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Only 1,162 non-serious AEFI reports from Covid-19

KUALA LUMPUR: Most of the Adverse Event Following Immunisation (AEFI) reports from the use of the Covid-19 vaccine were not serious and did not pose any potential health risk to vaccine recipients.

Health director-general Tan Sri Noor Hisham Abdullah said the non-serious cases comprised 94.2 per cent of the 20,131 AEFI reports.

He added that only 1,162 reports (5.8 per cent) were categorised as serious AEFI cases based on the World Health Organisation classification.

"Of the 1,162 reports received, only one case was identified as inflammation of the heart muscle likely linked to the Comirnaty vaccine taken.

"The reports were based on comprehensive evaluation conducted by the Covid-19 Vaccine Special Pharmacovigilance Committee and were received by the National Pharmaceutical Regulatory Agency (NPRA)," he said in a statement today.

At the same time, Dr Noor Hisham added that a total of 44,813,270 Comirnaty vaccines were given since the National Covid-19 Immunisation Programme (PICK) began on Feb 21.

"There are two types of mRNA Covid-19 vaccines that had been granted conditional registration by the Drug Control Authority, namely Comirnaty (Pfizer) and Spikevax (Moderna).

"However, only Pfizer is used in the PICK programme at the moment."

He said the Health Ministry would continuously monitor the safety risk of every registered vaccine used in the country, including Covid-19 vaccines through AEFI reports.

He said the Case-Based Monitoring of Adverse Events Following Covid-19 Vaccination study conducted with the Institute for Clinical Research revealed that the Comirnaty vaccine safety profile was at an acceptable level.

"It did not show an increased risk of myocarditis or pericarditis, acute facial paralysis, stroke and myocardial infarction within 21 days after receiving the Comirnaty vaccine. The reporting rate in the country is also consistent as reported abroad.

"Hence, the ministry encouraged the public to get their first and second booster shots if they are eligible, especially those who are in the high-risk category and have comorbidities," he said.

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