We can confirm that the FDA’s decisions on Covid booster shots were not entirely about “science.”
We received 112 pages from the Food and Drug Administration that show top officials being pressured by “companies and, for that matter the Administration, who try to impose timeless [sic] that make no sense.”
We received the records in response to a February 2022 FOIA lawsuit against the Department of Health & Human Services filed after HHS failed to respond to a September 3, 2021, FOIA request for 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 (No. 1:22-cv-00292)).
Drs. Gruber and Krause reportedly resigned during the White House’s push to approve the COVID-19 vaccine “booster shots.”
On September 13, 2021, Gruber and Krause were among a group of resigning doctors who agreed that, “Available evidence doesn’t yet indicate a need for COVID-19 vaccine booster shots among the general population …”
The records include an August 25, 2021, email by Marion Gruber to her boss, Center for Biologics Evaluation and Research (CBER) Director Peter Marks:
In an email exchange on August 27, 2021, Gruber replies to an email from Maureen Hess, a communications specialist at 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.”
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:
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.”
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:”
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.”
These documents confirm a politicized approval process for the controversial Covid-19 vaccine booster shots. It is a scandal that took months and a federal lawsuit to expose these troubling facts about this unprecedented and seemingly never-ending vaccine operation.
Judicial Watch Sues for Emails of Dr. Fauci’s Spouse, Christine Grady
We want basic information about the work Dr. Anthony Fauci’s wife, Christine Grady, who is also employed by the National Institutes of Health. The Biden administration is trying to block us.