FDA issues first COVID-19 vaccine EUA for Pfizer-BioNTech with no data on “preventing transmission”
On December 11, 2020, the US Food and Drug Administration (FDA) granted the first Emergency Use Authorisation (EUA) for a brand new technology product, the Pfizer-BioNTech COVID-19 mRNA vaccine, just 9 months after phase I trials began, and after only 108 days of regulatory safety review. In their press release they stated: "The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria for issuance of an EUA". The FDA stated the vaccine "may be effective in preventing COVID-19", then state it is 95% effective in "preventing" COVID-19, that 95% is based on "a 2 month study of a couple hundred people. That's it!". [3] The day before, on December 10, 2020, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to assess the Pfizer-BioNTech COVID-19 Vaccine and prepare a Briefing Document for the FDA. [6] The FDA stated "[t]he vaccine was 95% effective in preventing COVID-19 disease among these clinical trial participants with eight COVID-19 cases in the vaccine group and 162 in the placebo group." 8 plus 162 equals 170 trial participants was all that were used to determined the relative risk of "95% effective", where as the absolute risk (of all 36,523 trial participants)..> READ MORE