FDA Panel Endorses Covid-19 Vaccine

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.”

In its vote to approve, the panel said the benefits of the vaccine outweigh the risks for people 16 years of age and older.

“The efficacy is overwhelming” for the vaccine, said Eric Rubin, a Harvard microbiologist, panel member and editor-in-chief of the New England Journal of Medicine. “It’s very strong.”

“When you have 2,000 to 3,000 people a day—a day—dying of coronavirus, to me this was a clear choice,” said Ofer Levy, a panel member and director of the Precision Vaccines Program at Boston Children’s Hospital, after the vote.

ArchanaChatterjee, dean of the Chicago Medical School at Rosalind Franklin University of Science and Medicine, said she dissented from the recommendation vote because there isn’t enough data justifying including 16 and 17 year olds in an emergency authorization.

“They’re not a high-risk group,” she said in an interview. “My concern was that the data was very limited in the 16,17 year olds.” She said she would have voted in favor otherwise, saying that for adults the benefits of the vaccine outweigh the risks.

Oveta Fuller, a virologist at the University of Michigan Medical School, also dissented, saying in an interview that she would like to see at least two more months of data on trial participants that could help determine whether the vaccine reduces transmission.

That advisory committee’s decision paves the way for the FDA to green-light distribution of the vaccine. That step is expected as early as Friday or this weekend, given the magnitude of the public-health crisis and scientific analysis that showed the vaccine is safe and 95% effective in combating Covid-19 among test subjects.

Ref: Wall Street Journal