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FDA commissioner says agency will strike a balance in reviewing vaccine applications

CHARLESTON, W.Va. — The head of the U.S. Food and Drug Administration tells MetroNews the FDA will attempt to strike a balance with its consideration of vaccines for the coronavirus.

FDA Commissioner Dr. Stephen Hahn was a guest Tuesday on the MetroNews Morning News. Hahn said the FDA has received Pfizer’s emergency use operation application for its vaccine. Hahn said FDA scientists are reviewing it.

“Our criteria for authorization of these applications is very similar to what we would use for approval of a regular application and they’re very high standards for both safety and effectiveness and the quality of the vaccine,” Hahn said. “Our scientists will look at these vaccines and they’ll do the numbers crunching themselves and we’ll make our own conclusions.”

After that, the FDA will use an external advisory committee from experts around the country, which Hahn said is a public process.

“We’ll use their advice before we make a final decision,” he said.

Moderna and AstraZeneca are expected to soon file their applications for emergency use operation.

Hahn said he anticipates the FDA will move at a good pace on the applications.

“We, FDA, will not authorize a vaccine that we wouldn’t want to give to our own family. That is of critical importance. We want to balance that with the fact that we are in the middle of a pandemic, people are dying, people are sick and we want to prevent as much infection as possible and a vaccine is the best way doing that,” Hahn said.

The FDA boards meets next on Dec. 10 and could approval the Pfizer vaccine then.

Hahn, an appointee of President Donald Trump, said the quickness of how the sponsors have come up with vaccines is impressive.

“It just shows you want America can do when we put our minds to it,” he said. “In particular, the first two vaccines that were announced in terms of effectiveness, that’s just an example of a private-public partnership and what can occur,” Hahn said.

Hahn it’s likely many West Virginians won’t be able to be vaccinated for several more months so there’s no reason for them or anyone else to let their guard down against the virus.

“So in the meantime we have to continue these efforts to prevent the spread,” Hahn said.





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