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Key committee endorses Pfizer’s COVID-19 vaccine, paving way for clearance by FDA and vaccinations in US to begin

A committee of leading U.S. vaccine scientists recommended Thursday that the Food and Drug Administration authorize the first COVID-19 vaccine for Americans.

The endorsement paves the way for a final decision by the FDA and mass vaccinations to begin within days in thousands of front-line heath care workers and nursing home residents.

After an eight-hour public hearing, the independent Vaccines and Related Biological Products Advisory Committee voted 17 to 4 with 1 abstention to recommend the vaccine made by Pfizer and its partner BioNTech called BNT162b2.

Members found the benefits of the vaccine outweighed the risks for most people 16 years old and older.

"It's a huge milestone," said Dr. Ofer Levy, a pediatric infectious disease expert and head of the precision vaccine program at Boston Children's Hospital.

While some committee members struggled with whether to authorize the vaccine for use in teenagers ages 16 and 17, Levy argued that it was important to include children.

Most vaccines in the world are delivered to children, and their vaccination rates are far higher than adults', he said. To reach the kind of vaccination rates needed to stop widespread transmission of COVID-19 will require minors to be vaccinated he said.

Sixteen and 17 year-olds were added to the study this fall, so there was less long-term safety data available for them than for adults. Levy, who has treated teens with a complex immune problem caused by COVID-19, said he doesn't see any reason why a 17-year-old would be any different than an 18-year-old, and was comfortable with the FDA's recommendation that 16 and 17 year-olds be included in the authorization. 

Other committee members expressed more concern, including Dr. Cody Meissner, chief of the division of pediatric infectious disease at Tufts University School of Medicine, who said he supported authorization for adults, but not for minors. He abstained from voting for the measure.

The mixed vote is a good sign because it shows the group’s independence, said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicine in Nashville, Tennessee, who is not on the committee.

“Seventeen to four is not a put-up job, it’s a real committee,” he said.

“My general response to the vote is ‘Bravo!’” he added. “Now the hard part starts – we have to get the job done.”

National distribution of the vaccine, which will start almost immediately if the FDA gives the go-ahead, will be far more complicated than developing the vaccine, Schaffner said.

Pfizer/BioNTech are requesting an “emergency use authorization,” a more rapid review just shy of a full vaccine approval. While the companies have compiled as much short-term safety and effectiveness data as is typical with any vaccine, the process has been compressed, and it's not clear how long the vaccine will continue to be effective. 

Committee members also brought up other knowledge gaps they hope are filled in coming months, including how safe and effective the vaccine will be in pregnant and nursing women, in people with severe allergies, and in those who are immunocompromised from conditions such as HIV.

With the vote made, the committee’s recommendation now goes to the FDA, which could authorize the vaccine for emergency use as early as Friday. Once it's authorized, vials of the vaccine will begin shipping to all 50 states.

One last important meeting will take place Sunday, when an advisory committee to the Centers for Disease Control and Prevention meets to make a final recommendation on who should get the vaccine first when it is in very short supply.

While the Advisory Committee on Immunization Practices doesn’t have regulatory power, providers receiving COVID-19 vaccine sign agreements to comply with committee guidelines. If that committee gives its thumbs up, mass vaccination could start as early as Monday.