Two former top officials at the Food and Drug Administration (FDA) published an op-ed at the Washington Post on Thursday, slamming President Joe Biden’s administration for “sidelining” outside expert panels when making a decision on the authorization of COVID-19 vaccine booster shots.
Philip Krause, former deputy director of the FDA’s Office of Vaccines Research and Review, and Luciana Borio, former acting chief scientist at the agency, called into question the way FDA’s Nov. 19 approval of booster shots for all individuals above the age of 16 was made.
The two lamented the Biden administration’s decision to dispense without consulting independent panels of experts, which they said had been “the standard practice” in planning COVID-19 related measures before November.
“We believe that much is lost when decisions like these are made without consulting outside experts — whatever one believes about the merits of the policies in question,” the scientists wrote.
FDA vaccine deputy director who resigned over WH pressure on boosters is writing op eds critical of pushing boosters for teens without Ad Com.
WH is acting seriously reckless. If the last administration did this, all experts would be outraged. https://t.co/JRTsDUzHij
— Vinay Prasad, MD MPH 🎙️📷 (@VPrasadMDMPH) December 17, 2021
If the previous practice of bringing standing outside advisory committees was used, Krause and Borio argued, “at least some experts would probably have voiced opposition.” (RELATED: FDA Says It Needs Until Year 2076 To Reveal Data Pertaining To Pfizer Vaccine Approval)
“At this point in the pandemic, the world faces a host of new questions related to 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 bases for decisions, and so the public can be assured that science, not politics, is driving vaccine policy,” the former officials wrote.
The scientists warned of undesirable “long-term consequences” of such “convenient” disregard for experts’ opinions.
The FDA’s Vaccines and Related Biological Products Advisory Committee initially voted against approving Pfizer vaccine’s booster dose for all adults, giving a green light for its use in seniors only. Two months later, FDA Acting Commissioner Janet Woodcock approved the booster without holding the usual public meeting to review the data.