The FDA Panel Endorses Covid-19 Vaccine
Yesterday the US Food and Drug Administration (FDA) panel endorsed the Covid-19 the first vaccine in the US. This recommendation paves the way for regulatory agency to grant emergency authorization as early as today, Friday December 11th/2020.
A US Food and Drug Administration advisory panel recommended approval of the Covid-19 vaccine developed by Pfizer Inc. and BioNTech SE. This endorsement cleared the way for the FDA to grant emergency authorization of the vaccine as early as today 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 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.”