PETALING JAYA: Half of the 44 reports of deaths among booster recipients lodged with the National Pharmaceutical Regulatory Agency (NPRA) were found to have no links to the Covid-19 vaccine.
The rest are still pending evaluation.
“Twenty-two cases have been investigated and evaluated by the Covid-19 Vaccine Special Pharmacovigilance Committee and it was found that the deaths have no links to the vaccinations received.
“The remaining 22 reports are still in the process of being completed before these can be presented to the committee for evaluation,” said NPRA director Dr Roshayati Mohamad Sani during a briefing session with the media yesterday.
She said as of Feb 18, a total of 65,777,392 doses of the Covid-19 vaccine had been administered, including 13,768,697 boosters.
Out of these, 25,211 cases of adverse events following immunisation (AEFIs) were reported, including 1,186 cases among those who received their booster jabs and 58 cases among children.
About 93% of overall AEFIs or 23,453 cases were categorised as not serious while 1,758 AEFI reports were classified as serious, said Dr Roshayati.
“Non-serious AEFIs are usually resolved within one or two days. Examples of non-serious AEFIs include fever, pain at the injection site, headache, muscle ache and fatigue,” she said.
Serious AEFIs are classified as hospital admissions, prolonged stays at wards, life-threatening effects or suspected deaths.
From the AEFIs reported among booster recipients, 87 cases or 7.34% were classified as serious, putting the report rate at 86 cases per million doses.
“This rate is found to be lower than the overall rate of AEFIs, which stood at 383 reports per million doses,” she said.
For AEFIs among children aged between five and 11, only one was a serious case involving hospitalisation although the patient had since been discharged, said Dr Roshayati, adding that the remaining 57 were not serious.
Among the adverse events frequently reported among children were acute stress response, fever, skin reactions and shortness of breath.
“As of Feb 18, a total of 383,165 doses of the Covid-19 vaccine have been administered to children aged between five and 11. The report rate for this age group is at 0.1 report per thousand doses,” she said.
Dr Roshayati said the incidence rate of myocarditis and pericarditis reported in the country were at 1.2 per million doses of the Comirnaty vaccine, which was lower than the global rate.
For instance, the United Kingdom had a rate of between six and nine cases of myocarditis and pericarditis per million doses while Australia had between 10 and 20 cases per million doses, she said.
As for effects of venous thromboembolism with thrombocytopenia usually associated with the AstraZeneca vaccine, a rate of 0.54 reports were received per million doses in the country, said Dr Roshayati.
“The rate stands at about nine cases per million doses in the United Kingdom and between three and 20 per million doses in Australia,” she said.
Dr Roshayati urged members of the public to submit AEFI reports via the channels provided by the ministry, such as the MySejahtera app.
“Non-serious adverse effects can be reported through MySejahtera by selecting the options given in the app.
“AEFI reports can also be submitted online by filling up the Consumer Side Effect Reporting Form (ConSERF) on the NPRA website. This form can either be posted to the NPRA or emailed to firstname.lastname@example.org,” she said.
Dr Roshayati also advised those facing serious or prolonged side effects to go to the nearest healthcare facility for consultation and treatment.