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Pfizer, Moderna ask FDA to approve bivalent COVID-19 booster for kids

By Jonna Lorenz
Pfizer and BioNTech announced Monday they have filed an application with the U.S. Food and Drug Administration for emergency use authorization of their updated COVID-19 booster shot for kids as young as 5. Moderna said Friday it requested approval for its updated vaccine for kids as young as 6. File Photo by Debbie Hill/UPI | <a href="/News_Photos/lp/9e82aaa7d48ed41f2aae734a5e812a28/" target="_blank">License Photo</a>
Pfizer and BioNTech announced Monday they have filed an application with the U.S. Food and Drug Administration for emergency use authorization of their updated COVID-19 booster shot for kids as young as 5. Moderna said Friday it requested approval for its updated vaccine for kids as young as 6. File Photo by Debbie Hill/UPI | License Photo

Sept. 26 (UPI) -- Pfizer and BioNtech asked the U.S. Food and Drug Administration on Monday to approve their new Omicron-specific COVID-19 vaccine for children ages 5 to 11.

The companies submitted an application for emergency use authorization of a 10 microgram dose of the bivalent vaccine for that age group.

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The request comes on the heels of applications announced Friday by Moderna for emergency use authorization of its updated COVID-19 booster for children as young as 6.

Moderna made the announcement on Twitter, without including details about its applications, which include two groups of children -- ages 6 to 11 and 12 to 17. The Moderna booster currently is available only to adults.

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The new vaccines are adapted to target the Omicron BA.4 and BA.5 subvariants along with the original strain of COVID-19.

Pfizer said its application for emergency use authorization is based on safety and efficacy data trials of earlier vaccines and non-clinical data from the new vaccine.

Pfizer also has initiated studies of the safety, tolerability and efficacy of the vaccine in children ages 6 months to 11 years, including different vaccine dosing regiments, dose levels and ages.

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The FDA approved the booster shot at a dose of 30 micrograms for those age 12 and older in August. The FDA also approved Moderna's updated vaccine for adults at that time. The vaccines are approve to be administered at least two months after the most recent COVID-19 vaccine dose.

Moderna said its application for the booster for children as young as 6 months is expected to be completed later this year.

Dr. Anthony Fauci, the nation's top infectious diseases expert, has said COVID-19 vaccinations are likely to become an annual occurrence similar to shots against influenza.

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Last week, global deaths from COVID-19 fell to under 1,000 daily, the fewest since the World Health Organization declared COVID-19 a pandemic in March 2020. Cases dropped to 410,802, the lowest level since July 2021.

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