Pharmacovigilance and side effects
Poorly understood, pharmacovigilance data are often confused with the risk of side effects. To keep you from falling into the trap, BAM! explains the difference and what lies behind a term that was still unknown until recently: pharmacovigilance.
BAM!-DETOX*
“Covid vaccination: 1 serious side effect in 100, and what if it were your child?”
In an article published on the France Info website on 11 July 2022[1], the journalist explains that an “anti-vax” billboard, visible on a very busy road in Toulouse, had prompted protests from some passers-by. The billboard, referring to the Conseil Scientifique Indépendant (Independent Scientific Council)[2], read “ Covid vaccination: 1 serious side effect in 100, and what if it were your child?”, in order to invite passers-by to think before having their children vaccinated.
The billboard refers to the website of the European database of reports of suspected adverse drug reactions (EudraVigilance)[3]. This website, put online by the European Medicines Agency (EMA), therefore contains what are called in the jargon “pharmacovigilance data”, and gathers all incidents reported following the use of a medicine. Collecting and studying these data is an essential part of monitoring the safety of medicines. They are a priority when a medicine has received a conditional marketing authorisation, which is the case for the Covid vaccines. There are two types of pharmacovigilance: active and passive. Active pharmacovigilance is based on a cohort of volunteers who are regularly followed up by a medical team. Passive pharmacovigilance is based on spontaneous reports and is therefore much less reliable. EudraVigilance essentially contains passive pharmacovigilance data.
Not necessarily related to or caused by the vaccine
To clarify the distinction between passive pharmacovigilance data and the risk of side effects, the article quotes a warning from the EudraVigilance website[4]: “The information on this website concerns suspected side effects, i.e. medical events that have been observed following the administration of COVID-19 vaccines, but which are not necessarily related to or caused by the vaccine.”.
Which is correct. But the journalist stops there and forgets to point out that only some of the incidents after vaccination are reported. Some people do not necessarily make the connection, others lack the courage or the will (it will not change anything for them). Some doctors do not report them either, either because they are overloaded, or for ideological reasons, or because they consider that it is not linked to vaccination (yet it is not up to them to decide).
It is generally estimated that some of the actual incidents are indeed reported, but this figure can vary greatly[5] (country, type of incident, perception of the medicine and its side effects, confirmation bias,…).
For these reasons, pharmacovigilance data cannot be used directly to calculate the risk of side effects. It should be made clear that “1 serious side effect in 100” is therefore not demonstrated and rather means that out of one hundred incidents reported to pharmacovigilance, one incident is considered serious (myocarditis, pericarditis, thrombosis, stroke, blindness, … according to the billboard).
Once again, it is difficult to transpose this ratio onto the risk of side effects, since the seriousness of an incident can influence reporting, minor incidents probably being reported less frequently.
It should also be remembered that menstrual disorders frequently occur in women[6] and are considered not very serious, without the long-term implications being known. Some perhaps consider that women’s suffering is normal and remains a detail.
Be that as it may, frequent reports or reports of serious incidents should be the subject of in-depth studies. In the meantime, the competent authorities should, as a precaution, suspend the use of the Covid vaccine for people for whom the risks of serious Covid complications are low.
A Covid risk for whom?
Indeed, beyond the risk of side effects which, as we have seen above, is not yet well established and remains unknown to this day in the longer term, it is above all a matter of examining each person’s risk from Covid.
“Statistical analysis of these data showed that the risk of death (case fatality) of patients hospitalised for COVID-19 increased with the following pre-existing factors: advanced age, male sex, cardiovascular disease, diabetes, chronic kidney, liver or lung disease, neurological and cognitive problems, cancer. For patients under 65, obesity was also a significant risk factor.”[7]
To visualise the risk linked to age, here is a Sciensano graph showing the Belgian population who died of Covid (0 to 22.5%) from March 2020 to February 2021, by age group and sex.
SURVEILLANCE DE LA MORTALITÉ COVID-19 EN BELGIQUE - Figure 9 - page 12
Culpable carelessness and complicit concealment?
While it may be possible to establish a true measure of the risk linked to Covid, the obvious under-reporting in passive pharmacovigilance prevents any measurement, even approximate, of the vaccine risk. We therefore come back to this problem of the carelessness of the pharmacovigilance system in Belgium, where reporting is left entirely to the doctor’s discretion, feeling and convictions, instead of being systematic, as it should be.
Yet active pharmacovigilance data exist at the vaccine manufacturers and seem fairly complete and unbiased. However, the problem lies in the effort to conceal them: across the Atlantic, the FDA had asked for Pfizer’s studies to be kept secret for 75 years. The pretexts given were that it did not have sufficient resources (in the digital age and with a budget of 6.5 billion dollars) and that the public might precisely confuse pharmacovigilance with the risk of side effects…
A federal court in Texas finally decided otherwise, ordering the FDA to disclose the documents in its possession within a more reasonable time[8].
Here one can only denounce a perversion of the mission of institutions supposed to defend the public interest, and which end up protecting private interests in contempt of the general interest.
BAM! Detox.
* BAM!-DETOX brings together university professors, doctors, people working in the pharmaceutical and medical field and independent journalists. BAM!-DETOX aims to analyse and verify the information circulated in the media and on social networks.
[1] Vaccination Covid : l’étrange affiche antivax placardée dans Toulouse
[2] Conseil Scientifique Indépendant - CSI - Home | Facebook
[4] Base de données européenne des rapports sur les effets indésirables suspectés des médicaments - Covid-19 important messages
[6] Une enquête en ligne identifie un lien entre troubles menstruels et vaccin contre le covid
[7] SURVEILLANCE DE LA MORTALITÉ COVID-19 EN BELGIQUE 2.3. QUELLES ÉTAIENT LES CARACTÉRISTIQUES DES PERSONNES DÉCÉDÉES DE LA COVID-19 À L’HÔPITAL ? - page 12
[8] Why a Judge Ordered FDA to Release Covid-19 Vaccine Data Pronto
Photo source:
Image cropped and modified from the original image by Joel bubble ben on AdobeStock
