The US Centers for Disease Control and Prevention (CDC) had reported more than 300 cases of myocarditis (inflammation of the heart muscle) out of more than 20 million adolescents who had been vaccinated, most of them males under the age of 30.
In Singapore, six out of the nearly 1.9 million people who received both doses of an mRNA vaccine, either Pfizer-BioNTech or Moderna, were reported to have suffered myocarditis and pericarditis (inflammation of the outer layer of the heart) as of June 7. Four of them were males under the age of 30.
Responding to questions from FMT regarding such reports, health director-general Dr Noor Hisham Abdullah said that currently, only one type of mRNA vaccine, Comirnaty, has been approved for conditional registration in Malaysia.
“As of June 13, a total of 2,793,826 Comirnaty vaccines have been given to the Malaysian population, involving a total of 1,676,959 first doses and 1,116,867 second doses,” he said in a statement.
“To date, there are no reports of adverse events following immunisation (AEFI) specific to myocarditis/pericarditis received by the health ministry or the National Pharmaceutical Regulatory Agency (NPRA).
“Evaluation is still under way to determine the relationship of this issue to mRNA-type vaccines.”
Symptoms associated with myocarditis and pericarditis include chest pain, changes in heart rate and difficulty in breathing.
Noor Hisham said that to date, the health ministry has found that no regulatory action has been taken by international reference bodies, such as the European Medicines Agency (EMA) and the World Health Organization (WHO), on Covid-19 mRNA vaccine products.
“The current benefits of giving this vaccine far outweigh the risks,” he said.
Meanwhile, a Pfizer spokesman told FMT that the pharmaceutical giant was aware of “rare reports” of myocarditis and pericarditis, predominantly in male adolescents and young adults, after mRNA Covid-19 vaccinations.
The spokesman said that according to the EMA, most of these cases were mild and resolved within a few days, with symptoms mostly starting within several days of vaccination with the second dose.
“It is important to understand that a careful assessment of the reports is ongoing. It has not been concluded that the mRNA Covid-19 vaccines cause myocarditis or pericarditis,” said the spokesman.
The spokesman said that adverse events unrelated to, but close in timing to the vaccination, were expected to occur at a similar rate in vaccinated individuals as they would in the overall population.
The spokesman added that all adverse events are regularly and thoroughly reviewed by Pfizer as well as by regulatory authorities such as the EMA and CDC.
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