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Why Fauci and the NIH backed Covid-19 vaccine boosters before the FDA and CDC
Sep 16, 2021 3 mins, 50 secs
And by the end of March, the scientists at NIAID were experimenting with monkeys and reviewing early data from humans showing that booster shots provided a rapid increase in protective antibodies — even against dangerous variants.

Fauci, whose team has closely tracked research from Israel, the United Kingdom and elsewhere, said in an exclusive interview with KHN on Wednesday that "there's very little doubt that the boosters will be beneficial." But, he emphasized, the official process, which includes reviews by scientists at the Food and Drug Administration and the Centers for Disease Control and Prevention, needs to take place first.

"If they say, 'We don't think there's enough data to do a booster,' then so be it," Fauci said.

"I think that would be a mistake, to be honest with you."

The support for an extra dose of covid vaccine clearly emerged, at least in part, from an NIH research dynamo, built by Fauci, that for months has been getting intricate real-time data about covid variants and how they respond to vaccine-produced immunity.

Yet, Fauci said, "there is less disagreement and conflicts than seem to get out into the tweetosphere." He ticked off a number of prominent scientists in the field — including Surgeon General Vivek Murthy, acting FDA Commissioner Janet Woodcock and covid vaccine inventor Barney Graham — who were on board with his position.

All but Graham are members of the White House covid task force.

Another task force member, CDC Director Rochelle Walensky, said her agency was tracking vaccine effectiveness and "we're starting to see some waning in terms of infections that foreshadows what we may be seeing soon in regard to hospitalizations and severe disease." As to when so-called boosters should start, she told PBS NewsHour on Tuesday, "I'm not going to get ahead of the FDA's process."

Differences in the scientific community are likely to be voiced Friday when the FDA's vaccine advisory board meets to review Pfizer-BioNTech's request for approval of a third shot.

20, a date Fauci and colleagues had suggested to him as practical and optimal in one of their frequent meetings just days before — though he cautioned that boosters would need CDC and FDA approval.

Now it appears that that decision and the timing rest with the FDA, which is the normal procedure for new uses of vaccines or drugs.

And while other scientific leaders support boosters, many scientists believe Fauci and his colleagues at the NIAID — some of the world's leaders in immunology and vaccinology, men and women in daily contact with their foreign peers and their research findings — are leading the charge.

Fauci was hard-pressed to give exact dates for when his thinking turned on the need for boosters.

Emerging evidence suggests boosters make people far less likely to transmit the virus to others, an important added benefit.

To be sure, members of the White House covid response team — including Fauci and former FDA Commissioner David Kessler — had begun preparing a timeline for boosters months earlier.

She provided supporting data that Israeli scientists are bringing to the FDA meeting Friday.

Some U.S.

Scientists also share their findings on group email lists and in Zoom meetings every week — and on Twitter and in news interviews.

Kessler, chief science officer of the White House covid response team, said the case for boosters is "rooted in NIH science" but includes data from Israel, the Mayo Clinic, the pharmaceutical companies and elsewhere.

As Fauci put it: "Every 15 minutes, a pre-print server comes out with something I don't know."

The SAVE group, active since February, was organized by NIH officials who in normal times track influenza epidemics.

Biden's booster announcement "may have gotten ahead of the game, but the trajectory is pointing toward the need for boosters," Frieman said.

"We all saw the same data out of Israel," she said.

24 call with Israeli officials, Fauci urged them to publish that data, and a version appeared in the New England Journal of Medicine on Wednesday.

That study found that people receiving a third dose of the Pfizer-BioNTech vaccine were 11 times more likely to be protected from covid infection than those who had gotten only two doses.

Biostatisticians felt it had irregularities that raised questions about its worth.

"I don't want to say the study isn't correct, but it hasn't been reviewed and there are possible biases," said Longini, who helped design the 2015 trial that resulted in a successful Ebola vaccine and now works on global covid vaccine trials.

Fauci emphasized that no single study or piece of data led Biden or the members of the White House covid response team to conclude that boosting was necessary.

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