THE Covid-19 Vaccine Pharmacovigilance Special Committee’s (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 not related to the vaccine received.

National Pharmaceutical Regulatory Agency (NPRA) director Dr Roshayati Mohamad Sani said the 25 were out of the 56 AEFI reports involving deaths among recipients of the booster dose that were received by the agency 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 131 cases, or 8.6%, of the 1,526 AEFI reports of Covid-19 vaccine booster doses registered as of April 1 were classified as serious.

Booster doses were rolled out from October 13 last year. As of April 1, more than 15.8 million of the over 68.9 million Covid-19 vaccine doses administered under the National Covid-19 Immunisation Programme were booster shots. 

Roshayati said 26,005 Covid-19 vaccine AEFI reports were evaluated, including 1,526 involving booster dose recipients and 264 involving children aged five to 11.

She said 24,182 of the AEFI cases reported, or 93%, were non-serious and frequently reported ones such as fever, pain at the injection spot, headache and muscle aches that will go away in one to two days. 

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

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, 609 cases 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 149 other reports are being investigated before they are evaluated by JFK,” she said.

On the AEFIs among children aged between five and 11, Roshayati said so far, 264 reports involving this group have been received.

Of these AEFIs, only 15 reports have been categorised as serious. – Bernama, April 6, 2022.