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The risk of heart inflammation after receiving a Covid-19 mRNA vaccine is very rare and mild in the vast majority of patients, according to the UK’s independent Drug Safety Research Unit (DSRU).
The DSRU reviewed data on reported events of myocarditis and pericarditis following vaccinations with the Covid-19 mRNA vaccines from Pfizer / BioNTech and Moderna.
Myocarditis and pericarditis are inflammation of the heart muscle and the protective sac that surrounds the organ. Symptoms after vaccination included chest pain, shortness of breath, and palpitations.
DSRU research found that events were very rare and most cases were mild, with those vaccinated making a full recovery.
In the UK, as of August 4, 2021, 165 myocarditis events and 140 pericarditis events have been reported after the Pfizer or BioNTech Covid-19 vaccine. Two of these events were fatal.
This equates to approximately 7.93 cases of myocarditis and 6.73 cases of pericarditis per million vaccinees who received at least one dose of Pfizer / BioNTech vaccine.
Among those vaccinated who received the Moderna vaccine, there were 29 reports of myocarditis and 25 reports of pericarditis. None were fatal. This equates to 2.07 cases of myocarditis and 1.79 cases of pericarditis per million vaccinated.
Data from the United States and Europe show that the events were more common in men and people under the age of 30. Events appear to occur within a few days of vaccination and are more common after a second dose of mRNA vaccine.
The DSRU review echoes previous findings that men and people under the age of 30 are more likely to experience myocarditis and pericarditis after a COVID-19 mRNA vaccine.
The DSRU is now calling for larger-scale research to better understand cardiac events, especially as more young people are expected to start receiving vaccines.
So far, only data from spontaneous reporting – through which healthcare professionals and patients report side effects are available. This means that cases may have been missed and it is difficult to assess incidence rates.
Only mRNA vaccines have been approved for use in children over 12 years of age. Therefore, as vaccination programs around the world progress to younger age groups, the rates of myocarditis and pericarditis need to be monitored.
Professor Saad Shakir, who led the DSRU study, said: “Our review shows a similar picture in the UK, Europe and America and confirms that these are very rare adverse events. But very, very occasionally they are serious.
“All we have is passive information that is spontaneously reported at the moment, which is great for detecting signals but, like all pharmacovigilance methods, has limitations. Through proactive research, we can understand who is most at risk and why. And we can introduce measures to protect them.
Listen to our interview with Professor Saad Shakir of DSRU using the link below:
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