Informed Consent For The Coronavirus Vaccine Trials

What it means to give informed consent and who would be responsible in which situations in the event of severe adverse reactions (SAR), and what the possible redress mechanisms are.

In clinical trials signing of an informed consent is required before the application of a new vaccine. It is not because the vaccine is dangerous, but because participants should be well informed about the expected benefits, risks, and inconveniences based on the accumulated data, to make a free and well-informed decision. With the informed consent, a person agrees with the conditions of the leaflet, the so-called brief description of the vaccine.

An Informed consent does not completely relieve physicians and pharmaceutical companies of responsibility for the occurrence of post-vaccine reactions, when the requirements for their application are not met, or if reactions, which do not appear in the summary of product characteristics of the vaccines occur. Clinical trials are made exactly to clarify the frequency and severity of the untoward side effects (they always exist) and are they acceptable in view of the provided benefits.

When a vaccine is given and any side effects occur, they may occur for different reasons and therefore different subjects may be responsible.

When is the doctor responsible for noxious side effects and when not?

"If the requirements for contra-indications have been neglected during the clinical examination by the doctor, who administers the vaccine and are not met when the vaccine is administered, then the responsibility will be fully on the doctor because, in fact, the doctor would not have complied with the law when administering the vaccine.

The Immunization Ordinance clearly describes the conditions under which the vaccine should not be given. There may also be specific exceptions in the summary of product characteristics of the vaccine. The requirements of the Immunization Ordinance, which introduce the rules for storage, administration, and reporting of vaccines, must be fully followed. For example, if it is written that the vaccine should not be given to pregnant women, and the general practitioner gave it to a pregnant woman, in this case, it is his fault.

It is the obligation of doctors also to check whether the vaccines are within the expiration date, to follow the instructions for use, the brief description, to perform a medical examination on the day of immunization. When performing the examination, they establish whether there are contra-indications or not.

If there are no symptoms, questions may arise about how to know if a person is not infected during the examination, and whether they should be tested in advance. If contraindications cannot be identified during the examination, then the immunization can be performed. If the summary does not explicitly require a specific investigation, the general rules are followed. If a person has no clinical manifestation of symptoms, he is considered clinically healthy, as it is the normal practice. With the long asymptomatic incubation period of the Covid-19, this creates a problem.

"Otherwise, a pregnancy test will have to be done before the vaccine. A full body scan will also need to be done to ensure that the cancer patient is unaware of, or has, an autoimmune disease. Physicians cannot be held responsible for circumstances that cannot be objectively established by performing a clinical examination, or which the patient has not reported. In this situation the doctor will not be responsible.

 The doctor will be responsible if he has not performed the examination or has not performed it in full, or if, despite the examination and the contraindications available, he has administered the vaccine. Or if he has not complied with the storage conditions and has given an expired vaccine. In this situation it can be judged that the adverse reaction occurred not so much because of the vaccine, but because of the illegal action or inaction of the doctor.

Responsibility for transport and storage

If any adverse post-vaccination adverse reaction is found due to improper transport or improper storage, the relevant responsible person may also be held liable. These could be the vaccine manufacturing company, the Regional Health Authorities, hospitals, as well as the sponsor, if it has assigned a distributor, who has incorrectly fulfilled its obligations.

 Responsibility for expected and unexpected side effects

Information on liability in general is very scarce because the agreements between pharmaceutical companies and the Regulatory Authorities are confidential and therefore, we can not know for sure and can only speculate what exactly they have agreed. In principle there is a difference whether an adverse reaction that occurred is described in the summary of product characteristics of the vaccine, and it is known, e.g., expected, and predictable. And it is quite another case to have a reaction that is not described in the brief description, because it is so rare that it can happen once in 100,000 or 1 million people. If there still have been not enough vaccines administered to draw statistical conclusions on such rare events, it is not clear is the event a reaction to the vaccine, or to something else.

When there is an adverse reaction described in the short description of the vaccine, the person is aware of this risk in advance and has agreed to take it. The vaccine against coronavirus is not mandatory, but voluntary, and if you refuse to get it, you do not suffer sanctions such as a fine or refusal to admit your child to kindergarten.

 In this case, the rule applies: To whom you benefit, to him to bear he risk of possible harm. The subjects know the expected side effects and decide if they want to consume the benefits.

