Washington Washington – Dr. Scott. Scott Gottlieb, former commissioner of the Food and Drug Administration, said Sunday he did not believe there would be “full approval” Coronavirus vaccine For the general population in early 2021.
“We are likely to move in the direction of one step towards authorization of this vaccine for certain selected populations who are at high risk of contracting or having a bad outcome before the general population sees full approval,” Gottlieb said. Nation. “I think, again, full approval for the general population, where people can go on CVS and get shots – that’s really the event of 2021, maybe the first quarter of 2021, maybe the first half.”
The Trump administration has thrown billions of dollars behind the development of the coronavirus vaccine through Operation Worp Speed, which aims to deliver 300 million doses of the vaccine by January. There are several vaccine candidates in the Phase 3 trial, including three from Strazeneca, Pfizer and Moderna – who have received federal funding.
In an interview with the Financial Times, Stephen, who led the FDA. Stephen Hahn indicated that they were ready to approve the vaccine before the Phase 3 trial was over.
“It’s up to the sponsor [vaccine developer] To apply for authorization or approval, and we will decide on their application, “Hahn said.” If they do it before the end of Phase 3, we think it’s appropriate. We will find it inappropriate, we will decide. ”
But Gottlieb said the FDA won’t wait until October 3 or November to wait for a Phase 3 trial to “read” the data before determining the effectiveness of the vaccines. However, he noted that the first authorization of the vaccine would be the authorization of emergency use for certain populations at high risk of infection.
“I don’t think the FDA commissioner can step in and make a decision through professional staff,” he said. “And I don’t think he can stop these tests anytime soon.”
Gottlieb also responded to new guidelines issued by the Centers for Disease Control and Prevention this week that said people who have been exposed to coronavirus but do not remain asymptomatic need to be tested.
“We should check for people who are not infected and do not have an asymptomatic carrier because we know they can spread the infection,” he said. “They are less likely to spread the infection, but they can still spread the infection.”
Gottlieb said the motivation behind the new guidelines is that they have learned the need from some businesses that test negatively before workers can return.
“If this is the case and it’s a matter of concern, there were more targeted ways to address the problems and talk about it, as opposed to this very broad, massive change in the recommendations, which I think can 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 makes sense that we test people who may be at higher risk of contracting the infection.”
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