The Food and Drug Administration (FDA) has extended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to adolescents aged 12-15 years. Previously, the vaccine had only been approved for the prevention of COVID-19 in patients aged 16 and over.
The safety of the vaccine in this patient population was based on data from 2,260 adolescent participants in an ongoing randomized, placebo-controlled study in the United States. Participants were randomly assigned to receive either the vaccine (n = 1131) or the placebo (n = 1129), and more than half were followed up for at least 2 months after the second dose.
The most common side effects reported in the study were injection site pain, fatigue, headache, chills, muscle pain, fever, and joint pain. These side effects typically lasted 1 to 3 days and were more common after the second dose.
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In terms of efficacy, analysis of the immunogenicity data showed that immune responses to the vaccine in the youth group (n = 190) were not inferior to those in older participants (16-25 years old; n = 170). Additionally, a review of COVID-19 cases that occurred 7 days after the second dose in 12-15 year olds with no evidence of previous SARS-CoV-2 infection found that the vaccine was 100% effective at preventing COVID-19 . There were no cases in the 1005 participants who received the vaccine, while 16 cases were reported in the 978 placebo recipients.
“The FDA’s extension of emergency approval for the Pfizer-BioNTech COVID-19 vaccine to adolescents ages 12-15 is an important step in the fight against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock , MD. “Parents and guardians can be assured that the agency has carried out a rigorous and thorough review of all available data, as we have done with all of our COVID-19 emergency vaccine approvals.”
The Pfizer-BioNTech COVID-19 Vaccine Datasheet has been updated to include the new information. The same dosage (0.3 ml) and the same dosage regimen (2 doses 3 weeks apart) were approved for adolescents.
In a statement, the agency noted that between March 1, 2020 and April 30, 2021, around 1.5 million COVID-19 cases among 11 to 17 year olds reported to the Centers for Disease Control and Prevention (CDC The Immunization Practices (ACIP) will meet on May 12, 2021 to discuss recommendations for the use of the Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12-15 years based on the amended EEA.
reference
Coronavirus (COVID-19) Update: FDA Approves Pfizer-BioNTech COVID-19 Emergency Vaccine in Adolescents in Another Key Action to Combat the Pandemic. [press release]. Silver Spring, MD: United States Food and Drug Administration. May 10, 2021.
This article originally appeared on MPR
