February 18, 2021 (Children’s Health Defense) — Pfizer’s announcement in November 2020 that clinical trials showed its COVID-19 vaccine was “95% effective” prompted Dr. Sin Hang Lee, a Connecticut pathologist, to question Pfizer’s methodology and petition the U.S. Food and Drug Administration (FDA) to require accurate counts of COVID-19 cases in the Pfizer/BioNTech COVID-19 mRNA vaccine trial before granting the vaccine Emergency Use Authorization (EAU).
As The Defender reported in November, Lee, who is director of Milford Molecular Diagnostics, said:
“Until an accurate count of COVID-19 cases in the vaccinated and placebo groups has been determined for vaccine efficacy evaluation, we are asking the FDA to stay its decision regarding the emergency use authorization for this vaccine.”
Lee’s request was rejected by the FDA on Dec. 11, the same day the agency approved Pfizer’s vaccine for emergency use. On Feb. 8, Lee filed an amended reply.
Here’s the sequence of events as they unfolded:
On Nov. 23, 2020, Lee, along with Informed Consent Action Network (ICAN) and its counsel, submitted a Citizen Petition and petition for administrative stay of action to the FDA relating to the phase 3 trial of the BNT162b/Pfizer vaccine to prevent the novel coronavirus SARS-CoV-2.
In the petition and stay, Lee requested the FDA amend the study design for the late-stage trial of Pfizer’s COVID-19 vaccine. Specifically, Lee requests:
“Before an EUA or
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