The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on the leverage of Valneva’s chikungunya vaccine, Ixchiq, restricting its use in individuals aged 60 and over, those with certain underlying health conditions, and limiting the timing of vaccination prior to travel, according to a statement released by Valneva on February 13, 2026.
The revised recommendations follow a temporary suspension of Ixchiq’s use initiated by the MHRA after reports of serious adverse events in older adults during a vaccination campaign on Réunion Island, France. While the MHRA maintains that the benefit-risk profile of Ixchiq remains positive for individuals aged 18 to 59 at risk of chikungunya infection, the new guidance reflects increased caution regarding its use in the elderly population.
Valneva stated its commitment to adhering to the highest safety standards and will continue to monitor post-market safety data for Ixchiq, cooperating with relevant authorities to implement further measures if necessary. The company anticipates 2026 revenue of $225.43 million, with projections reaching $425.29 million in 2027, and the potential for earnings per share to turn positive in 2027, according to analysts. However, the MHRA’s updated guidance is expected to have a short-term negative impact on sales.
Chikungunya virus, transmitted by Aedes mosquitoes, causes high fever and severe joint pain, potentially leading to chronic pain and significant economic and medical burdens. The World Health Organization (WHO) has identified the virus as a major public health threat, citing the expansion of mosquito habitats due to climate change.
The regulatory developments regarding Ixchiq occur as Valneva is also collaborating with Pfizer on a Lyme disease vaccine, demonstrating the company’s focus on developing and commercializing innovative vaccines for infectious diseases.
In a separate development, Valneva withdrew its application for full approval of Ixchiq from the U.S. Food and Drug Administration (FDA) on February 19, following a previous deferral of approval in August 2025. The FDA had initially granted accelerated approval in November 2023 for use in adults aged 18 and older at risk of exposure to chikungunya virus, but paused the process after reports of four cases of severe chikungunya-like symptoms. The FDA subsequently informed Valneva of an additional decision to place the clinical trial plan on hold pending investigation of newly reported serious adverse events (SAEs) from overseas.
