Sun | Jun 13, 2021

Garth Rattray | We are not vaccine guinea pigs

Published:Monday | May 17, 2021 | 12:06 AM
A medic prepares to administer a dose of an AstraZeneca COVID-19 vaccine, marketed under the name CoviShield, to a colleague in a city hospital in Kyiv, Ukraine.
A medic prepares to administer a dose of an AstraZeneca COVID-19 vaccine, marketed under the name CoviShield, to a colleague in a city hospital in Kyiv, Ukraine.

The obsolete and bad old days of cruel and immoral pharmaceutical experimentation on human beings is precisely why we benefit from stringent and intensive bioethical systems composed of highly trained individuals, groups and international organisations that ensure that no ethical breaches occur during the production of new drugs/vaccines.

Modern-day experiments (studies) on pharmaceutical products are not simple. After the manufacturers decide what they want the product to do and formulate it, they must do animal studies. But they don’t experiment on just any animal; they choose the appropriate animals, the specie, age, gender, lifecycle, and so on. They choose the number of animals to be studied.

If all goes well during the detailed and prolonged animal-phase studies, perhaps necessary adjustment(s) to the formulation are made, and human studies are initiated. All studies, including during the animal phase, must meet rigorous ethical criteria. The human volunteers are chosen according to age, gender, geography, perhaps ethnicity, or are excluded if there are certain factors (exclusion criteria like pregnancy and medical issues). They must fully understand the ramifications of the study before signing on. The documents must be vetted and approved by ethical authorities before presented to the volunteers.

Prospective (cohort) studies were done for the COVID-19 vaccines. The bigger the groups, the better. The wider the variety of volunteers, the better. Double-blind studies involve administering the test drug/vaccine without the medical staff or the volunteers knowing who is getting the real deal or a placebo (dummy). The placebo and the real drug must be indistinguishable to the medical staff and to the volunteers.

Data is meticulously recorded and gathered after an agreed-upon timeline. If the real deal works far better than the dummy, then they know that the drug is effective. Any and all side effects and adverse reactions must be documented and reported. Again, ethical committees are involved at every stage of the process. After rigorous observations and medico-legal scrutiny, the results are reviewed by peers, published and then reviewed by international health concerns. If the drug is deemed necessary, effective, and if the side effects and adverse reactions are at an acceptably minuscule level, it may be approved for wide-scale manufacture.

MAKE INFORMED CHOICES

Because no pharmaceutical manufacturer can carry out studies on millions, or billions of human beings, the after-market experience provides more information regarding side effects and adverse reactions. It is at this stage that a few drugs are either modified, repurposed or withdrawn entirely. As with other aspects of our lives, we, the consumers, must make informed choices and weigh the possible risks against the benefits of taking a drug or vaccine.

For example, let’s take a look at low-dose aspirin. It is an extremely popular, over-the-counter product used to help prevent heart attacks and strokes. However, with possible side effects of – heartburn, abdominal pain, nausea, cramping, gastrointestinal ulcerations, stomach and/or diverticula bleeding, drowsiness, headache, or a rash, wheezing, difficulty breathing or collapse – low-dose aspirin is likely more dangerous than the COVID-19 vaccine. Yet, innumerable people take aspirin because the benefits far outweigh the risks. The reported possible vaccine adverse reactions are extremely rare. Scientific analysts believe that the extremely rare deaths following COVID-19 vaccination are overwhelmingly coincidental and due to underlying conditions.

We are not part of a worldwide vaccine experiment. As is customary for all pharmaceuticals, side effects and adverse reactions are logged and reported to the manufacturer, who, in turn, acts appropriately on the information. Taking the COVID-19 vaccine is safer than taking most medications, but anti-vaxxers make a huge hullabaloo about the vaccine to dissuade others from taking them.

The longer we take to achieve herd immunity, the more people will suffer, the more the economy will contract, the more our healthcare system will buckle, the less we can offer care to regular patients, the more people will die, and the more variants will emerge and cause all kinds of grief. Taking the vaccine is a wise and responsible decision.

Garth A. Rattray is a medical doctor with a family practice. Email feedback to columns@gleanerjm.com and garthrattray@gmail.com.