CAMBRIDGE – Moderna, Inc, (NASDAQ:MRNA), 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 conditional marketing authorization (CMA) to include a booster dose of Spikevax, the Company’s COVID-19 vaccine, at the 50 µg dose level for adolescents (12-17 years) at least three months after completion of the primary series.
“The recommendation to authorize the use of a booster dose of Spikevax in adolescents ages 12-17 is an important step to continue to protect this age group from COVID-19 and the emergence of new variants of concern,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We are grateful to the CHMP for their comprehensive review of our submission and look forward to an authorization decision from the European Commission.”
The CHMP based this positive opinion on scientific evidence shared by the company, including comprehensive safety data. The administration of a booster dose of 50 µg at least three months after administration of completion of the primary series is predicted to substantially increase the immune responses against variants of concern, including Omicron compared to pre-boost levels.
Spikevax (elasomeran mRNA vaccine) has been granted Conditional 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 six years 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.