The European Medicines Agency authorizes use of the Spikevax COVID-19 vaccine for children ages 12 to 17


On 23 July 2021, the European Medicines Agency (EMA) reported that the Committee for Medicinal Products for

Human Use (CHMP) recommended granting an extension of the indication for the COVID-19 vaccine Spikevax (formerly a Moderna COVID-19 vaccine) for use in children ages 12 to 17 (the vaccine had already been licensed for use in people ages 18 and older).

Administration of the Spikevax vaccine in children ages 12 to 17 will follow the same immunization schedule as for people 18 years old and older, i.e., two doses four weeks apart.

The recommendation for the authorization was based on a clinical trial involving 3,732 children between the ages of 12 and 17, which is part of the Spikevax pediatric research plan authorized by the EMA's Pediatric Committee. In this study, the Spikevax vaccine produced an antibody response in 12- to 17-year-olds comparable to that seen in young adults ages 18 to 25. The most common side effects in the study group were similar to those in the 18-year-old and older population.  


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