Mandate injury reporting

SOCIAL media is currently abuzz with the issue of post-vaccine injury among high-profile members of the public, and blame for this seems to be directed at the Health Ministry and National Security Council (NSC).

This shows that the public must understand that post-vaccine injury or adverse event following immunisation (AEFI) may or may not be causally related to the vaccine.

When a pharmaceutical company (pharma) or their agents want to market a new vaccine in a particular country, they submit an application to the drug regulatory authority (DRA) of that country. This DRA will then ask for proof of the new vaccine’s safety and efficacy.

The pharmaceutical company is allowed to conduct its own safety and efficacy studies with only random audits by the DRA. Fraud can, and seemingly does, happen at this stage, as pointed out recently by The British Medical Journal.

Vaccines/drugs are usually given “approval” for marketing, labelling and advertising purposes after Phase 1, 2 & 3 clinical trials. The manufacturer is required to report any safety or efficacy issue detected at the Phase 4 (post-marketing) stage to the DRA. Vaccines/drugs that are found to have too many serious adverse reactions are removed from the market based on the Phase 4 data.

It is a clinic/ward doctor’s ethical duty to submit an AEFI report, which will be reviewed by the country’s Pharmacovigilance Committee. Without this report, the patient might not be able to get any available financial compensation. Furthermore, other doctors will not know the underlying conditions that are a contraindication to giving the drug/vaccine concerned. The DRA will also not get an “early” warning to take a drug/vaccine off the market before more people are seriously injured.

Pharma is obliged to tell the end-user, including doctors, to inform it (Pharma) of any serious AEFI especially if established to be causally related to its product. Pharma is also obliged to inform the DRA of these reports even though it may end up with the drug/vaccine being withdrawn, causing huge losses for it.

Hence, it is known that pharma employs a variety of creative tactics to discourage doctors from reporting AEFI. The most common tactic is to enlist the help of doctors who are directly or indirectly on their payroll to go on mass and social media and constantly tout the drug/vaccine as safe and effective. Another tactic, which was revealed during an Australian court case, involves pharma making a “hit-list” of all “inconvenient” or outspoken doctors and trying to discredit them. The most logical and effective counter-measure to this problem is for governments to make it mandatory for medical doctors to personally report all AEFI to the DRA.

AEFI reporting is voluntary in Malaysia. Hence, if the Health Ministry has not made AEFI reporting mandatory for doctors before starting the Covid-19 vaccination drive, then it only has itself to blame.


Consultant histopathologist and statistician (GStat)

Subang Jaya

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