麻豆传媒

Moderna's COVID-19 vaccine showed 100% efficacy in adolescents ages 12 to 17, according to a from the manufacturer on Tuesday.

Starting 14 days after the second dose of vaccine, no cases of COVID-19 were reported in the vaccine group compared to four in the placebo group.

The company added they used the case definition from the adult study, but also looked at a milder case definition 14 days after the first dose, where the vaccine showed 93% efficacy. But absolute case numbers for this milder case definition were not given in the release.

"We are encouraged that mRNA-1273 was highly effective at preventing COVID-19 in adolescents. It is particularly exciting to see that the Moderna COVID-19 vaccine can prevent SARS-CoV-2 infection," said Moderna CEO Stéphane Bancel in a statement.

The study also met its primary endpoint, which was non-inferior immunogenicity in adolescents compared to the phase III adult study.

The TeenCOVE study was a phase II/III study of 3,732 adolescent participants (ages 12 to 17) who were randomized 2:1 to receive two doses of Moderna's COVID-19 vaccine or placebo.

While the study primarily used the case definition from the adult study, the milder case definition was derived from the CDC's definition (namely, one symptom and a positive test for SARS-CoV-2 via RT-PCR).

Examining safety, the vaccine had a consistent profile to that seen in adults, with injection site pain as the most common local adverse event, and headache, fatigue, myalgia, and chills as the most common systemic reactions following the second dose.

The company said it plans to submit these data to the FDA in early June, presumably as an amendment to their current emergency use authorization for adults ages 18 and older. Currently, only Pfizer's COVID-19 vaccine is authorized for adolescents as young as age 12.

Moderna also said they plan to submit the data to a peer-reviewed publication.

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