Moderna, 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 adopted a positive opinion recommending a variation to the marketing authorization (MA) to include a booster dose of Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214), at the dose level for children (6-11 years) of 12.5mcg/12.5mcg (0.25 mL) at least three months after the last prior dose of a COVID-19 vaccine.
“The recommendation to authorize the use of a booster dose of mRNA-1273.214 in children ages 6-11 is crucial to providing protection against Omicron and the emergence of new variants of concern, which is especially important during the winter period in Europe when respiratory diseases are on the rise,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We are grateful to the CHMP for their review of our submission and look forward to an authorization decision from the European Commission.”
The pediatric application is based on clinical trial booster data for Moderna’s original vaccine, Spikevax, which was administered to over a thousand participants. The application described data from a 25 μg booster dose administered to children ages 6 to 11 years old following a completed primary series of the Moderna COVID-19 vaccine. In addition, the application included clinical trial data from a Phase 2/3 studying mRNA-1273.214.
In November 2022, Moderna announced that its bivalent Omicron-targeting booster candidates (mRNA-1273.214 and mRNA-1273.222) trigger a superior antibody response compared to a booster dose of mRNA-1273, the Company’s prototype vaccine, against Omicron (BA.4-BA.5) in Phase 2/3 clinical trials. Both bivalent vaccines also met non-inferiority immunogenicity criteria to the original strain.
A Phase 2/3 trial evaluating mRNA-1273.214 as booster and primary series in children 6 months through 5 years of age is currently underway, with initial results expected in early 2023.