FDA authorizes Covid vaccine boosters for children 12-15

The Food and Drug Administration on Monday cleared the Pfizer-BioNTech Covid-19 booster dose for children ages 12 to 15.

The omicron variant is spreading rapidly among younger people in the U.S. According to NBC News data, the country set a record Sunday for total pediatric patients hospitalized with confirmed and suspected Covid, pointing to the need for young teens to be vaccinated.

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The FDA also shortened the timing of booster shots from six months to five months after the initial series of shots, based on Israeli research, for everyone over age 12.

Studies of more than 6,300 teens ages 12 to 15 in Israel suggested that a booster dose may protect kids from the omicron variant better when given at five months, rather than six.

“With the current wave of the omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing and social distancing in order to effectively fight Covid-19,” acting FDA Commissioner Dr. Janet Woodcock said in a statement.

The change in booster recommendation to five months after the initial vaccine series means millions more Americans will now be eligible for an extra dose. Currently, only about 33 percent of eligible people in the U.S. have received a Covid vaccine booster, even though two doses of the Pfizer vaccine have diminished effectiveness against the omicron variant.

The agency said that it found “no new safety concerns” following a booster shot in young teenagers, and that there were no new reports of two types of heart inflammation called myocarditis or pericarditis linked to the boosters.

The Pfizer booster shot is the exact same dosage as the first two shots.

Monday’s action from the FDA also includes a third vaccine dose for children ages 5-11 who have specific immune system deficiencies, such as those who have had organ transplants.

The Centers for Disease Control and Prevention will also have to sign off on the booster doses. The CDC has generally met with its advisory panel before officially recommending shots, but is not required to do so.

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