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# Administration Sidelining Vaccine Scientists: Ex-FDAers
- URL: https://www.fdaweb.com/administration-sidelining-vaccine-scientists-ex-fdaers/
- Published: 2021-12-16T12:00:00.000Z
- Updated: 2026-09-14T17:26:14.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5150786

Former FDA Office of Vaccines Research and Review deputy director **Philip Krause** and former FDA acting chief scientist **Luciana Borio** say the Biden administration has made recent vaccine decisions without consulting outside scientific experts, reversing what had been standard practice. Writing in a *Washington Post* [op-ed](https://www.washingtonpost.com/outlook/2021/12/16/vaccines-fda-cdc-boosters-expert-panel/?ref=fdaweb.com), the two cite the FDA decision authorizing boosters for all adults regardless of their job or underlying health conditions, the CDC saying that everyone age 18 and above should get a booster shot, and FDA authorization of Pfizer booster shots for 16- and 17-year-olds.

“Before last month, the standard practice was for the agencies to convene standing outside advisory committees, whose members inspect the relevant data, debate it, and vote,” Krause and Borio write. “That did not happen in these cases, meaning that the costs and benefits of these policy moves, from a medical perspective, were not fully aired publicly and discussed in advance.”

The authors say that with new questions being raised about vaccines and boosting, the recommendations of experts on the outside advisory committees are needed more than ever so the scientific community can understand the empirical basis for decisions, and so the public can be assured that science, not politics, is driving vaccine policy.

Krause and Borio suggest that in each of the three agency decisions cited, at least some experts would have voiced opposition, based on earlier scientific debates and votes the two committees had taken, which supported different conclusions. “That these experts were not given a chance to make their cases could hurt the credibility of these agencies,” they conclude.

The column says FDA explained that it did not convene the committee because approving boosters for 16- and 17-year-olds “does not raise questions that would benefit from additional discussion by committee members.” Krause and Borio say the explanation is “unpersuasive, given the previously expressed views of panel members.” The CDC has not explained why it did not convene its panel of experts before making a decision.

“FDA and the CDC need their experts,” the authors conclude. “This is a particularly challenging time in the pandemic, as scientists try to understand how omicron changes the picture. Some people, including us, predict that the original two-shot vaccination regimen for existing mRNA vaccines will continue to offer substantial protection against serious disease in people who aren’t at high risk, even with the new variant’s emergence. There are significant questions about how effective boosting with a non-omicron-specific vaccine will be or how long any effect will last. Others argue that boosters for all are absolutely essential. Still others are saying that not only is a third shot needed but probably a fourth one as well.”

Krause and Borio say people were appropriately outraged when, during the Trump administration, FDA made important decisions on hydroxychloroquine and convalescent plasma under what appeared to be extreme political pressure and without advisory committee input. “We should apply the same standards to the Biden administration,” they say.