Investigations and evaluations by the Covid-19 Vaccine Pharmacovigilance Special Committee (JFK) of 451 reports on adverse events following immunisation (AEFI) have found that none of the reported deaths were directly linked to the vaccine received.
National Pharmaceutical Regulatory Agency (NPRA) director Dr Roshayati Mohamad Sani said the findings were part of 607 serious AEFI reports received involving deaths among Covid-19 vaccine recipients.
The remaining 156 reports are still under investigation pending assessment by the JFK.
“All serious AEFI reports require a complete investigation and detailed evaluation before the relationship of the reported effects and the vaccines received can be determined,” she said at a virtual media briefing on Covid-19 vaccine side effects today.
She said the NPRA had received a total of 25,746 AEFI reports due to Covid-19 vaccines, including 1,411 reports involving booster dose recipients and 182 reports involving children aged 5 to 11.
She said 93% or 23,957 of the AEFIs were non-serious and frequently reported effects such as fever, pain at the injection site, headache and muscle aches which go away within one to two days.
Six serious cases of AEFI among children aged five to 11 were recorded as of March 6.
Five of the cases required hospitalisation while one case, a seven-year-old girl who had an underlying health condition, was classified as brought-in-dead.
“A complete report on this case has not been received as it is still under investigation,” Roshayati said.
To date, 1.09 million doses of Covid-19 vaccine have been given to children aged five to 11 under the Covid-19 Immunisation Programme for Children (PICKids) which began on Feb 3.