U.S. FDA to release guidance on COVID-19 vaccine approval – WSJ
Reporting by Manojna Maddipatla in Bengaluru; Editing by Shinjini Ganguli/Reuters
(Reuters) – The U.S. Food and Drug Administration plans to release guidance on Tuesday outlining its conditions for approving a vaccine for the coronavirus, the Wall Street Journal reported, citing a summary of the guidance.
The agency would require drugmakers to show “clearly demonstrated” proof of a vaccine’s safety and effectiveness through a clinical study, and at least 50% more effectiveness than a placebo, the report here said.
There is currently no U.S.-approved treatment or vaccine for the respiratory illness that has claimed over 126,100 lives in the country, according to a Reuters tally.
More than 100 vaccines are being tested worldwide against the virus, with only a handful in the human testing phase, including candidates from AstraZeneca Plc and Moderna Inc.
Experts have suggested that it could take a minimum of 12 to 18 months to guarantee a safe and effective vaccine through clinical trials.
The guidance is expected to be discussed by FDA Commissioner Stephen Hahn in an appearance before a Senate committee on Tuesday, the report said.