t seem to have learned the lessons that could have been learned or should have been learned when New York City and other big cities got hit. And that is to do some fundamental public health measures. I want to really be explicit about this, because whenever I talk about simple things like uniform wearing of masks, keeping physical distance, avoiding crowds (particularly indoors), doing things outdoors to the extent possible with the weather, and washing hands frequently, that doesn’t mean shutting down the country. You can still have a considerable amount of leeway for business, for economic recovery, if you just do those simple things. But what we’re seeing, unfortunately, is a very disparate response to that. And that inevitably leads to the kind of surges that we see now.

Q: Do you think we need a national policy like a national mask mandate? The current administration has left a lot of COVID-19 management to the states.

I think that there should be universal wearing of masks. If we can accomplish that with local mayors, governors, local authorities, fine. If not, we should seriously consider national. The only reason that I shy away from making a strong recommendation in that regard is that things that come from the national level down generally engender a bit of pushback from an already reluctant populace that doesn’t like to be told what to do. So you might wind up having the countereffect of people pushing back even more.

Q: What would a national mask mandate look like to you? It means different things in different states. Many states require face coverings, but not specifically masks. Many 20-somethings use only a bandanna.

I think it is unlikely that there’s a substantial difference. I mean, the typical type of a mask is the surgical mask. It’s not an N95 mask. One that has thick cloth, you know, can be equally as effective. We believe there may be some small differences between them, but the main purpose is that you prevent yourself from infecting others. Recent studies have shown that [wearing a mask] also has the good effect of partially protecting you. So it goes both ways.

Q: Many places that have mask mandates have had trouble enforcing them.

That’s really one of the reasons there’s a reticence on the part of many people, including myself [to support a national mandate]. If you have a mandate, you have to enforce it. And, hopefully, we can convince people when they see what is going on in the country. But I have to tell you, Elisabeth, I was stunned by the fact that in certain areas of the country, even though the devastation of the outbreak is clear, some people are still saying it’s fake news. That is a very difficult thing to get over: why people still insist that something that’s staring you right in the face is not real.

Q: People often think of shutdowns as binary. You’re open or you’re shut. Often, when you answer questions about how to live, you start with. ‘Well, I’m in a high-risk group. …” So I would love to hear Dr. Fauci’s hierarchy of “Safe and important to keep open with precautions” and “Things that aren’t safe under any circumstances.”

The reason I answer with some degree of trepidation is because the people who are the proprietors of these businesses start getting very, very upset with me. There are some essential businesses that you want to keep open. You want to keep grocery stores open, supermarkets open, things that people need for their subsistence. You might, if it’s done properly, keep open some nonessential businesses, you know, things like clothing stores, department stores.

Q: We’re heading into the winter months. You could social distance in a restaurant or in an indoor gathering. But would you feel OK being in there without a mask?

If we’re in the hot zone the way we are now, where there’s so many infections around, I would feel quite uncomfortable even being in a restaurant. And particularly if it was at full capacity.

Q: I see you’ve been getting your hair cut. What do you think about hair salons?

I mean, again, it depends. I used to get a haircut every five weeks. I get a haircut every 12 weeks now — with a mask on me, as well as a mask on the person who’s cutting the hair, for sure.

Q: Transportation? Trains? Planes? Metro? Where are we at the moment?

It depends on your individual circumstances. If you are someone who is in the highest risk category, as best as possible, don’t travel anywhere. Or if you go someplace, you have a car, you’re in your car by yourself, not getting on a crowded subway, not getting on a crowded bus or even flying in an airplane. If you’re a 25-year-old who has no underlying conditions, that’s much different.

Q: Bars?

Bars are really problematic. I have to tell you, if you look at some of the outbreaks that we’ve seen, it’s when people go into bars, crowded bars. You know, I used to go to a bar. I used to like to sit at a bar and grab a hamburger and a beer. But when you’re at a bar, people are leaning over your shoulder to get a drink, people next to each other like this. It’s kind of fun because it’s social, but it’s not fun when this virus is in the air. So I would think that if there’s anything you want to clamp down on, for the time being, it’s bars.

Q: Some airlines and some states are telling people you have to get a coronavirus test before you get on the plane or visit another state. Does that make sense medically?

If you’re negative when you get on the plane — except in the rare circumstance that you’re in that little incubation window before you turn positive — that’s a good thing.

