Report: FDA To Announce Tougher Coronavirus Vaccine Standards That May Dash Trump’s Election Day Goal

According to the report, the agency is expected to issue new guidance as early as this week to build public trust regarding the virus’s efficacy and safety, which polls show has significantly declined since May as President Trump has continued to emphasize a speedy release.

Instead of just green lighting the vaccine with emergency clearance, as was done with convalescent plasma and hydroxychloroquine, the FDA is expected to ask manufacturers to follow participants in late-stage clinical trials for a median of at least two months after they’ve received a second vaccine shot, two anonymous people familiar with the situation told The Washington post.

The FDA is also expected to require at least five severe Covid-19 cases in the placebo group for each trial, as well as a sampling of older people with the virus, to prove its efficacy. 

This new guidance would make the clearance of a vaccine before the election on November 3 fairly unlikely.

A detailed plan from Moderna, one of the two companies leading the race to develop a vaccine, predicted it could take until next year to assure the vaccine works, while Pfizer has said it could have data ready for the FDA to review by late October—though the trial timelines for both suggest having data ready by election day would be a close call.

The FDA did not immediately respond to Forbes’ questions verifying the report.