BRIEF-EMA Recommends To Include Transverse Myelitis As Side Effect Of Vaxzevria and COVID-19 Vaccine Janssen

AstraZeneca PLC: * EMA: MEETING HIGHLIGHTS FROM THE PHARMACOVIGILANCE RISK ASSESSMENT COMMITTEE (PRAC) 10 - 13 JANUARY 2022: 14/01/2022

* EMA: HAS STARTED A REVIEW OF MEDICINES THAT CONTAIN TERLIPRESSIN * EMA: PRAC RECOMMENDED CHANGE TO PRODUCT INFORMATION FOR VAXZEVRIA, COVID-19 VACCINE JANSSEN TO INCLUDE WARNING TO RAISE AWARENESS OF VERY RARE CASES OF TM FOLLOWING VACCINATION

* EMA SAYS ON VAXZEVRIA, FEWER CASES OF THROMBOSIS WITH THROMBOCYTOPENIA REPORTED AFTER SECOND DOSE * EMA: PRAC CONCLUDED THAT CAUSAL RELATIONSHIP BETWEEN VAXZEVRIA AND COVID-19 VACCINE JANSSEN AND TRANSVERSE MYELITIS IS AT LEAST REASONABLE POSSIBILITY

* EMA-PRAC RECOMMENDED UPDATING PRODUCT INFO FOR VAXZEVRIA TO ADD MORE INFO ABOUT VERY RARE CASES OF THROMBOSIS WITH TTS OCCURRED FOLLOWING VACCINATION * EMA SAYS A RECENT REVIEW OF AVAILABLE SAFETY DATA HAS CONCLUDED ON AN INCREASED RISK FOR LIVER INJURY FOLLOWING TREATMENT WITH MAVENCLAD Source text for Eikon: Further company coverage:

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