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Home » The European Union’s drug regulator authorizes the Moderna vaccine for children 12 and older.

The European Union’s drug regulator authorizes the Moderna vaccine for children 12 and older.

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The European Medicines Agency, the European Union’s main drug regulator, on Friday authorized the use of Moderna’s Covid vaccine for children age 12 and older, clearing the way for final approval by the bloc.

The agency approved the vaccine for those older than age 18 in January. The vaccine is also licensed for those 18 and older in the United States, Canada and Britain.

The protocol for children will be the same as for adults — two shots four weeks apart — the regulator said. Sore arms, headache and fatigue were the side effects most commonly reported among teenagers receiving the vaccine, it said, similarly to adults.

The agency’s recommendation will go to the European Commission, the bloc’s administrative arm, for a final approval. Deciding if and when to begin using the vaccine on children is up to the E.U.’s 27 national governments.

Until now, the only vaccine approved for those 12- to 17-years-old in Europe and North America has been the one from Pfizer-BioNTech. The bloc’s drug regulator recommended it for children in late May, and the European Commission swiftly approved it. More than a dozen E.U. countries have since begun vaccinating children.

The E.U. vaccination campaign has accelerated considerably in recent weeks, and even overtook the immunization level in the United States, with over 67 percent of the population now inoculated with at least one dose, and 53 percent fully immunized according to data gathered by the European Center for Disease Prevention and Control. Fifty-six percent of the U.S. population has received at least one dose, and 49 percent are fully vaccinated.

The bloc has obtained enough doses to reach its goal of fully vaccinating 70 percent of the adult population by the end of July, the commission said earlier this month. But despite the overall high level of immunization, important divergences remain between the bloc’s member nations.

The European Center for Disease Prevention and Control warned on Friday in a joint statement with the World Health Organization that the Delta variant is now dominant in the majority of the bloc’s nations, and urged the “fast rollout of vaccinations,” highlighting that full inoculation significantly reduces the risk of severe disease and death.

“When called to do so, people should get vaccinated,” Dr. Hans Henri P. Kluge, the W.H.O.’s director for Europe, said in a statement.


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