BRIEF-EMA Publishes New Safety Updates For COVID-19 Vaccines

European Medicines Agency: * EMA: EMA PUBLISHED NEW SAFETY UPDATES FOR COMIRNATY, COVID-19 VACCINE JANSSEN, SPIKEVAX AND VAXZEVRIA: 11/11/2021

* EMA - THERE IS CURRENTLY INSUFFICIENT EVIDENCE OF A POSSIBLE LINK BETWEEN COMIRNATY AND VERY RARE CASES OF MULTISYSTEM INFLAMMATORY SYNDROME (MIS) * EMA ON COMIRNATY - FURTHER ASSESSMENT OF MYOCARDITIS AND PERICARDITIS IS ONGOING

* EMA: THERE IS CURRENTLY INSUFFICIENT EVIDENCE OF A POSSIBLE LINK BETWEEN SPIKEVAX AND VERY RARE CASES OF MULTISYSTEM INFLAMMATORY SYNDROME * EMA: PRAC HAS STARTED A REVIEW OF A SAFETY SIGNAL TO ASSESS REPORTS OF CAPILLARY LEAK SYNDROME IN PEOPLE WHO WERE VACCINATED WITH SPIKEVAX

* EMA SAYS CVST WILL BE ADDED TO THE PRODUCT INFORMATION AS A SIDE EFFECT OF ASTRAZENECA COVID-19 VACCINE VAXZEVRIA. * EMA: AT THIS STAGE, IT IS NOT YET CLEAR WHETHER THERE IS CAUSAL ASSOCIATION BETWEEN SPIKEVAX VACCINATION AND REPORTS OF CAPILLARY LEAK SYNDROME

* EMA SAYS TRANSVERSE MYELITIS WAS RECOMMENDED BY PRAC TO BE ADDED TO THE PRODUCT INFORMATION AS A SIDE EFFECT OF COVID-19 VACCINE JANSSEN * EMA - PRAC HAS ASKED COMPANY THAT MARKETS COMIRNATY TO PERFORM IN-DEPTH REVIEW OF ALL PUBLISHED DATA ON ASSOCIATION OF MYOCARDITIS, PERICARDITIS WITH VACCINE

* EMA: THERE IS CURRENTLY INSUFFICIENT EVIDENCE OF POSSIBLE LINK BETWEEN COVID-19 VACCINE JANSSEN AND EITHER MIS OR MENSTRUAL DISORDERS Further company coverage:

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