Pfizer, BioNTech seek FDA authorization of COVID-19 booster for children

Pfizer and BioNTech said Thursday that they will be asking the FDA to authorize a COVID-19 booster dose for children aged 5 to 11 years.

The announcement came in a press release reporting the results of a phase 2/3 clinical trial that showed a booster dose of the vaccine produced a robust immune response, with no new safety signals.

“These data reinforce the potential function of a third dose of the vaccine in maintaining high levels of protection against the virus in this age group,” the companies said.

The clinical trial included 140 children aged 5 to 11 years who received a booster dose of the vaccine around 6 months after the primary series. A subanalysis of 30 sera samples from the study indicated a 36-fold increase in neutralizing titers against the omicron variant of SARS-CoV-2, the companies reported.

Immunogenicity data from the 140 participants in the trial who had no evidence of prior COVID-19 infection demonstrated a sixfold increase (95% CI, 5-7.6) in neutralizing titers against the SARS-CoV-2 wild-type strain 1 month after the booster, they said.

The vaccine has been available under an emergency use authorization for children aged 5 to 11 for around 5 1/2 months. Five months is when people aged 12 years or older who received either the Pfizer-BioNTech or Moderna vaccines are recommended to get a booster shot.

The Pfizer-BioNTech vaccine has been available for adolescents aged 12 to 15 years since last May. It is fully approved for anyone aged 16 years or older.

The FDA earlier this year postponed its review of Pfizer’s vaccine for children younger than age 5 years.