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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).
“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.”
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 unrestricted license is issued for the Pfizer vaccine, or for other vaccines for which PCR results are the primary evidence of infection, all “endpoints” or COVID-19 cases used to determine vaccine efficacy in the Phase 3 or 2/3 trials should have their infection status confirmed by Sanger sequencing, given the high cycle thresholds used in some trials. High cycle thresholds, or Ct values, in RT-qPCR test results have been widely acknowledged to lead to false positives … All RT-qPCR-positive test results used to categorize patient as “COVID-19 cases” and used to qualify the trial’s endpoints should be verified by Sanger sequencing to confirm that the tested samples in fact contain a unique SARS-CoV-2 genomic RNA.”
The petition makes these requests because the phase 2/3 clinical trial of the Pfizer COVID-19 vaccine uses a presumptive RT-qPCR (“PCR”) diagnostic test,