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FDA gives nod to COVID boosters for children as young as 5


Agency seeks to reduce exposure risks as in-person schooling resumes

Children as young as five now can receive COVID-19 vaccination booster shots.

On Wednesday the U.S. Food and Drug Administration (FDA) announced it had approved Moderna’s COVID-19 vaccine for use as a single booster dose in children down to age six, and Pfizer-BioNTech’s vaccine for children down to age five. The agency approved both drugs in their bivalent form.

“Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research said in the announcement.

The announcement comes less than two months after the FDA amended its emergency use authorizations for Moderna’s and Pfizer-BionTech’s bivalent COVID-19 vaccines for use as boosters at least two months after a person has gotten their primary or booster vaccinations.

The FDA first approved COVID vaccines for children age five to 11 in October 2021.

Marks added that while the disease tends to be milder in children than in adults, even mild cases can result in long-term effects. “We encourage parents to consider primary vaccination for children and follow-up with an updated booster dose when eligible,” he said.

Data from the Centers for Disease Control and Prevention show that childhood vaccination rates for COVID-19 remain relatively low. As of early October only 9% of children age six months to four years had received their first COVID-19 vaccine dose, while 31% of those age five to 11 had completed the two-dose vaccination series. Children who haven’t received a first vaccine dose aren’t eligible for the booster.

The FDA also said in its announcement that it was no longer authorizing the monovalent Pfizer-BioNTech vaccine as a booster for children ages five to 11. But both vaccines remain approved as primary vaccinations for those age six months and older.

The agency said the vaccines have been made “broadly protective” against both COVID-19 and its omicron variant by including an mRNA component of the original strain and its BA.4 and BA.5 lineages. The mRNA is a piece of genetic material that instructs cells in the human body to create the “spike” protein of the original virus strain and the omicron BA.4 and BA.5 variant lineages, the announcement said.


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