The vote was 14-0.
One committee member abstained from the vote.
The advice will now go earlier than CDC Director Dr. Rochelle Walensky for remaining approval.
FDA GRANTS PFIZER VACCINE GREEN LIGHT FOR USE IN KIDS AGED 12 TO 15
Committee members had been charged with voting on the next query: “Ought to vaccination with Pfizer-BioNTech COVID-19 vaccine (2-doses, IM) be really useful for individuals 12-15 years of age below an emergency use authorization?”
The Advisory Committee on Immunization Practices (ACIP) convened to debate use of the vaccine in children aged 12 to fifteen two days after the FDA expanded Pfizer’s emergency approval to be used amongst children as younger as 12.
The panel weighed information from Pfizer-BioNTech’s medical trials involving over 20,000 individuals, some 2,200 of which had been aged 12 to fifteen. The vaccine efficacy is 100% towards symptomatic lab-confirmed COVID-19 on this age group.
PFIZER SEEKS UK APPROVAL FOR COVID-19 VACCINE IN TEENS
A number of the commonest unwanted side effects had been injection website ache, fatigue, complications, chills, joint ache, muscle ache and fever. The information suggests the vaccine was nicely tolerated on this age group, Pfizer mentioned.
A handful of states jumped forward of the CDC’s committee vote to start out providing Pfizer-BioNTech’s coronavirus vaccine to teenagers ages 12 to fifteen. Delaware, Georgia, Pennsylvania and Arkansas reportedly started providing the pictures as quickly because the FDA expanded the emergency use authorization.
The committee additionally mentioned permitting coadministration of COVID-19 vaccines and different vaccines with out regard to timing. Some specialists expressed concern over a “double whammy” of unwanted side effects following coadministration, although elevated unwanted side effects with coadministration is unknown, the committee mentioned.
Fox Information’ Alexandria Hein contributed to this report.
Kayla Rivas is a Well being reporter and joined Fox Information in April 2020.