New Delhi: US Pharmaceutical company Moderna said that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) approved the use of its Covid-19 vaccine for children aged 12 and above. The company added that the vaccine Spikevax has been approved.
“The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (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 company said in a release on Friday.
“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.”
Once given the clearance from European Commission, the vaccine will be given in two doses, much like the doses given to people 18 years and above, each four weeks apart. The approval by the Amsterdam-based agency follows the nod for the first vaccine for European youngsters, by Pfizer/BioNTech in May.
On June 10, Moderna announced data from the ongoing Phase 2/3 study, which enrolled 3,732 participants ages 12-17 in the US. The study met its primary endpoint, successfully bridging immune responses to those observed in the COVE efficacy study in adults, said the biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines.
After two doses of the Moderna Covid-19 vaccine-Spikevax, 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 per cent starting 14 days after the second dose using the US Centers for Disease Control and Prevention’s (CDC) primary definition of Covid-19 infection.
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.
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.