PUTRAJAYA: The assessment of the COVID-19 Vaccine Pharmacovigilance Special Committee (JFK) on 460 reports of adverse effects of immunisation (AEFI), found that none of the reported deaths were directly related to the vaccine received.

National Pharmaceutical Regulatory Agency (NPRA) director Dr Roshayati Mohamad Sani said these findings were part of a total of 610 serious AEFI reports involving deaths among COVID-19 vaccine recipients which required a complete investigation and detailed assessment of the linkage to the vaccine.

"A total of 150 reports are still in the process of investigation before being evaluated by JFK," she said in a statement today on the status of the AEFI reports on the COVID-19 vaccine until April 8.

Dr Roshayati said the NPRA in total received 26,071 AEFI reports including 1,552 reports involving booster dose recipients and 288 reports involving vaccine recipients of children aged five to 11 years.

Of the 1,552 reports involving booster dose recipients, 137 reports or nine per cent of the total AEFI reports of booster doses were classified as serious, she said.





NPRA-AEFI 2 (LAST) PUTRAJAYA



As of April 8, a total of 69,116,358 vaccine doses have been administered under the National COVID-19 Immunisation Programme (PICK) of which 15,888,555 doses were booster shots.

Dr Roshayati said NPRA also received 57 AEFI reports involving deaths among booster dose recipients, and JFK showed 25 reports of deaths where investigations were completed and showed no connection with the vaccine received.

"The investigation process for 32 reports has not been completed for JFK assessment," she said.

With regard to the effects of AEFI on children aged five to 11, she said a total of 288 reports were received with 94 per cent of them displaying non-serious symptoms such as fever, skin rashes, stress response to the immunisation process, dizziness and headaches.

According to her, there was one case involving a death that took place outside of a health facility who was brought in dead (BID) which is still under further investigation, and initial reports found that the child had a pre-existing illness.

--BERNAMA



TAG: NPRA, Dr Roshayati Mohamad Sani, AEFI, JFK, COVID-19, vaccine