Moderna COVID-19 vaccine gets EU regulator endorsement for teens

Moderna’s COVID-19 vaccine could become the second shot okayed for adolescent use in the European Union after regulators on Friday recommended approving it for 12- to 17-year-olds ahead of U.S. authorities.

Use of the vaccine, Spikevax, will be the same in adolescents as in people over 18, the European Medicines Agency (EMA) said, adding the shot produced a comparable antibody response to that seen in 18- to 25-year-olds.

Vaccinating children has been considered important for reaching herd immunity and in light of the highly contagious Delta variant. Moderna in May said its vaccine was found to be safe and effective in teenagers.

The EMA said the two-dose vaccine is given four weeks apart, and its human medicines committee’s recommendation was based on a study of 3,732 participants.

Most children with COVID-19 develop only mild symptoms or none. Yet children remain at risk of becoming seriously ill and can spread the virus. Pfizer and German partner BioNTech’s vaccine was approved for teen use in May.

The regulator said common side effects in teenagers after vaccination with Spikevax were similar to those seen in older people. But due to a smaller study size, the trial could not detect new uncommon side effects or estimate the risk of known ones such as myocarditis and pericarditis.

“The overall safety profile of Spikevax determined in adults was confirmed in the adolescent study; the CHMP (Committee for Medicinal Products for Human Use) therefore considered that the benefits of Spikevax in children aged 12 to 17 outweigh the risks,” the EMA said https://www.ema.europa.eu/en/news/covid-19-vaccine-spikevax-approved-children-aged-12-17-eu.

Heart inflammation such as myocarditis and pericarditis have been listed by the EMA as a possible, but rare side effect from use of mRNA vaccines such as Moderna’s and Pfizer’s in adults.

Spikevax is already being used in the European Union for people over 18, and in the United States and Canada. The company has also sought authorisation in the United States and Canada for use in adolescents.

Moderna said on Friday it had submitted data to authorities around the world and expects authorisations for adolescents in the coming weeks.

Formal approval from the European Commission would be needed to start rolling out the vaccine for teenagers in Europe. The executive body typically follows EMA recommendations.