Benefits of vaccine must outweigh risks significantly

Emeritus Professor Tan Sri Dato' Dzulkifli Abdul Razak
Opinion - New Straits Times
January 5, 2021

THE recent survey report that focuses on the concerns about side effects of the vaccine among Malaysians who are not sure (17 per cent) or rejected it (16 per cent), is an eye-opener.

Over 83 per cent expressed "fear of possible side effects". Conducted online between Dec 21 and 28 by the Health Ministry, "only 67 per cent of the total 212,006 sampled said they would accept the Covid-19 vaccine".

The rule of thumb in the overall use of medicines is that the benefits must outweigh the risks in a significant way. Imagine buying a food item to be consumed, from a legitimate outlet approved by the relevant authority.

And the item is new and frozen well below room temperature. Word has it that it is produced by a "novel" technique never tried before, produced in less than a year.

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Yet it is claimed to be more than 90 per cent "good" for consumption with minimum implied side effects. Ironically, it is released on an "emergency " basis, not like the regular food items.

The why is not clear, nor if this is stated on the package labelling to heighten the awareness of the consumer in making decisions in case of an "emergency".

Otherwise, why the rush to get one and risk some possible unindicated effects yet to be documented, especially those associated with long-term use?

The buyer must be assured that the benefits outweigh the risks based on the evidence listed that the item claims to offer.

That said, the item is not just safe for use but also efficacious, and devoid of any untoward effect involving most of the targeted population at any period when the item is tested — namely, five to 10 years in regular cases thus far.

Which explains why over 83 per cent expressed "fear ". Data in other parts of the world seem to corroborate and begs the question why the information of longer-term side effects is still wanting.

More so why it is often glossed over in the eagerness to use it the world over. Now, imagine again that the item you are contemplating to buy is a medicinal item, like an over-the-counter (OTC) medicine for fever, or a prescribed item for infection like antibiotics, or an established vaccine that is well known against smallpox.

Finally, a novel vaccine (NV) that is less than a year in existence for a virus that is not well understood at all with several variants now being detected internationally.

One could almost sense the difficulty and complexity in arriving at a decision as one goes through the list from an OTC to a NV.

While the process is virtually the same, the weight depends almost solely on the availability and quality of information publicly accessible to all and every member of the society.

Where the public is to bear the cost from their own pocket or as taxpayers, it is more compelling that evidences provided by the responsible body are well verified, and complied to the fullest with regard to safety and efficacy according to the regulations and the laws.

Any deviation from this can only mean unverifiable risk or adverse reaction. The World Health Organisation (WHO) is clear that the said vaccines are not a cure nor should it be made mandatory.

This is reiterated by many countries, including Belgium, recently. The fact remains that the so-called "emergency" use is premature and has no firm legal basis for a wholesale global use. Indeed, for those who have special needs, the availability of full information approved by an independent body will be of help in deciding who among those are in real need based on the specific "emergency ".

Without that, it is arguable to assume that the item is "unsafe" for consumption. The reason is plain enough.

Once an untoward effect appears, it is not easy to resolve because it could be acute and life-threatening in the worst-case scenario.

Others may take a longer time to manifest. Worse when it involves the elderly and the very young. Not only is their body support system more fragile, their memories too are more vulnerable.

Resorting to opaque arguments in insisting to be vaccinated at all cost is untenable unless the situation could be urgently remedied by sharing the full information in showing that the benefits significantly outweigh the risks.

The writer, an NST columnist for more than 20 years, is International Islamic University Malaysia rector