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,” Dr. Doran Fink, who also worked under Gruber, wrote to Gruber and others.
“I had to bite my tongue … so as not to ask about the booster doses that the administration promised to everyone by Sept 20!” Fink wrote.
“He keeps on telling me that following this approval, he will sit down with us to hammer out a plan to get on top of the workload because ‘while I was gone he actually did an inventory and determined that our workload is no longer manageable’……at the same time he encourages sponsors to send in submissions and I am sure promises fast turn-around,” Gruber responded.
Johnson & Johnson also repeatedly emailed the FDA, asking for meetings to discuss data in preparation for submitting a booster authorization request. Karin Van Baelen of Moderna said that an executive was meeting with Marks and that Moderna had already made presentations to Fauci and Dr. Francis Collins, head of the National Institutes of Health. Gruber grew frustrated, culminating in the email to Marks.
In another message, Gruber pushed back when Marks messaged Fink to personally review work they were doing analyzing vaccine data, which Marks said was done at the behest of Woodcock.
“I am concerned and disappointed about the apparent lack of confidence and trust that Dr. Woodcock has in the OVRR team and that she has asked you to verify the information that we have provided to you in today’s meeting and in the email sent to you by Doran this afternoon,” Gruber said.
Edits ‘May be Rejected’
The rush to get boosters cleared was prompted by the joint statement from the White House and other Biden administration officials, according to Van Baelen.
“In view of the urgency created by the recent joint announcement by HHS and Medical Experts, we consider it important to be able to address the questions raised related to U.S. citizens who received the Janssen vaccine single dose regimen earlier this year as soon as possible,” she said.
Gruber at one point reached out to international colleagues, lamenting the “crazy controversy and very strong push towards boosting vaccinees that I am seeing here in the U.S., the E.U., and a few other countries.”
“The message appears to be ‘total buy-in in the need for boosters,'” Gruber wrote in another email, asking for edits on a statement the FDA was preparing. “This is not how I am writing the BD, I am trying to take a more neutral approach. This piece sounds as if we already decided to approve this supplement.”
Maureen Hess, a colleague, said that she would make edits but noted that Woodcock signed onto the joint statement, “so our edits may be rejected above us.”
Gruber and Dr. Phil Krause, who was deputy director at OVRR, resigned from the FDA because of the disagreements over the need for boosters.
“You had this corporate-government pressure on the civil servants who were over there and they objected so much, at least two of them resigned,” Tom Fitton, president of Judicial Watch, said on EpochTV.
Gruber, Krause, Moderna, Pfizer, and Johnson & Johnson did not respond to requests for comment.
The FDA, Marks, and Woodcock declined to comment.
The FDA’s outside advisory panel challenged the administration’s effort for boosters for all, voting only to recommend authorization of boosters for several subsets of Americans. However, the FDA soon bypassed the panel and authorized boosters for all adults, triggering public pushback from Krause and another former FDA scientist, Luciana Borio.
Second boosters have since been cleared for tens of millions of Americans because of the waning protection provided by the first booster, and there are signals that virtually all Americans will soon be advised to get second boosters.
Correction: A previous version of this article misspelled the name of Dr. Fink. The Epoch Times regrets the error.