The U.S. Food and Drug Administration cleared Omicron bivalent booster shots for children as young as 5 years old, ahead of an expected winter surge. 

The U.S. Centers for Disease Control and Prevention gave the final OK for Pfizer BioNTech Bivalent boosters for kids 5 to 11, and Moderna’s bivalent booster for kids 6 to 17. Children who have received a two-dose primary series of any vaccine and those who've received a booster are eligible to get the updated boosters as long as two months have passed since their last dose, the FDA said in a statement.

The bivalent booster contains Omicron BA.4 and BA.5 spike protein components to the current vaccine composition, helping to restore protection that has waned since the previous vaccination and targeting recent Omicron variants that are more transmissible and immune-evading, according to the CDC. 

“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. Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death,” Peter Marks, M.D., Ph.D. said in a news release. 

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, as the various waves of COVID-19 have occurred, more children have gotten sick with the disease and have been hospitalized. Children may also experience long-term effects, even following initially mild disease. We encourage parents to consider primary vaccination for children and follow up with an updated booster dose when eligible,” Marks continued.  

Pfizer’s new boosters were cleared for people 12 and older in September, while Moderna’s boosters were authorized for adults 18 and older. 

Pfizer said it will release shipments of the doses immediately

“As families across the country take part in fall festivities and plan for the upcoming holiday season, we aim to provide school-aged children with additional protection against the Omicron BA.4/BA.5 subvariants, which continue to account for more than 80% of cases in the U.S.,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Anticipating this need, we manufactured millions of booster doses, which will be made available, pending CDC recommendation, to help families stay up to date with COVID-19 vaccinations.”

Moderna said it is currently working to finalize its EUA application for children ages 6 months to 5 years old. The application is expected to be completed later this year.

"We are proud to have received authorization for our updated, bivalent COVID-19 booster for children and adolescents 6 to 17 years of age," said Stéphane Bancel, Chief Executive Officer of Moderna. "With bivalent boosters available for most age groups, families have access to updated tools as they head into the winter months and holiday gatherings. We are grateful to the FDA for their thorough and timely review."

More than 11 million Americans ages 12 and older have received the new booster shots so far, according to CDC data. 

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