Tipsheet

Key FDA Committee Approves Pfizer Vaccine

After a daylong meeting on Thursday, the independent FDA advisory panel, the Vaccines and Related Biological Products Advisory Committee, voted 17 to 4, with one abstention, to approve the coronavirus vaccine developed by Pfizer and BioNTech. In its final clinical trials, the vaccine was found to be over 95 percent effective.

With the committee's blessing, the FDA is expected to approve the vaccine within the next few days, perhaps as early as Friday.

A final meeting is taking place Sunday, when an advisory committee to the Centers for Disease Control and Prevention meets to make a final recommendation on who should get the vaccine first. Leading officials have noted that the first doses will go to health care workers and the elderly. As noted above, frontline workers could receive doses as early as next week.

The panel didn't approve the vaccine without voicing a few concerns. For instance, Dr. Arnold Monto, the committee’s chair, worried that some people may have allergic reactions to the vaccine.

“Facts may be important, but perception drives a lot of decisions,” he said.

And yet, the advisory panel concluded that the use of the vaccine outweighs the risks for individuals 16 years of age and older.

Next week, the FDA will also be considering the vaccine developed by Moderna, which was proven to be over 94 percent effective. After that, the agency is expect to consider the vaccine candidates from Johnson & Johnson and AstraZeneca.