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.

ok