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) works out to less than 1% effective. [4]

“At this time, data are not available to make a determination about how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.”

President Trump announced this as a “medical miracle” and vaccines would be available within 24 hours. [1, 2]

The rush to market was the result of President Trumps‘ Operation Warp Speed, where he allocated “$14 billion to accelerate vaccine development and to manufacture all of the top candidates in advance”.

  • 11 Dec 2020  – EUA* for Pfizer CV19 vax   – 30ug/dose
  • 18 Dec 2020 – EUA for Moderna CV19 vax [5] – 100ug/dose

*EUA for an unapproved product

Under EUA these new products referred to as ‘vaccines’ are still undergoing data collection and thus are experimental.  American frontline doctors have raised many concerns in a white paper, which includes:

  • No vaccine based on messenger RNA (mRNA) has ever been approved for any disease, or even entered final-stage trials until now, so there’s no peer-reviewed published human data to compare how mRNA stacks up against older technologies.
  • Previous coronavirus vaccine projects triggered re-challenge immune responses so strong that the test animals died, and the vaccine trials were halted. Scientists have never been able to create a successful coronavirus vaccine.

Is this new technology a “vaccine” or “medical device“?

The vaccines start rolling out across the US on Monday December 14, 2020, when early treatments are still suppressed.