Canada Proceeds with Chikungunya Vaccine Candidate

Valneva SE today announced that Health Canada has completed screening validation of the Company's regulatory application for marketing approval of its single-shot chikungunya vaccine candidate VLA1553 in persons aged 18 years and above and has determined that the New Drug Submission (NDS) application is sufficiently complete to permit a substantive review.

Based on Health Canada's performance standard to process an NDS application, the Company believes the regulatory review could be completed by mid-2024.

VLA1553 is currently the only chikungunya vaccine candidate worldwide for which regulatory review processes are underway. It could become the first licensed chikungunya vaccine to address this unmet medical need if approved. 

Juan Carlos Jaramillo, MD, Chief Medical Officer of Valneva, commented in a press release on August 29, 2023, "Chikungunya represents a major threat for people traveling to or living in areas where chikungunya virus and the mosquitos that transmit it are present, including popular destinations for U.S. and Canadian travelers."

"This threat continues to grow as shown by the recent epidemiological alert issued by the Pan American Health Organization."

"No vaccine or specific treatments are currently available for this debilitating disease, and we will continue to work diligently to make VLA1553 available in different territories as quickly as possible."

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 up to 97% of humans after four to seven 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.

As of July 2022, more than three million cases have been reported in the Americas, and the economic impact is considered significant.

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

This vaccine was granted PRIority MEdicine designation by the European Medicines Agency in 2020 and also received FDA Fast Track, Breakthrough Therapy, and Priority Review designations in 2018, 2021, and 2023, respectively.

Other Chikungunya vaccine candidates are also seeking approval.