Future regulatory authorisation is expected in Europe, following the US Food and Drug Administration (FDA)’s accelerated approval of IXCHIQ®.
The US Food and Drug Administration (FDA) has approved Valneva SE’s IXCHIQ®, the first chikungunya vaccine to be authorised in the world.
The single-dose, live-attenuated vaccine is indicated for preventing chikungunya virus disease in individuals over 18 years old who are at increased risk of contracting the virus. This indication is authorised under accelerated approval based on anti-chikungunya virus neutralising antibody titers.
In March 2022, Valneva reported final pivotal Phase III data for the vaccine showing a 98.9 percent seroresponse rate at 28 days with a single vaccination. IXCHIQ-induced seroresponse was sustained over time with a 96.3 percent seroresponse rate six months post-vaccination. The Phase III results were published in The Lancet in June 2023.
Rolling out access to the chikungunya vaccine
“The first-ever licensed chikungunya vaccine will play a crucial role in preventing the suffering caused by this debilitating disease,” Dr Richard Hatchett, Chief Executive Officer of the Coalition for Epidemic Preparedness Innovations (CEPI) commented.
Dr Juan Carlos Jaramillo, Chief Medical Officer of Valneva stated that the company is aiming to make the vaccine “available to the largest number of people that will benefit from it”.
Dr Hatchett explained: “Through our partnership with Valneva and Instituto Butantan, CEPI – with support from the EU – will help to make this vaccine accessible to the people most affected by the virus in low- and middle-income countries.”
Data from the Phase III study is also expected to support European regulatory approval. In October 2023, Valneva submitted a marketing application for the chikungunya vaccine to the European Medicines Agency (EMA), which included initial safety data from the trial. The vaccine was granted PRIority MEdicine (PRIME) designation by the EMA in 2020.
As part of the US FDA approval, the FDA stated that the company is required to conduct a postmarketing study to assess the serious risk of severe chikungunya-like adverse reactions following administration of IXCHIQ.
Valneva declared it plans to begin commercialisation of IXCHIQ in the US in early 2024.