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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) – EMA

European Medicines Agency (EMA) has assessed several rare adverse events for COVID-19 vaccines and one gene therapy for treating thalassemia in their latest Pharmacovigilance Risk Assessment Committee (PRAC) meeting.

During this meeting from 5-8 July 2021, EMA’s PRAC has concluded that myocarditis and pericarditis can occur in very rare cases following vaccination with Comirnaty and Spikevax (previously COVID-19 Vaccine Moderna).


The Committee is therefore recommending listing myocarditis and pericarditis as new side effects in the product information for these vaccines, together with a warning to raise awareness among healthcare professionals and people taking these vaccines.


The PRAC has recommended that people who have previously had capillary leak syndrome must not be vaccinated with COVID-19 Vaccine Janssen.


The PRAC has recommended a change to the product information for Vaxzevria (formerly COVID-19 Vaccine Astrazeneca) to include a warning to raise awareness among healthcare professionals and people taking the vaccine of cases of Guillain-Barre syndrome (GBS) reported following vaccination.


EMA’s safety committee PRAC, has concluded that there is no evidence Zynteglo causes a blood cancer known as acute myeloid leukemia (AML).


Zynteglo, gene therapy for the blood disorder beta-thalassemia, uses a viral vector (or modified virus) to deliver a working gene into the patient’s blood cells.


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