A top FDA official has threatened to resign if the Trump administration moves too quickly to approve a vaccine for COVID-19, according to a published report.
Peter Marks, director of the agency’s Center for Biologics Evaluation and Research (CBER), made the threat over concerns a vaccine would be approved without being proven safe and effective, according to a report by Reuters. The news agency quoted Marks as saying that he is not under political pressure to speed a vaccine to market but that he would quit if that changed.
“I could not stand by and see something that was unsafe or ineffective that was being put through,” Marks told Reuters. “You have to decide where your red line is, and that’s my red line. I would feel obligated (to resign) because in doing so, I would indicate to the American public that there’s something wrong.”
Public health officials have expressed concern that the administration might move too quickly on a COVID-19 vaccine as the presidential election looms in November.
FDA commissioner Stephen Hahn said in a statement on Thursday that data produced from COVID-19 vaccine trials “will be the deciding factor for any FDA approval. CBER scientists are monitoring those trials.” On Saturday, President Trump accused Hahn and the FDA of deliberately delaying such trials, according to a report by CNN.
“The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” Trump tweeted Saturday. “Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!” Trump ended the tweet with “@SteveFDA,” Hahn’s Twitter handle.
Critics have been warning for months that rushing a COVID-19 vaccine would be dangerous, and top federal scientists, including Dr. Anthony Fauci, have said that no vaccine would be ready until early 2021. Polls have shown that one-fifth of adults would decline a coronavirus vaccine partly out of fear that politics rather than science led to its approval, according to a report by Politico. A POLITICO/Morning Consult poll taken earlier this month showed that just 14% of voters would be inclined to take a vaccine recommended by the Trump.
I have managed clinical trials for many cardiovascular drugs and have had many dealings with the FDA on approval of these drugs. For the Trump administration to pressure an early release of a vaccine by the FDA without proper evaluation of safety and efficacy from all clinical trials would be inappropriate, dangerous to the public and the end of the FDA. If Dr. Hahn cannot carry on without bending to political pressure he should resign now as he does not deserve to administer the FDA. Such behavior would eventually find its way to approval of addition unsafe and ineffective products any administration deems needed for political purposes.