Moderna Announces Interim Data of COVID-19 Vaccine for Ages 6 to 11 Years

The company plans to submit data to the European Medicines Agency, FDA, and other global regulators.

Moderna has announced positive interim data from the phase 2/3 of the KidCOVE study that showed a neutralizing antibody response after 2 doses of the mRNA-1273 at the 50 µg for children aged 6 to 12 years.

“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,” Stéphane Bancel, chief executive officer of Moderna, said in a statement. “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.”

Moderna plans to submit the data to the European Medicines Agency, FDA, and other global regulators.

Investigators compared the geometric mean ratio response in children to the response in young adults from the phase 3 COVE study and found it was 1.5, with a seroresponse rate of 99.3%, representing a difference of 0.6% to the phase 3 benchmark.

The results of the data showed a favorable safety profile.

The most common adverse events were fatigue, fever, headache, and infection site pain.

The cohort enrolled 4753 individuals who were aged 6 to 11 years, and the results showed the vaccine was generally well tolerated with a safety and tolerability profile, consistent with the phase 3 COVE study in adolescents and adults.

KidCOVE is an observer-blind, placebo-controlled, randomized expansion study to evaluate the effectiveness, reactogenicity, safety, and tolerability of the 2 COVID-19 doses given to healthy children, 28 days apart.

Reference

Moderna announces positive top line data from phase 2/3 study of COVID-19 vaccine in children 6 to 11 years of age. Businesswire. News release. October 25, 2021. Accessed November 5, 2021. https://www.businesswire.com/news/home/20211025005471/en