Valneva’s Chikungunya virus vaccine receives breakthrough designation status from the USFDA

FRANCE – Valneva, a French pharma company with vaccine speciality, has received a breakthrough therapy designation form the US Food and Drug Administration (FDA) for its Chikungunya vaccine.

The chikungunya vaccine, VLA1553, has also previously been awarded an FDA fast track designation and a European Medicines Agency (EMA) PRIME designation, in December 2018 and October 2020 respectively.

Valneva currently has the vaccine undergoing phase three trials which began in April 2021 and they expect to relay data in a couple of months.

VLA1553 is a live-attenuated, single dose vaccine candidate for protection against chikungunya disease. It has been designed by deleting a part of the chikungunya virus genome.

To Valneva’s knowledge, VLA1553 is currently the only chikungunya vaccine candidate in Phase 3 clinical trials that targets long-term protection following the administration of a single dose.

In the Phase 1 clinical trial of VLA1553, Valneva observed 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 has advanced directly into Phase 3 clinical development.

The Company has also received confirmation for its proposal to seek licensure under the accelerated approval pathway from the FDA.

Under this pathway, Valneva plans to seek licensure of the vaccine based on a surrogate of protection agreed with the FDA that is reasonably likely to predict protection from chikungunya infection.

VLA1553 would expand Valneva’s existing travel vaccine portfolio and as such, Valneva intends to commercialize this vaccine, if approved, leveraging its existing manufacturing and commercial operations.

The global market for vaccines against chikungunya is estimated to exceed $500 million annually by 2032.

To make VLA1553 more accessible to Low- and Middle-Income Countries (LMIC), Valneva and Instituto Butantan in Brazil signed an agreement for the development, manufacturing and marketing of VLA1553.

The collaboration falls within the framework of the funding agreement between Valneva and the Coalition for Epidemic Preparedness Innovations (CEPI) signed in July 2019, which provides funding of up to $23.4 million, with support from the European Union’s (EU’s) Horizon 2020 programme.

About Chikungunya

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 4 to 7 days following the mosquito bite. While mortality with CHIKV is low, morbidity is high.

Clinical symptoms include acute onset of fever, debilitating joint and muscle pain, headache, nausea, rash and chronic arthralgia.

Chikungunya virus often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating.

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 and the economic impact is considered to be significant.

The medical and economic burden is expected to grow as the CHIKV primary mosquito vectors continue to spread geographically.

There are no preventive vaccines or effective treatments available and, as such, chikungunya is considered to be a major public health threat.

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