EMA finds potential link between heart inflammation and Pfizer-BioNTech and Moderna vaccines
DUBLIN: The European Medicines Agency (EMA) has issued a warning after identifying a possible link between Pfizer-BioNTech and Moderna COVID-19 vaccines and very rare heart inflammation.
The EU drug regulator lists myocarditis and pericarditis as side-effects of the two mRNA vaccines. According to the EMA’s safety committee, such cases could occur within 14 days of inoculation. The committee also warned against administering Johnson & Johnson vaccines to persons who have a history of the rare blood disorder capillary leak syndrome (CLS).
The EMA says such cases are more common after the second dose and in younger adult men. This is similar to the findings made in the United States last month. Symptoms include breathlessness, palpitations and chest pain. The warning comes after reviewing more than 300 cases of myocarditis and pericarditis from the EU, Iceland, Norway and Liechtenstein. More cases have been reported in connection with the Pfizer vaccine.
The EMA also examined whether the Johnson &Johnson and AstraZeneca vaccines cause similar side-effects. But no evidence of this has been found so far. The EMA said it had requested more data from drug manufacturers. The J&J and AstraZeneca vaccines use similar technology, but different versions of a cold virus.
The EU watchdog stated that the benefits of all authorised COVID-19 vaccines continue to outweigh the risks, but reminded all groups of people to remain vigilant after vaccination.
Pfizer, meanwhile, said in a statement that cases of myocarditis and pericarditis are generally not frightening and will recover in a short time after normal treatment and rest.
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