A “reinforced device“. This is what the National Medicines Safety Agency (ANSM) announces set up to monitor the adverse effects of covid vaccines.
The objective is to be particularly vigilant since these vaccines are marketed with less hindsight than usual, due to a health crisis. However, some side effects are far too rare to appear among the tens of thousands of participants in clinical trials.
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Autoimmune diseases, allergies …
What effects can it be? Serious adverse events, which can occur after any vaccination but in exceptional circumstances. For example diseases of the central nervous system, disorders of the immune system called autoimmune diseases, or, as observed in the UK, severe allergic reactions.
These risks remain extremely rare and much lower than the benefit of vaccination. The whole issue of the announced follow-up is, moreover, to confirm that this fundamental balance is preserved throughout the vaccination campaign.
In practice, what will the device consist of? On the one hand, the ANSM plans to facilitate the reporting of side effects via the site reporting.social-sante.gouv.fr. It aims in particular to facilitate the procedure for health professionals, who are still too few to complete these declarations, and to encourage the patients themselves to report any symptoms.
And secondly, a report on side effects reported by healthcare professionals, patients and laboratories will be published every week.
Special monitoring for the elderly
In addition, the emphasis will be on monitoring the elderly, who are few in number in clinical trials. Each must integrate a specially created national file, SI Vac. This file will be linked to the database which systematically lists all our care, the national health data system (SNDS) to establish any possible link between a symptom and the vaccination.
By coupling this watch with the reports, the Agency undertakes to follow up “in real time“.
“Human resource requirements”
An unprecedented device in terms of responsiveness, mobilization, but also transparency. Problem: do the health authorities have the necessary means to ensure this reinforced surveillance? This is the whole point. The ANSM has already announced in the press “human resources requirements to process the report and carry out expert assessments“, which is indeed a colossal job.
To date, the agency has not yet communicated on the additional staff that would be allocated to it.