A senior administration official said the main issue regarding the FDA’s new guidelines for Emergency use Authorization (EUA) is the agency’s planned instruction that vaccine developers follow patients enrolled in their trials for at least two months to rule out safety issues, reports CNBC News.
Under the updated EUA rules, the FDA is expected to ask manufacturers seeking this authoriation to “follow participants in late-stage clinical trials for a median of at least two months, starting after they receive a second vaccine shot.”
The White House official confirmed on Monday night that the administration believes there is “no clinical or medical reason” for the additional requirement. This action is just the latest example of the administration undercutting its own medical experts working to combat the pandemic that has killed more than 210,000 Americans.
FDA Commissioner Stephen Hahn – caught between a rock-and-a-hard-place with pleasing the Trump administration and assuring the public gets a safe and effective vaccine – has said more than once that scientists, not politicians, will decide if the shots are safe.
But despite the need to let science be the deciding factor behind getting a vaccine to market, President Trump continues to insist that a coronavirus vaccine could be authorized before Election Day – even though top government scientists say it is highly unlikely.
According to US News, seven former FDA commissioners blasted the administration for “undermining the credibility” of the FDA in a Washington Post op-ed last week. They also called for the release of the new FDA guidelines. They warned that politicizing the vaccine could derail efforts to vaccinate millions of Americans.
The administration’s efforts might be all for naught, though. Only one pharmaceutical company, Pfizer, has suggested it could have data on the safety and effectiveness of its vaccine before Election Day. Even then, it would still be questionable, seeing as the FDA has to review all the data before giving any approval, reports the Associated Press.
Meanwhile, competitors Moderna, AstraZeneca and Johnson & Johnson have longer research timelines. Dr. Peter Marks, the head of FDA’s vaccine division, in an online interview last week, said, releasing the guidelines was “an attempt to help the public see what we’re requiring of COVID-19 vaccines.” He added that the guidelines would explain that all upcoming vaccines would be reviewed by FDA’s independent panel of vaccine advisers, before the agency makes its own final decision.
