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US biotech Moderna submitted data on Monday for conditional EU approval to market its COVID-19 vaccine for adolescents aged 12 to 18.
It is the second COVID-19 vaccine maker to apply for a license for children in the EU, after BioNTech / Pfizer, whose mRNA vaccine was approved for adolescents on May 28th.
In adolescents, two doses of Moderna’s mRNA vaccine was shown to be 100 percent effective in preventing COVID-19 disease in a study of 2,500 participants. In addition, 14 days after the first dose, it was found 93 percent effective at preventing disease, including milder cases, in a study of 3,732 people.
Moderna CEO Stéphane Bancel said the filing of the filing with the European Medicines Agency is the same day as a similar filing in Canada. The company also intends to submit data for an emergency use permit in the US for this age group.
The arrival of vaccines for children in Europe is the next test for politicians as they grapple with the tense ethical decision of whether to extend vaccination to children or to donate vaccines to those in the rest of the world who need them most.
So far, no EU country has committed to postponing vaccinations for children and sending those vaccines elsewhere, although the pandemic is still raging in many other parts of the world, including South Asia and South America