Moderna on Thursday requested an emergency authorization from the Food and Drug Administration for the use of its coronavirus vaccine in children aged 12 to 17. If authorized, as expected, the vaccine would provide a second option to protect teens from the coronavirus, and accelerate 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, Chief Executive Stefan Bunsell said in a statement. Authorization by the FDA usually takes three to four weeks.
Last month, the FDA Extended Emergency Use Authorization For a vaccine made by Pfizer and BioNTech for use in children 12 to 15 years of age. That vaccine was already available to anyone over the age of 16. Nearly 7 million children under the age of 18 have received at least one dose of the vaccine so far, and about 3.5 million are completely protected.
Moderna’s vaccine was authorized for use in adults in December. Its application to the FDA for young adolescents is based on study results. reported last month. That clinical trial enrolled 3,732 children aged 12 to 17 years, with 2,500 given two doses of the vaccine and the remainder given a saltwater placebo.
The trial found no cases of symptomatic COVID-19 in fully vaccinated adolescents, 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 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 injection, headache, fatigue, muscle aches, and chills.
An independent safety monitoring committee will follow up all participants for 12 months after their second injection to assess long-term safety and security.