FDA green lights Pfizer vaccine for kids 12-15, with CDC still to act

WASHINGTON – The U.S. Food and Drug Administration on Monday signed off on expanding the use of Pfizer’s COVID-19 vaccine to children ages 12 to 15, clearing one key hurdle before that age group can begin receiving the two-shot vaccine.

But another step is needed before tweens and teens can line up for shots. The Centers for Disease Control and Prevention’s vaccine advisory panel also must give its recommendation. That group is scheduled to meet Wednesday, and the CDC then will act on that recommendation.

Previously, those 16 and older could receive the Pfizer shot under the emergency use authorization issued in December. The other two COVID-19 shots authorized in the U.S. can be used in patients 18 and older, with Moderna conducting trials for using its vaccine for children.

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” said Dr. Janet Woodcock, acting FDA commissioner. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

The FDA authorization comes as vaccine demand among adults has been declining across the country. States have been ordering fewer doses, while President Joe Biden and his administration have been encouraging those who are skeptical to get a shot.

While overall COVID-19 infections have been declining, the age of infected and hospitalized Americans also has dropped after a vaccination campaign that prioritized older Americans due to their increased risk of severe complications.

Children who have tested positive for the virus have typically reported milder symptoms than adults. But some children have developed complications, including a rare, dangerous inflammatory syndrome.

Among the younger age group, the Pfizer vaccine would still be administered as a series of two doses, three weeks apart. They also will receive the same dosage as those 16 and older.

In Pfizer’s clinical trial of 2,260 adolescents, side effects were consistent with those reported in the trial of people 16 and older, according to the FDA: more common after the second dose, and typically including pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain.

The immune response also was found to be highly effective and comparable to the adult study, according to the FDA. There were no COVID-19 cases among those who received the vaccine and 16 cases among the placebo group.