U.S. biotech Moderna filed Monday data for an EU conditional marketing authorization for its COVID-19 vaccine for adolescents aged 12 to 18.
It’s the second COVID-19 vaccine maker to apply for a license in children in the EU after BioNTech/Pfizer, whose mRNA vaccine was approved for adolescents on May 28.
In adolescents, two doses of Moderna’s mRNA vaccine were shown to be 100 percent effective at preventing illness from COVID-19 in a 2,500-participant trial. In addition, it was shown to be 93 percent effective at preventing illness, including milder cases, 14 days after the first dose in a 3,732-person trial.
Stéphane Bancel, chief executive of Moderna, said the European Medicines Agency filing comes the same day as a similar submission in Canada. The company also intends to submit data for an emergency use authorization in the U.S. for this age group.
The arrival of vaccines for children in Europe is the next test for politicians, who now grapple with the ethically fraught decision of whether to expand vaccination to children or donate jabs to those who need them most in the rest of the world.
As yet, no EU country has pledged to delay jabs for kids and send these vaccines elsewhere, despite the fact that the pandemic is still raging in several other parts of the world, including South Asia and South America