Judicial Watch: FDA Records Show Top FDA Officials Concerned About Biden Administration Vaccine Booster Timelines That “Make No Sense”

"The 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.

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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.

In an email exchange on August 27, 2012, Gruber replies to an email from Maureen Hess, a communications specialist in 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.”"

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