COVID-19 Resource Center

COVID-19 Resource Center

Disclosures: Ali reports consulting for DM Clinical Research. Please see the study for all other authors’ relevant financial disclosures.
August 12, 2021
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Moderna COVID-19 vaccine safe, efficacious in adolescents

Disclosures: Ali reports consulting for DM Clinical Research. Please see the study for all other authors’ relevant financial disclosures.
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Phase 2/3 data now published in The New England Journal of Medicine showed that the Moderna COVID-19 vaccine was safe and generated strong activity against SARS-CoV-2 in adolescents, with an immune response similar to that of young adults.

Moderna previously publicized the data in May and used them in its submission to the FDA in early June seeking authorization for the vaccine in adolescents.

Source: Adobe Stock.
Source: Adobe Stock.

For the study, Kashif Ali, MD, a pediatrician at Kool Kids Pediatrics in Houston, and colleagues enrolled 3,732 participants aged 12 to 17 years and randomly assigned them to receive either the vaccine (n = 2,489) or placebo (n = 1,243).

The researchers recorded no serious adverse events related to the vaccine, and no cases of COVID-19 were reported 2 weeks after participants received the second dose, compared with four cases in the placebo arm.

In the primary analysis, the geometric mean titer ratio for neutralizing antibodies in adolescents relative to young adults was 1.08 (95% CI, 0.94-1.24), the authors said. Additionally, the absolute difference in serologic response was 0.2 percentage points (95% CI, –1.8 to 2.4), they noted

“The immune response was similar to that in young adults, and the vaccine was efficacious in preventing COVID-19,” the authors wrote.