BRIEF-Moderna's COVID-19 Vaccine Approved For Children Aged 12 To 17 In EU - EMA

European Medicines Agency: * EMA: COVID-19 VACCINE SPIKEVAX APPROVED FOR CHILDREN AGED 12 TO 17 IN EU: 23/07/2021

* EMA SAYS THE USE OF THE SPIKEVAX VACCINE IN CHILDREN FROM 12 TO 17 YEARS OF AGE WILL BE THE SAME AS IN PEOPLE AGED 18 AND ABOVE * EMA SAYS MOST COMMON SIDE EFFECTS IN CHILDREN AGED 12 TO 17 ARE SIMILAR TO THOSE IN PEOPLE AGED 18 AND ABOVE.

* EMA SAYS RECOMMENDED GRANTING EXTENSION OF INDICATION FOR COVID-19 VACCINE SPIKEVAX TO INCLUDE USE IN CHILDREN AGED 12 TO 17 YEARS * EMA SAYS OVERALL SAFETY PROFILE OF SPIKEVAX DETERMINED IN ADULTS WAS CONFIRMED IN ADOLESCENT STUDY

* EMA SAYS SPIKEVAX PRODUCED A COMPARABLE ANTIBODY RESPONSE IN 12- TO 17-YEAR-OLDS TO THAT SEEN IN YOUNG ADULTS AGED 18 TO 25 YEARS * EMA SAYS CHMP NOTED DUE TO LIMITED NUMBER OF CHILDREN AND ADOLESCENTS INCLUDED IN STUDY, TRIAL COULD NOT HAVE DETECTED NEW UNCOMMON SIDE EFFECTS

* EMA SAYS CHMP THEREFORE CONSIDERED THAT BENEFITS OF SPIKEVAX IN CHILDREN AGED 12 TO 17 OUTWEIGH RISKS * EMA: NOTED TRIAL COULD NOT HAVE DETECTED ESTIMATED RISK OF KNOWN SIDE EFFECTS SUCH AS MYOCARDITIS & PERICARDITIS DUE TO LIMITED NUMBER OF CHILDREN IN STUDY

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