Strengthened Pharmacovigilance in France for Monitoring COVID-19 Vaccines and Therapeutics Toward a New Surveillance Era?

Introduction: Following the emergence of SARS-CoV-2, a range of measures have been put in place in France: strengthened surveillance of COVID-19 therapeutics and vaccines, using tools and methods developed to detect promptly any safety issues in order to take appropriate risk minimisation measures [1]. For COVID-19 therapeutics, ANSM has mobilized the French Network of regional pharmacovigilance centers (CRPV) to ensure continuous monitoring and assessment of adverse reaction reports through a specific survey. The results were discussed at an experts' monitoring committee which involves several scientific experts. The members assess collegially the potential safety signals. Then, a specific communication associated with the investigation reports are published on the ANSM website. For COVID-19 vaccines, a similar organization was put in place with additional components. Artificial intelligence and an information system have been used to optimize reports processing and improve specific data collection. Information sheets on adverse events have been made available to patients and healthcare professionals. Finally, pharmaco-epidemiological studies have been conducted in case of a potential signal for confirmation or to quantify the risk. Objective: To evaluate the implementation of strengthened monitoring of vaccines and therapeutics used in COVID-19. Methods: Potential signals detected on vaccines and drugs used in COVID-19 following the implementation of new pharmacovigilance tools and methods were analysed. Results: As of March 31th, 2022, more than 140 million doses of COVID-19 vaccines administered with more than 150,000 adverse reactions reports, 45 monitoring committees held and 43 potential signals of COVID-19 vaccines have been transmitted by ANSM to European authorities to reinforce or initiate a signal. As of January 26, 2022, more than 2 300 adverse reactions reports collected for treatment used for patients with COVID-19, 21 monitoring committees held and 3 signals were identified. Conclusion: The use of tools and methods in COVID-19 vaccines and medicines monitoring have allowed for early detection of signals and implementation of appropriate risk minimisation measures. This has been made possible thanks to the whole organization of strengthened surveillance which remains agile along the pandemic crisis. Furthermore, facilitation was given to accelerate evaluation, methods to prioritize a large volume of spontaneous reports, and different channel