Going against scientific wisdom, FDA head proposes fast-tracking a vaccine

The commissioner of the Food and Drug Administration, Dr. Stephen Hahn — who recently apologized for advertising an unproven COVID-19 treatment — is now facing fire for telling the Financial Times last week that his agency is prepared to authorize a vaccine before Phase Three clinical trials are complete. Former FDA Commissioner Dr. Peggy Hamburg was quoted by MSNBC journalist Andrea Mitchell as saying, "Given the importance of a vaccine, its safety, its efficacy and the willingness of people to take it and the clear levels of political interference going on, I would urge to proceed with caution." While this statement was consistent with Trump's claims that plasma "had an incredible rate of success" in treating the novel coronavirus — and Trump himself had tweeted only a little while earlier that "the deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics" and "must focus on speed" — scientists recognized that it was a significant exaggeration. According to the U.S. Department of Health and Human Services, Phase Three trials of a potential medicine "are conducted to confirm and expand on safety and effectiveness results from Phase 1 and 2 trials, to compare the drug to standard therapies for the disease or condition being studied, and to evaluate the overall risks and benefits of the drug."