Moderna COVID-19 vaccine safe for children ages 12 to 17, company says
CNN – Moderna appears to be safe and effective in adolescents, the company said on Tuesday.
In a Phase 2/3 trial of 3,732 children ages 12 to 17 in the United States, blood tests showed that the vaccine produced an immune response that was equivalent to earlier findings in adults, CNN reported.
While the trial did not specifically look at efficacy, initial observations showed that none of the children got sick with COVID-19 starting 14 days after their second dose. Four of the children who received the placebo tested positive for COVID-19, which Moderna says is “consistent with a vaccine efficacy of 100%.”
The company said the figures could shift as more data is gathered.
According to the results, the vaccine was 93% effective at preventing mild doses of COVID-19 after one dose.
Moderna announced the results Tuesday in a news release, and the results have not yet been peer reviewed or published.
The company said they did not find any significant safety concerns. Side effects included headache, fatigue, muscle pain and chills after administration of the second dose. Pain at the injection site was also sometimes observed.
Moderna, which is already authorized for use in people ages 18 and older, is planning to submit the results to the US Food and Drug Administration in early June along with a request for authorization to use the vaccine in adolescents. It also plans to submit the trial data to a peer-reviewed publication, the company said.
After Moderna asks the FDA for emergency use authorization of its vaccine for adolescents, the agency will review data submitted by the company, potentially consulting its advisers. If the data is solid, the FDA will give the vaccine the green light for this vaccine to be used in younger people, CNN reported.
Earlier this month, the FDA expanded the emergency use authorization for Pfizer/BioNTech’s COVID-19 vaccine to include people ages 12 to 15.
Both Pfizer and Moderna are currently testing their vaccines in younger children, ages 6 months to 11 years.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, recently said elementary age children likely won’t be vaccinated until the end of the year.
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