A new document from the Food and Drug Administration (FDA) stated the FDA does not “require demonstration of the prevention of infection or transmission” in order to authorize a vaccine.
The letter from Dr. Peter Marks, a top official for the FDA, came in response to recommendations from the Coalition Advocating for Adequately Labeled Medicines and called for updated labels on the Pfizer and Moderna COVID-19 vaccines.
Dr. Marks rejected many of the recommendations, some of which included “language clarifying that phase III trials were not designed to determine and failed to provide substantial evidence of vaccine efficacy against SARS-CoV-2 transmission or death must be added to labels,” according to the coalition.
Reporting from The Epoch Times:
Linda Wastila, a professor in the Department of Practice, Sciences, and Health Outcomes Research at the University of Maryland School of Pharmacy, said she was surprised by Marks’ assertion. “I am totally flabbergasted that the FDA responded that proof of prevention of infection and transmission is not necessary for an EUA [Emergency Use Authorization] vaccine,” Wastila, who is part of the coalition, told The Epoch Times via email. The comment “makes me wonder if the FDA has ANY standards of safety and efficacy of the EUA vaccines,” she added.
