Evaluation of mRNA-1273 SARS-CoV-2 Vaccine in Adolescents.

Abstract

BACKGROUND:

The incidence of coronavirus disease 2019 (Covid-19) among adolescents between 12 and 17 years of age was approximately 900 per 100,000 population from April 1 through June 11, 2021. The safety, immunogenicity, and efficacy of the mRNA-1273 vaccine in adolescents are unknown.

METHODS:

In this ongoing phase 2-3, placebo-controlled trial, we randomly assigned healthy adolescents (12 to 17 years of age) in a 2:1 ratio to receive two injections of the mRNA-1273 vaccine (100 μg in each) or placebo, administered 28 days apart. The primary objectives were evaluation of the safety of mRNA-1273 in adolescents and the noninferiority of the immune response in adolescents as compared with that in young adults (18 to 25 years of age) in a phase 3 trial. Secondary objectives included the efficacy of mRNA-1273 in preventing Covid-19 or asymptomatic severe acute respiratory syndrome coronavirus 2 infection.

RESULTS:

A total of 3732 participants were randomly assigned to receive mRNA-1273 (2489 participants) or placebo (1243 participants). In the mRNA-1273 group, the most common solicited adverse reactions after the first or second injections were injection-site pain (in 93.1% and 92.4%, respectively), headache (in 44.6% and 70.2%, respectively), and fatigue (in 47.9% and 67.8%, respectively); in the placebo group, the most common solicited adverse reactions after the first or second injections were injection-site pain (in 34.8% or 30.3%, respectively), headache (in 38.5% and 30.2%, respectively), and fatigue (in 36.6% and 28.9%, respectively). No serious adverse events related to mRNA-1273 or placebo were noted. The geometric mean titer ratio of pseudovirus neutralizing antibody titers in adolescents relative to young adults was 1.08 (95% confidence interval [CI], 0.94 to 1.24), and the absolute difference in serologic response was 0.2 percentage points (95% CI, -1.8 to 2.4), which met the noninferiority criterion. No cases of Covid-19 with an onset of 14 days after the second injection were reported in the mRNA-1273 group, and four cases occurred in the placebo group.

CONCLUSIONS:

The mRNA-1273 vaccine had an acceptable safety profile in adolescents. The immune response was similar to that in young adults, and the vaccine was efficacious in preventing Covid-19. (Funded by Moderna and the Biomedical Advanced Research and Development Authority; Teen COVE ClinicalTrials.gov number, NCT04649151.).

• Authors: Kashif Ali, Gary Berman, Honghong Zhou, Weiping Deng, Veronica Faughnan, Maria Coronado-Voges, Baoyu Ding, Jacqueline Dooley, Bethany Girard, William Hillebrand, Rolando Pajon, Jacqueline M Miller, Brett Leav, Roderick McPhee
• Journal: The New England journal of medicine (N Engl J Med) Vol. 385 Issue 24 Pg. 2241-2251 (12 09 2021) ISSN: 1533-4406 [Electronic] United States
• PMID: 34379915 (Publication Type: Clinical Trial, Phase II, Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2021 Massachusetts Medical Society.

Chemical References

• Antibodies, Neutralizing
• Antibodies, Viral
• 2019-nCoV Vaccine mRNA-1273

Topics

• 2019-nCoV Vaccine mRNA-1273 (administration & dosage, adverse effects, immunology)
• Adolescent
• Antibodies, Neutralizing (blood)
• Antibodies, Viral (blood)
• COVID-19 (prevention & control)
• Child
• Female
• Humans
• Immunogenicity, Vaccine
• Male
• Single-Blind Method
• Vaccine Efficacy