* 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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