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PUTRAJAYA – The Covid-19 Vaccine Pharmacovigilance Special Committee (JFK) has evaluated 25 reports on adverse effects of immunisation (AEFI) and found that the fatalities involved were not linked to administered Covid-19 vaccine booster doses.
National Pharmaceutical Regulatory Agency (NPRA) director Dr Roshayati Mohamad Sani said they were part of the 58 AEFI reports involving deaths among booster dose 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’s AEFI reporting system has received a total of 26,160 reports on the Covid-19 vaccine 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.
Roshayati said that based on the result of evaluations of the reports received, 93% or 24,320 of the AEFI reports were for non-serious cases.
Of the total number of AEFI reports received, 1,840 reports were categorised as serious based on the classification by the World Health Organisation.
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 suspicion of causing death.
Roshayati said a majority or 93.5% of the 324 AEFI reports involving children aged 5 to 11 were not serious while 21 reports were categorised as serious. – Bernama, April 27, 2022