FDA Sets Bar For COVID-19 Vaccine Approval: Must Prevent Or Decrease Disease Severity For At Least Half
The FDA released guidance Tuesday on the criteria it will use to approve any coronavirus vaccine. Any candidates must prevent or decrease disease severity in at least 50% of the people inoculated. Temporary authorizations may be considered on a “case-by-case basis,” the agency said.
The Washington Post:
FDA Will Require Covid-19 Vaccine To Be At Least 50 Percent More Effective Than Placebo, Agency Says
The Food and Drug Administration said Tuesday that to win regulatory approval, any covid-19 vaccine will have to prevent disease, or decrease its severity, in at least 50 percent of the people who receive it. The agency also said it would require drug companies to monitor the vaccine’s performance after approval for any emerging safety problems. (McGinley, 6/30)
Reuters:
U.S. FDA Comes Out With Guidance For COVID-19 Vaccine Approval
“While the FDA is committed to expediting this work, we will not cut corners in our decisions,” the FDA said on Tuesday. ... “The guidelines are pretty standard, they look pretty much like influenza vaccine guidelines,” Gregory Poland, director of Mayo Vaccine Research Group said. “I don’t think that’s a high bar. I think that’s a low to maybe an appropriate bar for a first-generation COVID-19 vaccine.” (Maddipatla and Nadeem, 6/30)
The Hill:
Trump Officials Seek To Reassure Public About Safety Of A Potential Coronavirus Vaccine
Top Trump administration health officials are seeking to reassure the public that any potential coronavirus vaccine will only be approved if it is safe and that the fast-track process won't be influenced by political pressure. Democratic lawmakers and public health experts have expressed concern that President Trump's focus on developing a vaccine will pressure the Food and Drug Administration into approving one before it's safe. (Weixel, 6/30)
