The European Medicines Agency (EMA) recommended, on Friday 9 July, that myocarditis and pericarditis - two inflammatory conditions of the heart - be listed as side effects of the Covid-19 messenger RNA vaccines developed by Pfizer/BioNTech (Comirnaty) and Moderna (Spikevax).
The EMA states that these conditions are likely to occur only in very rare cases and that the risk/benefit ratio of both vaccines remains positive.
The Agency examined more than 100 cases of myocarditis and pericarditis in people vaccinated with Comirnaty and 19 cases of myocarditis and pericarditis in people vaccinated with Spikevax. All this in the European Economic Area (EEA), where 177 million doses of Comirnaty and 20 million doses of Spikevax had been administered by 31 May 2021.
The observed cases occurred mainly after a second dose and in young adult males. In five cases, people “of advanced age or had concomitant diseases” died, the EMA said.
Capillary leak. On the same day, the EMA also recommended that people with a history of capillary leak syndrome - a condition that causes fluid to leak from small blood vessels - should not be vaccinated with the vaccine from Johnson&Johnson. It had reached a very similar conclusion about AstraZeneca’s vaccine in early June (see EUROPE 12739/8). (Original version in French by Agathe Cherki)