Q: If you had a national plan for testing, what would it be?

Surveillance testing. Literally flooding the system with tests. Getting a home test that you could do yourself, that’s highly sensitive and highly specific. And you know why that would be terrific? Because if you decided that you wanted to have a small gathering with your mother-in-law and father-in-law and a couple of children, and you had a test right there. It isn’t 100%. Don’t let the perfect be the enemy of the good. But the risk that you have — if everyone is tested before you get together to sit down for dinner — dramatically decreases. It might not ever be zero but, you know, we don’t live in a completely risk-free society.

Q: There are a number of vaccine candidates that are promising. But there’s also a lot of skepticism because we’ve seen the FDA come under both commercial and, increasingly, political pressure. When will we know it’s OK to take a vaccine? And which?

It’s pretty easy when you have vaccines that are 95% effective. Can’t get much better than that. I think what people need to appreciate — and that’s why I have said it like maybe 100 times in the last week or two — is the process by which a decision is made. The company looks at the data. I look at the data. Then the company puts the data to the FDA. The FDA will make the decision to do an emergency use authorization or a license application approval. And they have career scientists who are really independent. They’re not beholden to anybody. Then there’s another independent group, the Vaccines and Related Biological Products Advisory Committee. The FDA commissioner has vowed publicly that he will go according to the opinion of the career scientists and the advisory board.

Q: You feel the career scientists will have the final say?

Yes, yes.

Q: And will the decisions that are being made in this transition period — like the vaccine distribution plan — in any way limit the options of a new administration?

No, I don’t think so. I think a new administration will have the choice of doing what they feel. But I can tell you what’s going to happen, regardless of the transition or not, is that we have people totally committed to doing it right that are going to be involved in this. So I have confidence in that.

Q: When do you think we’ll all be able to throw our masks away?

I think that we’re going to have some degree of public health measures together with the vaccine for a considerable period of time. But we’ll start approaching normal — if the overwhelming majority of people take the vaccine — as we get into the third or fourth quarter [of 2021].

Q: Thank you so much. And have a nice Thanksgiving.

Take care, and you too.

[Editor’s note: Dr. Fauci has said his family is forgoing the usual family Thanksgiving gathering this year because his adult children would have to fly home and that travel would expose him to risk.] 

You can listen to the full interview on KHN’s “What the Health?” podcast.

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KHN’s ‘What the Health?’: What Would Dr. Fauci Do?


Can’t see the audio player? Click here to listen on SoundCloud.


Since the mid-1980s, whenever there’s been a public health crisis, America — and six U.S. presidents — have turned to Dr. Anthony Fauci. As director of the National Institute of Allergy and Infectious Diseases (one of the National Institutes of Health), Fauci has helped guide the U.S. and the world through the HIV/AIDS epidemic, as well as various flu epidemics and outbreaks of SARS, Ebola and Zika.

Now Fauci is facing the difficult task of navigating the turbulent waters between the outgoing Trump administration and incoming Biden administration in the midst of an escalating pandemic. As a member of the Trump administration’s COVID-19 task force, Fauci has taken heat from President Donald Trump and his supporters for delivering news and advice that does not match what the president wants to hear. And with the transition delayed because the federal government has not yet recognized Joe Biden as president-elect, Fauci is not free to meet with Biden’s team.

On this special episode of KHN’s “What the Health?” podcast, Fauci sits down for an interview with KHN Editor-in-Chief Elisabeth Rosenthal, a fellow physician. They explore the thorny political landscape and discuss how regular Americans should prepare to get through the coming months — as the pandemic surges and we wait for vaccines to become available.


To hear all our podcasts, click here.

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Government-Funded Scientists Laid the Groundwork for Billion-Dollar Vaccines

When he started researching a troublesome childhood infection nearly four decades ago, virologist Dr. Barney Graham, then at Vanderbilt University, had no inkling his federally funded work might be key to deliverance from a global pandemic.

Yet nearly all the vaccines advancing toward possible FDA approval this fall or winter are based on a design developed by Graham and his colleagues, a concept that emerged from a scientific quest to understand a disastrous 1966 vaccine trial.

Basic research conducted by Graham and others at the National Institutes of Health, Defense Department and federally funded academic laboratories has been the essential ingredient in the rapid development of vaccines in response to COVID-19. The government has poured an additional $10.5 billion into vaccine companies since the pandemic began to accelerate the delivery of their products.

