Pfizer and BioNTech plan on asking 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, the companies announced on April 14.
The submission will be based on data from a Phase 2/3 clinical trial that showed a boost in antibodies from a booster dose, according to the companies.
One hundred and forty children in the trial received a booster 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. The trial was also said to have shown “no new safety signals.”
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