'Very rare' heart disease risks with Covid vaccines, confirms EMA 

The EMA said: 'The benefits of all authorised Covid-19 vaccines continue to outweigh their risks, given the risk of Covid-19 illness and related complications, and scientific evidence shows that they reduce deaths and hospitalisations due to Covid-19.'

An analysis of links between Covid-19 vaccination and heart disease has found this risk remains “very rare” – meaning up to one in 10,000 vaccinated people may be affected.

The European Medicine’s Agency safety committee (PRAC) examined the risk of myocarditis and pericarditis developing after vaccination with the Pfizer vaccine called Comirnaty and that from Moderna known as Spikevax.

“The PRAC has determined that the risk for both of these conditions is overall 'very rare', meaning  up to one in 10,000 vaccinated people may be affected,” the EMA said on Friday.

“Additionally, the data show that the increased risk of myocarditis after vaccination is highest in younger males.” 

The EMA also said: “The benefits of all authorised Covid-19 vaccines continue to outweigh their risks, given the risk of Covid-19 illness and related complications, and scientific evidence shows that they reduce deaths and hospitalisations due to Covid-19.” 

In a statement, it said in these rare cases that the disease follows the expected patterns.

It found in these rare cases, myocarditis and pericarditis can develop within just a few days after vaccination, and have primarily occurred within 14 days. They have been seen more often after the second vaccination.

Its analysis included data from the French national health system (Epi-phare and) and Nordic registry data.

The French study showed in the seven days after the second dose, there were about 0.26 extra cases of myocarditis in 12- to 29-year-old males per 10,000 compared to unexposed persons.

In the Nordic study, there were 0.57 extra cases of myocarditis in 16- to 24-year-old males per 10,000 compared to unexposed persons in the 28 days after the second dose.

Looking at the Spikevax vaccine from Moderna, the French study showed in a period of seven days after the second dose there were about 1.3 extra cases of myocarditis in 12- to 29-year-old males per 10,000 compared to unexposed persons.

The Nordic study shows that up to 28 days after the second dose of Spikevax, there were about 1.9 extra cases of myocarditis in 16- to 24-year-old males per 10,000 compared to unexposed persons.

Symptoms of these heart conditions can include breathlessness, a forceful heartbeat that may be irregular (palpitations), and chest pain.

The EMA will continue to monitor these and all the Covid-19 vaccines, and they said vaccine packaging will be updated.