PETALING JAYA: Only two serious reports of adverse events following immunisation (AEFI) involving children between the ages of five and 11 have been recorded as at Feb 25.
National Pharmaceutical Regulatory Agency (NPRA) director Dr Roshayati Mohamad Sani said the cases involved a girl who already had asthma and a boy with Bell’s Palsy or facial paralysis, both 10.
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 added.
“The asthma case needed immediate hospitalisation and treatment and was subsequently discharged.
“The boy is also said to be recovering well,” said Dr Roshayati.
She also said 22 out of 45 deaths involving recipients of the Covid-19 booster dose that were reported to the NPRA were found to be unrelated to the vaccine.
The findings were made by the Covid-19 Vaccine Pharmacovigilance Special Committee after assessing the report on the death of the 22 cases, she added.
Sister strength: Siblings Danisha Shafiz, 11, Dhamia, nine, and Shifa, 8, holding hands while they wait their turn to get vaccinated at PPV Ideal DCC Shah Alam. — AZLINA ABDULLAH/The Star
Assessment on the reports of death in the remaining 23 cases were still in the process and would be tabled for evaluation by the committee when completed, she said.
She said as at Feb 25, the NPRA has received 25,445 reports of AEFI, of which 93% or 23,682 were non-serious cases while 1,763 reports were categorised as serious AEFI.
Of the total reports, NPRA received 1,275 AEFI reports involving the booster dose, with 90 cases or 7.06% of these classified as serious, she told a joint media briefing on AEFI Covid-19 vaccine, which was conducted virtually yesterday.
According to WHO, an AEFI is “any untoward medical occurrence which follows immunisation, and which does not necessarily have a causal relationship with the usage of the vaccine”.
It said that if the matter was not rapidly and effectively dealt with, it could undermine confidence in a vaccine, and with untoward consequences for immunisation coverage and disease incidence.
WHO, which has established a Global Advisory Committee on Vaccine Safety in order to respond promptly to any concern over vaccines, said vaccine-associated adverse events may affect healthy individuals and should be promptly identified to allow additional research and appropriate action to take place.
Health care providers are required to report AEFI, which is unwanted or unexpected health effect that happens after someone receives a vaccine, which may or may not be caused by the vaccine.
Caregivers or the vaccine recipient themselves may also report AEFIs to NPRA.
When someone reports an AEFI, he or she is providing vital information that is needed to monitor vaccine safety, and this information is also used to report on vaccine safety to authorities, which further contributes to the success of immunisation programmes, though it should be noted that the acceptance of such reports does not mean or suggest that the vaccine caused the adverse event.
An AEFI report can be made through MySejahtera, or via www.npra.gov.my.