It was two weeks ago today when Donald Trump first raised the prospect of rejecting strict FDA guidelines on possible coronavirus vaccines. “That has to be approved by the White House,” the president said. “We may or may not approve it.”
Around the same time, the Republican suggested FDA officials were conspiring against him, “delaying” the vaccine as part of a pre-election “political hit” against him.
It was against this backdrop that the public learned this week that White House officials were, in fact, blocking the tougher federal vaccine guidelines. That is, until yesterday, when the White House relented and released the stricter standards.
The Food and Drug Administration said Tuesday that manufacturers of Covid-19 vaccines will need to follow tens of thousands of study participants for at least two months to look for any possible safety issues before the agency would consider authorization…. The FDA will require two months of follow-up for at least half of the study participants after they receive their last doses of vaccine. The vaccine candidates furthest ahead in phase 3 clinical trials, from Moderna and Pfizer, each require two doses, given about one month apart.
This will, among other things, make it impossible for a vaccine to be available before Election Day, which had been a presidential priority.









