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Pfizer, BioNTech Ask FDA To Authorize COVID-19 Vaccine Booster For Children Aged 5–11


Pfizer and BioNTech on Tuesday asked the U.S. Food and Drug Administration (FDA) to grant emergency use authorization for a booster for their COVID-19 vaccine for children aged 5- to 11-years-old.
Earlier this month, the companies released data from a mid-to-late stage study that they said showed a boost in antibodies from a third dose of their vaccine, providing increased protection against the novel coronavirus and the Omicron variant.
The trial saw 140 children be administered a booster dose approximately six months after the second dose. The shot comes in a two-dose primary series.
The children saw a 6-fold increase in antibodies against the Wuhan strain of SARS-CoV-2 one month after the booster, the companies said. A sub analysis of 30 participants demonstrated a 36-fold increase in neutralizing antibody titers.
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