The Food and Drug Administration (FDA) issued new rules Tuesday for companies developing COVID-19 vaccines. “While the FDA is committed to helping expedite this work, we are not going to cut corners in our decision making, and we are clarifying in our guidance what data we need, which needs to be submitted, to meet our regulatory standards for approval, “FDA Commissioner Dr. Stephen Hahn said Tuesday during a Senate committee hearing. The guideline states that the primary efficacy endpoint in a placebo-controlled efficacy clinical trial must be at least 50%, meaning that the vaccine needs to “reduce the risk of disease caused by COVID-19 by 50% “Compared to placebo, according to Brad Loncar, a biotech investor and CEO of Loncar Investments. There are several drug manufacturers that develop COVID-19 vaccine candidates, including AstraZeneca AZN,
and the University of Oxford, Inovio Pharmaceuticals Inc. INO,
and Moderna Inc. MRNA,
two of which (Inovio and Moderna) have revealed preliminary data from their Phase 1 trials. The return to economic normality has been largely related to the advent of vaccines that can prevent coronavirus infections. “There is no guarantee … that we will have a safe and effective vaccine, but we are cautiously optimistic,” said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, at the same hearing.
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