Pfizer COVID-19 vaccine faces last hurdle before US decision
Pfizer COVID-19 vaccine faces last hurdle before US decision
By LAURAN NEERGAARD and MATTHEW PERRONE
WASHINGTON: Pfizers COVID-19 vaccine faces one final hurdle as it races to become the first shot greenlighted in the U.S.: a panel of experts who will scrutinize the companys data for any red flags.
Thursdays meeting of the Food and Drug Administrations vaccine advisory panel is likely the last step before a U.S. decision to begin shipping millions of doses of the shot, which has shown strong protection against the coronavirus.
The FDA panel functions like a science court that will pick apart the data and debate in public and live-streamed whether the shot is safe and effective enough to be cleared for emergency use. The non-government experts specialize in vaccine development, infectious diseases and medical statistics. The FDA is expected to follow the committees advice, although it is not required to do so.
The FDAs decision comes as the coronavirus continues surging across much of the world, claiming more than 1.5 million lives, including more than 289,000 in the U.S.
Hanging over the meeting is a warning from U.K. officials that people with a history of serious allergic reactions shouldnt get the vaccine. Government officials there are investigating two reports of reactions that occurred when the country began mass vaccinations.
Still, a positive recommendation and speedy U.S. approval seem nearly certain after FDA scientists issued an overwhelmingly positive initial review of the vaccine earlier this week.
FDA said results from Pfizers large, ongoing study showed the shot, which was co-developed with Germanys BioNTech, was more than 90
