Paina 93.1 trial#

Paina 93.1 trial#

Randomized trial of a third dose of mRNA-1273 vaccine in transplant recipients external icon. Reprinted with permission from Massachusetts Medical Society. Copyright В© 2021 Massachusetts Medical Society. From the New England Journal of Medicine, Ali et al., Evaluation of mRNA-1273 SARS-CoV-2 vaccine in adolescents.

Four cases of COVID-19 occurred in the placebo group, and no cases of COVID-19 with an onset of в‰Ґ14 days after the 2 nd injection were reported in the mRNA-1273 group. Cumulative incidence of symptomatic COVID-19 в‰Ґ14 days after the 1 st injection in the modified intention-to-treat population. Implications: Adolescents vaccinated with 2 doses of mRNA-1273 had immunogenicity and vaccine efficacy comparable to young adults, with no serious adverse events noted. Limitations: Low incidence of COVID-19 in the trial population (4 cases in the placebo group only). Doses were administered 28 days apart to >98% of participants median follow-up was 83 days (range 9вЂ“151 days). Immunogenicity was assessed in a random sample of vaccinated adolescents (n = 340). adolescents (aged 12вЂ“17 years) receiving 2 doses of mRNA-1273 (Moderna, n = 2,489) or saline placebo (n = 1,243) in December 2020вЂ“February 2021 as part of the manufacturerвЂ™s Teen COVE ( corona virus efficacy) phase 2-3 randomized trial were compared with previously reported phase 3 trial results from young adults (aged 18вЂ“25 years). Methods: In this bridging study, data on immunogenicity as well as vaccine efficacy and adverse reactions among U.S.

Vaccine efficacy against symptomatic COVID-19 in adolescents was 93.3% (95% CI 47.9%-99.9%) in the per-protocol population and 92.7% (95% CI 67.8%-99.2%) in the intention-to-treat population.

Geometric mean titers (GMT) of neutralizing antibody were noninferior among adolescents compared with young adults (GMT ratio: 1.08, 95% CI 0.94-1.24).

Most vaccinated persons seroconverted (98.8% of adolescents, 98.6% of young adults).

No serious adverse events related to mRNA-1273 or placebo were noted.

Most common side effects within 7 days of 1 st and 2 nd dose, respectively, were injection site pain (93.1% and 92.4%), headache (44.6% and 70.2%), and fatigue (47.9% and 67.8%).

mRNA-1273 vaccine (100 micrograms per dose) had an acceptable safety profile in adolescents.

Evaluation of mRNA-1273 SARS-CoV-2 vaccine in adolescents external icon.