The Moderna vaccine, whose remarkable effectiveness in a late-stage trial was announced Monday morning, emerged directly out of a partnership between Moderna and Graham’s NIH laboratory.

Coronavirus vaccines are likely to be worth billions to the drug industry if they prove safe and effective. As many as 14 billion vaccines would be required to immunize everyone in the world against COVID-19. If, as many scientists anticipate, vaccine-produced immunity wanes, billions more doses could be sold as booster shots in years to come. And the technology and production laboratories seeded with the help of all this federal largesse could give rise to other profitable vaccines and drugs.

The vaccines made by Pfizer and Moderna, which are likely to be the first to win FDA approval, in particular rely heavily on two fundamental discoveries that emerged from federally funded research: the viral protein designed by Graham and his colleagues, and the concept of RNA modification, first developed by Drew Weissman and Katalin Karikó at the University of Pennsylvania. In fact, Moderna’s founders in 2010 named the company after this concept: “Modified” + “RNA” = Moderna, according to co-founder Robert Langer.

“This is the people’s vaccine,” said corporate critic Peter Maybarduk, director of Public Citizen’s Access to Medicines program. “Federal scientists helped invent it and taxpayers are funding its development. … It should belong to humanity.”

Moderna, through spokesperson Ray Jordan, acknowledged its partnership with NIH throughout the COVID-19 development process and earlier. Pfizer spokesperson Jerica Pitts noted the company had not received development and manufacturing support from the U.S. government, unlike Moderna and other companies.

The idea of creating a vaccine with messenger RNA, or mRNA — the substance that converts DNA into proteins — goes back decades. Early efforts to create mRNA vaccines failed, however, because the raw RNA was destroyed before it could generate the desired response. Our innate immune systems evolved to kill RNA strands because that’s what many viruses are.

Karikó came up with the idea of modifying the elements of RNA to enable it to slip past the immune system undetected. The modifications she and Weissman developed allowed RNA to become a promising delivery system for both vaccines and drugs. To be sure, their work was enhanced by scientists at Moderna, BioNTech and other laboratories over the past decade.

Another key element in the mRNA vaccine is the lipid nanoparticle — a tiny, ingeniously designed bit of fat that encloses the RNA in a sort of invisibility cloak, ferrying it safely through the blood and into cells and then dissolving, thereby allowing the RNA to do its work of coding a protein that will serve as the vaccine’s main active ingredient. The idea of enclosing drugs or vaccines in lipid nanoparticles arose first in the 1960s and was developed by Langer and others at the Massachusetts Institute of Technology and various academic and industry laboratories.

Karikó began investigating RNA in 1978 in her native Hungary and wrote her first NIH grant proposal to use mRNA as a therapeutic in 1989. She and Weissman achieved successes starting in 2004, but the path to recognition was often discouraging.

“I keep writing and doing experiments, things are getting better and better, but I never get any money for the work,” she recalled in an interview. “The critics said it will never be a drug. When I did these discoveries, my salary was lower than the technicians working next to me.”

Eventually, the University of Pennsylvania sublicensed the patent to Cellscript, a biotech company in Wisconsin, much to the dismay of Weissman and Karikó, who had started their own company to try to commercialize the discovery. Moderna and BioNTech later would each pay $75 million to Cellscript for the RNA modification patent, Karikó said. Though unhappy with her treatment at Penn, she remained there until 2013 — partly because her daughter, Susan Francia, was making a name for herself on the school’s rowing team. Francia would go on to win two Olympic gold medals in the sport. Karikó is now a senior officer at BioNTech.

In addition to RNA modification and the lipid nanoparticle, the third key contribution to the mRNA vaccines — as well as those made by Novavax, Sanofi and Johnson & Johnson —- is the bioengineered protein developed by Graham and his collaborators. It has proved in tests so far to elicit an immune response that could prevent the virus from causing infections and disease.

The protein design was based on the observation that so-called fusion proteins — the pieces of the virus that enable it to invade a cell — are shape-shifters, presenting different surfaces to the immune system after the virus fuses with and infects cells. Graham and his colleagues learned that antibodies against the post-fusion protein are far less effective at stopping an infection.

