The European Medicines Agency’s (EMA) safety committee on 9 July warned that mRNA COVID-19 vaccines produced by Pfizer/BioNTech and Moderna could be linked to 321 cases of rare heart inflammation.
In a press release, the EMA said that it had reviewed 164 cases of myocarditis (inflammation of the heart muscle) and 157 cases of pericarditis (inflammation of the heart’s outer lining), linked to the two mRNA vaccines. Symptoms of both conditions include breathlessness, chest pain, and heart palpitations.
EMA’s safety committee said that 145 cases of myocarditis were observed in individuals who received the Pfizer/BioNTech vaccine and a further 19 among people who received Moderna’s vaccine.
Additionally, 138 cases of pericarditis were observed following the use of Pfizer/BioNTech’s vaccine, along with 19 cases seen following vaccination with the Moderna vaccine.
“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,” a press release read.
In total, 177 million doses of Pfizer/BioNTech’s COVID-19 vaccine and 20 million doses of Moderna’s vaccine were administered in the European Economic Area as of 31 May.