BackCoronavirus treatment: US govt to release guidelines for approval of COVID-19 vaccine
Drugmakers to show 'clearly demonstrated' proof of vaccine's safety and effectiveness through a clinical study, at least 50% more effectiveness than a placeboExperts say min 12 to 18 months to guarantee a safe and effective vaccine through clinical trials, over 100 vaccines tested worldwide
PremiumUSA : 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-approval-11593516090 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.
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.
Unlock a world of Benefits! From insightful newsletters to real-time stock tracking, breaking news and a personalized newsfeed – it's all here, just a click away! Login Now!
This story has been published from a wire agency feed without modifications to the text.
