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Pfizer and BioNTech have announced their intention to seek Emergency Use Authorization (EUA) from the FDA for a booster dose of their COVID-19 vaccine for children aged 5 to 11. This decision is based on encouraging results from a study involving 140 children who received a third dose of the 10-microgram vaccine at least six months after their second dose.
In a subset of 30 children from this group, researchers observed that a month after the booster, antibody levels targeting the Omicron variant had increased 36 times compared to levels prior to the booster. Additionally, antibody levels against the original COVID-19 strain were found to be six times higher following the booster compared to a month after the second dose. Importantly, the study reported no new safety concerns among the participating children. According to a Pfizer news release, these findings “underscore the importance of a third dose in sustaining robust protection against the virus in this age demographic.”
During the Omicron surge, a report from the New York State Department of Health indicated that the standard two-dose regimen of the Pfizer vaccine was less effective against the rapidly spreading variant. However, a follow-up study by the CDC revealed that while vaccine effectiveness had diminished during the Omicron wave, the vaccine still significantly reduced the risk of hospitalization or death. Currently, no vaccines have been approved for children under 5, though ongoing trials are yielding positive outcomes. Companies like Moderna have also requested EUA for younger age groups based on favorable results. Vaccines for children aged 5 to 11 were initially authorized by the CDC in early November 2021. There are approximately 28 million American children in this age group, with about 10 million having received at least one vaccine dose.
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In summary, Pfizer and BioNTech are looking to secure emergency authorization for a COVID-19 booster for children ages 5 to 11, following promising findings that show significant increases in antibody levels against the Omicron variant after the third dose.
Keyphrase: Pfizer COVID booster for children
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