The company plans to submit these results to the FDA and EMA for review.
Interim results of Moderna’s Phase 2/3 KidCOVE study (NCT04796896) show that the company’s mRNA COVID-19 vaccine is generally well tolerated and produces a significant antibody response in a pediatric population, according to a company news release.1
These interim data demonstrated a “robust neutralizing antibody response” following two 50-µm doses of the company’s mRNA-1273 COVID-19 vaccine, as well as a favorable safety profile.
KidCOVE is a randomized, observer-blind, placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity, and effectiveness of the vaccine administered to healthy children 28 days apart. The current data are for the study cohort of 4753 children between 6 and 11 years of age; additional cohorts include children between 2 and under 6 years and children 6 months to under 2 years of age.
Study investigators evaluated the SARS-CoV-2 neutralizing antibody geometric mean ratio compared with the same response in young adult participants in the Phase 3 COVE study. Seroresponse rate in COVE was 99.3%, with a 0.6% difference from the Phase 3 benchmark. The current results show a strong immune response and met the co-primary immunogenicity endpoints.
“We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to under 12 years and are pleased that the study met is primary immunogenicity endpoints,” said Moderna CEO Stéphanie Bancel in a press release. “We look forward to filing with regulators globally and remain committed to doing our part to help end the COVID-19 pandemic with a vaccine for adults and children of all ages.”
Safety data are still being collected as the study continues to enroll children between 6 months and under 6 years of age. The company plans to submit the current results to the FDA and the European Medicines Agency, as well as other global regulatory agencies.