US FDA Delays Approval for Moderna Vaccine in Adolescents... Myocarditis Side Effect Investigation Needed

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Hyunwoo Lee] The U.S. Food and Drug Administration (FDA) announced that it will delay approval of Moderna's COVID-19 vaccine for adolescents aged 12 to 17, which was applied for last May. The FDA plans to take at least until January of next year for the review period. This is reportedly due to concerns over myocarditis side effects commonly observed in mRNA (messenger RNA) based vaccines such as Moderna and Pfizer.

According to foreign media including CNBC on the 31st (local time), Moderna stated in a press release, "We have received notification from the FDA that additional time is needed to review Moderna's emergency use authorization (EUA) application for the vaccine for adolescents aged 12 to 17," adding, "The FDA explained that the review may not be completed until January of next year."

Earlier, on May 25, Moderna announced that clinical trials on adolescents aged 12 to 17 showed antibody formation in all trial participants, and subsequently applied for emergency approval of the adolescent vaccine to the FDA starting in early June.

The main reason the FDA delayed approval of Moderna's adolescent vaccine is reportedly due to myocarditis side effects commonly observed not only in Moderna's vaccine but also in other mRNA-based vaccines such as Pfizer's. This side effect, which involves inflammation of the heart muscle, has so far been reported at a rate of about 1 in 300,000 people in the U.S. and 1 in 1,000,000 people in Europe. It is especially known to occur mainly in males aged 16 to 30.

With the delay in emergency approval for the adolescent vaccine, Moderna is also reportedly planning to postpone its approval request for the vaccine for children aged 6 to 11, which it had been preparing to submit earlier.

This content was produced with the assistance of AI translation services.