EMA panel probes heart inflammation with Pfizer/BioNTech COVID vaccine

Phil Taylor
May 10, 2021


A review of side effects reported with coronavirus vaccines by the EMA’s safety committee has uncovered cases of inflammation of the heart in people receiving the Pfizer/BioNTech Comirnaty shot.
The Pharmacovigilance Risk Assessment Committee (PRAC) says it is aware of cases of myocarditis and pericarditis – inflammation of the heart muscle and membrane around the heart – with the vaccine.
At the moment, there’s no indication that the cases are linked to the vaccine itself, but the EMA has asked the companies to provide “further detailed data, including an analysis of the events according to age and gender,” as it looks into the signal.
It is also asking for similar data from Moderna, which manufacture a COVID-19 vaccine that like Comirnaty is based on mRNA.
While still very preliminary, the investigation will be a worry to the EU, which made the Pfizer/BioNTech vaccine the mainstay of its COVID-19 vaccination programme. On Saturday, the bloc extended its contract with the companies to provide up to 1.8 billion doses through 2023.

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