Chikungunya Vaccine Rollout Halted for Older Adults
Health agencies in the United States and Europe are taking precautionary measures regarding Valneva’s Ixchiq vaccine, the first-ever approved vaccine for the chikungunya virus, following reports of serious adverse events [[3]]. The Franco-Austrian pharmaceutical company Valneva announced that both the U.S.Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have recommended suspending the use of Ixchiq in older adults.
safety Concerns Trigger Regulatory Action
The decision follows similar actions by the European Medicines Agency (EMA) and the Ministry of Health in France, prompted by the observation of significant side effects, including two suspected deaths, in the French Department of reunion Island, which is currently battling a chikungunya epidemic. The EMA has initiated a review of Ixchiq to evaluate the benefits and risks associated with the vaccine [[1]].
The American Agency for Food and Medicines (FDA) and the Center for Disease Prevention and Control (CDC) have recommended (…) the suspension of the use of a unique dose and administered against Chikungunya produced by Valneva, IXCHIQ, for the elderly.Valneva Press Release
Reported Adverse Events and Investigations
Among the reported adverse events are two perhaps linked fatalities. One case involves an octogenarian who developed encephalitis, which French authorities believe is highly likely to be connected to the vaccination. The other involves a septuagenarian with Parkinson’s disease who experienced deadly complications,although the link to the vaccine is considered less certain.
The FDA has documented 17 serious events in global post-marketing reports, including the two deaths [[2]]. These reports have raised concerns about neurologic and cardiac safety, especially in older adults.
Divergent Age Restrictions
While European authorities have suspended vaccination for individuals over 65, the U.S. has implemented a stricter prohibition, halting vaccination for those over 60.This difference highlights the varying risk assessments and regulatory approaches across different regions.
Valneva’s Stance and Future Outlook
Despite the safety concerns and regulatory actions, Valneva maintains its confidence in the Ixchiq vaccine.
Valneva continues to believe that the benefit/risk ratio of the vaccine is positive for the vast majority of potentially exposed to the disease.Valneva Press Release
The company emphasizes that a definitive causal link between the vaccine and the reported adverse events has not yet been established. As the examination continues, the future of the chikungunya vaccine rollout remains uncertain, particularly for older adults in affected regions.
Chikungunya Outbreak: A Growing Threat
The chikungunya virus, transmitted through mosquito bites, continues to pose a significant public health challenge, especially in tropical and subtropical areas.The recent outbreak has affected tens of thousands of individuals, resulting in multiple fatalities. The need for effective prevention and treatment strategies remains critical, even as the safety profile of the available vaccine undergoes further scrutiny.