Report: FDA to release guidance on coronavirus vax approval

June 30, 2020

The FDA is planning to release baseline conditions this week for the approval of a coronavirus vaccine. 

According to a report in the Wall Street Journal, the FDA is planning to require that to win approval, a coronavirus vaccine will need to be at least 50 percent more effective than a placebo at preventing the illness. The agency is also planning to require that the vaccine do more than simply produce antibodies in the bloodstream because it is not known what level of antibodies is sufficient to preventing the spread of the coronavirus. 

Like other therapies, the FDA will also require post-market analysis of any approved vaccine to monitor patient safety and drug efficacy for at least a year. The clinical trial requirements being laid out by the FDA will also likely require 30,000 participants.

The news comes as the FDA faces scrutiny over its potentially rushed handling of coronavirus-related approvals, including its failure to stop faulty antibody tests from flooding the market, and its emergency approval of hydroxychloroquine as a treatment, which was later linked to a higher risk of death.

The requirements could also help the FDA fend off political pressure. Some have speculated that President Trump could try to create an “October surprise” by pressuring the FDA to approve a coronavirus vaccine ahead just of the November election.