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Moderna has filed for emergency use authorization from the U.S. Food and Drug Administration to give its vaccine to adolescents aged 12-17, the company said in a news release.
If Moderna receives authorization, it would become the second vaccine distributed to adolescents in the United States. The Pfizer/BioNTech vaccine was authorized in May for use in children aged 12-15.
"We are encouraged that the Moderna COVID-19 vaccine was highly effective at preventing COVID-19 and SARS-CoV-2 infection in adolescents," Moderna CEO Stéphane Bancel said in thenews release on Thursday. "We have already filed for authorization with Health Canada and the European Medicines Agency and we will file with regulatory agencies around the world for this important younger age population."
Moderna announced in late May that its COVID-19 vaccine was safe and appears to be effective in children ages 12 to 17.
The company released early results from a clinical trial that enrolled 3,732 adolescents, including two-thirds who received two doses. Blood tests showed that the vaccine created an immune response similar to that in adults.
President Joe Biden has said that getting adolescents vaccinated is a key part of his plan to bring the COVID pandemic under control.
The two-dose Moderna vaccine saw approval for adults18 years of age and older in mid-December. The Pfizer vaccine was approved that same month for people 16 and older. The one-shot Johnson & Johnson vaccine, which was approved for emergency use in February, is a single-shot option for those who are 18 and up as well
Moderna. "Moderna Files for Emergency Use Authorization for its COVID-19 Vaccine in Adolescents in the United States"
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Cite this: Moderna Seeks FDA OK for Adolescent COVID Vaccine - Medscape - Jun 11, 2021.