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Moderna Seeks FDA Clearance for Covid Vaccine in Young Adolescents and Adolescents

Moderna filed for emergency use authorization with the Food and Drug Administration on Thursday to use its Covid-19 vaccine in adolescents aged 12 to 17.

If cleared by the FDA, it will become the second Covid-19 vaccine available in the United States for teens under 18 with Pfizer-BioNTech’s vaccine, which has been cleared for teens ages 12 to 15. years in May.

Moderna said in May that the results of his clinical trial in children aged 12 to 17 showed his two-dose mRNA vaccine to be safe and highly effective. The trial included more than 3,700 participants.

The side effects were generally mild or moderate, the company said. Arm pain at the injection site was the most common side effect after the first dose and headache, fatigue, muscle aches and chills were the most common after the second dose.

“We are encouraged that the Moderna Covid-19 vaccine has been very effective in preventing Covid-19 and SARS-CoV-2 infection in adolescents,” Moderna CEO Stéphane Bancel said Thursday, in a press release.

Moderna’s vaccine for adults 18 years of age and older has been administered in the United States since December. But childhood vaccinations were seen as key to controlling the pandemic in the United States, the company began testing its Covid-19 vaccine in young children aged 6 months to under 12 in March.

Pfizer-BioNTech also began studying its two-dose Covid-19 vaccine in children aged 5 to 11 in March. Earlier this week, Pfizer said it was expanding its vaccine trials to include children aged 6 months to under 5 years old.

Moderna has already applied for authorization from Health Canada and the European Medicines Agency for the use of the vaccine in young adolescents, the company said.

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