Tipsheet

FDA Approves Pfizer Vaccine for Emergency Use

The Food and Drug Administration (FDA) has awarded an emergency authorization to Pfizer for its COVID vaccine. In its final clinical trial, the vaccine, developed by Pfizer and BioNTech, was over 95 percent effective. The vaccine requires two doses for full protection.

The New York Times reported the agency’s chief scientist, Dr. Stephen Hahn, signed the emergency use authorization Friday evening. Pfizer is working with the federal government to provide 100 million doses of the vaccine, free to the public, by March 2021. The first doses of the vaccine are expected to be administered within days.

An independent FDA advisory panel, the Vaccines and Related Biological Products Advisory Committee, met on Thursday and voted 17 to 4, with one abstention, to approve the vaccine.

On Tuesday, following an analysis, the FDA concluded that the Pfizer vaccine "met the prescribed success criteria."

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.

President Trump blasted Dr. Hahn in a tweet earlier on Friday, telling the FDA commissioner to approve the vaccine and accusing the top doctor of "playing games."

The FDA is meeting again on Dec. 17 to discuss the emergency authorization request from Moderna. Its vaccine candidate was over 94 percent effective.