25 AEFI reports on fatalities found not linked to COVID-19 vaccines - NPRA

PUTRAJAYA: The COVID-19 Vaccine Pharmacovigilance Special Committee (JFK) evaluation of 25 reports of adverse events following immunisation (AEFI), which involved deaths among recipients of the booster dose, found that the fatalities were unrelated to the vaccine received.

National Pharmaceutical Regulatory Agency (NPRA) director Dr Roshayati Mohamad Sani said the 25 reports were out of the 56 AEFI reports involving deaths among recipients of the booster dose vaccine that was received by the NPRA for investigation and evaluation.

In a statement on the status of the COVID-19 vaccine AEFI as of April 1, she said 31 more cases are still being investigated before they are tabled for evaluation by JFK.

She said a total of 131 cases, or 8.6 per cent, of the 1,526 AEFI reports of COVID-19 vaccine booster doses reported as of April 1 were classified as serious.

Booster doses were rolled out from Oct 13 last year. As of April 1, 15,813,417 of the 68,924,040 COVID-19 vaccine doses administered under the National COVID-19 Immunisation Programme (PICK) were booster shots.

On the AEFI report as a whole, Dr Roshayati said a total of 26,005 COVID-19 vaccine AEFI reports were evaluated, including 1,526 reports involving booster dose recipients and 264 reports involving children aged between 5 and 11.

According to her, 93 per cent or 24,182 of the AEFIs reported were non-serious and frequently reported ones such as fever, pain at the injection site, headache and muscle aches which will go away within one to two days.

Of the total AEFI reports received, she said there were 1,823 reports that had been categorised as serious based on the classification of the World Health Organization (WHO).

This refers to effects that result in ward admission or extended ward stay, a threat to life, significant disability or requiring intervention to prevent permanent bodily damage, birth defects or suspected of causing death.

She said the total number of serious AEFI reports received included 609 cases that involved fatalities among COVID-19 vaccine recipients.

"A total of 460 reports have been investigated and evaluated by JFK, of which no deaths were reported to be directly related to the vaccine received, while a total of 149 more reports are being investigated before they are evaluated by JFK," she said.

On the AEFIs among children aged between 5 and 11, Dr Roshayati said so far there has been a total of 264 reports involving this group.

Of the 264 AEFIs reported for children aged between 5 and 11, 15 reports were categorised as serious while the majority were classified as not serious.

-- BERNAMA