22 AEFI deaths not linked to boosters, says agency

22 AEFI deaths not linked to boosters, says agency

The National Pharmaceutical Regulatory Agency says reports on another 22 deaths among booster recipients are being completed.

Forty-four deaths among booster recipients have been reported as at Feb 18.
PETALING JAYA:
The National Pharmaceutical Regulatory Agency (NPRA) has ruled out booster shots as the cause of deaths in 22 cases of adverse events following immunisation (AEFI).

These 22 cases are half of the 44 deaths reported among booster recipients as at Feb 18.

The remaining 22 reports are being completed before they can be presented to the committee for evaluation, NPRA director Dr Roshayati Mohamad Sani said at a press briefing today.

She added that the health ministry will provide regular updates on the probe.

According to Roshayati, NPRA received 25,211 AEFI reports in total.

“This includes 1,186 involving booster recipients, and 37 involving children aged 5-11 years old who received their doses under the PICKids programme,” she said.

She added that the 1,186 AEFI cases among booster recipients (or 86 reports per million doses), is far lower than the overall rate of AEFI reporting (383 reports per million doses).

Of the total number of AEFI reported among booster recipients, only 87 reports (or 7.34%) are classified as serious, that is, at a rate of about 6.3 reports per million doses.

“Of the 37 cases reported among children aged 5-11 years old, only one was classified as serious, but the patient has since recovered after hospitalisation,” Roshayati said.

She added that the most commonly reported side effects among children are fever, skin reactions, acute stress response, and breathing difficulties.

Meanwhile, from the 25,211 cases reported, only 1,758 cases (7%, or 27 reports per million doses) were classified as serious AEFI.

The remaining 23,453 were non-serious, where vaccine recipients experienced side effects like fever, pain in the injected area, headache, muscle pain, and fatigue.

Serious cases are categorised as those who were hospitalised, faced life-threatening conditions, or suspected to have resulted in death.

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