How A COVID Vaccine Approval Process Works And Why It Will Take Weeks

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How A COVID Vaccine Approval Process Works And Why It Will Take Weeks
Now that Pfizer has requested emergency use authorization for its COVID vaccine, what's next?
SHOW TRANSCRIPT

FDA officials have said the review will take weeks. Here’s what we know about the process that will take place.

Right now, the FDA’s painstakingly going through lots of data. That’s in addition to the research and manufacturing plans and other information that both Pfizer and BioNtech previously submitted.  The FDA will release its own internal analysis.

Pfizer will also have to present their findings to an advisory committee made up of outside medical experts that make recommendations to the FDA. That’s going to be the public’s first chance to see the data. It’s been reported that it will be in early December. 

"When I'm sitting there, listening to those data presented to us at the FDA's vaccine advisory committee meeting, I will be looking to answer the question, would I take this myself? Dr. Paul Offit, FDA Vaccine and Related Products Advisory Committee member, said.

A few days following any FDA emergency approval, a CDC committee will then meet to make official recommendations about who will get the vaccine first.  

"We're interested in complete transparency. These meetings are open to the public on your computer," Dr. William Schaffner, member of CDC Advisory Committee on Immunization Practice,s said. 

The CDC’s interim playbook says in the first phase, vaccines would go to paid and unpaid persons in healthcare settings who have contact with infectious patients or materials.  Lindsey Theis, Newsy, Denver.