“These FDA documents confirm a politicized approval process for the controversial Covid-19 vaccine booster shots,” says Judicial Watch President Tom Fitton.
Judicial Watch announced Tuesday, July 26th that it has received 112 pages from the Food and Drug Administration (FDA) that show top officials being pressured by “companies and, for that matter the Administration, who try to impose timeless [sic] that make no sense.”[i]
“These FDA documents confirm a politicized approval process for the controversial Covid-19 vaccine booster shots,” says Judicial Watch President Tom Fitton. “It is a scandal that it took months and a federal lawsuit to these troubling facts about this unprecedented and seemingly never-ending vaccine operation.”
The records were produced to Judicial Watch in response to a February 2022 Freedom of Information Act (FOIA) lawsuit against the Department of Health & Human Services (HHS) that was filed after the Department failed to respond to a September 3, 2021 FOIA request. Judicial Watch had sought the records of communication from the former director and deputy director of the FDA’s Office of Vaccines Research and Review, Dr. Marion Gruber and Dr. Philip Krause, respectively (Judicial Watch v. U.S. Department of Health and Human Services.
“Available evidence doesn’t yet indicate a need for COVID-19 vaccine booster shots among the general population …”[iv]
The obtained records include an August 25, 2021, email by Marion Gruber to her boss, Center for Biologics Evaluation and Research (CBER) Director Peter Marks:
“Over the last couple of days, Janssen has bombarded us with emails regarding their booster dose studies. I am also very concerned that companies (such as Pfizer and Janssen) are trying to put pressure on OVRR [Office of Vaccines Research and Review] by way of PR [public relations]. 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 (e.g., Sep 20)…. It appears that at least Pfizer’s data will not be aligned with this approach and the ‘n’ [test numbers] they have is grossly insufficient. Obviously, we have to review the data but we have taken a peak and have serious concerns. Lastly, and this is my personal opinion, data we have seen so far from various companies (Pfizer, Janssen, Moderna) appear to suggest that boosters are not needed.”[v]
In an email exchange on August 27, 2012, Gruber replies to an email from Maureen Hess, a communications specialist in the Center for Biologics Evaluation and Research:
“Well, the message appears to be ‘total buy-in in the need for boosters,’ this is not how I am writing the BD [likely board decision], I am trying to take a more neutral approach. This piece sounds as if we already decided to approve this supplement.”[vi]
Hess responds, “Okay, I’ll make some additional edits (but JW [likely Acting FDA Commissioner Janet Woodcock] was included on this statement – https://www.cdc.gov/media/releases/2021/s0818-covid-19-booster-shots.html – so our edits may be rejected above us.” After sending more emails about edits Hess made, Gruber replies, “From my perspective this is as good as it can get. Obviously, this statements [sic] puts us into a real bind but the damage is already done.”
In an Aug. 20, 2021, email exchange Dr. Doran Fink, the Deputy Director of the FDA’s Division of Vaccines and Related Products Applications raises questions regarding new data, that Moderna was submitting to FDA about its COVID vaccine. Fink told Drs. Gruber, Krause and other colleagues:
I had to bite my tongue when Peter [likely Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research] mentioned this morning we wouldn’t be doing rushed reviews anymore so as not to ask about the booster doses that the administration promised to everyone by Sept 20!
And then there is the question of the data that will support these booster doses – maybe I’m wrong, but my understanding is that Pfizer is proposing that their sBLA include the Phase 1 booster data from a grand total of 23 subjects. I’m not sure what Moderna will have, but the data Fauci presented in the press conference from NIAID studies, which was ~25 subjects per treatment arm.
Gruber states in an August 17, 2021, email
“They [Dr. Doran’s team] fully understand that the Acting Commissioner would like to approve this product [Pfizer Covid booster vaccine] very soon and are trying their best to complete their review and assessment, while at the same time, maintaining our high standards and scientific and clinical integrity.”[vii]
Philip Krause, in an August 10, 2021 email, complains:
“It sounds like Peter [likely Center for Biologics Evaluation and Research Director Peter Marks] thinks he has taken over all vaccine operations, not just the Pfizer BLA [Biologics License Application] …”
On August 23, 2021, Dr. Arnold Monto, Professor in the Department of Epidemiology of the University of Michigan School of Public Health, emails Drs. Gruber and Krause using the subject
“VRBPAC and boosters:”
The Surgeon General last night made a statement that the FDA and CDC advisory committees would be reviewing Hope that he misspoke about the VRBPAC (Vaccines and Related Biological Products Advisory Committee) Doesn’t seem to be enough time to get it organized Just got asked about flu vaccination and Covid boosters being given at the same time. Gave my personal information, don’t
Gruber then replies to Monto:
“We will be discussing the ‘booster question’ and related submissions including whether VRBPAC should be held. We do not know yet and you are right that timing will be an issue once again.”
On September 22, 2021, the FDA approved use of a booster dose of the Pfizer drug. According to the organization’s news release, the FDA, “amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series” for people at “high risk” of “severe COVID-19.”[viii]