tetano
Editor, Senior Moderator
N Engl J Med
. 2021 Aug 11.
doi: 10.1056/NEJMoa2109522. Online ahead of print.
Evaluation of mRNA-1273 SARS-CoV-2 Vaccine in Adolescents
Kashif Ali[SUP] 1 [/SUP], Gary Berman[SUP] 1 [/SUP], Honghong Zhou[SUP] 1 [/SUP], Weiping Deng[SUP] 1 [/SUP], Veronica Faughnan[SUP] 1 [/SUP], Maria Coronado-Voges[SUP] 1 [/SUP], Baoyu Ding[SUP] 1 [/SUP], Jacqueline Dooley[SUP] 1 [/SUP], Bethany Girard[SUP] 1 [/SUP], William Hillebrand[SUP] 1 [/SUP], Rolando Pajon[SUP] 1 [/SUP], Jacqueline M Miller[SUP] 1 [/SUP], Brett Leav[SUP] 1 [/SUP], Roderick McPhee[SUP] 1 [/SUP]
Affiliations
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.).
. 2021 Aug 11.
doi: 10.1056/NEJMoa2109522. Online ahead of print.
Evaluation of mRNA-1273 SARS-CoV-2 Vaccine in Adolescents
Kashif Ali[SUP] 1 [/SUP], Gary Berman[SUP] 1 [/SUP], Honghong Zhou[SUP] 1 [/SUP], Weiping Deng[SUP] 1 [/SUP], Veronica Faughnan[SUP] 1 [/SUP], Maria Coronado-Voges[SUP] 1 [/SUP], Baoyu Ding[SUP] 1 [/SUP], Jacqueline Dooley[SUP] 1 [/SUP], Bethany Girard[SUP] 1 [/SUP], William Hillebrand[SUP] 1 [/SUP], Rolando Pajon[SUP] 1 [/SUP], Jacqueline M Miller[SUP] 1 [/SUP], Brett Leav[SUP] 1 [/SUP], Roderick McPhee[SUP] 1 [/SUP]
Affiliations
- PMID: 34379915
- DOI: 10.1056/NEJMoa2109522
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.).