FDA Says COVID-19 Vaccine Must Be At Least 50% Effective To Be Approved

reports the US Food and Drug Administration on Tuesday said that to be approved a COVID-19 vaccine must “prevent disease, or decrease its severity, in at least 50 percent of the people who receive it.” Still, “many people believe a vaccine initially would be made available through a much lower standard for temporary approvals.” FDA Commissioner Stephen Hahn “said the FDA is committed to expedite a covid-19 vaccine, but ‘will not cut corners in our decision-making.’” Hahn also said that he is “optimistic” that another treatment for covid-19 will be approved by the fall. Politico (6/30, Owermohle) reports that while the FDA’s guidance requires “any vaccine candidate be at least 50 percent more effective than a placebo,” it “also left open the possibility it would issue an emergency use authorization for a vaccine.” The Wall Street Journal (6/30, Burton, Subscription Publication) reports that the FDA said it would not approve a vaccine based on it resulting in antibodies in a patient’s bloodstream. https://www.washingtonpost.com/health/2020/06/30/coronavirus-vaccine-approval-fda/