Weekly updates on adverse effects following Covid immunisation

COVID-19 | The Health Ministry’s National Pharmaceutical Regulatory Agency (NPRA) has vowed to provide the latest information on Covid-19 adverse events following immunisation (AEFI) cases every week.

The plan is to share the updates every Wednesday for data up until the previous Friday, said NPRA Pharmacovigilance Section (Centre for Compliance and Quality Control) head Dr Azuana Ramli in a media briefing today.

In the first of such updates this morning, NPRA director Dr Roshayati Mohamad Sani disclosed the agency had not determined any deaths directly caused by Covid-19 vaccinations as of Feb 18.

“From our investigation by the special pharmacovigilance committee on Covid-19 vaccines, none of the AEFI reported deaths can be directly linked to the Covid-19 vaccinations administered, until today,” she said.

Overall, the agency has received 25,211 AEFI reports, of which 1,758 were classified as “serious” and the rest not serious. This is out of over 65.7 million doses administered.

This means the number of serious AEFI reports account for 0.0027 percent of all doses administered.

Serious AEFI cases are when vaccinations are believed to be the cause of hospitalisations, long hospital stays, life-threatening conditions, and the suspected cause of death.

Roshayati also shared a breakdown of the number of AEFI reports received by the NPRA for each vaccine type.

A bulk of the reports were from those who received the Pfizer-BioNTech Cominarty vaccine - making up 75 percent of all overall reports and 60 percent of serious reports.

Booster, children reports

During the briefing, Roshayati said the NPRA received 1,186 AEFI reports involving booster vaccinations.

Of this, 44 were on suspected deaths following booster jabs. Half remain under consideration.

“Twenty-two reports were analysed by the special pharmacovigilance committee on Covid-19 vaccines and found that these deaths had no link to the vaccine received.

“Another 22 reports are still in the process of completion before they can be presented to the special pharmacovigilance committee,” she said.

National Pharmaceutical Regulatory Agency director Dr Roshayati Mohamad Sani

Roshayati added that confidentiality concerns prevented the ministry from publishing all details of each AEFI case.

As for children under 12, the NPRA received 38 AEFI reports of which one was “serious” - involving a recipient who was hospitalised and later recovered.

This is out of the 383,165 Covid-19 vaccine doses administered to children aged between five and 11 as of Feb 18.

Overall, this means the number of all AEFI reports account for 1 out of every 10,083 doses administered to children under 12.

Vaccine injury case under probe

As for the AEFI case of 50-year-old Christina Selvamoney, Roshayati said the special pharmacovigilance committee was waiting on one last “laboratory test” before making a conclusion.

“Actually we have already received the report and there is one test that is still pending.

“We are waiting for that pending test for us to identify whether there is any causality with the vaccine or not.

“The rest of the report we have received, (there is) only one pending laboratory test. So we just wait for that test. Once we have received (it), we will discuss it in our special pharmacovigilance committee,” Roshayati said.

Christina previously told Malaysiakini no pulse could be detected in two fingers on her left hand after receiving a booster shot on Jan 6, 2022.

She was also informed she may have to amputate the two fingers, which terrified her. - Mkini