France is set to deploy a country-wide system for monitoring possible side-effects of the Covid-19 vaccines after the first injections begin in January 2021.
The monitoring system will be rolled out by medical safety agency l'Agence nationale de sécurité du médicament et des produits de santé (ANSM).
It will follow people who have had the vaccine to check on the effectiveness of the jab - to see if it is indeed fulfilling its aims, which are to reduce the number of cases, hospitalisations, and deaths linked to Covid-19.
The system will also be alert to any possible side-effects of the vaccine, and “identify any possible unwanted effects that may not have been observed during clinical trials”.
Another aim of the process is to help improve support among people in France for the vaccine overall. Polls have shown increasing distrust of and reticence towards the vaccine and vaccination in general in France.
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Side-effect monitoring
France will consider six vaccinations - pre-ordered by the European Union - which use four different kinds of vaccine technology, across a yet-to-be-confirmed vaccination calendar.
These vaccines will be evaluated by medicine committee le Comité des médicaments à usage humain (CHMP) and are then expected to be put on the market, according to the European Medicines Agency.
The process will then enter the next stage. This will see several hundred thousand people being injected, which will allow authorities to monitor any possible undesirable side-effects seen during previous stages.
Regional safety centre le Centre régional de pharmacovigilance de Toulouse has reminded the public that “all medicines have side-effects”, and the vaccines will probably be no different.
However, it said: “Clinical trials evaluate the benefits but are not enough or a study of the medical risk because they include too few patients, are too short, or frequently exclude at-risk subjects.
“Only following up after commercialisation [of the vaccine] will allow us to be clear about the unwanted effects and therefore the benefit/risk ratio of the drug.”
Data from the clinical trials and scientific publications will also be closely considered to establish an “evolving list” of possible side-effects to consider.
Side-effects among elderly people and those who suffered severe forms of Covid-19 will especially be monitored as clinical trials often do not include them, said Rosemary Dray-Spira, co-director of Epi-phare, an independent committee that works with ANSM and l’Assurance maladie.
Dr Dray-Spira said: “Our objective is to be very reactive, and not take six months to respond [to any issues].”
Epi-phare is also set to run its own studies on specific groups in order to identify any possible issues. French medical research centre Inserm will also run its own tests.
France will also look to other countries for information about possible side-effects.
Professor Bernard Bégaud, pharmacology specialist who was president of the ANSM’s clinical trial commission for 14 years, told news source FranceInfo: “When we start vaccinating in France, the English will have already vaccinated more than a million people.
“That is very precious [data] for us, because we will have a perspective of at least a month on mass vaccination.”
Close monitoring
The vaccines and their effects will be “systematically monitored very closely”, as happens with all new vaccines, said Dr Annie-Pierre Jonville-Bera, president of the pharmaceutical monitoring network le Réseau français des centres régionaux de pharmacovigilance.
She said: “We are going to systematically record as much as possible, to monitor very closely, so that we do not let anything through.”
The ANSM has said that “the form to signal [any side-effects] will be adapted so that we can collect all necessary extra data relevant to Covid-19”.
The form will be available online via the government’s existing healthcare side-effect site here.
Cathy Gaches, president of the vaccination victims’ network le Réseau des victimes d'accidents vaccinaux (Revav), said that the website is “very fastidious”, even though “most people don’t even know about it”.
Doctors and pharmacists are already required by law to declare any side-effects that are suspected of being linked to a medicine or treatment to the government.
The ANSM has assured the public that any side-effects will be communicated.
Another platform, SI-Vaccination, will also gather together data on the distribution of the vaccine, the profile or patients who have had it, and other conditions and relevant information.
Dr Jonville-Bera said: “For the vaccines that we have now (for example, flu or hepatitis B), we know that after three months, there are no longer any side-effects, even for very rare effects. The point now, with new vaccines, is to ensure this is true [for these too].”
Data from the tests and monitoring will be published each week by ANSM, in a bid to keep the data as transparent and in “real-time” as possible, and communicate any alerts quickly.
The European Medicines Agency has said it will do the same.
What if a side-effect is noted?
Vaccination centres will also benefit from assistance to ensure that they are only reporting genuine side-effects that could require further investigation.
Dr Jonville-Bera said: “If it says on the medicine pack that there could be a localised skin reaction or a bit of redness around the site of injection, there is no need to signal that [as a side-effect] except if it is especially widespread or has extra complications, for example.”
ANSM has said: “If a safety alert is validated, appropriate measures to the nature of the risk will be put in place. These will aim to reduce the probability of extra risk among vaccinated people.”
In the UK, for example, an extra warning was issued after two people had an allergic reaction to the Pfizer/BioNTech vaccine.
But Professor Bégaud sought to reassure the public that the evaluation process was standard procedure, and not cause for concern.
He said: “It is perfectly normal to look at data in real-time. We do not know what will happen, but that is normal. Pharmacovigilance is an open system that is used to surprises. We know how to deal with them.
“We are going to have several million people who are going to be vaccinated in the initial stages. That is not huge compared to what we are used to studying in pharmacovigilance.”
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