rEVIeW OF Evaluation of mRNA-1273 Covid-19 Vaccine in Children 6 to 11 Years of Age—cREECH 2022

"This is a brief audio review. In the article Evaluation of mRNA-1273 Covid-19 Vaccine in Children 6 to 11 Years of Age published, 2022 by Creech and Colleagues, The outcomes and key points are as noted: Children must be vaccinated against coronavirus illness 2019 (Covid-19). mRNA-1273 vaccination safety, immunogenicity, and efficacy in 6 to 11-year-olds are uncertain. Part 1 of this phase 2-3 trial was open label for dose selection; part 2 was an observer-blinded, placebo-controlled dose expansion. In part 2, we randomly allocated 6 to 11-year-olds mRNA-1273 (50 g each) or placebo 28 days apart. Primary objectives were to evaluate vaccine safety in children and immune response non-inferiority to young adults (18 to 25 years old) in a related phase 3 experiment. Secondary goals included determining confirmed Covid-19 and SARS-CoV2 infections, regardless of symptoms. Reports interim analysis results. In part 1 of the experiment, 751 children got 50-g or 100-g injections of the mRNA-1273 vaccine, and the 50-g dose level was selected for part 2. 4016 youngsters were randomly randomized to receive two injections of mRNA-1273 (50 g each) or placebo and were observed for 82 days (14 to 94) after the first injection. This dosage level was related with temporary injection-site discomfort, headache, and weariness. As of the data cutoff date, there were no vaccine-related major adverse events, MSIS in children, myocarditis, or pericarditis. One month after the second injection (day 57), the neutralizing antibody titer in children who received mRNA-1273 at a 50-g level was 1610 (95 percent confidence interval [CI], 1457 to 1780), compared with 1300 (95 percent CI, 1171 to 1443) in young adults. Serologic responses were seen in at least 99.0 percent of participants in both age groups, meeting the non-inferiority success criterion. Estimated vaccine effectiveness against Covid-19 14 days or more after the first injection was 88% (CI, 70.0 to 95.8) when B.1.617.2 (delta) was the major circulating variation. Two 50-g doses of the mRNA-1273 vaccine were safe and efficacious in generating immune responses and preventing Covid-19 in children 6 to 11 years old. (Funded by BARDA and NIAID; KidCOVE ClinicalTrials.gov number, NCT04796896.)”