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FDA authorizes Pfizer-BioNTech vaccine in children 12-15

Posted 10 May 2021 | By Michael Mezher 

FDA authorizes Pfizer-BioNTech vaccine in children 12-15

The US Food and Drug Administration (FDA) on Monday authorized Pfizer and BioNTech’s COVID-19 vaccine for use in adolescents 12 to 15 years of age.
"The FDA's expansion of the emergency use authorization [EUA] for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic," said Acting FDA Commissioner Janet Woodcock in a statement. "Today's action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic. Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations."
FDA said its decision to authorize the vaccine for the new age group is based on data from 2,260 adolescents ages 12 to 15 enrolled in an ongoing randomized, placebo-controlled Phase 3 trial. Patients were followed for a median of more than two months following their second dose. Common side effects reported in the trial are similar to those reported for adults and include pain at the injection site, tiredness, headache, chills, muscle pain, fever and joint pain.
Effectiveness was measured based on immunogenicity and an analysis of COVID-19 cases among participants. Comparing the immune response of 180 participants ages 12-15 to 170 participants ages 16-25, “the immune response of adolescents was non-inferior to (at least as good as) the immune response of the older participants,” FDA said.
Among 1,005 vaccine recipients in the trial without evidence of prior infection with SARS-CoV-2, there were no cases of COVID-19 reported within seven days of receiving the second dose of the vaccine compared to 16 cases reported among 978 participants in the placebo arm.
FDA also said that Pfizer has updated its safety monitoring plan from its original EUA request to include the newly authorized population.
The expanded authorization comes the same day as the agency announced it would convene its Vaccines and Related Biological Products Advisory Committee (VRBPAC), this time to discuss the use of COVID-19 vaccines in pediatric populations.
On 10 June, the committee will meet virtually, as it has several times during the pandemic, to discuss the development and authorization of COVID-19 vaccines and to hear from FDA about its approach to COVID-19 vaccines in adolescents 12-17 years of age. The committee will also be tasked with considering what data is needed to support an emergency use authorization (EUA) or biologics license application (BLA) for a COVID-19 vaccine in children under 12.
So far, FDA has granted EUAs for three COVID-19 vaccines developed by Pfizer and BioNTech, Moderna and Johnson & Johnson (Janssen). The Pfizer-BioNTech vaccine is currently the only vaccine authorized for adolescents, while the Moderna and Johnson & Johnson vaccines are authorized for adults 18 and up. Pfizer and BioNTech are also the first companies to initiate a rolling biologics license application (BLA) submission to obtain full licensure for their COVID-19 vaccine.
“We recognize that the next critical step is having vaccines available for use throughout the pediatric population. As with the initial COVID-19 vaccine authorizations, we want to ensure that the public has a clear understanding of our expectations for the data and information needed to support requests for emergency use authorization and biologics license applications for vaccines intended to prevent COVID-19 in this pediatric age range,” said Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), in the announcement.
FDA, VRPBAC meeting announcement
Editor's note: This article has been updated to reflect the authorization of the Pfizer-BioNTech COVID-19 vaccine in individuals ages 12-15


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