22 out of 45 deaths involving booster jab recipients unrelated to vaccine, says drugs authority

Twenty-two out of 45 deaths involving recipients of Covid-19 booster jabs reported to the National Pharmaceutical Regulatory Agency (NPRA) have been 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 reports on the deaths.

The remaining 23 cases are still being processed and, once complete, will be tabled for evaluation by the JFK.

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

Of the total reports, 1,275 were on booster jabs, with 90 cases or 7.06% classified as serious, she said at a joint media briefing on the side effects of Covid-19 vaccines, conducted online today.

Roshayati said a total of 94 AEFI reports involving vaccine recipients aged between five and 11 had been received as of Feb 25, with only two reports categorised as serious.

She said the two serious cases comprised a five-year-old girl with severe asthma symptoms who was admitted to 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 received by the NPRA is not much different from what is reported by other regulatory reference countries,” she added.

In another development, Dr Azuana Ramli, head of the Pharmacovigilance Section, NPRA Compliance and Quality Control Centre, said individuals with AEFI from Covid-19 vaccines could lodge a report 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 receiving a Covid-19 vaccine had AEFI-related symptoms.

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

Recipients of Covid-19 vaccine who experience adverse effects can report the matter through the MySejahtera application and online by filling out the Consumer Side Effect Reporting Form available at the NPRA website.