LONDON — The European Medicines Agency says its expert committee has concluded that the COVID-19 vaccines made by Pfizer and Moderna are possibly linked to very rare cases of chest pain and heart inflammation in some people following vaccination.
That echoes a similar conclusion reached by U.S. officials in June. In a statement on Friday, the EU drug regulator is recommending that the two conditions, myocarditis and pericarditis, be included as side effects on the vaccine labels, together with a warning to raise awareness among health workers and people receiving the shots.
The decision was made based on a review of more than 300 cases of chest and heart inflammation among more than 190 million doses of the two vaccines administered across Europe. Health officials say the benefits of the coronavirus vaccines far outweigh the small risks of side effects.
Also, the EMA is recommending people who have a history of a rare condition that causes blood vessels to leak avoid the coronavirus vaccine made by Johnson & Johnson. Its experts examined three cases of capillary leak syndrome in people who received the J&J vaccine; two died shortly after being vaccinated.
The regulator says the syndrome should be recognized as a new side effect of the J&J shot and advised a warning to raise awareness among health workers.