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May 25, 2021

Moderna's COVID-19 vaccine found to be effective, safe for adolescents, study shows

The drugmaker said it will submit its clinical trial data to U.S. regulators in early June for an emergency use authorization

A second coronavirus vaccine for teenagers could become available soon, after Moderna reported Tuesday that its two-dose regimen is effective and safe for adolescents.

The vaccine was 100% effective at preventing COVID-19 in adolescents two weeks after receiving the second dose during a late-stage clinical trial

No COVID-19 infections were found in study participants who received both shots of the vaccine four weeks apart. Moderna's vaccine also was found to be 93% effective two weeks after participants received their first dose. 

The vaccine was found to be safe and well-tolerated among adolescents. No significant safety concerns were identified, as most side effects were mild to moderate in severity.

The most common side effect was pain at the injection site. Other common side effects after the second dose included headache, fatigue, myalgia and chills. 

The study enrolled 3,700 participants ages 12-17 in the U.S. Two-thirds of the study population received both doses of the vaccine, while a third of the group received a placebo. Four cases of COVID-19 were discovered in the placebo group.

All study participants will be monitored for 12 months after their second doses to assess their long-term protection and safety from the virus. An independent safety monitoring committee is continuing to analyze data from the study.

Moderna said it will submit its clinical trial data to U.S. regulators in early June, with hopes of receiving an emergency use authorization for adolescents. 

"We are encouraged that mRNA-1273 was highly effective at preventing COVID-19 in adolescents," CEO Stéphane Bancel said. "It is particularly exciting to see that the Moderna COVID-19 vaccine can prevent SARS-CoV-2 infection. We remain committed to doing our part to help end the COVID-19 pandemic."

Moderna's vaccine would become the second available to adolescents in the U.S. The U.S. Food and Drug Administration authorized Pfizer's vaccine earlier this month for adolescents ages 12-15. Pfizer plans to seek authorization for children ages 2-11 in September.

The FDA authorized Moderna's vaccine for use in adults last December after the two-dose regimen was found to be safe and highly effective in a Phase 3 trial

Moderna's vaccine uses mRNA technology to strengthen the immune system's response to the coronavirus. It can be stored at regular refrigerator temperatures, either for a month at 35-46 degrees Fahrenheit or for up to six months at -4 degrees.

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