On January 7, the FDA announced new safety labeling for the Abrysvo and Arexvy RSV vaccines, warning that there is evidence of a potential increased risk of the rare neurological disorder Guillain-Barré syndrome for 42 days after vaccination. The warning is based on an observational FDA study that found seven to nine excess GBS cases per million doses in adults 65 and older. Yet, the agency noted that “available evidence is insufficient to establish a causal relationship.” Vaccine opponents are misrepresenting the FDA’s alert to suggest that RSV vaccines are unsafe and that GBS is a common side effect. Some social media users expressed outrage that the vaccine will remain in use, while others argued against the need for any vaccines, claiming they will “trust” their immune systems.
Recommendation
Legitimate concerns about the safety of new vaccines are often exploited to advance the false narrative that vaccines cause widespread death and serious health complications. Messaging may explain that the FDA added a new safety label to the Abrysvo and Arexvy RSV vaccines after detecting a potential increased risk of a rare neurological disorder. Debunking messaging may emphasize that the risk (an additional seven to nine cases per million vaccinations) is low and that the FDA did not find evidence that RSV vaccines caused the disorder, just that it occurred in a small number of vaccine recipients. The early detection and labeling of a rare potential adverse reaction is an example of vaccine monitoring systems working as they should.
Fact-checking sources: Pharmacy Times
