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’s not required to do so.
The FDA’s decision will come 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., according to the tally kept by Johns Hopkins University. That surpasses the number of deaths in the nation with the second-most, Brazil, by some 110,000.
The U.S. just set a single day record of more than 3,000 COVID-19 deaths, as noted by Vice President-elect Kamala Harris:
Columbia University biologist Dr. Lucky Tran called it “a historic tragedy”:
U.S. hospitals are filling up. More than one-third of all Americans live near hospitals that are critically short of intensive care unit beds, according to The New York Times.
But hanging over the FDA 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.
The agency 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 were tolerable.
“The data presented in the briefing report were consistent with what we heard before and are really exciting,” said Dr. William Moss, head of Johns Hopkins’ International Vaccine Access Center. “Nothing that I see would delay an emergency use authorization.”
The meeting also gives regulators an opportunity to try to boost public confidence in the breakneck development process that has produced the Pfizer-BioNTech vaccine and a string of other upcoming shots in less than a year.
The FDA has also faced weeks of verbal abuse from President Donald Trump for not rushing out a vaccine before Election Day.
“There have been a lot of questions about why it takes us so long or ‘are we being rigorous enough?'” said FDA Commissioner Stephen Hahn in an interview. “I’m hoping that people will see with our transparency that we have taken a very rigorous stance on this.”
Hahn said the agency has already teed up the process to authorize the vaccine by filling out all the legal paperwork in advance, regardless of the ultimate decision.
