Pfizer and BioNTech requested on Friday that the Food and Drug Administration expand the emergency use authorization for their coronavirus vaccine
Pfizer and BioNTech requested on Friday that the Food and Drug Administration expand the emergency use authorization for their coronavirus vaccine to permit its use in children ages 12 to 15. If approved, it could allow young adolescents to start getting vaccinated before going back to school in the fall.
The companies plan to request similar authorizations from health agencies around the world in the coming days, they said in a joint statement.
“These submissions represent a critical step in Pfizer’s and BioNTech’s ongoing efforts to support governments in broadening global vaccination efforts,” the statement said. Clinical trial results found the vaccine highly effective in that age group, the companies said last month.
The Pfizer-BioNTech vaccine is currently approved for use via emergency authorization in people 16 and older. Granting approval for its use in the younger age group would also speed the country’s efforts to reach herd immunity, which will depend on vaccinating children.
More than 2,000 young adolescents participated in a Phase 3 trial of the vaccine. Among those who received the vaccine, none developed symptomatic coronavirus infections or exhibited serious side effects, the companies said last month. The vaccinated 12- to 15-year-olds also produced higher levels of antibodies, on average, than older adolescents and young adults did.
The trial results have not yet been published in a scientific journal.