Drugs and vaccines: balancing benefits and harms

For drugs to be approved, they must prove to be safe and effective, which means that the benefits of the drug appear to be greater than the known risks. Still, sometimes not everything is known about a drug’s side effects, until after it enters the market-place and more people start using it.

It is a basic principle of pharmacotherapy that all medicines have beneficial and harmful effects and drug reactions can go from minor to life-threatening events.

Drug side effects/adverse effects
A side effect, “adverse effect” or “adverse reaction”, meaning an unwanted side effect, is usually regarded as an undesirable secondary effect which occurs in addition to the desired therapeutic effect of a drug or medication.

Even though all medicines can cause side effects, as well as interactions, not everyone will get them or get them alike. Side effects may vary for each individual depending on the person’s disease state, age, weight, gender, ethnicity and general health.

It does not matter whether we are talking about aspirin, paracetamol, or the most sophisticated pharmaceutical product on the market. All types of medicines including prescription, over the counter and any herbal alternative natural medicines, can cause unwanted side effects.

Not all side effects are serious, most are mild, although some medicines have serious side effects. Adverse effects from drugs can vary widely, from a mild “discomfort” to death. Side effects happen when a treatment causes a problem because it does more than treat the target issue.

Even when good scientific data is available, people’s interpretation of risks and benefits will be different.

Side effects from vaccinations
Are vaccines a good idea? The fear of side effects can result in serious and fatal diseases from not having a vaccination. In an epidemic, those who have not been vaccinated will be most at risk. No doubt, side effects may occur as a result of a vaccine, but it is very important to consider the balance between the risk and the preventive benefits. It is important to weigh up the “pros and cons” of vaccinating or not vaccinating.

The fewer people having the vaccination the greater the threat to public health and the chance of an epidemic.

Would anyone rationally decide not to have cancer treatment because of knowing that although it aims to destroy a tumour or reduce its size, it also damages and kills unwanted healthy cells?

These are, most of the time, severe adverse effects but not doing the treatment would most probably mean death.

Would you decide, as well, not to take an antibiotic for fear of having from a mild allergic reaction to anaphylaxis? In such a case, there is a possibility of dying with septicemia.

Safety of COVID-19 vaccines
There is no question that the current vaccines are effective and safe. The risk of severe reaction to a COVID-19 jab, say researchers, is outweighed by the protection it offers against the deadly coronavirus.

Results from monitoring efforts are reassuring. Some people have no side effects. Many people have reported only mild side effects after COVID-19 vaccination.
Anaphylaxis after COVID-19 vaccination is rare. So far, it has occurred in approximately two to five people per million vaccinated. Severe allergic reactions can occur after any vaccination.

If this occurs, the reaction can be treated effectively and immediately.

Reports of death after COVID-19 vaccination do not necessarily mean the vaccine caused the death. To date, no patterns were detected in the cause of death that would indicate a safety problem with COVID-19 vaccines.

Side effects are classified as:
Very common: one in 10 people
Common: five in 100 people
Uncommon: five in 1,000 people
Rare: five in 10,000 people
Very rare: Fewer than 10 in 100,000 people meaning a percentage of less than 0.01%

Over 109 million doses of RNA COVID-19 vaccines were administered in the United States from December 14, 2020, through March 15, 2021. During this time, among people who received a COVID-19 vaccine, a percentage of 0.0018% death reports, not proved to be related directly with vaccination, were received. This percentage should be classified as very, very extremely rare!

A review of available clinical information including death certificates, autopsy, and medical records revealed no evidence that vaccination contributed to patient deaths.

Meantime, rates of Covid19 infection, hospitalisation and death remain high.

It is a scientific reality that vaccination is the single most effective way to reduce deaths and severe illness from COVID-19.

As with all vaccines and medicines, the safety of COVID-19 vaccines is continuously monitored and benefits and possible risks remain under review.

The percentage of risk is probably higher to go out into the streets than having a vaccine.

Undoubtedly the risk of dying with Covid19 when not vaccinated is much, much higher than the risk of dying of a non-proved adverse reaction of a vaccine.

All vaccines and medicines have some side effects. These side effects need to be continuously balanced against the expected benefits in preventing illness.

So far, the benefits of the vaccines against COVID-19 continue to outweigh any possible risks.

Let us be rational, accept that nothing is perfect and exempt of risks.

Living is a continuous, permanent risk, but it is important to profit from it and take the best of it!

Best health wishes,
Maria Alice
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Dr Maria Alice is a consultant in General and Family Medicine. General Manager/Medical Director – Luzdoc International Medical Service. Medical Director – Grupo Hospital Particular do Algarve/ Hospital S. Gonçalo de Lagos