Regulatory agency receives over 1,000 reports on Pfizer vaccine side effects

The National Pharmaceutical Regulatory Agency had received 1,047 reports of adverse events following immunisation (AEFI) associated with the Pfizer-BioNTech Covid-19 vaccine as of Jan 31, said its director Dr Roshayati Mohamad Sani.

Of the total, 992 cases involved the primer dose and 55 involved booster jabs.

As for the Sinovac vaccine, she said 544 AEFI reports were received comprising 537 involving the primer dose and seven involving booster shots.

Meanwhile, 138 reports were recorded on the AstraZeneca vaccine – 136 involving the primer dose and two involving booster jabs.

“All these serious AEFI reports will be investigated and evaluated to determine the link between the adverse effects and the Covid-19 vaccine received,” she said during an online engagement session with the media on AEFI and the National Covid-19 Immunisation Programme for Children (PICKids) yesterday.

Meanwhile, Tunku Azizah Hospital paediatrics and subspecialty paeds dermatology consultant, Dr Sabeera Begum Kader Ibrahim, said a total of 174 cases of multisystem inflammatory syndrome in children (MIS-C) were reported among children infected with Covid-19 since November 2021.

She said of the total, 56% involved children aged five to 11, and 25 children under the age of one year. She said among the effects of MIS-C are inflammation and other chronic diseases.

“It is timely to embark on children vaccination programme as they are exposed to Covid-19 which can lead to severe infection and complications,” she said.

PICKids kicked off in the Klang Valley on Feb 3. It is estimated that four million children aged five to 11 are eligible to receive the vaccine.

The programme is being implemented on a voluntary basis and no restrictions will be imposed on unvaccinated children.

Health deputy director-general (research and technical support) Dr Hishamshah Mohd Ibrahim said one of the important strategies to enable children to return to school was through Covid-19 vaccination.

He said unvaccinated children are more exposed to Covid-19 infection and are also at risk of infecting adults.