IT'S OUR BEST SHOT
FDA panel clears Pfizer vax
Pandemic-weary Americans are about to get a shot in the arm.
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 it the green light.
In a 17-4 vote with one abstention, the FDA’s Vaccines and Related Biological Products Advisory Committee concluded that the shot appears safe and effective for emergency use in people 16 and older.
The FDA is expected to follow the recommendation from its expert advisers and could make its ruling at any time. Depending on how fast the agency signs off, shots could begin within days for some health-care workers and nursing-home residents.
The inoculation would be the first approved in the United States against the virus, which has killed nearly 300,000 Americans.
The panel’s thumbs-up came despite questions from several members about whether 16- and 17-year-olds should be included in the recommendation, since risks to those age groups are low and there wasn’t much data about them in the vaccine trial.
Ultimately, the panel voted yes on the question put forth by the FDA, which included 16- and 17year-olds. Pfizer has asked for emergency-use authorization for its two-dose vaccine in people ages 16 to 85.
The vote followed a daylong hearing that 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.”
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.
But Pfizer reps told the panel that while they were aware of the British reports, they had not seen any signs of allergic reactions in their trial.
The panel also discussed Pfizer’s plan to give volunteers who received a placebo in its study the option to get the vaccine when they become eligible for it.
One commenter in the meeting, Evan Fein, said he was a Phase 1 trial participant and urged the panel to approve the drug.
“I think I got a real vaccine and not a placebo,” he said, adding that he experienced pain in the injection site as well as fever and chills 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.”
Some participants gave startling statistics supporting the need to get the shot out quickly.
Steven Goodman, of Stanford University’s School of Medicine, said the average American has a 1 in 1,000 chance of dying of COVID in the next six months, while Aron Hall of the Centers for Disease Control and Prevention said the actual number of coronavirus infections is two to seven times higher than the 15 million cases officially reported.
The FDA said that the results of Pfizer’s large, ongoing study showed 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 of Johns Hopkins University.