PUTRAJAYA, March 16 — Based on 451 reports on adverse events following immunisation (AEFI) that have been investigated and evaluated by the Covid-19 Vaccine Pharmacovigilance Special Committee (JFK), it was found that no 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, of which another 156 reports were still under investigation before being assessed by 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 during a virtual media briefing on Covid-19 vaccine AEFI today.
Dr Roshayati said NPRA had received a total of 25,746 AEFI reports due to the Covid-19 vaccine, including 1,411 reports involving booster dose recipients and 182 reports involving children aged between 5 and 11.
She said 93 per cent or 23,957 of the AEFIs 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.
Dr Roshayati said six serious cases of AEFI among children aged five to 11 were recorded as of March 6.
She said 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 (BID).
“A complete report on this case has not been received as it is still under investigation,” she said.
To date, 1.09 million doses of the Covid-19 vaccine have been given to children aged five to 11 under the Covid-19 Immunisation Programme for Children (PICKids) which began on February 3.
— Bernama
