Moderna Inc.
09/12/2025 | Press release | Distributed by Public on 09/12/2025 17:05
Statement on the Safety of Spikevax
Cambridge, MA - September 12, 2025 - The safety of Spikevax is rigorously monitored by Moderna, the U.S. FDA, and regulators in more than 90 countries. Multiple, overlapping safety monitoring systems are in place that work to detect and evaluate any new or evolving safety considerations. With more than one billion doses distributed globally, these systems - including in national health systems across Europe, the United Kingdom, Canada, Australia, and the U.S. - have not reported any new or undisclosed safety concerns in children or in pregnant women.
Moderna is not aware of any deaths in the last year or new information from prior years. Published, peer-reviewed research by multiple governments, independent investigators and by Moderna has demonstrated the safety profile of Spikevax.
Additional context:
• COVID-19 vaccination has not been shown to cause miscarriage, stillbirth, preterm birth, or birth defects. Importantly, vaccination protects pregnant individuals from severe COVID-19, which is linked to higher rates of maternal complications and mortality. Similarly, global pediatric surveillance data continues to demonstrate the safety profile of Spikevax in pediatric populations.
Moderna Inc. published this content on September 12, 2025, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on September 12, 2025 at 23:05 UTC. If you believe the information included in the content is inaccurate or outdated and requires editing or removal, please contact us at [email protected]