The trial, which included 2,260 adolescents, also showed that the vaccine was well tolerated by the group. The companies plan to submit the data to the U.S. Food and Drug Administration and the European Medicines Agency for a requested amendment to the emergency use authorization of BNT162b2; the companies also will request an expansion to the European Union conditional marketing authorization for the vaccine as soon as possible.
Additionally, Pfizer and BioNTech have initiated a study on the safety and efficacy of the vaccine in children ages 6 months to 11. Children ages 5 to 11 were the first to be given the vaccine.
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