AEFI: 22 out of 45 deaths involving recipients of booster dose found not related to vaccine

PUTRAJAYA, March 2 -- Twenty-two out of 45 deaths involving recipients of the COVID-19 booster dose that were reported to the National Pharmaceutical Regulatory Agency (NPRA) were found to be unrelated to the vaccine.

NPRA director Dr Roshayati Mohamad Sani said the findings were made by the COVID-19 Vaccine Pharmacovigilance Special Committee (JFK) after after assessing the report on the death of the 22 cases.

She said the report on the death of the remaining 23 cases were still in the process and would be tabled for evaluation by JFK when completed,

As of Feb 25, he said NPRA had received 25,445 reports of adverse effects following immunisation (AEFI) of the COVID-19 vaccine, of which 93 per cent or 23,682 of them were non-serious cases, while 1,763 reports were categorised as serous AEFI.

Of the total reports,  NPRA received 1,275 AEFI reports involving booster dose, with 90 cases or 7.06 per cent of the AEFI reports classified as serious, she said at a joint media briefing on AEFI COVID-19 vaccine, which was conducted virtually today.

Dr Roshayati said a total of 94 AEFI reports involving vaccine recipients aged between five and 11-years-old were received as of Feb 25, with only two reports categorised as serious

She said the two serious cases involved a five-year-old girl with severe asthma symptoms who was admitted to a hospital for two days for treatment, and a 10-year-old boy who suffered from facial paralysis, but is recovering.

“Overall, the trend of AEFI reports involving children aged five to 11 years received by the NPRA is not much different from what is reported by other regulatory reference countries,” she added.

 In another development, Head of the Pharmacovigilance Section, NPRA Compliance and Quality Control Centre, Dr Azuana Ramli said individuals with AEFI of COVID-19 vaccine could lodge a report themselves to the NPRA without waiting for confirmation from a doctor.

She said this followed claims that there were doctors who were reluctant to confirm that patients who sought follow-up treatment after the COVID-19 vaccine had AEFI-related.

"Even if the treating doctor does not suspect and does not report the patient's AEFI to the NPRA, the patients who feel they are affected by the vaccine can report it through the NPRA channel," she said.

Recipients of the COVID-19 vaccine who experience adverse effects can report the AEFI through the MySejahtera application and online by filling in the Consumer Side Effect Reporting Form  (ConSERF) through the NPRA website, www.npra.gov.my.

-- BERNAMA