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.
In a 17-4 vote with one abstention, the committee of health experts concluded that the shot appears safe and effective for emergency use in people 16 and older. This means the inoculation will likely become the first approved in the U.S. to beat the virus that’s killed nearly 300,000 Americans.
The FDA is expected to follow the recommendation from its expert advisers. Depending on how fast the agency signs off, shots could begin within days for some health care workers and nursing home residents.
The thumbs up came despite questions from several members about whether 16 and 17 year olds should be included in the recommendation, since risk to those age groups are low and there wasn’t much data about them in the vaccine trial.
Ultimately, the panel voted on the question put forth by the FDA, which included 16 and 17 years old. Pfizer has asked for emergency use authorization for its two-dose vaccine in people aged 16 to 85.
The vote followed a daylong hearing from the FDA’s Vaccines and Related Biological Products Advisory Committee including 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.”