Because the FDA was NOT transparent, and did not hold a meeting the public could access, we have no idea what data they reviewed to support their decision to approve the first COVID vaccine. This decision took place behind closed doors.
One year ago, FDA Mark Peters and former FDA director Stephen Hahn promised that they would be transparent in their decision-making by holding VRBPAC meetings where the public can listen to the discussions relating to COVID vaccine decisions:
“FDA is also committed to ensuring that data from COVID-19 vaccine trials is reviewed in a transparent, deliberative manner. To this end, the agency intends to convene its Vaccines and Related Biological Products Advisory Committee (VRBPAC) when data from trials becomes available.”
Ensuring the safety and effectiveness of a COVID-19 vaccine, published in Health Affairs, August 2020
“By convening VRBPAC, FDA will ensure public transparency around discussions of vaccine safety and effectiveness tp provide a window into its decision-making process and help address potential concerns from vaccine-hesitant populations.”
Ensuring the safety and effectiveness of a COVID-19 vaccine, published in Health Affairs, August 2020
However, that promise was broken. The FDA did not hold a VRBPAC meeting related to approval of the Pfizer vaccine. We’ve heard that the FDA reviewed all of the data from the overwhelmingly short period of time that the vaccine has been administered (6 months); however, there was no mention of the 13,000 deaths reported on the CDC and FDA reporting system for vaccine adverse events (VAERS), nor the ~5,000 cases of bells palsy, or the thousands of emergency room visits. The direct link to the VEARS system is here.
A snapshot of SOME COVID vaccine injuries, as of August 20th:
The only thing that was publicly shared from the FDA regarding the approval was a media Zoom call in which the Acting FDA Commissioner Janet Woodcock, M.D. reviewed information published in the FDA letter of approval (see below).
The FDA Pfizer COVID vaccine approval letter dated August 23, 2021, tell us:
“The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.
What are these differences? The FDA does not explain.
At the CDC’s Advisory Committee on Immunization Practices (ACIP) most recent meeting, Demetre Daskalakis, MD, CDC Director of the Divison of HIV/AIDS Prevention (DHAP), pointed out that “BOOSTER” shots do not have emergency use authorization, nor are they FDA-approved, so the provider administering the shot could be open to lawsuits, as the booster wouldn’t be covered under the PREP Act. There is also interest at ICAN in regards to reviewing the PREP Act and ACIP Guidelines to check the timing of second doses, and if it is ‘covered’ by the PREP Act, depending on how early or late the second dose is obtained, in relation to the first dose.
