FDA Expected to Allow Pfizer Booster Shots for Ages 12-15

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The FDA is expected to broaden eligibility for COVID-19 vaccine booster shots on Monday, allowing ages 12-15 to get third doses of the Pfizer vaccine, according to The New York Times.

In addition, the FDA plans to allow both adults and adolescents to get a booster shot of the Pfizer vaccine five months after receiving a second dose, rather than the current waiting period of six months. The agency will likely also authorize a booster shot for ages 5-11 who have immune deficiencies.

The CDC’s vaccine advisory committee will meet in the middle of next week to vote on whether to recommend the changes. If the committee agrees with the FDA’s decisions, then Rochelle Walensky, MD, director of the CDC, is expected to support the changes, the newspaper reported.

The FDA had hoped to announce the decision as early as Thursday but agreed to wait until Monday because Walensky said she wanted to hear recommendations from the CDC’s advisory committee, the newspaper reported.

The move to expand booster eligibility is meant to enhance the fight against the contagious Omicron variant, which has sparked record-high numbers of cases across the U.S.

The FDA is partly basing its decision on data from Israel that showed no safety concerns for thousands of kids between ages 12-15 who received a third Pfizer dose, the newspaper reported. The data showed that there were no reports of myocarditis. Myocarditis is a rare side effect that involves inflammation of the heart muscle. It has been observed in some younger men after receiving a COVID-19 vaccine.

The FDA is also deciding to allow a booster dose as early as five months after the second dose based on the Israeli data, the newspaper reported. The data showed that the shorter interval is effective.

Nearly 66% of those ages 5 and older who are eligible for a vaccine are fully vaccinated, according to the latest CDC data, including 71% of ages 12 and older. About 36% of adults have received a booster dose.

Although younger groups are less likely to experience severe COVID-19, pediatric hospitalizations are increasing, and public health experts are urging vaccination for all eligible people, including children.

“All you have to do is go to any pediatric hospital right now, virtually anywhere in the country, and you see children there who are suffering, some even dying, who need not be in that situation if they were vaccinated,” Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said Thursday on NewsNation’s “Morning in America.”

“Virtually all, not 100% but close to that, the children who are seriously ill in our hospitals from COVID-19 are children whose parents decided they did not want to vaccinate them,” he added. “That is avoidable.”

Sources:

The New York Times: “FDA Plans to Allow 12- to 15-Year-Olds to Receive Pfizer Boosters.”

CDC: “COVID-19 Vaccinations in the United States.”

NewsNation Now: “Morning in America, Fauci: Arguments against vaccinating kids don’t ‘make any sense.'”

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