The US Food and Drug Administration (FDA) has suddenly banned the use of Valneva’s chikungunya vaccine Ixchiq, citing 21 hospitalizations and three deaths, including one from encephalitis directly linked to the live-attenuated vaccine. The decision comes after four reports of side effects were received by the Vaccine Adverse Event Reporting System (VAERS), each occurring outside the US.
Valneva CEO Thomas Lingelbach stated that the company “remains fully committed” to maintaining access to its vaccine globally, while acknowledging the FDA’s concerns. However, the company believes all cases describe symptoms consistent with previous reports during clinical trials and post-marketing experience, particularly among elderly individuals.
The FDA’s decision is a blow to efforts to combat chikungunya outbreaks worldwide, which have seen over 8,000 reported cases in southern China since June. The US Centers for Disease Control and Prevention (CDC) has issued travel alerts for affected regions.
With Ixchiq grounded, Bavarian Nordic’s virus-like particle vaccine Vimkunya is now the only shot approved for prevention of chikungunya in the US. While originally endorsed for adults only, Vimkunya can be used by those 12 and older. The company is also testing the shot in children ages 2 to 11.
The FDA’s decision follows uncertainty over vaccines in the US under new Health and Human Services Secretary Robert F. Kennedy Jr.’s watch, who has expressed anti-vaccine views. Earlier this month, HHS announced plans to end mRNA vaccine work funded by BARDA.
Source: https://www.fiercepharma.com/pharma/fda-does-180-suspending-use-valnevas-chikungunya-vaccine