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 comes after promising data from a study involving 140 children in this age group who received a third 10-microgram vaccine dose at least six months after their second shot.
In a focused analysis of 30 children from this group, researchers discovered that antibody levels targeting the Omicron variant increased by a staggering 36 times one month after the booster. Furthermore, antibody levels against the original COVID-19 strain were found to be six times higher following the booster compared to the levels observed a month post the second dose. No new safety concerns were reported during the trial. According to a Pfizer press release, these findings “underscore the potential role of a third dose in sustaining high levels of protection against the virus for this age group.”
During the Omicron surge, it was reported by researchers from the New York State Department of Health that the standard two-dose regimen of the Pfizer vaccine showed limited effectiveness against this highly contagious variant. However, a subsequent study from the CDC indicated that while vaccine effectiveness had diminished during the surge, the vaccine still significantly reduced the risk of hospitalization and death. Currently, there are no authorized vaccines for children under the age of 5. Ongoing trials show promise, with companies like Moderna also seeking FDA EUA for younger children based on favorable results. The CDC first authorized vaccines for children aged 5 to 11 in early November 2021, with about 10 million of the 28 million American children in this demographic having received at least one dose.
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In summary, Pfizer’s upcoming request for a booster dose for children aged 5 to 11 is supported by strong evidence showing a significant increase in antibody levels against the Omicron variant. This booster could play a crucial role in maintaining protection for younger populations as the pandemic continues.
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