Valneva Preparing for the FDA’s decision on the chikungunya vaccine

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Valneva Preparing for the FDA's decision on the chikungunya vaccine

Just a few months away from the FDA making a judgment on Valneva’s marketing application for the chikungunya vaccine VLA1553, the company has released data that supports the clinical case for the injection.

Valneva is competing to develop the first chikungunya vaccine and bring it to market. The pivotal Phase III  trial that served as the basis for Valneva’s biologics license application (BLA) in the US has just been published in The Lancet. The study found that adult recipients had an antibody response rate of 98.9% 28 days after receiving a single injection, and nearly all participants (96%), continued to have this response for at least six months after vaccination.

Chikungunya Vaccine

According to the paper, the clinical profile of VAL1553 makes it “an excellent candidate for the prevention of disease caused by chikungunya virus.” The immune response elicited by the live-attenuated vaccine was similar in both younger and older adults, and it was safe and well-tolerated.

The antibody response rate remained at 99% after 12 months, according to previously released trial findings from Valneva.

The programme is Valneva’s best chance of bouncing back from a challenging 2022, when the European Commission nearly all of its orders for the business’s COVID-19 vaccine VLA2001 were canceled, forcing it to take a €8 million charge to write down its investment in the shot’s manufacturing and refocus on its travel vaccines.

Valneva Gears Up For FDA Decision: Revolutionary Chikungunya Vaccine Awaits Regulatory Approval

VLA1553, a potential chikungunya vaccine, has a Prescription Drug User Fee Act (PDUFA) review deadline set for the end of August 2023. Additionally, a regulatory application has been submitted to Health Canada. Approval from Health Canada could make VLA1553 the first authorized vaccine for chikungunya, effectively addressing the current lack of medical solutions for this condition. In addition to launching a Phase III trial in Brazil to test if VLA1553’s label may be expanded to cover patients who are adolescents, the company plans to follow up with files in additional regions, including Europe, in the second part of this year. Results from this trial are anticipated soon.

By 2032, the company predicts that the worldwide market for chikungunya vaccinations would approach approximately $500 million annually.

Valneva faces competition from two prominent players in the chikungunya vaccine development space, namely Emergent BioSolutions and Bharat Biotech. Emergent BioSolutions is currently in Phase III of clinical trials with their candidate, while Bharat Biotech is in Phase II/III. This suggests that both competitors are at advanced stages of vaccine development, signaling the growing interest and efforts to address the unmet medical need for a chikungunya vaccine. The race between these companies highlights the competitive landscape and the urgency to provide an effective solution for chikungunya prevention and treatment.

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