Moderna requested an urgent permit from the Food and Drug Administration on Thursday for the use of the coronavirus vaccine at ages 12-17. If approved, as expected, the vaccine offers a second option to protect adolescents from the coronavirus, accelerating the return of middle and high school students to normal.
The company has already applied for approval from Health Canada and the European Medicines Agency and will seek approval in other countries, CEO Stephane Bancel said in a statement. FDA approval usually takes 3-4 weeks.
Last month, the FDA Extended Emergency Use Authorization For vaccines manufactured by Pfizer and BioNTech for use in children aged 12 to 15 years. The vaccine was already available to anyone over the age of 16. Received by about 7 million children under the age of 18 At least one dose About 3.5 million vaccines to date are fully protected.
The Moderna vaccine was approved for use in adults in December. FDA application for teens is based on research results Report last monthThe clinical trial enrolled 3,732 children between the ages of 12 and 17, 2,500 were vaccinated twice, and the rest were saline placebo.
The study found no cases of symptomatic Covid-19 among fully vaccinated teens. This corresponds to 100% effectiveness, the same number that Pfizer and BioNTech reported for that age group. The study also found that a single dose of the Moderna vaccine was 93% effective. Participants did not experience more serious side effects than seen in adults: injection site pain, headache, malaise, myalgia, chills.
An independent safety oversight committee will track all participants for 12 months after the second injection and assess their long-term protection and safety.
Moderna Apples for adolescent Covid vaccine approval
Source link Moderna Apples for adolescent Covid vaccine approval