Jul. 23, 2021: Moderna, a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Medicines Agency’s CHMP adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine (Spikevax) to include adolescents 12 years of age and older.
Spikevax is the trade name authorized by the European Medicines Agency (EMA) for the Moderna COVID-19 vaccine.
“The CHMP recommendation of the authorization of our COVID-19 vaccine for use in individuals 12 years of age and older in the European Union is a positive step forward toward authorization of our vaccine in this age group,” said Stéphane Bancel, Chief Executive Officer of Moderna.
“As we help to combat the pandemic, we hope to be able to help get adolescents safely back to school this fall.”
Following the CHMP’s positive opinion, the European Commission will consider authorizing the use of the Moderna COVID-19 Vaccine in adolescents ages 12 years of age and older.
On June 10, Moderna announced data from the ongoing Phase 2/3 study, which enrolled 3,732 participants ages 12 to less than 18 years in the U.S. The study met its primary endpoint, successfully bridging immune responses to those observed in the COVE efficacy study in adults. After two doses of the Moderna COVID-19 vaccine, no cases of COVID-19 were observed in the vaccine group using the case definition from the adult Phase 3 COVE study, compared to four cases in the placebo group, resulting in a vaccine efficacy of 100% starting 14 days after the second dose using the U.S. Centers for Disease Control and Prevention’s (CDC) primary definition of COVID-19 infection. The Moderna COVID-19 vaccine was generally well tolerated with a safety and tolerability profile consistent with the Phase 3 COVE study in adults. The majority of adverse events were mild or moderate in severity. The most common solicited local adverse event was injection site pain. The most common solicited systemic adverse events after the second dose of mRNA-1273 were headache, fatigue, myalgia and chills.
Safety data continue to accrue, and the study continues to be monitored by an independent safety monitoring committee. All participants will be monitored for 12 months after their second injection to assess long-term efficacy and safety. The Company will revise the age range to capture adolescent data in its ongoing and planned post-authorization studies.
Moderna has submitted data from the Phase 2/3 study to a peer-reviewed publication.
These data have also been submitted to health authorities around the world and the Company expects authorizations for adolescents in the coming weeks.
Moderna is also conducting a Phase 2/3 study, called the KidCOVE study, of mRNA-1273 in children ages 6 months to less than 12 years.”
