COVID-19 Vaccine Safety Confirmed as Monitoring Evolves

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.

Five Years of Intensive Monitoring

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.

Investigation Findings

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. According to the ANSM.

Continued Surveillance

Despite the shift in monitoring strategy, the ANSM assures that these vaccines will remain closely monitored with continuous analysis of significant cases reported by the regional pharmacovigilance centers (CRPV). This ongoing surveillance ensures continued vigilance regarding vaccine safety.

Broader Safety Data

A study published in December in the journal JAMA Network Open conducted by researchers from Epi-Phare, a French organization bringing together ANSM and Health Insurance, found that COVID-19 vaccines have not caused an increase in mortality in France since their appearance in the early 2020s. The effectiveness and safety of anti-COVID vaccines have been documented by numerous studies.

2025-2026 Vaccination Guidance

For the 2025-2026 vaccination schedule, the CDC recommends COVID-19 vaccines for individuals ages 6 months and older, based on individual-based decision-making. Moderna’s Spikevax is the only COVID-19 vaccine approved for children ages 6-23 months. Children previously vaccinated with Pfizer-BioNTech should receive doses of the 2025-2026 Moderna COVID-19 Vaccine.