FDA panel endorses Pfizer vaccine for public use in final step before authorization

Food and Drug Administration vaccine experts recommended that Pfizer’s coronavirus vaccine be authorized for public use, the final step before the agency issues its emergency use authorization as early as Friday.

The Vaccines and Related Biological Products Advisory Committee voted Thursday to endorse the vaccine created by Pfizer and BioNTech for emergency use authorization 17-4, with one abstention. If the agency grants the EUA on Friday, shots will start moving out to states within 24 hours, and immunizations could begin next week.

The authorization would kick off the huge government undertaking of distributing the initial 100 million doses, enough to immunize 50 million people, to healthcare workers and nursing home residents.

After a full day of debates and question-and-answer sessions about the clinical trial results, members of the panel voted on whether “the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older.” Some members of the panel said they would prefer the vaccination age be pushed back to 18 given that young people have a lower chance of becoming seriously ill and doses that would go to 16- and 17-year-olds should instead go to high-risk populations.

“The argument is they are going off to college, but I’m not sure how many can receive the vaccine between now and then given the staging [of the distribution process],” said Mark Sawyer, a pediatrician at University of California, San Diego School of Medicine.

The Trump administration has been criticized in recent days for passing up Pfizer’s offer to provide additional vaccines beyond what the administration and the companies agreed upon in a multibillion-dollar contract over the summer. Now, Pfizer cannot guarantee that supplies will last.

The FDA reported in an extensive analysis on Dec. 8 that the Pfizer vaccine had proven effective within about 10 days of the first dose and that it worked well regardless of a trial volunteer’s age or weight.

The panel’s decision comes shortly after the United States endured the deadliest day of the pandemic so far, with a record 3,054 deaths confirmed on Wednesday, according to the COVID Tracking Project. The number of people hospitalized with COVID-19 on Wednesday also reached a record high of 106,688.

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