Safety profile of mRNA vaccine remains positive - Health DG

KUALA LUMPUR: No cases of myocarditis or pericarditis following the use of the mRNA COVID-19 vaccine have been detected in Malaysia thus far, said Health director-general Tan Sri Dr Noor Hisham Abdullah.

He said the National Pharmaceutical Regulatory Agency (NPRA) had conducted risk assessments on safety issues related to the matter, based on information obtained from regulatory bodies and international references.

"The Ministry of Health (MOH) has concluded that the safety profile of this vaccine remains positive, and its use in the National COVID-19 Immunisation Programme is not 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 muscle while pericarditis refers to inflammation of the outer layer of the heart. Symptoms or symptoms associated with the matter include chest pain, changes in heart rate and difficulty breathing.

Dr Noor Hisham said this following reports by several countries such as the United States, United Kingdom and Singapore recently, on the risk of myocarditis and pericarditis associated with the use of the mRNA COVID-19 vaccine.

He said that currently there is only one type of mRNA vaccine, Comirnaty, produced by Pfizer-BioNTech, which is approved for conditional registration in Malaysia.

Dr Noor Hisham said that up to June 13, a total of 2,793,826 vaccines of this type were administered in the country, involving 1,676,959 first doses and 1,116, 867 second doses.

"Until now, there have been no adverse events following immunisation (AEFIs) experienced after receiving the vaccine, specific for myocarditis or pericarditis, received by NPRA and MOH," he explained.

He added that the MOH also found that no regulatory action was taken by other international reference bodies, such as the European Medicines Agency (EMA) and the World Health Organisation (WHO) on mRNA COVID-19 vaccine products.

"Evaluation is ongoing to determine the relationship between this issue and the mRNA COVID-19 vaccine.

"The MOH will always conduct continuous monitoring through the quality monitoring programme of registered products, and pharmacovigilance, to ensure that the quality, safety and effectiveness of vaccine products are always guaranteed," he said.

-- BERNAMA