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FDA Authorizes Pfizer Booster Shot for Kids Age 12 to 15

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Two hands in light blue gloves hold a syringe inserted into an upside-down vial.
A nurse practitioner fills a syringe with the Pfizer COVID-19 vaccine at the Beaumont Health offices in Southfield, Mich., on Nov. 5. (Jeff Kowalsky/AFP via Getty Images)

Updated 8:34 a.m. Monday

The Food and Drug Administration has authorized the use of a Pfizer-BioNTech booster in kids 12 to 15 years old.

The agency on Monday also shortened the time between the completion of primary vaccination of the Pfizer-BioNTech COVID-19 vaccine and a booster dose from six months to five.

Finally, the FDA allowed for a third dose of vaccine in immunocompromised children age 5 to 11.

The director of the Centers for Disease Control and Prevention, Rochelle Walensky, must still weigh in with a recommendation on the FDA's announcement before the changes can take effect.

"Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind," acting FDA Commissioner Janet Woodcock said in a statement.

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Woodcock said it's critical for the public to take "effective, life-saving preventative measures," including booster shots, during the current surge of infections driven by the omicron variant.

More kids are getting sick

The authorization comes amid an explosion of COVID-19 cases nationwide driven by the omicron variant. Though the new strain appears milder in vaccinated people, there has been a spike in pediatric hospitalizations.

Many schools have delayed the resumption of in-person classes due to the rapid rise in cases as well as faculty and staff being home sick with the virus.

"Now, in the next few weeks, it will be challenging for some schools given the rise in cases. We know some schools made temporary emergency decisions based on their staffing in particular," Vivek Murthy, the U.S. surgeon general, told NPR's Morning Edition on Monday.

"But our goal should be to make sure that these disruptions are short-lived and we can get our kids back to school safely. Our best chance of doing that is to implement the mitigation measures that we know have worked to get our kids vaccinated," he added.

Israel finds side effects in boosted kids are rare

The FDA said it reached its decision after reviewing data from Israel, which included information on 6,300 people age 12-15 who received a booster shot at least five months after their initial two-dose vaccination. The data showed no new cases of two possible side effects that had been observed in some young people who received the vaccine — myocarditis, an inflammation of the heart, and pericarditis, an inflammation of the saclike tissue surrounding the heart.

The CDC recommended the Pfizer vaccine for children age 12-15 in May and for kids 5-11 in November. There is still no vaccine authorized in the U.S. for children under age 5.

Copyright 2022 NPR. To see more, visit npr.org.

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