Health|Moderna applies for U.S. authorization of its vaccine for use in adolescents.
https://www.nytimes.com/2021/06/10/health/moderna-fda-teen-vaccine.html
Moderna requested an emergency authorization on Thursday from the Food and Drug Administration for use of its coronavirus vaccine in 12- to 17-year-olds. If authorized, as expected, the vaccine would offer a second option for protecting adolescents from the coronavirus, and hasten a return to normalcy for middle- and high-school students.
The company has already filed for authorization with Health Canada and the European Medicines Agency, and plans to seek approval in other countries, the chief executive Stéphane Bancel said in a statement. Authorization by the F.D.A. typically takes three to four weeks.
Last month, the F.D.A. expanded emergency use authorization for the vaccine made by Pfizer and BioNTech for use in children ages 12 to 15 years. That vaccine was already available to anyone older than 16. About 7 million children under 18 have received at least one dose of the vaccine so far, and about 3.5 million are fully protected.
Moderna’s vaccine was authorized for use in adults in December. Its application to the F.D.A. for young teens is based on study results reported last month. That clinical trial enrolled 3,732 children ages 12 to 17 years, with 2,500 receiving two doses of the vaccine and the remaining a saltwater placebo.
The trial found no cases of symptomatic Covid-19 among fully vaccinated teens, which translates to an efficacy of 100 percent, the same figure that Pfizer and BioNTech reported for that age group. The trial also found that a single dose of the Moderna vaccine has an efficacy of 93 percent. Participants did not experience serious side effects beyond those seen in adults: pain at the site of the injection, headache, fatigue, muscle pain and chills.
An independent safety monitoring committee will follow all participants for 12 months after their second injection to assess long-term protection and safety.
