US FDA to release guidance on Covid-19 vaccine approval
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
The US 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 https://www.wsj.com/articles/fda-to-issue-guidance-on-covid-19-vaccine-a... said.
There is currently no US-approved treatment or vaccine for the respiratory illness that has claimed over 126,100 lives in the country, according to a Reuters tally.
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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.
