New Delhi|HL
The very fast decision to grant emergency use authorization to the first coronavirus vaccine in the United States cut no corners and was based on a deep review of safety and efficacy data, two top US Food and Drug Administration officials said Saturday as reported by CNN .cnn
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.The FDA has been pummeled by a White House clamoring for a fast win and caught between public forces desperate for something — anything — to help fight a pandemic that has killed close to 300,000 Americans, but also deeply suspicious of new scientific technology developed in a highly charged political atmosphere.
FDA Commissioner Dr. Stephen Hahn said his agency’s scientists, considered the best in the world, stayed above the upheaval as they reviewed the data about Pfizer and BioNTech’s vaccine.”Science and data guided the FDA’s decision,” Hahn told a Saturday morning news conference carried by webcast and broadcast over social media.The FDA listened to 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.”We held a public advisory committee on Thursday about the Pfizer and BioNTech application,” Hahn said. “The committee overwhelmingly agreed that the vaccine’s benefits outweighs its risks.”Hahn said the FDA has been transparent about the data.
“First of all the representations in the press that I was threatened to be fired if we didn’t get it done by a certain date is inaccurate,” Hahn said.”Dr. Marks and I have been very clear from the beginning that we are going to maintain the integrity of the scientific process. We are going to let our scientists do their job and review and go through the fairness of that review, the gold standard if you will,” Hahn added.
