“Look at this, already almost 19,000 deaths from vaccines in Europe and the figures are under reported”,
an Internet user is alarmed to its approximately 18,000 followers on Twitter. Since the start of the vaccination against Covid-19 in France and around the world, this kind of alarmist statements have been swarming on social networks and anti-tax gatherings. They are all based on the figures reported in pharmacovigilance databases, whether French, European or American, and are very often a weighty argument in the discourse of notorious disinformers and other unscrupulous researchers.
Until recently, the photograph of a flyer claiming to “take stock of the Covid vaccination in Europe” flooded the web and indicated that vaccination (all vaccines combined) had caused more than 17,000 deaths on the continent (slim, it was not supposed to be 19,000?). Hazardous statements that result from a deep ignorance of the basics of pharmacovigilance and their usefulness.
So, in order to understand how these famous bases work, and how a pharmacologist works, the “Fake off” section of 20 minutes asked Francesco Salvo, co-director of the Bordeaux pharmacovigilance center and coordinator of the safety investigation on the Pfizer vaccine in France.
What is the interest of a pharmacovigilance database?
To be precise, we speak of a spontaneous notification base. They allow healthcare professionals – whether they are doctors or pharmacologists – and patients to notify an undesirable effect potentially linked to taking a drug, in this case a vaccine against Covid-19. This real-time monitoring system intervenes after a marketing authorization and makes it possible to identify rare undesirable effects which cannot be detected during clinical trials carried out by pharmaceutical companies, which have necessarily carried them out on a sample of the population. less important.
It is in particular thanks to the pharmacovigilance bases and the undesirable effects which will be reported therein that a marketing authorization can be withdrawn. It is also thanks to them that new undesirable effects can be detected, such as cases of atypical thrombosis of the Astra Zeneca vaccine, thus making it possible to establish new vaccine recommendations (reserve the vaccine for people over 55 years of age ), and to record a particular reaction as an adverse reaction.
We read in your latest Pfizer vaccine reportThat 761 deaths have been reported in France since the start of its distribution. Can we say that these deaths were caused by the injection?
Absolutely not ! The deaths reported in this database are deaths occurring after vaccination and which, according to health professionals, require a detailed analysis. The purpose of our databases is not to be exhaustive, but to create security alerts. Our job is to analyze these deaths on a case-by-case basis, to identify common features, then to sound the alarm bells with the health authorities so that they can make the necessary decisions and draw up new recommendations.
For the moment, nothing allows us to affirm that deaths were caused by the Pfizer vaccine in France, except in elderly and fragile people, whom we vaccinated at the very beginning of the campaign (in nursing homes for example) , and who died of flu-like symptoms that could be caused by the vaccine.
Today, the data coming back to us are very reassuring, and the number of deaths reported is not only much lower than that which could be expected, but it is above all absolutely not worrying in view of the very large number of people vaccinated so far. ‘here.
How do you investigate whether or not an adverse reaction or death is linked to vaccination?
The first thing is whether there is any factual basis that allows us to establish a causal link. We are therefore looking for known symptoms and side effects. If a patient tells us that their arm hurts or feels flu-like symptoms within two days of the injection, we can easily link these effects to vaccination, for example. We then learn about the patient’s medical history, co-morbidities and any concomitant illnesses that could cause death.
It is only after the context is established that we can start to draw conclusions, and it is not that simple. Imagine that a person dies suddenly fifteen minutes after receiving a vaccine. It might sound like the vaccine, but in reality it hasn’t had time to take effect yet, and is still more or less in the patient’s arm. There is therefore very little chance that the death is due to the vaccination. For this type of case, we look for signs of a severe and instantaneous allergic reaction, such as a drop in blood pressure or difficulty breathing. It is only after everything else is ruled out that it can be said that a drug or vaccine caused the death of a patient.