KUALA LUMPUR (June 19): The Ministry of Health (MoH) said today it has not received any reports of heart inflammation from people who had been administered with Pfizer-BioNTech's Cormirnaty vaccine in Malaysia.
The ministry said in a statement today in the wake of reports by several countries such as the United States, United Kingdom and Singapore on the risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of two outer layers of tissue surrounding the heart) associated with Covid-19 vaccines using mRNA technology, namely Pfizer and Moderna.
“Currently, only one type of mRNA vaccine, namely Comirnaty produced by Pfizer-BioNTech has been approved for conditional registration in Malaysia," said Health Director-General Tan Sri Dr Noor Hisham Abdullah (pictured).
He said the National Pharmaceutical Regulatory Agency has carried out risk assessments on the safety issue based on information obtained from other regulatory agencies and international references.
“The MoH has concluded that the safety profile of the (Pfizer) vaccine remains positive and its usage for the National Covid-19 Immunisation Programme will not be affected," he said, stressing that the benefits of the vaccine far outweigh the risks.
“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,” Dr Noor Hisham said.
He said MoH also noted 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 the Covid-19 mRNA vaccine products.
“MoH will continuously monitor through a registered product quality monitoring programme and pharmacovigilance to ensure the quality, safety and effectiveness of the vaccine.
“MoH also will inform the public of the latest developments from time to time,” he added.
Symptoms associated with myocarditis and pericarditis include chest pain, changes in heart rate and difficulty in breathing.
The US Centers for Disease Control and Prevention (CDC) has reported more than 300 cases of myocarditis out of more than 20 million adolescents who had been vaccinated, most of them males under the age of 30.
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