FDA panel clears way for Pfizer vaccine

An FDA advisory panel has endorsed the Pfizer Covid-19 vaccine, clearing the way for final approval by the authority.

Thomas M. Burton and Jared S. Hopkins from the Wall Street Journal reported:

A Food and Drug Administration advisory panel recommended approval of the Covid-19 vaccine developed by Pfizer Inc. and BioNTech SE, clearing the way for the FDA to grant emergency authorization of the vaccine as early as Friday.

The approval—by a vote of 17-4 with one abstention after a daylong hearing—came as Covid-19 infections continued surging, claiming about 290,000 American lives.

The disease is now “essentially out of control,” Kathrin Jansen, Pfizer’s PFE -0.29% head of vaccine research and development, told the Vaccines and Related Biological Products Advisory Committee. “Vaccine introduction is an urgent need.”

CNBC’s Berkeley Lovelace Jr. wrote:

It’s unclear whether the FDA will authorize Pfizer and BioNTech’s vaccine for use in certain groups. Some people, including pregnant women and young children, will likely have to wait to get the vaccine in the U.S. until Pfizer can finish trials on those specific groups. The FDA said Tuesday that there is currently insufficient data to make conclusions about the safety of the vaccine in children under age 16, pregnant women and people with compromised immune systems. Regulators in Canada, the U.K. and Bahrain have all cleared the vaccine for use by most adults.

CNN’s Maggie Fox, Amanda Watts and Jacqueline Howard reported:

“The question is never when you know everything. It’s when you know enough and I think we know enough now to say that this appears to be our way out of this awful, awful mess,” Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the committee, told CNN’s Wolf Blitzer after the vote.

“That’s why I voted yes.”

Dr. James Hildreth, president and chief executive officer of Meharry Medical College, said he would have hoped more minorities had been enrolled in the clinical trials of the vaccine.

“I just feel that we need this vaccine and the benefits outweigh the risks,” Hildreth, a temporary voting member of the committee, told CNN.