Washington — Dr. Scott Gottlieb, the former commissioner of the Food and Drug Administration, said Sunday he does not believe there will be “full approval” of afor the general population until early 2021.
“We’re likely to see a stepwise progression of authorization of this vaccine for certain select populations that are at higher risk of either contracting it or having a bad outcome before we see a full approval for the general population,” Gottlieb said on “Face the Nation.” “I think, again, 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.”
The Trump administration has thrown billions of dollars behind the development of a coronavirus vaccine through Operation Warp Speed, which aims to deliver 300 million doses of a vaccine by January. There are several vaccine candidates that are in Phase 3 trials, including three — from AstraZeneca, Pfizer and Moderna — that have received federal funding.
In an interview with the Financial Times, Dr. Stephen Hahn, who helms the FDA, suggested he is open to approving a vaccine before Phase 3 trials are completed.
“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 3, we may find that appropriate. We may find that inappropriate, we will make a determination.”
But Gottlieb said the FDA is going to wait for the Phase 3 trials to “read out” data before determining the efficacy of the vaccines, which will not occur until October or November. He did, however, note the first authorization of vaccines will be an emergency use authorization for specific populations at higher risk of infection.
“I don’t think the FDA commissioner could step in and obviate a decision by the professional staff,” he said. “And I don’t think he can stop these trials early.”
Gottlieb also responded to the new guidance issued by the Centers for Disease Control and Prevention this week that said people who have been exposed to the coronavirus but remain asymptomatic may not need to be tested.
“We should be testing those people to make sure they haven’t become infected and aren’t asymptomatic carriers because we know that they can spread the infection,” he said. “They’re less likely to spread the infection, but they can still spread the infection.”
Gottlieb said he learned one motivation behind the new guidance was a requirement from some businesses that workers test negative before they can return to work.
“If that’s the case and that was a concern, there were more targeted ways to address that and speak to that problem, as opposed to making this very broad, sweeping change in the recommendations, which I think could be misinterpreted by the general public and certainly by public health agencies within states,” he said. “And so I don’t think this changed guidance is likely to be followed by many states. I think it’s prudent that we test people who might be at high risk of contracting the infection.”