PETALING JAYA: The number of suspected serious adverse effects reported by healthcare professionals after Covid-19 vaccination in Malaysia is 1,852, or 26 reports per one million doses administered (0.0026%).
According to the National Pharmaceutical Regulatory Agency (NPRA), the most frequently reported serious side effects were shortness of breath, chest pains, palpitations and anaphylactic (allergic) reactions.
About one-third of the reports – 611 in total – involved deaths.
However, investigations to date by the healthcare facilities involved were unable to directly link the vaccine administered to the cause of death.
A total of 26,377 suspected adverse effects following vaccination (AEFIs) for Covid-19 were reported to the NPRA by healthcare professionals as of June 10.
This is 371 reports per one million doses administered (0.0371%).
The remaining 24,525 AEFIs (93%) were deemed as non-serious, i.e. short-term and not a threat to the patient’s health.
There were 208 suspected AEFIs per one million doses (0.0208%) reported in adolescents aged 12 to 17.
Of these, 14 per one million doses (0.0014%) were considered serious.
For children aged five to 11, a total of 148 suspected AEFIs per one million doses (0.0148%) were reported, with 94% of them considered non-serious.
Both reported that AEFI rates for adolescents and children were less than those for adults and the overall reported rate.
A total of 978,401 reports of minor AEFIs were made through the MySejahtera app.
This comprises 13,778 responses per one million doses administered (1.378%).
These include common side effects such as pain at the injection site, headache, fatigue, joint or muscle pain, lethargy and fever, all of which disappear after a few days.
Each side effect is considered one response, so an individual may report more than one response.
Every suspected AEFI reported by healthcare professionals to the NPRA is investigated by the healthcare facility involved, it said.
These investigation reports are then reviewed by the Covid-19 Vaccines Pharmacovigilance Special Committee, followed by the Malaysian Adverse Drug Reactions Advisory Committee.
According to the NPRA, while AEFIs may occur soon after Covid-19 vaccination, they are not necessarily caused by the vaccine.
Consultant infectious diseases physician Datuk Dr Christopher Lee said: “When we are vaccinating millions of people, there will be some people who may actually have some adverse effects – which is why we are collecting data – but a lot of other things can also happen to that person.”
He added that this was particularly so when it came to older adults, who could have undiagnosed medical conditions.
As an example, Dr Lee shared how his medical school roommate, who was 62 and apparently healthy aside from having high blood pressure, passed away suddenly during an afternoon nap.
“But if they are young people who die or have unexpected side effects that are not predictable, then we should consider the vaccine.
“So, I think that while it is important to take anecdotal studies into account, in the end, we have to look at the data. We are now out of this pandemic because of vaccination,” he said.Vaccination, he added, was the “nuclear bomb”, while other precautionary measures such as hand-sanitising, face masks and physical distancing were like guns and knives in the war against Covid-19.
