PUTRAJAYA, April 27 — The COVID-19 Vaccine Pharmacovigilance Special Committee (JFK) has evaluated 25 reports which have been fully investigated and found that the fatalities involved were not linked to the COVID-19 booster dose vaccine received.

National Pharmaceutical Regulatory Agency (NPRA) director Dr Roshayati Mohamad Sani said they were part of the 58 reports on adverse effects of immunisation (AEFI) involving deaths among booster dose vaccine recipients that were received as of April 22 for investigation and evaluation.

“There are still 33 more reports still under investigation before they are tabled for evaluation by JFK,” she said in a statement today.

Overall, she said, the NPRA AEFI reporting system has received a total of 26,160 reports on the COVID-19 vaccine AEFI that needed to be evaluated, including 1,581 reports involving booster shot recipients and 324 reports for child vaccine recipients aged between five and 11.

“The NPRA AEFI System has, overall, recorded 374 reports for every million doses inoculated,” she said.

Dr Roshayati said that based on the result of evaluations of the reports received, 93 per cent or 24,320 of the AEFI that were reported were for non-serious cases.

Of the total number of AEFI reports received, 1,840 reports were 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.

Dr Roshayati said a majority or 93.5 per cent of the 324 AEFI reports involving children aged 5 to 11 were not serious while 21 reports were categorised as serious.

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