Gottlieb questions FDA chief’s coronavirus vaccine fast-track comments: Full approval a ‘2021 event’

Former Food and Drug Administration (FDA) Commissioner Scott Gottlieb is questioning FDA Commissioner Stephen Hahn’s comments about fast-tracking a coronavirus vaccine, stating that a full approval of a vaccine for the general population likely won’t happen until 2021. 

Hahn said in an interview published by The Financial Times on Sunday that he is willing to fast-track a coronavirus vaccine before clinical trials are complete if it is determined to be “appropriate.” 

“I don’t know what is meant by saying before the phase three trials are completed,” Gottlieb said later on CBS’s “Face the Nation,” in response to Hahn’s interview. 

“These phase three trials are event-based trials, meaning that they’re going to start to read out data after a certain amount of events accrue in the clinical trials. And those events are people getting COVID infection. And so as the trials progress, if we start to see lower rates of COVID infection in the active group, the group that receives the vaccine versus the placebo group, the group that hasn’t received the vaccine,” Gottlieb added. 

He said the trials could read out data earlier, in October, if the vaccines are “very effective.” 

“And so I’m not sure what he means by approving it earlier than when the trials are completed. They’re going to wait for these trials to read out before they can make a decision around the efficacy of these vaccines,” Gottlieb said. 

“I think, again, of full approval for the general population, where people can go to CVS and get a shot, that’s really a 2021 event, maybe the first quarter of 2021, probably more likely the first half,” he added. 

Hahn told the Financial Times that politics would play no part in any decision to fast-track a coronavirus vaccine. 

“It is up to the sponsor [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application,” Hahn said. “If they do that before the end of Phase Three, we may find that appropriate. We may find that inappropriate, we will make a determination.”

Drug manufacturers around the world are working to develop a coronavirus vaccine. The virus has infected more than 25 million people and resulted in more than 843,000 worldwide, according to data compiled by Johns Hopkins University.