Fauci On The Disconnect Between FDA Panel's Guidance And Biden's Booster Plan
RACHEL MARTIN, HOST:
For more now, we're going to turn to a frequent guest on this program, Dr. Anthony Fauci, the nation's top infectious disease doctor and President Biden's chief medical adviser. Dr. Fauci, welcome back.
ANTHONY FAUCI: Thank you very much. Good to be with you.
MARTIN: President Biden wanted to be ready as early as today to have vaccine boosters available to everybody 16 years old and up. Why is there an apparent disconnect between what the president wanted and the FDA committee's recommendation?
FAUCI: Well, what the president had said and what the medical advisers, including myself, had said is that we need to plan to be able to deliver boosters to everyone 16 and older on the week of September 20, pending the evaluation of all the data by the FDA and their advisory committee, as you just mentioned. The advisory committee felt that at this particular time, there wasn't enough data to allow the booster recommendation for everyone. So they made the recommendation for those 65 years of age and older and those 18 to 64 who are in the situation where they may be at high risk to develop severe disease, namely underlying conditions that are delineated by the CDC, as well as those who, because of either occupational or institutional exposure, may be at a higher risk of getting infected.
So they didn't give the go-ahead for all of the booster-eligible people or those that were felt to possibly be eligible for boosters. But I think, as you just mentioned, this is a fluid situation. And we fully expect as more data come in, both on the safety of the booster for younger people - because that's the group of people, particularly younger men, in which there is a rare adverse event called myocarditis, not enough to preclude giving the double dose, the single and then followed by the second dose. But as one of the people that was interviewed now just said, there isn't enough data, according to some people, to have safety confidence in that. And that's the reason.
But I believe, Rachel, as we go along in the next weeks or so, you're going to see...
FAUCI: ...More data rolling in that could actually modify and expand the recommendation. But for now, we'll go with what the FDA advisory committee has recommended.
MARTIN: Most of the focus around boosters has been centered around Pfizer. What about those people who got the Moderna and Johnson & Johnson vaccines? When will we learn more about whether people who got those vaccines will need boosters?
FAUCI: Yeah. Well, I - I'm almost certain that they will need it. The question is, when will there be enough data to be able to be submitted to the FDA to get a recommendation, likely through an emergency use authorization? And I would imagine, Rachel, that that will likely be within the next couple to three weeks, hopefully for both of them at that time so that there isn't a delay for the people who originally got Moderna and who originally got J&J.
MARTIN: Can you be more specific about what data still needs to be collected to make these decisions?
FAUCI: Well, there are two sets of data. The first set of data is the diminution in the incidence, or the waning, as it were, of protection against hospitalization across all of the age groups. When you look at the Israeli data, their data suggests strongly that, ultimately, you're going to see a waning of protection. Certainly, we know it's waning against protection against infection in general and mild to moderate disease. But the waning of protection against severe disease resulting in hospitalization looks more - at least in the data that we're seeing in the United States - much more leaning towards the elderly individual and not yet towards those in the younger group, whereas if you look at the Israeli data, they, in general, when it comes to every aspect of this outbreak, fall about a month or so ahead of us...
FAUCI: ...In their vaccinations and in their observation. They are seeing it among a younger age group. The group that was advising the FDA last Friday felt that we really need to wait and get more data before we push into the younger group.
MARTIN: I understand. In our remaining minute, I want to ask, speaking of data, is the federal government in any way - health officials at the federal level - tracking breakthrough cases, cases where fully vaccinated people are getting the virus?
FAUCI: Yes. In general, certainly those who are getting clinically ill and going to the hospital. We need to do more on those who might get infected but have either no or minimal symptoms.
MARTIN: And how does that data help in combating a disease that's obviously affecting people we thought were protected?
FAUCI: Well, it gives you an idea of what the broad range of waning of immunity are.
MARTIN: Dr. Anthony Fauci, President Biden's chief medical adviser, we appreciate you as always. Thank you for taking the time.
FAUCI: My pleasure.
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