KUALA LUMPUR: Up to 25,746 adverse events following immunisation (AEFI) have been reported to the National Pharmaceutical Regulatory Agency (NPRA) up to March 11.

NPRA director Dr Roshayati Mohamad Sani said the numbers include 1,411 reports involving effects from booster doses, while 182 were from the recipients of the Covid-19 Immunisation Programme for Children (PICKids).

She said a majority of the AEFI received, amounting to 93 per cent, were non-serious effects such as fever, pain at injection site, headache, muscle pain and fatigue which goes away within a day or two.

Up to 1,789 reports were categorised as serious AEFI based by the World Health Organisation (26 reports for per million doses) where these cases refer to incidents such as ward admission or extended ward stay, life threatening or possible deaths, she added. 

"The 1,411 AEFI reports received from booster doses recipients which is 93 per million doses, is lower than the overall AEFI report rate which is 379 for per million doses.

"Only 110 0r 7.8 per cent from the total AEFI reports received for booster doses were classified as serious, with 7.2 report rate per million doses.

"NPRA has received 54 AEFI reports involving deaths among booster dose recipients which requires investigation and assessment.

"Of this, 24 reports received have been assessed by the Covid-19 Vaccine Special Pharmacovigilance Committee which found that the deaths had no links to the vaccines dispensed.

"30 more reports are in the process of completion before it is presented for the assessment of the committee," she said in a press briefing via Zoom on Covid-19 AEFI today.

Dr Roshayati added that the NPRA is monitoring safety issues associated with the Covid-19 vaccine known as the Adverse Events of Special Interest (AESI) at the global level.

She said they are monitoring four types of AESI which are myocarditis or pericarditis, venous thromboembolism with thrombocytopenia, anaphylaxis and acute facial paralysis or Bell's Palsy which were reported globally after the Covid-19 vaccine immunisation.

"Our observation found that these effects are extremely rare which is consistent with what had been reported at global level.

"In Malaysia until March 11, for anaphylaxis there were 0.9 to 4.7 report rate for per million doses and 2.0 to 3.2 for acute facial paralysis per million doses.

"For myocarditis or pericarditis, it is 1.2 report rate per million doses (Cominarty) and 0.5 report rate per million doses (AstraZeneca) for venous thromboembolism with thrombocytopenia," she said.

Up to March 11, a total of 67,978,370 doses of Comirnaty (Pfizer), CoronaVac (Sinovac), AstraZeneca (AZ), Convidecia (CanSino) and Covilo (Sinopharm) have been administered.

https://www.nst.com.my/news/nation/2022/03/780603/npra-receives-25746-aefi-reports-march-11