Top FDA Officials Concerned About Pressure to Authorize COVID-19 Vaccine Boosters: Emails

Top officials at the U.S. Food and Drug Administration (FDA) were worried about what they saw as pressure being placed on them by vaccine companies and the White House to clear booster shots, according to newly released emails.

Dr. Marion Gruber, the director of the FDA’s Office of Vaccines Research and Review (OVRR), said that she was “very concerned that companies (such as Pfizer and Janssen) are trying to put pressure on OVRR by way of PR,” or public relations, in one of the missives.

“We need to be given time to consider their data and cannot be pushed by these companies and, for that matter the Administration, who try to impose timeless [sic] that make no sense,” Gruber told Dr. Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research, in the Aug. 25, 2021, email.

The 126 pages of emails, obtained and released (pdf) by the nonprofit Judicial Watch, show that there was increasing pressure on OVRR from both inside and outside the government to take action on requests for authorization for boosters.

The pressure was triggered in part by a joint statement signed by FDA Acting Commissioner Janet Woodcock, longtime National Institute of Allergy and Infectious Diseases Director Anthony Fauci, and other Biden administration officials.

The group said that the protection from the COVID-19 vaccines were declining over time and that “a booster shot will be needed to maximize vaccine-induced protection and prolong its durability.”

Marks was encouraging Moderna to submit a formal request for booster authorization Michelle Olsen, a Moderna executive, told Sudhakar Agnihothram, who worked under Gruber, via email two days later. Marks urged Moderna to file the request “as soon as possible,” according to the emails.

‘Bite My Tongue’

In a discussion around that time, Marks told staffers that “we wouldn’t be doing rushed reviews anymore,”

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