EU regulator finds possible link between rare heart inflammation and mRNA vaccines

Europe's drug regulator has found a possible link between very rare heart inflammation and Covid-19 vaccines from Pfizer and Moderna, it said on Friday, stressing that the benefits of the shots outweighed any risks.

Heart conditions myocarditis and pericarditis must be listed as possible side effects of the two mRNA vaccines, the safety committee of the European Medicines Agency (EMA) said, adding that such cases primarily occurred within 14 days of vaccination.

It added that the conditions occurred more often after the second dose and in younger adult men. This is in line with US findings last month.

The EMA reviewed more than 300 cases of myocarditis and pericarditis overall in the EU, plus in Iceland, Norway and Liechtenstein, in reaching its decision. Most of the cases occurred after inoculation with Pfizer's vaccine, called Comirnaty, the EMA said.

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Pfizer’s vaccine has been used more widely in the EU than Moderna’s.

Pfizer said in a statement that the cases were “generally mild” and individuals “tend to recover within a short time following standard treatment and rest”. Its German partner on the vaccine, BioNTech, was not immediately available for comment.

The EMA had also been looking into such cases with Johnson & Johnson (J&J) and AstraZeneca vaccines, but on Friday said it had not found any causal relationship so far.

Symptoms from the conditions include breathlessness, palpitations and chest pain.

“EMA confirms that the benefits of all authorised Covid-19 vaccines continue to outweigh their risks,” it said.

Blood disorder

The EMA’s safety panel also advised that people who have a history of a rare blood disorder called capillary leak syndrome (CLS) must not be vaccinated with J&J’s single-shot vaccine, after a review.

J&J did not immediately respond to a request for comment.

The watchdog in June asked CLS to be added as a side effect of AstraZeneca’s shot, Vaxzevria.

The EMA then too said people who had previously sustained the condition, in which fluids leak from the smallest blood vessels, causing swelling and a drop in blood pressure, should not receive that shot.

Both AstraZeneca and J&J vaccines use different versions of a cold virus to deliver instructions for making coronavirus proteins produce an immune response. – Reuters