CAMBRIDGE – Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending a variation to the marketing authorization (CMA) to include a 25 µg two-dose series of Spikevax (mRNA-1273) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in children 6 months to 5 years. Following the CHMP’s positive opinion, the European Commission will make an authorization decision on the use of Spikevax in children ages 6 months to 5 years.
“This recommendation by the CHMP reaffirms the effectiveness and safety of mRNA-1273 and provides parents across Europe with another option to protect their young children against COVID-19, a group at high risk of infection and where additional health prevention measures may not always be feasible,” said Stéphane Bancel, Moderna’s Chief Executive Officer. “We are grateful to the CHMP for their review and look forward to an authorization decision from the European Commission.”
Positive interim results from the Phase 2/3 KidCOVE study showed a robust neutralizing antibody response in the 6-month to 5 years of age group after a two-dose primary series of mRNA-1273 and a favorable safety profile. The antibody titers in the pre-specified 6 months to 23 months and 2 years to 5 years of age sub-groups met the statistical criteria for similarity to the adults in the COVE study, which satisfied the primary objective of the study. Preliminary efficacy analysis on PCR-confirmed cases collected during the Omicron wave showed similar efficacy estimates against Omicron in the 6-month to 5 years of age group to those in adults after two doses of mRNA-1273.
The KidCOVE study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. The ClinicalTrials.gov identifier is NCT04796896.
mRNA-1273 has been authorized for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6 months to 5 years in a number of countries worldwide, including Australia, Canada, and the US. In addition, Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214), a bivalent vaccine candidate that contains mRNA-1273 and a vaccine candidate targeting the Omicron variant of concern (BA.1), is approved as a booster dose for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older, who have previously received at least a primary vaccination course against COVID- 19.
Spikevax (elasomeran mRNA vaccine) has been granted Marketing Authorization by the European Commission, based upon the recommendation of the European Medicines Agency, and is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 6 months of age and older. A booster dose may be given at least three months after the second dose for people aged 12 years and older.