Vaccines and Covid-19: in the event of adverse effects, against whom can patients turn?

It is only a matter of months, or even weeks, before the French can be vaccinated against Covid-19. Indeed, several laboratories have announced the end of phase 3 of their clinical trials, that is to say those carried out on humans, with good results.

However, according to a survey published this Thursday, December 3 by the public health agency France, only 53% of French people questioned in November want to be vaccinated. A drop from last July, when 64% were in favor. One of the main reasons is the lack of confidence in these vaccines. To remedy this, the Minister Delegate for Industry, Agnès Pannier-Runacher, affirmed this same Thursday, December 3 that the legal responsibility of the laboratories would be engaged in the event of adverse effects of vaccines against Covid-19. But is this guarantee sufficient? And what are the risks incurred by future vaccinees?

3 levels of proof to provide

According to articles 1245 and following of the Civil Code transposing the European directive of July 25, 1985, a producer – whoever he is – is liable for the damage caused by a defect in his product, whether or not he 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 consumer safety. Nevertheless, legally, it is up to the victim to provide proof, and this at three levels: the damage suffered, the defect of the vaccine and the cause between the two. In other words, that it is indeed the deficiency of the vaccine which has caused one or more side effects. For the first proof, it is quite simple. All you have to do is provide a medical certificate, examinations, a hospitalization report or any other medical proof. On the other hand, the case thickens for the second and third proofs.

The defect of a product, therefore considered as defective, is legally accepted if it does not guarantee the security that can legitimately be expected. In this case, the vaccine must have a safety defect and the victim can prove it, which is quite complex for the majority 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 hazards of health products, which the manufacturer can hardly eliminate and which therefore cannot be charged to him. The authority therefore decided to give precedence to the benefit/risk method. This consists in estimating the advantages of a health product in relation to the possible undesirable effects in order to determine its defect.

A long but not impossible legal procedure

As for the third proof – the causal link between the damage suffered and the defect of the vaccine – it is just as difficult. The victim will have to prove that the undesirable effect(s) they are experiencing are linked to the vaccine. However, these may also be diseases caused by other factors: genetics, lifestyles, risky behavior, etc. In this case, it is difficult to affirm the degree of responsibility of the vaccine against Covid-19, and therefore of the laboratory. Nevertheless, still according to the Court of Cassation, the assessment is left to the judges through the method of the bundle of indices, such as the chronological proximity between vaccination and the onset of the disease, the absence of personal history or family, the number of victims of the disease after vaccination. The legal process for a victim could therefore be long, but not impossible.

For now, a few short-term side effects have been reported by Pfizer and Moderna laboratories during phase 3 of their clinical trials last September. None were serious. Some participants, for example, experienced fever, body aches, headaches or immense fatigue. Overall, all these ailments disappeared after 24 hours. Same observation and same warning on the Covireivac platform, an interface for recruiting participants in French clinical trials developed by the National Institute of Health and Medical Research (Inserm): “The side effects in the context of a trial are, as with a vaccination, most of the time not serious. Possible side effects may manifest as fever, malaise, muscle pain, headache, redness or swelling at the injection site. But in the majority of cases, they disappear spontaneously within a few days.”

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

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