in case of adverse reactions, who can patients turn to?

It is only a matter of months, if not weeks, before the French can be vaccinated against Covid-19. Several laboratories, in fact, have announced the end of phase 3 of their clinical trials, or those conducted on humans, with good results. However, according to a survey published Thursday, December 3 by the health agency Public Health France, only 53% of French people surveyed in November want to be vaccinated. A drop compared to last July, when 64% was in favor. One of the main reasons is the lack of confidence in these vaccines. To remedy this, the Minister of Industry, Agnès Pannier-Runacher, said on Thursday 3 December that the legal responsibility of the laboratories would be engaged in the event of negative effects of the vaccines against Covid-19. But is this guarantee sufficient? And what are the risks for future vaccinates?

3 levels of evidence to be provided

Pursuant to articles 1245 and following of the civil code transposing the European directive of 25 July 1985, a manufacturer – whatever it is – is liable for damage caused by a defect in its product, whether or not it is bound by a contract with the victim. . This law therefore applies to laboratories that manufacture health products. It is up to them to ensure the safety of consumers. However, legally, it is up to the victim to provide proof, at three levels: the damage suffered, the vaccine defect and the cause between the two. In other words, it is the vaccine deficiency that has caused one or more side effects. For the first try, it’s pretty simple. All you need to do is provide a medical certificate, exams, hospitalization report, or other medical evidence. On the other hand, the case thickens for the second and third trials.

The defect of a product, therefore considered defective, is legally accepted if it does not guarantee the safety that can be legitimately expected. In this case, the vaccine must have a safety flaw and the victim must be able to prove it, which is quite complex for most of the population. On the other hand, the vaccine can be dangerous without being defective: an individual is protected from Covid-19 thanks to the vaccine even if it has side effects. In France, the Court of Cassation considers that these undesirable effects are risks for health products, which the manufacturer can hardly eliminate and therefore cannot be charged to him. The authority therefore decided to prioritize the benefit / risk method. It consists in evaluating the advantages of a product for health compared to possible negative effects in order to determine the defect.

A long but not impossible legal process

As for the third test – the causal link between damage suffered and vaccine failure – it is equally difficult. The victim will have to prove that the side effects he is experiencing are related to the vaccine. However, they can also be diseases caused by other factors: genetics, lifestyles, risk behaviors, etc. In this case it is difficult to confirm the degree of responsibility of the vaccine towards Covid-19, and therefore of the laboratory. However, again according to the Court of Cassation, the evaluation is left to the judges through the method of the bundle of clues, such as the chronological proximity between vaccination and the onset of the disease, the absence of personal anamnesis. or family, the number of victims of the disease after vaccination. Court proceedings for a victim could therefore be lengthy, but not impossible.

For now, some short-term side effects have been reported by Pfizer and Moderna labs during Phase 3 of their clinical trials last September. Nobody was serious. Some participants, for example, experienced fever, body aches, headache or extreme fatigue. Overall, all these complaints disappeared after 24 hours. Same observation and same warning on the Covireivac platform, an interface for the recruitment of participants in French clinical trials developed by the National Institute of Health and Medical Research (Inserm): “Side effects in a trial are, like a vaccination, most of the time not serious. Possible side effects can be fever, malaise, muscle pain, headache, redness or swelling at the injection site. But in most cases they disappear spontaneously within a few days.”

In the long term, the consequences of the vaccine remain unknown

But what is most frightening are the long-term consequences of the vaccine, which are still unknown. “There is general agreement that serious events can occur up to 6 months after a vaccination and very rare side effects may occur that you will not see until you have vaccinated a large number of people. of people“, estimates Marie-Paule Kienny, president of the Covid-19 Vaccine Committee in an interview with Le Figaro. Participants in a clinical trial are closely monitored in order to address any side effects as quickly as possible. However, the majority of these patients are young and in good health, which limits the evaluation of the effectiveness of vaccines on people at risk. However, according to the vaccination plan presented by the prime minister, Jean Castex, on Thursday 3 December, they will be among the first to be vaccinated.