On the Aug. 24 morning edition of “War Room: Pandemic,” vaccinologist Dr. Robert Malone called out the Food and Drug Administration for playing a “bureaucratic shell game” with their supposed early approval of the Pfizer Covid-19 vaccine.
In fact, Malone noted, the FDA issued two separate and distinct letters.
“There is a letter for Pfizer and a letter for BioNTech. The New York Times and the Washington Post got it wrong. The authorization is not for Pfizer. The authorization is for BioNTech, and itÂ will only be initiated at the time BioNTech product becomes available…
“The liability coverage, the blanket coverage that allows Pfizer to not be liable for any adverse event, only applies to the Pfizer product, which is still under emergency use authorization.”
Therefore, Malone recommends that anyone who has to get the vaccine “hold off” for the BioNTechÂ Â product. “That’s the one that will no longer have liability protection in the same way the the Pfizer emergency use authorization does.”
In other words, if something goes wrong, you cannot sue Pfizer if you use that company’s vaccine, but you will be able to sue BioNTech if you use their product.
Malone also noted with considerable incredulity that:
- The FDA bypassed/disregarded the normal advisory committee and public comment process for this license. See p2 â€œWe did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion.â€
The two letters are available for download from FDA:
Letter to Pfizer: https://www.fda.gov/media/150386/download
Letter to BioNTech: https://www.fda.gov/media/151710/download