KUALA LUMPUR: The Health Ministry today said it has not received reports on myocarditis and pericarditis associated with the use of the Covid-19 mRNA vaccine in the country.
In a statement, Health director-general Tan Sri Dr Noor Hisham Abdullah said the vaccine's profile remained positive and the use of it in the Covid-19 National Immunisation Programme (NIP) will not be affected.
This, after reports from several countries such as the United States, United Kingdom, and Singapore, on the risk of myocarditis and pericarditis associated with the use of the Covid-19 mRNA vaccine.
Dr Noor Hisham said the National Pharmaceutical Regulatory Division (NPRA) has conducted a risk assessment on the safety issues based on information obtained from regulatory bodies and international references.
"The ministry has concluded that the safety profile of this vaccine (mRNA) remained positive, as such its usage in the NIP will not be affected.
"The current benefits of giving this vaccine far outweigh the risks," he said in a statement today.
Myocarditis is an inflammation of the heart muscles, while pericarditis refers to inflammation of the outer layer of the heart.
Among symptoms associated with myocarditis and pericarditis include chest pain, changes in heart rate, and breathing difficulties.
At present, only one mRNA vaccine is being used in Malaysia; Comirnaty produced by Pfizer-BioNTech that has received conditional registration approval here.
Up until June 13, a total of 2,793,826 doses were administered to Malaysians, involving 1,676,959 first doses, and 1,116,867 as second doses.
"To date, no reports of adverse events following immunisation (AEFI) effects related to myocarditis or pericarditis has been received by the ministry and the NPRA.
"Also to date, no regulatory action has been taken by other international reference bodies such as the European Medicines Agency (EMA) and the World Health Organisation (WHO) on Covid-19 mRNA vaccine products.
"Evaluations are still ongoing to determine the matter concerning myocarditis or pericarditis with the Covid-19 mRNA type vaccine," he said.
Dr Noor Hisham added the ministry has been continuously monitoring registered products and pharmacovigilance through a quality monitoring programme to ensure the quality, safety, and effectiveness of vaccine products.
"The ministry will inform the public of the latest developments from time to time."