The safety profile of mRNA COVID-19 vaccines – Comirnaty (Pfizer-BioNTech) and Spikevax (Moderna) – remains robust, according to recent findings from the French National Agency for the Safety of Medicines and Health Products (ANSM). After five years of intensive monitoring, the agency is adjusting its national pharmacovigilance investigation, while maintaining a commitment to ongoing surveillance of these critical vaccines. This confirmation of vaccine safety comes as public health officials continue to emphasize the importance of vaccination in protecting against severe illness and hospitalization from COVID-19.
Two new pharmacovigilance reports, analyzing data from February 2024 to June 2025, “confirm once again that these vaccines are safe,” the ANSM stated in a recent communiqué. The agency’s decision to shift from a national investigation to a more focused regional monitoring system reflects the extensive data collected and the absence of new safety signals. Over 160 million doses of these vaccines have been administered in France, and billions globally, providing a substantial dataset for analysis.
The investigations focused on 21 cases flagged as potentially significant adverse events following Comirnaty vaccination. However, the ANSM found “no link with the vaccination” established in any of these instances. These cases included conditions such as central retinal vein occlusion, uveitis, postural orthostatic tachycardia syndrome (POTS), myalgic encephalomyelitis, chronic fatigue syndrome, HELLP syndrome, and amyotrophic lateral sclerosis (SLA). Similarly, analysis of five noteworthy cases following Spikevax administration – including two cases of SLA, one case of dermatomyositis, and cases of chronic fatigue syndrome – also revealed no established connection to the vaccine.
This shift in monitoring strategy represents what the ANSM describes as an “unprecedented regression” in surveillance, built upon decades of expertise, more than 160 million doses administered in France, and billions worldwide. Despite the change, the agency assures the public that these vaccines will continue to be closely monitored through ongoing analysis of significant cases reported by regional pharmacovigilance centers (CRPV).
Further supporting the safety of COVID-19 vaccines, a study published in December in JAMA Network Open, conducted by researchers from Epi-Phare (a French organization combining the ANSM and the Health Insurance), found that COVID-19 vaccines have not led to an increase in mortality in France since their introduction in the early 2020s. Read the study in JAMA Network Open. This finding aligns with numerous previous studies documenting the efficacy and safety of COVID-19 vaccines.
Addressing Misinformation
The ANSM acknowledges that misinformation regarding vaccine safety, particularly concerning mRNA vaccines and alleged links to deaths, has been circulating. The agency emphasizes that official mortality data focuses on deaths directly attributable to COVID-19, with a relatively short follow-up period post-vaccination, and does not support these claims.
Updated Vaccine Formulations
The U.S. Food and Drug Administration (FDA) approved and authorized updated mRNA COVID-19 vaccines in August 2024, targeting the Omicron variant KP.2 strain. Learn more about the updated vaccines from the FDA. These updated formulations, including Comirnaty and Spikevax, are approved for individuals 12 years of age and older and authorized for emergency use in younger children. The move to a monovalent vaccine, focusing on a single strain, aims to provide better protection against currently circulating variants.
Looking ahead, the ANSM will continue to analyze data from regional centers, ensuring ongoing vigilance regarding the safety of mRNA COVID-19 vaccines. The agency’s decision to adjust its monitoring strategy reflects a growing body of evidence supporting the safety and effectiveness of these vaccines, while maintaining a commitment to protecting public health. Continued monitoring and data analysis will be crucial in adapting vaccination strategies to evolving variants and ensuring ongoing protection against COVID-19.
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Disclaimer: This article provides informational content and should not be considered medical advice. Please consult with a qualified healthcare professional for any health concerns or before making any decisions related to your health or treatment.
