Pfizer’s COVID-19 Vaccine Passes Last Big Hurdle In FDA Review

A panel of independent experts advising the U.S. Food and Drug Administration on Thursday recommended overwhelmingly that the agency authorize Pfizer’s COVID-19 vaccine for widespread use in the U.S.

The panel spent the day reviewing data on Pfizer’s breakthrough vaccine, based on clinical trials that have been running this year. In the trials, the vaccine reduced the incidence of symptoms and confirmed cases of the coronavirus by 95%, with only “mild to moderate” side effects including arm pain, fatigue and temporary fever.

The final vote was 17 yes, 4 no and 1 abstention. The main concern among those voting no was the recommendation to authorize use for those ages 16 and up. Given the lack of data on 16- and 17-year-olds, some members of the committee thought the cutoff should begin at 18.

The committee’s recommendation now goes to the FDA itself, which is expected to agree and authorize the vaccine ― most likely in the next few days. Shipment and distribution of the shots would then begin immediately, federal officials have said.

If the FDA gives Pfizer’s vaccine the go-ahead, it will be through an “emergency use authorization” that allows for expedited review in cases of dire medical need ― something that is very much the case right now, with the U.S. setting daily records for hospitalizations and deaths.

“We have been looking forward to presenting our robust data package to the committee of vaccine experts for the U.S. government since we began our efforts to develop a novel COVID-19 vaccine earlier this year,” Albert Bourla, Pfizer’s chairman and CEO, said in a statement. “We are pleased with the vote, and if the FDA issues an authorization, stand at the ready to bring this vaccine to people in the U.S. in an effort to help combat this devastating pandemic.”

Next week the advisory committee will review data from a similar vaccine, manufactured by Moderna, that has shown similar results. It, too, is expected to get a recommendation and then authorization from the agency.

The Pfizer and Moderna vaccines are the first to use messenger RNA, or mRNA, technology, which delivers specially engineered genetic material into the body of recipients, causing them to produce proteins that are part of the coronavirus. The immune system reacts so that, when it encounters the full virus for real, it can fight off the disease.

The speedy development of these vaccines and several others represents a remarkable, unprecedented scientific achievement. But distributing and then administering the vaccines are a whole separate challenge.

Health care workers and elderly residents of long-term care facilities will be the first to get the shots, followed by essential workers, under guidelines the federal government has issued. But as the supply ramps up, vaccines will become available to the rest of the population ― and it’s an open question how well federal, state and local authorities will be able to handle that kind of volume.

President-elect Joe Biden said Thursday that the panel’s recommendation was a “bright light in a needlessly dark time.”

“We are grateful to the scientists and public health experts who evaluated the safety and efficacy of this vaccine free from political influence,” Biden said in a statement. He continued: “Vaccines don’t equal vaccinations. Our challenge now is to scale up manufacturing and distribution to distribute 100 million shots in the first 100 days of my administration.”