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Moderna and Pfizer-BioNTech ask FDA to authorize omicron boosters for children

Washington Examiner logo Washington Examiner 9/26/2022 Abigail Adcox
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Vaccine manufacturers Pfizer-BioNTech and Moderna have asked the U.S. Food and Drug Administration to authorize their omicron-specific COVID-19 booster candidates for school-aged children.

Pfizer-BioNTech submitted an application for emergency use authorization for its updated booster targeting the omicron variant for children aged 5-11 years, while Moderna requested that the FDA expand the authorization to children aged 6-17 years.

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The Centers for Disease Control and Prevention signaled it will recommend the updated booster to younger school-aged children in early- to mid-October, pending FDA authorization.

Last month, the FDA authorized Moderna's updated booster for people 18 and older and Pfizer-BioNTech's booster candidate for people 12 years and older. People are eligible to receive the new shots after at least two months have passed since they got their last booster or their primary two-dose vaccination series.

Though the updated boosters, which target both the original strain of the virus from 2020 and omicron subvariants BA. 4 and BA.5, could soon be available for more children, only a portion will be eligible to receive them, as many have yet to receive their primary vaccination series. Only 31% of children 5-11 years old had completed their initial two-dose vaccinations as of last week, according to CDC data. The agency recommends that children aged 5-11 receive a booster at least 5 months after getting their first two shots.

"Vaccination with a primary series among this age group has lagged behind other age groups leaving them vulnerable to serious illness," CDC Director Rochelle Walensky said in May. "I encourage parents to keep their children up to date with CDC’s COVID-19 vaccine recommendations."

Some experts have expressed doubts that the updated boosters would significantly benefit healthy people.

"A healthy young person is unlikely to benefit from a booster dose, so I hope they target it more specifically to those really who are most likely to benefit from this additional dose," Dr. Paul Offit, a member of the FDA's Vaccines and Related Biological Products Advisory Committee, told CNN.

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Boosters for the country's youngest could also be on the horizon. Moderna indicated that it expects to put forward an application for children aged 6 months to under 6 years later this year. Pfizer-BioNtech said Monday it has also started a study to evaluate the "safety, tolerability, and immunogenicity" of different dosing regimens for children 6 months to 11 years old.

 

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Tags: Coronavirus, News, children, Vaccination, FDA

Original Author: Abigail Adcox

Original Location: Moderna and Pfizer-BioNTech ask FDA to authorize omicron boosters for children

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