Moderna applied to the Food and Drug Administration on Thursday for emergency clearance to use its coronavirus vaccine in 12-17 year olds. If approved as expected, the vaccine would offer a second option to protect teens from the coronavirus and accelerate the return to normal for middle and high school students.
The company has already applied for approval from Health Canada and the European Medicines Agency and is planning approval in other countries, CEO Stéphane Bancel said in a statement. Approval by the F.D.A. usually takes three to four weeks.
Last month the F.D.A. Expanded emergency approval for Pfizer and BioNTech's vaccine for use in children ages 12-15. This vaccine was already available to anyone over the age of 16. About 7 million children under the age of 18 have received at least one dose of the vaccine to date, and about 3.5 million are fully protected.
Moderna's vaccine was approved for use in adults in December. Its application at the F.D.A. for young teenagers based on study results published last month. This clinical trial enrolled 3,732 children, ages 12-17, with 2,500 receiving two doses of the vaccine and the remainder receiving a saltwater placebo.
The study found no cases of symptomatic Covid-19 in fully vaccinated teenagers, representing 100 percent effectiveness, the same number that Pfizer and BioNTech reported for this age group. The study also found that a single dose of the Moderna vaccine was 93 percent effective. Participants did not experience any serious side effects beyond those seen in adults: injection site pain, 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.