Pfizer COVID-19 vaccine faces last hurdle before US decision
WASHINGTON (AP) — Pfizer's 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 company’s data for any red flags.
Thursday’s meeting of the Food and Drug Administration’s 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 committee’s advice, although it is not required to do so.
The FDA’s 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 shouldn’t 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 Pfizer’s large, ongoing study showed the shot, which was co-developed with Germany’s BioNTech, was more than 90% effective across people of different ages, races and underlying health conditions, including diabetes and obesity. No major safety issues were uncovered and common vaccine-related side effects like fever, fatigue and injection site pain...
