Pfizer and BioNTech requested on Friday that the Meals and Drug Administration broaden the emergency use authorization for his or her coronavirus vaccine to allow its use in youngsters ages 12 to fifteen. If authorised, it may enable younger adolescents to begin getting vaccinated earlier than going again to high school within the fall.
The businesses plan to request comparable authorizations from well being companies around the globe within the coming days, they stated in a joint assertion.
“These submissions signify a crucial step in Pfizer’s and BioNTech’s ongoing efforts to assist governments in broadening world vaccination efforts,” the assertion stated. Medical trial outcomes discovered the vaccine extremely efficient in that age group, the businesses stated final month.
The Pfizer-BioNTech vaccine is presently authorised to be used by way of emergency authorization in individuals 16 and older. Granting approval for its use within the youthful age group would additionally pace the nation’s efforts to succeed in herd immunity, which can rely upon vaccinating youngsters.
Greater than 2,000 younger adolescents participated in a Section 3 trial of the vaccine. Amongst those that obtained the vaccine, none developed symptomatic coronavirus infections or exhibited severe unintended effects, the businesses stated 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.