Top officials at the 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 COVID-19 vaccine booster doses, according to newly released emails.
Dr. Marion Gruber, director of the FDA's Office of Vaccines Research and Review (OVRR), said 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, director of the FDA's Center for Biologics Evaluation and Research, in an Aug. 25, 2021, email.
The group stated that the protection from the COVID-19 vaccines was declining over time and that "a booster shot will be needed to maximize vaccine-induced protection and prolong its durability."
'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.
Gruber responded, "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."
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 Janssen said 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 to analyze vaccine data, which Marks said was done at the behest of Woodcock.
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.
At one point, Gruber reached out to international colleagues, lamenting the "crazy controversy and very strong push towards boosting vaccines 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 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 their disagreements over the need for vaccine booster doses.
Gruber, Krause, Moderna, Pfizer, and Johnson & Johnson didn't respond to requests for comment.
The FDA, Marks, and Woodcock declined to comment.
Second vaccine booster doses 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.