Washington – Dr Scott Gottlieb, a former commissioner of the Food and Drug Administration, said on Sunday that he did not believe there would be “full approval” offor the population until the beginning of 2021
“We are likely to see a gradual progression in the authorization of this vaccine for certain selected populations that are at higher risk of either contracting or having a poor outcome before we see full approval of the general population,”
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 vaccine by January. There are several vaccine applicants 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 heads the FDA, suggested that he was open to approving the vaccine before the Phase 3 trials were completed.
“It depends on the sponsor [vaccine developer] to apply for a permit or approval and we make a decision on their application, “Hahn said.” If they do it before the end of Phase 3, we may consider it appropriate. We may consider it inappropriate, we will make a decision. ”
But Gottlieb said the FDA would wait for phase 3 trials to “read” data before determining the effectiveness of the vaccines, which won’t happen until October or November. However, he noted that the first vaccine authorization would be an emergency authorization for specific populations with a higher risk of infection.
“I don’t think the FDA commissioner could intervene and abandon the decision of the professional staff,” he said. “And I don’t think he can stop these trials sooner.”
Gottlieb also responded to new guidelines issued by the Centers for Disease Control and Prevention this week that people who have been exposed to coronavirus but remain asymptomatic may not need testing.
“We need to test these people to make sure they are not infected and are not asymptomatic carriers because we know 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 a motivation behind the new guidelines was that some businesses require workers to take a negative test before they can return to work.
“If this is the case and this is worrying, there are more targeted ways to address this and talk about this issue, instead of making this very broad, large-scale change in the recommendations, which I think can be misinterpreted. from the general public and certainly from the public health agencies in the states, “he said.” And so I don’t think this changed leadership is likely to be followed by many countries. I think it’s sensible to test people who may be at high risk of infection. “