20,131 vaccine effects were reported as of December 26


PUTRAJAYA: The Malaysian Ministry of Health (KKM) through the National Pharmaceutical Regulatory Division (NPRA) received 20,131 Adverse Effects Following Immunization (AEFI) reports as of December 26.

Director General of Health, Tan Sri Dr. Noor Hisham Abdullah said that the amount received was from recipients of Comirnaty’s (Pfizer) Covid-19 MRNA vaccine which was equivalent to 499 reports for every one million doses.

He said, based on the report, 94.2 percent were non-serious cases, temporary in nature and did not pose any potential risk to the health of vaccine recipients.

“Fever, pain at the injection site, headache, muscle pain and fatigue are among the adverse effects often reported by vaccine recipients.

“Of the total number of AEFIs, 1,162 reports were categorized as serious AEFIs based on the World Health Organization (WHO) classification.

“Of the 1,162 serious AEFI reports, only one case of heart muscle inflammation is likely to be related to the Comirnaty vaccine taken,” he said in a statement today.

He said the reporting rate in Malaysia was consistent with that reported abroad and the safety profile of the Comirnaty vaccine was at an acceptable level.

Noor Hisham said, it also did not show an increased risk of myocarditis/pericarditis, acute facial paralysis, stroke and myocardial infarction within 21 days after receiving the Comirnaty vaccine.

According to him, since the start of the National Covid-18 Immunization Program (PICK) on 24 February 2021 until 26 December, a total of 44,813,270 doses of the Comirnaty vaccine have been given.

“Until last December 26, the local reporting rate for AESI was anaphylaxis (1.6 per million doses), acute facial paralysis (2.0 per million doses), myocarditis/ pericarditis (1.5 per million doses) and VITT (0.02 per million doses ),” he said.

He said the Ministry of Health also encouraged health professionals and vaccine recipients to report the effects of AEFI experienced through the channels provided.

He explained further, vaccine recipients who experience AEFI can make a notification through the MySejahtera application for non-serious adverse effects listed in the application.

In addition, he said, AEFI reports can also be made online by filling out a reporting form for consumers, namely the Consumer Side Effect Reporting Form (ConSERF) which can be accessed on the NPRA website (www.npra.gov.my). – MESSENGER





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