A government advisory panel on Thursday backed the use of Pfizer’s COVID-19 vaccine, paving the way for the Food and Drug Administration to grant the vax the final green light.
The vote from the committee of 23 health experts means the vaccine will likely become the first approved in the U.S. to beat the virus that’s killed nearly 300,000 Americans.
Depending on how fast the FDA signs off on the panel’s recommendation, shots could begin within days for some health care workers and nursing home residents.
The daylong hearing from the FDA’s Vaccines and Related Biological Products Advisory Committee included a public comment portion involving other health officials and vaccine advocates.
“The American public demands and deserves a rigorous, comprehensive and independent review of the data,” said the FDA’s Dr. Doran Fink.
“We expect a high bar for efficacy,” he added.
Among the topics discussed was a warning from British health officials that individuals with “significant” allergic reactions may not be able to get vaccinated.
Two people who received the COVID-19 shot in the UK on Tuesday suffered severe allergic reactions to it.
However, Pfizer reps told the panel that, while they’re aware of the British reports, they haven’t seen any signs of allergic reactions in their trial of the vaccine.
One commenter, Evan Fein, said he was a Phase 1 trial participant and rallied for the panel to approve the drug.
“I think I got a real vaccine and not a placebo,” he said, adding that he experienced fever, chills and pain in the injection site but no long-term effects.
“I was called repeatedly by doctors and researchers to see if I was OK. And I was. Nothing felt rushed and I never felt like a guinea pig.”
Calling the pandemic an “emergency,” he said, “An [emergency use authorization] must be granted, and it must be granted tonight.”
The FDA said that the results of Pfizer’s large, ongoing study showed that the vaccine — developed with Germany’s BioNTech — was more than 90 percent effective across a large swath of people and that no major safety problems were uncovered.
“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 University’s International Vaccine Access Center.
“Nothing that I see would delay an emergency use authorization.”
source nypost