EU Drugs Regulator Recommends Moderna Shot for Teenagers

(Bloomberg) -- European regulators cleared Moderna Inc.’s Covid-19 shot for children aged 12 to 17, offering a second weapon in the push to vaccinate teenagers on the continent as the delta variant spreads.

The authorization from the European Medicines Agency follows earlier green lights for the Pfizer Inc. and BioNTech SE shot -- which like Moderna’s product is based on messenger-RNA technology -- for people of that age bracket. Health authorities are rushing to inoculate as many young people as possible in the coming weeks before schools reopen. Moderna shares rose as much as 4.7%.

The overall safety of the Moderna Spikevax vaccine in adults was confirmed in the adolescent study, the EMA said. It found the vaccine produced a comparable antibody response in 12-to-17-year-olds to that seen in young adults aged 18 to 25 years. The injection will be given to children in two doses, four weeks apart.

The EMA’s decision comes as Covid case numbers are spiking again across Europe, despite the fact that about half of the population of member states like Germany, France and Spain are fully vaccinated. The fast-spreading delta variant is particularly infecting those who aren’t fully inoculated, many of whom are young. That’s upended some reopening plans, complicated vacation season and raised concerns about the potentially vast toll of people suffering from so-called “Long Covid.”

Last month, Moderna filed for U.S. emergency-use authorization of the vaccine in adolescents. The U.S. Food and Drug Administration has already cleared the Pfizer/BioNTech shot for that age group.

Regulators are scrutinizing, among other things, reports of rare instances of cardiac inflammation known as myocarditis and pericarditis. Despite that, the potential benefits of vaccinating teens against Covid outweigh the risks, the U.S. Centers for Disease Control and Prevention maintains.

The Moderna study, which involved about 3,700 children, is too small to detect “new uncommon” side effects or estimate the risk of heart inflammation, the EMA agency said. It continues to monitor the safety and efficacy profiles of this and other approved vaccines.

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