During the Informed consent process, the participants get acquainted with the known side effects and decide whether they want to protect themselves from the virus or do not want to risk the side effects from the short description. If you agree to be vaccinated, you also take the risk of developing the rare side effects described in this summary. Just like when they do chemotherapy with the presumption that it will work well against cancer, but it also has known side effects, and no one can be responsible for them.

Why no informed consent is signed for other drugs?  

In general, when you take a medicine by mouth, you do not sign an informed consent but even over-the-counter drugs that are advertised on television are warned: "Read the instructions before use”. However, a vaccine is considered an invasive activity by law. Mandatory vaccines do not require informed consent because the person's disagreement is irrelevant, they are mandatory. Due to the exceptionally large public discussion and the unnecessary problematization of the Covid-19 vaccines and the doubts about them, informed consent is introduced to verify that the patients are familiar with its brief characteristics.

Informed consent does not relieve the responsibility of doctors and companies

It is not true that informed consent is envisaged because the coronavirus vaccine is dangerous. Informed consent assumes responsibility when adverse post-vaccine reactions occur, only when they are described in the summary of product characteristics and are expected. But even if you didn’t sign such informed consent, if you have read the brief description and have expressed a desire for the doctor to give the vaccine to you, you have expressed such consent.  Informed consent is just a method is currently being introduced to verify that you have actually read the brief description and met the inclusion criteria. But this does not mean that the vaccine is dangerous.

The law case is clear and so it is in most of the countries: informed consent will not release a doctor if he has not complied with the vaccination requirements. Nor will the pharmaceutical company be held liable if a person develops an adverse post-vaccination reaction that is not described in the summary of product characteristics. Because you do not know what adverse reaction may show up to consent accepting the risk in advance, this will be fully known only after several years of use.

Compensation funds

The compensation for the damages, caused to the subject health and welfare during a clinical trial is regulated by the general procedures for damages, which exist in the country. It the country Health Care Insurance does not cover such risks, the company conducting the trial is obliged to contract such insurance. The doctors also have their own insurance against professional errors and omissions.

In extraordinary circumstances of an emergency health situation, like the current developing pandemic, the governments can undertake these compensations. The Covid-19 pandemic, which required emergency FIH (First in Humans) testing of new mRNA-based type of vaccines and their immediate application without accumulating enough data on their longer-term effects, is such an unprecedented example that is presently discussed.

Here again, the question arises as to whether a fund or compensation scheme can be envisaged in the event of severe post-vaccination reactions. In some countries, there are functioning compensation funds for severe post-vaccination reactions.

This is done for three reasons: First, to strengthen overall confidence in the safety of vaccines through a state-guaranteed right to compensation for anyone seriously injured. Second, to offer more security for pharmaceutical companies in carrying out research and development activities and in the production of vaccines. Because if several lawsuits are filed, even if they are completely unfounded, they can involve delays and huge financial resource, and pharmaceutical companies practically may not be able to produce enough vaccines. Thirdly, in some countries these funds are set up in solidarity: people are obliged to be vaccinated in the name of the common good and the security of public health, but on the other hand, there is a fund to compensate them in the event of serious unexpected harm.  

Such funds have been established in Germany since 1961, in France, Great Britain, Norway, Switzerland, Denmark, Sweden, the United States, Quebec (Canada), New Zealand, Japan, Taiwan.

In the United States, where there is such a fund. Data on the type of vaccine and the manufacturer are published each year, what side effects you may get and how long after the vaccine application they can be expected. The causal relationship between the vaccine and the reaction has not been fully studied, but if you have a reaction, you are entitled to compensation. This facilitates access and introduces an alternative court procedure. In some vaccines such as hepatitis A, hepatitis B and others. throughout the period of its existence from 1989 to 2013, no claim has been made for deaths resulting from them.

Out of 13,615 claims to the fund, 3,368 people have been compensated. This is an argument against the opinion of many anti-vaccinators that if there is a compensation fund, then vaccines are extremely dangerous. In this way, an easy, cheap, and effective compensation procedure is created.

It is a matter of decision whether the fund will cover all severe side effects or only those that have not been described in the summary.

If there are such compensation funds, they are an alternative to lawsuits against pharmaceutical companies. But whether there will be any immunity for pharmaceutical companies against lawsuits is still unclear.