EMA Lifts Chikungunya Vaccine Restrictions for Older Adults

On July 11, 2025, the European Medicines Agency (EMA) announced that it has lifted temporary restrictions on the use of the Ixchiq chikungunya vaccine for individuals aged 65 and older. This decision follows a thorough review by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC), which had previously imposed the restrictions due to reported serious side effects associated with the vaccine. While the EMA recognizes the potential benefits of the vaccine, it has emphasized that it should only be administered when there is a significant risk of chikungunya infection.

Chikungunya is a viral disease transmitted primarily by the Aedes aegypti and Aedes albopictus mosquito species, which are also known carriers of the dengue and Zika viruses. The disease is endemic in various regions, particularly in Africa, Asia, the Caribbean, and parts of South and Central America, with sporadic cases reported in Europe and the United States. Symptoms of chikungunya include fever, rash, and severe joint pain, with approximately 30%-40% of infected individuals developing chronic joint pain that can persist for months or even years.

The PRAC's safety update revealed that since the Ixchiq vaccine's authorization in June 2024, around 36,000 doses had been administered globally. However, 28 cases of serious side effects were reported, predominantly among older adults and those with pre-existing comorbidities such as cardiovascular diseases and diabetes mellitus. Tragically, three of these cases resulted in fatalities. The EMA cautioned that many of these side effects mirrored the symptoms of chikungunya itself, complicating the assessment of the vaccine's safety and efficacy.

Dr. Emily Carter, a public health expert at the University of London, stated, "While the lifting of restrictions on the chikungunya vaccine is a positive step, it is crucial for healthcare providers to weigh the risks against benefits carefully, especially for older patients who may have multiple underlying health issues."

The PRAC has reiterated that the Ixchiq vaccine should not be administered to immunocompromised individuals, as they are at increased risk of complications from vaccines containing live-attenuated viruses. This precaution remains in place following the latest review. The updated product information for the Ixchiq vaccine will reflect these recommendations, and healthcare professionals will be informed through direct communications from the EMA.

The recommendations will be submitted to the Committee for Medicinal Products for Human Use for further review, leading to a legally binding decision by the European Commission that will apply across all EU Member States.

As chikungunya continues to pose a public health challenge, particularly in endemic regions, the EMA's updated guidance underscores the importance of careful vaccination practices. The agency's proactive approach aims to ensure that the benefits of vaccination are maximized while minimizing the risks to vulnerable populations.

In light of the ongoing global health landscape and the potential for increased vector-borne diseases due to climate change, the EMA's decision may have broader implications for public health strategies in the European Union and beyond. As noted by Dr. Sarah Johnson, an infectious disease specialist at the World Health Organization, "The careful monitoring of vaccine safety and efficacy is essential as we adapt our strategies to combat emerging infectious diseases."

In conclusion, while the lifting of restrictions marks a significant development in the fight against chikungunya, it is imperative that ongoing vigilance and public health education accompany the rollout of the Ixchiq vaccine to ensure that the most vulnerable populations are protected effectively.