The discovery arose in part through Graham’s studies of a 54-year-old tragedy — the failed 1966 trial of an NIH vaccine against respiratory syncytial virus, or RSV. In a clinical trial, not only did that vaccine fail to protect against the common childhood disease, but most of the 21 children who received it were hospitalized with acute allergic reactions, and two died.

About a decade ago, Graham, now deputy director of NIH’s Vaccine Research Center, took a new stab at the RSV problem with a postdoctoral fellow, Jason McLellan. After isolating and obtaining three-dimensional models of the RSV’s fusion protein, they worked with Chinese scientists to identify an appropriate neutralizing antibody against it.

“We were sitting in Xiamen, China, when Jason got the first image up on his laptop, and I was like, oh my God, it’s coming together,” Graham recalled. The prefusion antibodies they discovered were 16 times more potent than the post-fusion form contained in the faulty 1960s vaccine.

Two 2013 papers the team published in Science earned them a runner-up prize in the prestigious journal’s Breakthrough of the Year award. Their papers, which showed it was possible to plan and create a vaccine at the microscopic structural level, set the NIH’s Vaccine Research Center on a path toward creating a generalizable, rapid way to design vaccines against emerging pandemic viruses, Graham said.

In 2016, Graham, McLellan and other scientists, including Andrew Ward at the Scripps Research Institute, advanced their concept further by publishing the prefusion structure of a coronavirus that causes the common cold and a patent was filed for its design by NIH, Scripps and Dartmouth — where McLellan had set up his own lab. NIH and the University of Texas — where McLellan now works — filed an additional patent this year for a similar design change in the virus that causes COVID-19.

Graham’s NIH lab, meanwhile, had started working with Moderna in 2017 to design a rapid manufacturing system for vaccines. In January, they were preparing a demonstration project, a clinical trial to test whether Graham’s protein design and Moderna’s mRNA platform could be used to create a vaccine against Nipah, a deadly virus spread by bats in Asia.

Their plans changed rapidly when they learned on Jan. 7 that the epidemic of respiratory disease in China was being caused by a coronavirus.

“We agreed immediately that the demonstration project would focus on this virus” instead of Nipah, Graham said. Moderna produced a vaccine within six weeks. The first patient was vaccinated in an NIH-led clinical study on March 16; early results from Moderna’s 30,000-volunteer late-stage trial showed it was nearly 95% effective at preventing COVID-19.

Although other scientists have advanced proposals for what may be even more potent vaccine antigens, Graham is confident that carefully designed vaccines using nucleic acids like RNA reflect the future of new vaccines. Already, two major drug companies are doing advanced clinical trials for RSV vaccines based on the designs his lab discovered, he said.

In a larger sense, the pandemic could be the event that paves the way for better, perhaps cheaper and more plentiful vaccines.

“It’s a silver lining, but I think we are definitely pushing forward the way everyone is thinking about vaccines,” said Michael Farzan, chair of the department of immunology and microbiology at Scripps Research’s Florida campus. “Certain techniques that have been waiting in the wings, under development but never achieving the kind of funding they needed for major tests, will finally get their chance to shine.”

Under a 1980 law, the NIH will obtain no money from the coronavirus vaccine patent. How much money will eventually go to the discoverers or their institutions isn’t clear. Any existing licensing agreements haven’t been publicized; patent disputes among some of the companies will likely last years. HHS’ big contracts with the vaccine companies are not transparent, and Freedom of Information Act requests have been slow-walked and heavily redacted, said Duke University law professor Arti Rai.

Some basic scientists involved in the enterprise seem to accept the potentially lopsided financial rewards.

“Having public-private partnerships is how things get done,” Graham said. “During this crisis, everything is focused on how can we do the best we can as fast as we can for the public health. All this other stuff is going to have to be figured out later.”

“It’s not a good look to become extremely wealthy off a pandemic,” McLellan said, noting the big stock sales by some vaccine company executives after they received hundreds of millions of dollars in government assistance. Still, “the companies should be able to make some money.”

For Graham, the lesson of the coronavirus vaccine response is that a few billion dollars a year spent on additional basic research could prevent a thousand times as much loss in death, illness and economic destruction.

“Basic research informs what we do, and planning and preparedness can make such a difference in how we get ahead of these epidemics,” he said.

This KHN story first published on California Healthline, a service of the California Health Care Foundation.

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