Pfizer Seeks FDA Approval for COVID-19 Vaccine in Children 5 to 11
Company has proposed giving children one-third of the adult dosage
THURSDAY, Oct. 7, 2021 (HealthDay News) -- Pfizer announced Thursday that it has asked the U.S. Food and Drug Administration for emergency approval for its COVID-19 vaccine to be given to children between the ages of 5 and 11 years. The agency has scheduled an Oct. 26 meeting to consider the Pfizer request, with a ruling expected between Halloween and Thanksgiving, The New York Times reported.
Pfizer has proposed giving children one-third of the adult dosage, which may require adding more diluent to each injection or using a different vial or syringe, The Times reported. Vaccine doses for children will likely require new labeling and special codes that would enable the U.S. Centers for Disease Control and Prevention to track specific vaccine lots in the event of reports of serious side effects. In May, the FDA granted emergency use of the Pfizer vaccine in 12- to 15-year-olds.
The FDA review of a Pfizer dose for children ages 5 to 11 years is likely to be closely scrutinized, public health experts said. Approval will not only pivot on the strength of the trial data, but on whether Pfizer shows it can properly produce a pediatric version of the vaccine.
The 2,268 children in the Pfizer study submitted to the FDA was a noticeably small number, Norman Baylor, former director of the FDA vaccines office, said during a virtual panel on COVID-19 last week, The Times reported. The company's adult trial included about 44,000 participants.
"It does beg the question of the size, given what we have for the adults: Would one expect more for the pediatric population?" Baylor said. "They may be thinking, 'Well, we know the vaccine is safe, because look at how many people we had in the adults.' But as we know, things may shift in that pediatric population."