Pfizer and BioNTech requested on Friday that the Meals and Drug Administration broaden the emergency use authorization for their coronavirus vaccine to allow its use in youngsters ages 12 to fifteen. If permitted, it may enable younger adolescents to start out getting vaccinated earlier than going again to high school within the fall.
The businesses plan to request related authorizations from well being businesses around the globe within the coming days, they mentioned in a joint statement.
“These submissions signify a crucial step in Pfizer’s and BioNTech’s ongoing efforts to help governments in broadening world vaccination efforts,” the assertion mentioned. Clinical trial results discovered the vaccine extremely efficient in that age group, the businesses mentioned final month.
The Pfizer-BioNTech vaccine is at the moment permitted to be used through emergency authorization in folks 16 and older. Granting approval for its use within the youthful age group would additionally pace the nation’s efforts to achieve herd immunity, which can rely on vaccinating youngsters.
Greater than 2,000 younger adolescents participated in a Part 3 trial of the vaccine. Amongst those that obtained the vaccine, none developed symptomatic coronavirus infections or exhibited critical unintended effects, the businesses mentioned final month. The vaccinated 12- to 15-year-olds additionally produced larger ranges of antibodies, on common, than older adolescents and younger adults did.
The trial outcomes haven’t but been printed in a scientific journal.