Initial results showed a strong neutralizing antibody response and favorable safety profile among the participants.
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Interim data from Moderna’s Phase II/III KidCOVE trial shows that its COVID-19 vaccine is well-received by children ages 6 to 12 years old.
Initial results showed a strong neutralizing antibody response and favorable safety profile among the 4,753 participants after they were given two 50 µg doses of mRNA1273, spaced 28 days apart.
The findings are taken from the KidCOVE study, which evaluates children split into three age groups: 6 months to 2 years, 2 to 6 years, and 6 to 12 years. The interim results reflect findings one month after the second dose, though all participants will continue to be monitored closely for 12 months after completion of the two-dose series. The company has yet to share interim results for the two younger age groups.
The 6 to 12 cohort enrolled 4,753 participants and compared the response of these children to the response of the young adults who were enrolled in the Phase III COVE study. The SARS-CoV-2-neutralizing antibody geometric mean ratio (GMR) turned out to be 1.5, with a 99.3% seroresponse rate.
The vaccine’s tolerability and safety profiles are also consistent with the Phase III COVE study, with only mild to moderate adverse events logged. Some of these events include headache, fatigue, injection site pain and fever.
“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. 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,” said Stéphane Bancel, the chief executive officer of Moderna, in a statement.
The Moderna COVID-19 vaccine is an mRNA vaccine encoding for a prefusion stabilized form of the Spike (S) protein. It was granted emergency use authorization by the U.S. Food and Drug Administration (FDA) in December 2020 in individuals aged 18 years and up. The vaccine also has EUAs in more than 50 countries and an emergency use listing (EUL) from the World Health Organization.
Enrollment for the highlighted cohort is complete, but the Phase II/III trial continues to enroll participants ages 6 months to under 6 years for the other two cohorts. The goal is to continue collecting data and monitoring the children for one year to evaluate the vaccine’s long-term safety and protection. End dates may change depending on how their data collection efforts go. So far, Moderna has gathered data from around 5,700 pediatric participants in the U.S. and Canada.
The company said it plans to submit its KidCOVE findings to the FDA, the European Medicines Agency (EMA), and other international regulatory authorities soon.
