EMA Seeks More Data on Myocarditis After COVID-19 Shots
The European Medicines Agency (EMA) safety committee is continuing its review of myocarditis and pericarditis following vaccination with COVID-19 vaccines.
“Currently, further analysis is needed to conclude whether there is a causal relationship with the vaccines, and the PRAC requesting additional data from the companies marketing them,” the EMA said in a statement issued Friday.
The Pharmacovigilance Risk Assessment Committee (PRAC) started its review in April after reports of myocarditis following vaccination with the Pfizer-BioNTech COVID-19 vaccine Comirnaty in Israel.
Most of these cases were mild and resolved within a few days. They mainly affected men younger than 30 years of age, with symptoms mostly starting within several days of vaccination with the second dose, the EMA said.
Cases of myocarditis and/or pericarditis following vaccination with all COVID-19 vaccines have also been reported in the European Economic Area (EEA) that includes the European Union, Iceland, Liechtenstein, and Norway.
In the EudraVigilance database at the end of last month, there were 122 reported cases of myocarditis associated with Comirnaty, 16 with the Moderna COVID-19 vaccine, 38 with Vaxzevria (AstraZeneca) and none for the Janssen/Johnson & Johnson COVID-19 vaccine.
Cases of pericarditis reported in the database as of May 31 were: 126 (Pfizer BioNTech), 18 (Moderna), 47 (AstraZeneca) and 1 (Janssen).
The exposure in the EEA for each vaccine was around 160 million doses for Comirnaty, 19 million doses for Moderna, 40 million for Vaxzevria, and 2 million for Janssen, the EMA said.
