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984 AEFI incidents reported so far among booster recipients

KUALA LUMPUR; A total of 24,411 adverse events following immunisation (AEFI) have been reported to the Health Ministry since the onset of the national vaccination drive in 2021.

This includes 984 AEFI incidents reported for those taking boosters.

Health director-general Tan Sri Dr Noor Hisham Abdullah said the reports, captured by the National Pharmaceutical Regulatory Agency's system had found that for boosters there there were 0.1 AEFI for every 1,000 shots administered.

"The overall AEFI reported for Covid-19 vaccinations were 0.4 incidents for 1,000 administered."

He said 51 cases or 5.2 per cent of the cases were classified as serious.

Such cases of severe effects according to Dr Noor Hisham said was equivalent to 0.005 reports for every 1,000 doses distributed.

"Our analysis has found that there has been no increase in AEFI reporting from what was observed during the administration of the booster dose compared to when the primer was administered.

"The same reporting trend has also been observed in other countries."

He said the most common symptoms reported were fever, pain at the injection spot, headaches and fatigue.

A total of 61,723,654 vaccines for Covid-19 have been administered in Malaysia since the onset of the programme, including 10,192,887 booster shots.

Dr Noor Hisham said the ministry was in the midst of conducting active safety studies.

He said recipients who received at least one vaccine dose and received treatment in 216 public and private hospitals for low platelet count; venal blood clots; stroke; heart disease including myocardial infarction; Bell's Palsy; epilepsy and cramps are among the Adverse Event of Special Interest (AESI) that are the focuses of the study.

He said the analysis that was done from February to September last year involved the admission data of 433,674 people.

The study also recorded data on the type of vaccines that were administered such as the Comirnaty, AstraZeneca and CoronaVac inoculation.

Based on the analysis, it shows that AESI which are rare, varies based on vaccine, the particular dose taken, be they prime or boosters, age group and sex of recipients.

However, Dr Noor Hisham said AESI rates that were recorded so far were also low.

He said the Case-Based Monitoring of Adverse Events Following Covid-19 Vaccination (SAFECOVAC) study has concluded that the benefits of the vaccines still outweigh the risk.

He confirmed that the team analysing the interim data would publish and share their findings soon.

Dr Noor Hisham said the ministry would continue to monitor the safety of all Covid-19 vaccines registered in Malaysia conditionally to ensure that the safety and health of those receiving the vaccines are cared for.

"If there is clear evidence that the vaccines are unsafe, the ministry would not hesitate to take reasonable regulatory action."

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