The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Moderna's COVID-19 vaccine Spikevax for use in the vaccination of children aged six to 11 in the European Union (EU) on Thursday, Feb. 24.
Spikevax is now awaiting conditional marketing authorization (CMA) from the European Commission.
The biotechnology company conducted a study, phase two-thirds of “KidCOVE”, where two doses of the Spikevax (50 μg mRNA-1273) vaccine were given to healthy children around 28 days apart.
Data given to the CHMP showed that the vaccine was generally well tolerated by the respondents and showed positive direct efficacy.
Moderna conducted the trial tests in cooperation with the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), the Biomedical Advanced Research and Development Authority (BARDA), the Office of the Assistant Secretary for Preparedness and Response, and the US Department of Health and Human Services (HHS).
Stéphane Bancel, the chief executive officer of Moderna, lauded the EMA-CHMP’s positive opinion on the vaccine’s use for the age group.
“The CHMP recommendation to authorize the use of our COVID-19 vaccine in children, ages 6-11 years, in Europe is an important milestone. It highlights the effectiveness and safety of our vaccine in this age group and helps to keep our children safe and able to experience a normal school and family life,” Bancel said.
Previously, the Therapeutic Goods Administration in Australia allowed provisional registration of the Moderna vaccine for children aged six to 11.
For the adult use of Spikevax in the EU, the EMA-CHMP has recommended the administration of the booster shots at least three months after the second dose, instead of six months.
The EMA also considered the administration of heterologous or “mix-and-match” booster doses in the EU.