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BRIEF-EMA Says Assessing Reports Of Capillary Leak Syndrome After Moderna COVID-19 Shot

Nov 11 (Reuters) - European Medicines Agency (EMA):

* 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 SAYS CVST WILL BE ADDED TO THE PRODUCT INFORMATION AS A SIDE EFFECT OF ASTRAZENECA COVID-19 VACCINE VAXZEVRIA.

* 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 WITHOUT THROMBOCYTOPENIA HAS BEEN OBSERVED VERY RARELY FOLLOWING VACCINATION WITH 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 - 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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