KUALA LUMPUR, Feb 23 – Risk mitigation measures and early treatment helped to prevent deaths caused by side effects from Covid-19 vaccination, the National Pharmaceutical Regulatory Agency (NPRA) said today.
The medical regulator has yet to confirm a single death caused by adverse events following immunisation (AEFI) with the coronavirus vaccine, with more than 66.4 million doses administered to date.
Dr Azuana Ramli, the head of NPRA’s pharmacovigilance division, said today that the post-vaccination monitoring period, as well as quick identification and treatment of patients with AEFI, prevented fatalities caused by adverse reactions to the vaccine.
In order to manage anaphylaxis at Covid-19 vaccination centres, risk management measures were taken, like keeping vaccinated individuals under observation for at least 15 to 30 minutes immediately after their jab.
“That decision was made based on the risk that we identified during the clinical trial,” Dr Azuana explained in a media briefing today.
Post-jab monitoring was carried out during the primary Covid-19 vaccination programme, but not during the booster rollout.
Anaphylaxis is a severe allergic reaction that can be life-threatening at times. It generally occurs within seconds or minutes when the body is exposed to allergy triggers.
Dr Azuana pointed out that several other conditions like thrombocytopenia (low blood platelet count) has emerged as a cause of death due to Covid-19 vaccination in other countries.
“Fortunately, none of these (thrombocytopenia and anaphylaxis) seem to cause death in our country.”
She added that early treatment and quick identification of the symptoms have also prevented deaths directly linked to the Covid-19 vaccine.
When asked if the Ministry of Health (MOH) will publish the case details of deaths that are directly or indirectly linked to the Covid-19 vaccine, NPRA said it would not do so in order to maintain patient confidentiality.
She also pointed out that countries like the United States and the United Kingdom did not publish case details of individuals who died following Covid-19 vaccination either.
“Usually, the cause of death will be determined by the attending physician. We don’t change the cause of deaths,” said Dr Azuana.
The reports will then be examined by the district or state health department and relevant tests will be conducted based on the given cause of death. Then a complete report will be submitted to the Covid-19 Vaccine Pharmacovigilance Special Committee (JFK) for an assessment.
Dr Azuana said that the committee, which consists of relevant health experts from university hospitals and private health care facilities, will examine the reports, including a patient’s health history and post-mortem report to determine the cause of death.
“Once the investigation is done, based on all information, the post-mortem reports and so on, the cause of death will be determined by the findings of the investigation. It depends on what was found during the investigation that determines the cause of death.”
In Malaysia, death certificates can be extremely restrictive, without taking into account an individual’s medical history. Cancer, for example, is under-reported in Malaysia, according to the Breast Cancer Welfare Association, as a person may have died due to complications of cancer, but their cause of death is certified as old age or a heart attack.
The International Classification of Diseases, Tenth Revision (ICD-10) – a publication by the World Health Organization (WHO) for countries to use comparable classification and presentation of mortality statistics – was updated to include Covid-19 coding.
“Covid-19 vaccines causing adverse effects in therapeutic use, unspecified” is coded as U12.9 in the ICD-10.
Malaysia also uses the ICD-10 to code causes of death. An MOH manual for physicians to certify causes of death acknowledges that “medical causes of adult deaths are not so straightforward, when based solely on symptom description by relatives.
“This is because a number of such causes have common symptom complexes, and it is sometimes difficult to distinguish between different causes of death from such descriptions.”
NPRA stated in its media briefing today that it has received 1,758 reports of serious AEFI in the entire Covid-19 vaccination programme as of February 18, but did not specify how many of these were deaths.
CodeBlue is seeking further clarification from the NPRA on the total number of deaths reported among Covid-19 vaccine recipients and if any of these were coded as U12.9.
The UK, on the other hand, publishes monthly mortality analysis datasets using ICD-10 codes for causes of death. From March 2020 to December 2021, England reported 15 deaths “involving” U12.9, as well as 10 deaths “due to” U12.9 as the “underlying cause”.
The NPRA has yet to clarify if any deaths reported among Covid-19 vaccine recipients in Malaysia “involved” adverse effects from the vaccine, or the U12.9 code, even if none were confirmed so far to be “due to” this.
Dr Azuana also clarified the role of its pharmacovigilance practices — mainly to identify health safety signals and come up with precautionary measures.
“This is why, if you notice any effects or allergic reactions that you suspect due to the vaccine, you must report it. That is the role of pharmacovigilance and that is how new signals are identified.”