USA TODAY International Edition
Fauci on vaccines: Trust the process
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, discussed COVID vaccine development last week during a meeting with USA TODAY’s Editorial Board. Questions and answers have been edited for length, clarity and flow.
Q. Can you understand why some people are skeptical about Operation Warp Speed?
A. I know there’s a lot of stuff coming out of Washington to get people concerned. Is there ( political) pressure, or what have you? But I can tell you that the process is such that I would — when it gets approved by the FDA, given the time of my turn, when it comes — take the vaccine and I would recommend that my family take the vaccine.
Q. What is the approval process?
A. The data and safety monitoring board is beholden to no one, not to the administration, not to the company and not to me. They’re independent, and they independently and intermittently look at the data. And the last time they looked at the ( Moderna vaccine) data, this independent group said the data are extraordinary. There were 95 cases ( of COVID- 19) — 90 in the placebo group and five in the vaccine group, which was a 94.5% efficacy. There were 11 severe cases — zero in the vaccine group, 11 in the placebo group.
Q. What happens next?
A. The data will be presented to the FDA to get an emergency use authorization. The career scientists, who are beholden to no one, will look at the data and then they will get advice from their advisory board, which is called the Vaccines and Related Biological Products Advisory Committee. That group will then advise the FDA as to whether or not they should approve the vaccine for an EUA or for a biological license application. Then those data will be published and will be public for all the scientists around to look at. It is transparent, and it’s independent.
Q: A survey that came out in September said that only 32% of Black Americans said that they would trust the vaccine enough to take it. How would you reach out to the Black community and reassure people that taking the vaccine is actually safe?
A: The first thing is that we need to understand the truly understandable reasons why minority communities, particularly African Americans, feel that way. Because the history of the interaction between the federal government and the arena of health is not a good history dating back to the Tuskegee issues and even others that have followed. … So there are two things. One, show transparency and consistency and independence. And two, outreach to the community by people who are trusted by the community.
Q. Were minority groups adequately represented in the clinical trials for the Moderna vaccine developed in collaboration with the National Institutes of Health?
A. Here at NIH ( we worked) very hard to get minority representation in the actual clinical trial. So that when the clinical trial is proven to be safe and effective, you can go to the brown and Black community and say, you know, you all participated in the trial and we know it works and is safe in you because here’s the data from the trial. What you don’t want to do is to get a ‘ white man’s vaccine’ and say we’re going to give it to Black people, or say that it’s not been properly tested in an equitable way in brown and Black people.
Q: And then you need to persuade people to take it.
A: That’s really important. We know we have an efficacious vaccine. We’ve proven it. It’s 94.5%- 95% efficacious. It would not be effective if people don’t take it. If you have 30%, 40%, 50% of the population that don’t want to take it, you have an efficacious vaccine that is being blocked from being effective because people aren’t taking it. It would be extremely detrimental if we have an efficacious vaccine and people don’t take it. It would be a tragedy.
Q: Once you get the vaccine, how long does it take to develop immunity?
A: You can expect that about seven days or so following the second ( dose), you can actually get a considerable degree of protection. In fact, some people might even get a degree of protection after the first dose, maybe two weeks or three weeks after the first dose.
Q. How long will that immunity last?
A. We do not know that. That’s an important question. And that’s the reason these studies go out for two years.
Q: At what point does it become unethical to keep people in the placebo groups?
A: It becomes unethical if you have widespread availability of the vaccine that’s highly effective and just for the purpose of the study, you’re keeping them in a placebo group. But you can extend it for a week or two to get data to really nail down what you’re dealing with, because the long- range benefit to the individual and society would likely be much, much greater for that extra week or two that you keep them on.
Q. If multiple vaccines are available, how do I know which one to take?
A. The availability of the distribution is going to be recommended to the CDC ( Centers for Disease Control and Prevention), which is the final decider as to what the prioritization is. … You’re going to see kind of a graded rollout of vaccines. What you might find, which we’ve seen with other vaccines, is that some might be more appropriate for the elderly versus the young, some maybe more for pregnant women versus people with underlying conditions. We don’t know that yet. … What we’re hearing in the preliminary analysis of the data is that ( the first two vaccines appear) to be effective across all the subgroups, which is quite good news.
Q: What concerns you most right now?
A: If you go into the winter or the late fall and the ( daily) baseline of infections is over 100,000, it becomes so difficult ( to control surges) because the degree of community spread that represents is really profound. And it makes what we have to do so much more difficult. Which is the reason why I get back to what I said: Please folks, hang on to the extent that we can, because help is on the way with a vaccine. This is not going to be an to be an indefinite situation. It will change, and it will end.