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FDA to release guidance on COVID-19 vaccine approval

Coronavirus

SAN FRANCISCO (KRON) – The U.S. Food and Drug Administration (FDA) on Tuesday plans to issue guidance detailing its conditions for approving a vaccine for the coronavirus, the Wall Street Journal reports.

According to the guidance, the FDA 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 said.

At this time there is no US-approved vaccine or treatment for the coronavirus.

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 Tuesday.

Thanks to the federal “Operation Warp Speed” vaccine acceleration program, Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Disease, said he expects the US will have “hundreds of millions of doses” of the vaccine ready to deploy by early 2021. 

Several companies are working on antiviral drugs to treat people who have COVID-19, while others are working on vaccines that could be used as a preventative measure against the virus.

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