By IDSE News Staff
The KidCOVE study showed a robust neutralizing antibody response among children 6 to 11 years of age who received two doses of the Moderna messenger RNA (mRNA) COVID-19 vaccine.
Moderna plans to submit these data to the FDA for an expanded emergency use authorization.
KidCOVE (ClinicalTrials.gov Identifier: NCT04796896) is a randomized, observer-blinded, placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity and effectiveness of two 50-mcg doses of mRNA vaccine given to healthy children 28 days apart. The entire study population was divided into three age groups: 6 to 11 years, 24 months to 5 years and 6 months to 23 months years.
This cohort enrolled 4,753 participants who were 6 to 11 years of age. In the trial, the SARS-CoV-2-neutralizing antibody geometric mean ratio comparing the response in children with the response in young adults from the phase 3 COVE study was 1.5 (95% Cl: 1.3, 1.8), with a seroresponse rate of 99.3%, representing a difference of 0.6% (95% CI, –2.8% to 2.8%) to the phase 3 benchmark.
These results demonstrate a strong immune response in this cohort of children one month after the second dose and met the coprimary immunogenicity end points for children 6 to less than 11 years of age in KidCOVE.
The vaccine was well tolerated with a safety and tolerability profile generally consistent with the phase 3 COVE study in adolescents and adults. Most adverse events were mild or moderate in severity. The most common solicited adverse events were fatigue, headache, fever and injection site pain.
Safety data continue to accrue, and the study continues to be monitored by an independent safety monitoring committee. All participants will be monitored for 12 months after their second injection to assess long-term protection and safety. Moderna plans to submit the data to a peer-reviewed publication. These data are subject to change based on ongoing data collection.
The enrollment for children 6 to 11 years is complete, but the phase 2/3 study continues to enroll children 6 months to 5 years of age. Moderna has enrolled approximately 5,700 pediatric participants in the United States and Canada into the trial.
The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority.
“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 its primary immunogenicity endpoints,” said Stéphane Bancel, the CEO of Moderna. “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.”
