Valneva’s Chikungunya vaccine gets FDA breakthrough designation

08-Jul-2021 - Last updated on 08-Jul-2021 at 13:51 GMT

Pic:getty/rolfaasa

Vaccine company Valneva has been awarded Breakthrough Therapy Designation for its single-shot chikungunya vaccine candidate, VLA1553, by the US Food and Drug Administration (FDA).

Valneva completed recruitment for the vaccine’s Phase 3 trial in April this year and topline data is expected in the summer.

The Breakthrough Therapy Designation milestone is in addition to the FDA Fast Track designation (received in December 2018) and the European Medicines Agency’s PRIME designation (received in October 2020).

Chikungunya: high morbidity

Breakthrough Therapy Designation intends to facilitate and expedite development and review of new drugs for serious or life-threatening conditions where preliminary clinical data demonstrates that the drug may have substantial improvement for at least one endpoint over available therapies

Chikungunya is a mosquito-borne viral disease caused by the chikungunya virus (CHIKV), a Togaviridae virus, transmitted by Aedes mosquitoes.

Infection leads to symptomatic disease in 72-92% of humans after four to seven days following the mosquito bite. While mortality with CHIKV is low, morbidity is high.

The high risk areas of infection for travelers are places where chikungunya virus-carrying mosquitos are endemic, including the Americas, parts of Africa, and Southeast Asia. As of September 2020, there were more than 3 million reported cases in the Americas: with the impact expected to grow as mosquitos carrying the virus continue to spread geographically.

Valneva's vaccine is a live-attenuated, single-dose vaccine candidate: which has been designed by deleting a part of the chikungunya virus genome.

Phase 1 trials saw development of antibodies to chikungunya virus resulting in 100% seroconversion of the 120 healthy participants. Antibody titers were sustained after 12 months. Based on these results and Valneva’s discussions with regulators, VLA1553 was advanced directly into Phase 3 clinical development. The vaccine is being assessed on the basis of immunity 28 days after the single-dose shot.

VLA1553 would expand Valneva’s existing travel vaccine portfolio, with the company estimating the global market for vaccines against chikungunya being worth more than $500m annually by 2032.

Valneva currently has two travel vaccines on the market: Ixiaro (Japanese Encephalitis) and Dukoral (cholera).