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Now U.S. manufacturer Moderna has also applied to the EU Medicines Agency (EMA) for approval of its coronavirus vaccine for children and adolescents aged 12 years and older. The company made the announcement today. So far, only the vaccine from manufacturers Biontech and Pfizer has been approved in the EU for young people. Moderna currently has EU approval for ages 18 and older.
The application was based on a Phase II/III study of the Moderna vaccine, called mRNA-1273, in 2,500 adolescents between the ages of 12 and 18 in the United States, the company said. Efficacy was 100 percent, it said. Safety and tolerability profiles were as in the adult Phase III study, it added. The drug was “generally well tolerated.”
The Moderna vaccine has had conditional marketing authorization for adults in the European Union since January 6. It has now been injected millions of times. The EU Commission had initially ordered 160 million doses of the preparation on behalf of the 27 member states. This was followed in February by a second contract for up to 300 million more doses.
- source: orf.at/picture: unsplash.com
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