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Legitimacy of Clinical Trials for COVID-19 Vaccines

Covid19

Since the rise of the COVID-19 pandemic caused by the novel coronavirus, scientists worldwide have been diligently working to develop a vaccine for this affliction that has plagued us for over two years. Despite the research conducted on the coronavirus in medical laboratories, these studies and experiments were insufficient for approving an effective vaccine after the virus entered the human body. Consequently, scientists turned to experimenting with various vaccines on patients and carriers of the virus. They began trials on carriers in their dormant state and extended to those who experienced severe symptomatic conditions.

 

As clinical trials on humans began, they faced significant criticism. Some critiques questioned their infringement on the principle of “bodily integrity,” which grants a special sanctity to human body safety. Others raised concerns about the lack of consideration for the proportionality between the benefits and risks of experimenting on humans, sparking significant debate over the legitimacy of these experiments. Therefore, it becomes essential to inquire about the criteria that must be considered for conducting diverse medical vaccine trials on humans to combat the COVID-19 pandemic.

 

International society has long prioritized medical trials because of their potential danger to human safety. The Helsinki Declaration issued in 1964 exemplifies this concern, outlining the roadmap for establishing controls on human experiments since then. Three main controls can be derived from this: the therapeutic goal, satisfaction with the medical experiment, and consideration of proportionality between the benefits and harms arising from the experiment.

 

Understanding the therapeutic goal as one of the controls for human trials, we must first recognize its importance in medical practices in general. It is well-known that the legitimacy of medical procedures is based on a reason recognized by law or, more simply, on the patient’s consent to what they will be subjected to. For example, if a doctor performs surgery on a patient with the goal of treating them, the patient is not compensated for the injuries necessary for their recovery. In contrast, if the doctor injures someone for any reason other than treatment, they are not protected by the reason for consent and may be civilly liable for damages and criminally charged with assault or homicide.

 

 

In comparison to medical procedures, medical trials, especially clinical trials, require even stricter adherence to having the goal be therapeutic. The goal cannot merely be experimentation. An example of this was a case in a French court where a doctor was convicted of intentionally inflicting harm for performing an experimental treatment on a child suffering from syphilis, despite the child’s condition improving after the experiment. This reaffirms the principle that the primary goal of the experiment must be therapeutic and not merely experimental.

 

It is noteworthy that the above does not close the door to the use of modern medical means in clinical trials for new vaccines for COVID-19, as long as the primary goal is therapeutic and not just experimentation, and these means have been assessed and experimented on animals before humans.

 

In reviewing the above, we find that it is not enough by itself to guarantee the rights of the patient experimented with the new drug or vaccine. It was imperative to add another condition to govern this process, which is the condition of the patient’s satisfaction with the experiment before its commencement. If satisfaction is a fundamental pillar in any contract, it is also the same for medical contracts. For example, if a patient needs surgery, the doctor must inform them and make them aware of all the procedures and results they will face. This is to ensure that their satisfaction encompasses everything they will face in the future. In this context, a doctor is found responsible during surgery for a patient who had a benign tumor removed that posed no danger to the patient’s life. This is because the contract between him and the patient did not include that removal.

 

Based on the foregoing, we find that the element of satisfaction holds greater importance in the context of medical trials, especially considering that the Egyptian Constitution in Article 60 states, “The human body is inviolable, and assaulting it, deforming it, or using it is a crime punishable by law. Trafficking its organs is prohibited, and no medical or scientific experiment may be conducted on it without free and documented consent, in accordance with the established principles of medical science, regulated by law.” Therefore, the experimenter must inform the patient of all the risks and expected benefits of the experiment.

 

In the case of COVID-19 vaccine trials on patients, they must be informed of symptoms they may experience, such as elevated body temperature, dizziness, extreme fatigue, etc. Additionally, it is essential to inform the patient of the potential benefits resulting from receiving the vaccine, such as strengthening the patient’s immune system against the coronavirus or enhancing their ability to resist the virus when infected. All of this is to achieve the complete informed consent of the patient for all aspects of the medical trial conducted on them.

 

Despite all the above, it was not sufficient to curb the problems arising from experiments on humans. There remained a need for additional controls to tighten regulation on these experiments and to safeguard the safety of every individual. Thus, the principle of balancing the benefits and harms arising from the experiment was introduced. This principle is crucial concerning medical experiments. A balance must be struck between the benefits the patient may receive and the potential harm they may endure. If the harms outweigh the benefits, the experiment should not proceed, and if it has already commenced, the results should not be recognized. For example, when the COVID-19 vaccines first appeared, allegations surfaced, claiming that the vaccines cause permanent loss of the sense of smell, lead to strokes, and even result in male infertility. These claims confirm that they are nothing more than rumors, as these harms surpass the targeted benefits of the experiment. The primary goal of the experiment is to strengthen the patient’s immune system to face the coronavirus upon infection, nothing more.

 

Some who have embraced these rumors argue that even if these harms are genuine, they are less severe than death resulting from infection with the virus. However, such an argument cannot be accepted, as death is not a foregone conclusion, and the results of the vaccine are not definite. For instance, the death rate due to infection with the virus does not exceed 1.7% of the total number of infections. Death is not a confirmed outcome, as is the case with some diseases. For example, death is confirmed in cases of infection with rabies after an animal attack and failure to receive the antidote in time. On the other hand, the result of the vaccine is not a confirmed matter; it neither cures the disease nor acts as a preventive measure. We have heard about cases of death from COVID-19 despite the deceased receiving the vaccine. Therefore, these harms cannot be accepted or endorsed based on the balance between benefits and harms.

 

In reviewing the three aforementioned controls, we find that the vaccines currently in use, in all their various forms, must have undergone these controls. No vaccine can be approved before ensuring the legitimacy of the experiment that led to its discovery. All we need to do is scrutinize and apply reason to what we hear in terms of rumors and opinions. This way, we can distinguish the truth from what undermines facts. Even if you are skeptical about the effectiveness of these vaccines, rest assured that they will not harm you if they do not benefit you. Therefore, we recommend that anyone presented with the opportunity should receive the COVID-19 vaccines and not be swayed by rumors to protect themselves and others from the danger of this.

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