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Healthcare

BRIEF-EMA Says Assessing Reports Of Guillain-Barre Syndrome With Astrazeneca's COVID-19 Vaccine

May 7 (Reuters) - European Medicines Agency (EMA):

* SAYS PRAC CONCLUDES REVIEW OF SIGNAL OF FACIAL SWELLING WITH COVID-19 VACCINE COMIRNATY

* SAYS PRAC HAS RECOMMENDED A CHANGE TO PFIZER COVID-19 VACCINE COMIRNATY’S PRODUCT INFORMATION.

* SAYS PRAC IS CLOSELY MONITORING WHETHER MRNA VACCINES MIGHT ALSO BE LINKED TO CASES OF RARE, UNUSUAL BLOOD CLOTS WITH LOW BLOOD PLATELETS

* SAYS PRAC ASSESSING REPORTS OF GUILLAIN-BARRE SYNDROME WITH ASTRAZENECA’S COVID-19 VACCINE

* SAYS PRAC ASSESSING REPORTS OF MYOCARDITIS WITH COMIRNATY AND COVID-19 VACCINE MODERNA

* SAYS FOLLOWING REVIEW OF REPORTS OF SUSPECTED SIDE EFFECTS, PRAC CONSIDERS AT THIS STAGE NO SAFETY SIGNAL FOR MRNA VACCINES; ONLY FEW CASES OF BLOOD CLOTS WITH LOW BLOOD PLATELETS REPORTED

* SAYS PRAC IS ANALYSING DATA PROVIDED BY ASTRAZENECA ON CASES OF GUILLAIN-BARRE SYNDROME (GBS) REPORTED FOLLOWING VACCINATION

* SAYS AWARE OF CASES OF MYOCARDITIS AND PERICARDITIS MAINLY REPORTED FOLLOWING VACCINATION WITH COMIRNATY

* SAYS PRAC HAS REQUESTED PFIZER TO PROVIDE FURTHER DETAILED DATA, INCLUDING AN ANALYSIS OF MYOCARDITIS EVENTS

* SAYS THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME WILL BE ADDED AS ‘IMPORTANT IDENTIFIED RISK’ IN RISK MANAGEMENT PLAN FOR JANSSEN’S COVID-19 VACCINE

* SAYS PRAC CONCLUDED FACIAL SWELLING IN PEOPLE WITH AHISTORY OF INJECTIONS WITH DERMAL FILLERS SHOULD BE INCLUDED AS SIDE EFFECT FOR PFIZER VACCINE Source text: (bit.ly/2QUE7H4) Further company coverage:

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