BRIEF-European Medicines Agency Evaluating Data On Booster Dose Of COVID-19 Vaccine Comirnaty

European Medicines Agency: * EMA: EMA EVALUATING DATA ON BOOSTER DOSE OF COVID-19 VACCINE COMIRNATY: 06/09/2021

* EMA SAYS STARTED EVALUATING AN APPLICATION FOR USE OF A BOOSTER DOSE OF COMIRNATY TO BE GIVEN 6 MONTHS AFTER SECOND DOSE IN PEOPLE AGED 16 YEARS AND OLDER. * EMA: CHMP WILL CARRY OUT AN ACCELERATED ASSESSMENT OF DATA SUBMITTED BY THE COMPANY THAT MARKETS COMIRNATY,

* EMA SAYS ALSO ASSESSING DATA FROM LITERATURE ON USE OF ADDITIONAL, THIRD DOSE OF MRNA VACCINE (COMIRNATY OR SPIKEVAX) IN SEVERELY IMMUNOCOMPROMISED PEOPLE * EMA SAYS CHMP WILL RECOMMEND WHETHER UPDATES TO PRODUCT INFORMATION ARE APPROPRIATE

* EMA: OUTCOME OF THIS EVALUATION IS EXPECTED WITHIN THE NEXT FEW WEEKS, UNLESS SUPPLEMENTARY INFORMATION IS NEEDED * EMA: WHILE EMA ASSESSES RELEVANT DATA, MEMBER STATES MAY ALREADY CONSIDER PREPARATORY PLANS FOR ADMINISTERING BOOSTERS AND ADDITIONAL DOSES Further company coverage:

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