EU regulator: mRNA coronavirus vaccines possibly linked to heart swelling - POLITICO Europe

The mRNA vaccines from BioNTech/Pfizer and Moderna are possibly linked to rare cases of heart inflammation, according to analysis of 321 cases post-vaccination released Friday by the European Medicines Agency.

Myocarditis and pericarditis are inflammatory conditions of the heart, with symptoms including breathlessness, palpitations and chest pain.

The safety committee PRAC analyzed 145 cases of myocarditis and 138 cases of pericarditis after the BioNTech/Pfizer vaccine. For Moderna’s jab, PRAC analyzed 19 cases of each condition.

By the end of May, around 177 million doses of the BioNTech/Pfizer vaccine and 20 million doses of Moderna’s had been given in the European Economic Area.

PRAC recommended updating the product information to include this side effect and raise awareness among health care staff and vaccine recipients.

The committee also recommended restricting the Johnson & Johnson vaccine marketing authorization so that people with a history of capillary leak syndrome don't receive it. It advised adding a side effect warning for the serious condition, in which fluid leaks from small blood vessels causing swelling, low blood pressure, blood thickening and low blood albumin levels.

Three of such cases have been reported to the EMA, one in a person with prior history of the syndrome, following the Johnson & Johnson jab. All cases occurred within two days of vaccination; two of the three died. As of June 21, 18 million doses of the single-shot vaccine have been administered worldwide.

Finally, PRAC advised that the product information for the Oxford/AstraZeneca vaccine include a warning to raise awareness of cases of Guillain-Barre syndrome (GBS) that might have been reported following vaccination.

The syndrome causes nerve inflammation and can result in pain, numbness, muscle weakness and difficulty walking.

Currently, available data "neither confirms nor rules out a possible association with the vaccine," PRAC said. But given the seriousness of GBS, it advised warning people of cases.

This article is part of POLITICO’s premium policy service: Pro Health Care. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email [email protected] for a complimentary trial.

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