Malaysia has so far seen 20,131 reports of side effects for over 44.8 million doses of Pfizer’s Covid-19 vaccine Comirnaty which had been given, with the majority or 94.2 per cent of such reports not for serious cases, the Health Ministry said today.
Health director-general Tan Sri Dr Noor Hisham Abdullah noted that 44,813,270 doses of Comirnaty had been administered in Malaysia since the national immunisation programme began on February 24, 2021, up until December 26, 2022.
This means the 20,131 adverse effects following immunisation (AEFI) reports received by the ministry’s National Pharmaceutical Regulatory Agency would be equivalent to 449 reports for each one million doses. Or in other words, 0.045 per cent of the 44.8 million doses given.
He explained that AEFI reports are reports on side effects suspected to be or possibly caused by vaccines.
Out of the 20,131 AEFI reports of side-effects from Comirnaty, he said the majority or 94.2 per cent involves cases which are not serious, temporary and not raising any potential of risk to the health of those who were injected with the vaccine, listing commonly reported side-effects as including fever, pain at the injection site, headache, muscle ache and fatigue.
Only the remaining 5.8 per cent or a small number of 1,162 out of the 20,131 reports were classified as serious AEFI — based on the World Health Organisation’s classification which refers to side-effects resulting in ward admissions or extension of time being warded, potential to jeopardise health or cause significant loss of capacity or require intervention to prevent permanent damage to the body, resulting in disability upon birth or suspected of causing deaths.
Based on this 1,162 of the 20,131 serious AEFI reports received, it would translate to 25.9 per cent of such reports for every one million of the Cominarty dose.
Out of these 1,162 serious AEFI reports received and following investigations and comprehensive evaluation by the Covid-19 Vaccine Pharmacovigilance Special Committee, Dr Noor Hisham said only one case of myocarditis or inflammation of heart muscles had the possibility of being related to the Comirnaty vaccine.
Dr Noor Hisham said the reporting rates in Malaysia are consistent with what has been reported abroad, noting that a Safecovac study carried out with the Institute for Clinical Research has found that the Comirnaty vaccine’s safety profile is “acceptable” and not showing increased risk of myocarditis, pericarditis, acute financial paralysis, stroke and myocardial infarction or heart attack in the 21 days after Comirnaty is administered.
He noted that NPRA had monitored for several safety issues linked to the Covid-19 vaccine which have been identified at the global level as Adverse Events of Special Interest (AESI), namely serious allergic reactions that can be life-threatening (anaphylaxis), acute facial paralysis or Bell’s Palsy, myocarditis or pericarditis, vaccine-induced immune thrombocytopenia and thrombosis (VITT).
Dr Noor Hisham said that as of December 26, reporting rates for AESI are 1.6 cases of anaphylaxis for each million dose, 2 acute facial paralysis cases per million dose, 1.5 cases of myocarditis or pericarditis per million dose, 0.02 cases of VITT per million dose.
He said the NPRA also ensured that the product insert for the Comirnaty vaccine in Malaysia is updated with the latest safety information from time to time.
Those who had been injected with Covid-19 vaccine can make AEFI reports by using the MySejahtera app to make notifications regarding non-serious side effects listed there or fill up the Consumer Side Effect Reporting Form (ConSERF) which can be accessed online at NPRA’s website (www.npra.gov.my), or print that form to fill up before sending it through email to email@example.com or post it to the NPRA.
He also encouraged vaccine recipients who had experienced side effects to discuss with professional health personnel such as doctors or pharmacists before sending such AEFI reports, to enable further clinical information to be given based on the medication records of vaccine recipients to enable a better evaluation.
“As a whole, monitoring by NPRA finds that the benefit over risk of Comirnaty vaccine in Malaysia remains positive,” he said, adding that the Health Ministry through the NPRA is committed to continue monitoring the quality, safety and effectiveness of Covid-19 vaccines.
“Therefore the Health Ministry continues to encourage the public to obtain the first and second booster doses if they are already eligible, especially those who have high risk and have co-morbidities,” he said, praising those who have received such booster doses and who are helping the ministry to encourage others to also receive their Covid-19 vaccine doses. – Malay mail