BioNTech, Pfizer ask for EU Covid vaccine approval for 12-15 year-olds

Berlin, Apr 30 (EFE).- Pharmaceutical companies BioNTech and Pfizer have applied to the European Medicines Agency (EMA) to extend the authorization of their Covid-19 vaccines to adolescents between 12 and 15 years of age, the companies said Friday.

In a joint statement, they explained that they have tested their formula against the coronavirus in phase III in 2,260 adolescents and that, as they announced at the end of March, the vaccine was 100% effective, with a “robust” immune response. In the trials, the statement adds, the vaccine was “generally well tolerated”.

Adolescents participating in the trial, however, will continue to be monitored regularly over the next two years to check the vaccine’s long-term protection and safety.

In their statement, Germany’s BioNTech and the U.S.-based Pfizer also said that they have already taken a similar step in the United States, where they have asked for their current emergency license to be adapted.

The two pharmaceutical companies were the first to announce last November that their vaccine against the new coronavirus – based on BioNTech’s proprietary novel messenger ribonucleic acid (mRNA) technique – was highly effective.

The formulation was approved weeks later in the United States and the United Kingdom, and subsequently in the European Union (EU), where it began to be administered at the end of last year. EFE


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