Yesterday, the FDA revised the Factsheets for Providers Administering Pfizer BioNTech (both Purple and Gray) and Moderna COVID-19 Vaccines, permitting boosters of these unapproved products to Americans 18 years of age and older because of an ongoing emergency. The FDA took this action without reconvening the Vaccines and Related Biological Products Advisory Committee, a panel of national health authorities.
Yesterday’s action overrules the recommendation made by the Advisory Committee at its 167th meeting on September 17 when the panel voted 16-2 against the question, “Do the safety and effectiveness data from clinical trial C4591001 support approval of a COMIRNATY booster dose administered at least 6 months after completion of the primary series for use in individuals 16 years of age and older?” True, the previous question was for 16 and above, not 18 and above, but the spirit of the committee discussion was for targeted boosters, not blanket boosters.
According to the FDA press release issued yesterday, “The FDA did not hold a meeting of the Vaccines and Related Biological Products Advisory Committee on these actions as the agency previously convened the committee for extensive discussions regarding the use of booster doses of COVID-19 vaccines and, after review of both Pfizer’s and Moderna’s EUA requests, the FDA concluded that the requests do not raise questions that would benefit from additional discussion by committee members.”
This action comes days after Alex Berenson, formerly of the New York Times, reported an error in Pfizer’s publicly reported safety data. Initially, Pfizer reported that two vaccine recipients died during trials, compared to four placebo recipients. In a July update, the count was revised to 21 deaths among vaccine recipients compared to only 17 in placebo recipients.
Then there’s FDA’s response to a freedom of information act (FOIA) request on Pfizer’s COVID-19 vaccine. Instead of transparency, the agency filed a petition in U.S. District Court to delay its response for 55 years.
Up to now, I’ve just been reporting the news, but here comes commentary. These facts create a disturbing trend. What could they be hiding? I’m forced to one conclusion. The FDA and the pharmaceutical industry are colluding to coverup data and debate so they can sell vaccines. If you can reach another conclusion rationally, please tell me. I can’t.
The events of last week occurred in the open. Imagine what’s happening out of view.
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