KUALA LUMPUR: The National Pharmaceutical Regulatory Agency (NPRA) has recorded 25,445 adverse events following immunisation (AEFI) reports as of Feb 25.
This, NPRA director Dr Roshayati Mohamad Sani said this included 1,275 reports involving booster doses (6.3 reports per one million doses) and 94 reports involving children between five and 11 years old.
"Of the total 25,445 AEFI reports (381 reports per one million doses) received by NPRA, 93 per cent (or 23,682 cases) were not serious and recovered within one to two days. Among the non-serious AEFI are fever, pain at the injection site, headache, muscle aches and fatigue.
"The agency received 1,763 reports that had been categorised as serious AEFI cases (26 reports per one million doses) which required hospitalisation, prolonged time in the ward, life-threatening or possible fatalities," she said in a virtual media briefing today.
Dr Roshayati also said 596 AEFI incidents involving deaths among Covid-19 recipients were reported and assessed by the Covid-19 Vaccine Special Pharmacovigilance Committee (JFK), of which 433 of them were found to have no links with the vaccine and 163 others were still under investigation.
As of Feb 25, a total of 66,767,854 doses of the Covid-19 vaccines had been administered in Malaysia, comprising Comirnaty (Pfizer), CoronaVac (Sinovac), AstraZeneca (AZ), Convidecia (CanSino) and Covilo (Sinopharm).
The NPRA director said on AEFI involving booster doses, only 90 reports (7.06 per cent) were classified as serious (6.3 reports per one million doses).
"Up to Feb 25, Malaysia has administered 14,369,227 booster doses."
On AEFI cases among vaccine recipients aged 5 to 11 years old, Dr Roshayati said the NPRA had received 94 reports (0.1 per 1,000 doses administered).
"Majority of the reports (97 per cent) were non-serious and only two were serious.
"The most commonly reported side effects were fever, stress from the injection or vaccination process, itchy skin reactions, dizziness and headache."
She said of the total AEFI reported (all doses), 19,089 reports were received from recipients administered with Pfizer, involving 18,017 reports were not serious and 1,072 were serious; 5,011 recipients administered with Sinovac (4,467 not serious, 544 serious); 1,297 recipients administered with AZ (1,153 not serious, 144 serious); 46 recipients administered with CanSino (43 not serious, three serious) and two recipients administered with Covilo (both not serious).
She said the Health Ministry through the NPRA had been keeping a close watch of things and evaluating AEFI to safeguard the welfare of those involved.
"Every AEFI data received is important to ensure that the benefit over the risk of vaccine products remains positive in preventing the transmission of Covid-19."