Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, announced today that their pivotal Phase 3 data for their single-shot chikungunya vaccine candidate, VLA1553, has been published in The Lancet – the world’s premier, peer-reviewed medical journal. This major milestone marks a significant breakthrough in the development of the vaccine, demonstrating its safety and efficacy in reducing the spread of this disease.
The ground-breaking Phase 3 trial on VLA1553, a live-attenuated single-shot chikungunya vaccine, reveals the astounding immunogenic properties and safety profile of the vaccine. An incredibly high seroresponse rate of 98.9% was established in participants 28 days after administration. Moreover, 96% still retained this response even after 6 months have passed. Furthermore, VLA1553 was equally well tolerated in both younger and older adults, making this a truly remarkable scientific breakthrough.
Dr. Juan Carlos Jaramillo, Chief Medical Officer of Valneva, expressed his delight after the results of their Phase 3 study was featured in the renowned Lancet medical journal. He said: “This publication is a reflection of the advanced scientific research that has gone into developing VLA1553, our single-shot chikungunya vaccine candidate. We are excited to make these detailed results available to the medical and public health communities.”
Valneva has made impressive progress with their vaccine, VLA1553: in March 2020, they reported remarkable Phase 3 results; in May 2020, they released lot-to-lot consistency data; in December 2020, they revealed favorable twelve-month persistence data. To further strengthen the vaccine, they are currently conducting a clinical study for adolescents in Brazil, with enrollment and vaccination completion reported in February 2021.
VLA1553 could be the first chikungunya vaccine available to the public, with regulatory review processes underway. The U.S. Food and Drug Administration (FDA) is conducting a priority review of its Biologic License Application, with a target date at the end of August 2023. A regulatory application has also been filed with Health Canada, potentially offering a much-needed solution to this global unmet medical need. If approved, VLA1553 could be the world’s first licensed anti-chikungunya vaccine.
Chikungunya, a viral disease transmitted by Aedes mosquitoes, is a major global public health threat. Symptoms are often sudden and include fever, intense joint and muscle pain, headaches, nausea, a rash, and chronic arthralgia. An estimated three million cases have already been reported in the Americas and Southeast Asia and the virus has spread to over 110 countries.
With no available vaccines or effective treatments, its economic impact is predicted to exceed $500 million a year by 2027 – and the spread of CHIKV-carrying mosquitos means the medical and economic burden is likely to increase. People living in endemic locations are particularly at risk of infection and should take extra precautionary measures. Chikungunya may be a mosquito-borne disease, but it’s up to us to stop it.
Valneva is behind the inspiring effort to develop VLA1553, a single dose, live-attenuated vaccine intended to protect against chikungunya virus, which has spread across more than 110 countries. Promising data from Phase 3 trials is expected to be available by March 2022, followed by lot-to-lot consistency results in May 2022 and twelve-month persistence data in December 2022.
Following successful completion of the indications, Valneva is poised to add VLA1553 to its existing commercial vaccines portfolio and leverage its existing manufacturing and commercial operations. This breakthrough vaccine embodies the endless possibilities of innovation and promises hope and protection to those in need.
In 2021, Valneva and the Instituto Butantan in Brazil signed an agreement to make VLA1553 more accessible to Low- and Middle-Income Countries (LMICs). Supported by the European Union’s Horizon 2020 program, the collaboration is part of a $24.6 million investment for the development, manufacturing and marketing of VLA155314.
To date, VLA1553 has earned Fast Track, Breakthrough Therapy and Priority Review designations from the US Food and Drug Administration, as well as PRIority MEdicine (PRIME) designation from the European Medicines Agency (EMA). This pact will help bring the much-needed vaccine to millions of people around the world.
About Valneva SE
At our specialty vaccine company, we are dedicated to the development, manufacturing, and commercialization of vaccines to make a difference in the lives of people who suffer from outbreaks of infectious diseases. We have an in-depth understanding of vaccine science, expertise in multiple vaccine modalities, and established vaccine development capabilities that allow us to rapidly make progress in the development of vaccines against diseases which are not currently vaccine-preventable or for which there are limited treatment options. Right now, our team is actively working on advancing candidates vaccines against chikungunya virus and Lyme disease!