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Tag: Vaccine trials

Pathologist Petitions FDA to Halt Pfizer Emergency Use Authorization Until Vaccine Efficacy Confirmed

Pathologist Petitions FDA to Halt Pfizer Emergency Use Authorization Until Vaccine Efficacy Confirmed

Connecticut pathologist Dr. Sin Hang Lee and Informed Consent Action Network (ICAN) have petitioned 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. “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,” said Dr. Lee, director of Milford Molecular Diagnostics Laboratory. The major reason for petitioning the FDA for a stay of action is that the Phase 2/3 clinical trial of the Pfizer vaccine used a presumptive RT-qPCR diagnostic test.

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