Agency announcement follows Thursday’s positive review of Moderna’s shot by outside advisers
The Food and Drug Administration said Thursday night that it will “rapidly work toward” emergency authorization of Moderna’s coronavirus vaccine, just hours after agency advisers endorsed the shot. The announcement appeared to pave the way for another weapon against a pandemic that has killed about 310,000 people in the United States.
The FDA statement came after the agency’s vaccine advisory panel voted almost unanimously — 20 in favor, with one abstention — that the benefits of the highly effective vaccine outweighed its risks for people 18 years of age and older. The FDA intends to authorize the vaccine Friday, according to knowledgeable individuals who spoke on the condition of anonymity because they were not authorized to speak publicly about the schedule.
“I just want to make the point of what a remarkable scientific achievement this is, and pay thanks to all the scientists, present and past, who contributed to this,” James E.K. Hildreth, president of Meharry Medical College and a member of the advisory panel, said at the close of the committee meeting on Thursday. “To go from having a [genetic] sequence of a virus in January, to having two vaccines available in December, is a remarkable achievement.” Continue reading.