Quick OK of first US Covid-19 vaccine cut no corners, FDA officials promise

Quick OK of first US Covid-19 vaccine cut no corners, FDA officials promise

 

The very fast decision to grant emergency use authorization to Pfizer and BioNTech's coronavirus vaccine was based on a deep review of safety and efficacy data, two top FDA officials said Saturday.   The FDA granted the EUA -- the first-ever for a vaccine for use in the general public in the United States -- late Friday, just a day after advisers recommended it.   "There was a desire for us to move as quickly as possible," said FDA Commissioner Dr. Stephen Hahn. "Our absolute obligation to the American people was to make sure we did a thorough scientific review. We needed to assure our gold star in assessing the safety and efficacy of the vaccine was done and was done properly."   The FDA also considered the advice of its Vaccines and Related Biological Products Advisory Committee (VRBPAC), a group of experts with no financial ties to the vaccine process, who voted 17-4 -- with one abstention -- to recommend EUA of the vaccine after two public meetings.   "The committee overwhelmingly agreed that the vaccine's benefits outweighs its risks," Hahn said. He added that the FDA has been transparent about the data.