Valneva is a Franco-Austrian specialty vaccine company focused on developing, manufacturing, and commercializing vaccines for infectious diseases with high unmet medical needs.
Valneva has commercialized four vaccines so far: for Japanese encephalitis, cholera, Covid-19 and chikungunya. The latter received its approval by the US FDA in November 2023. What is the significance of this milestone?
Chikungunya is our third vaccine developed entirely in-house from bench to licensure, a remarkable achievement for a company of our size. The disease represents a growing medical need, closely linked to climate change, as mosquito-transmitted infections are on the rise globally. While chikungunya is endemic to tropical and subtropical regions, we are increasingly seeing outbreaks in southern Europe and parts of the United States. Infected travelers often bring the virus home, where it spreads via local mosquito populations.
Chikungunya outbreaks are explosive, infecting large portions of the population in a short time. The disease has a major economic and health impact, as approximately one-third of those infected experience severe and prolonged symptoms. This vaccine serves two key purposes. First, it protects travelers visiting endemic regions. Second, we aim to provide access to people living in low- and middle-income countries where the virus is prevalent year-round. We have partnered with local institutions such as Instituto Butantan in Brazil and the Serum Institute of India to help make this vaccine widely available. From a business perspective, we expect chikungunya to generate revenue that can be reinvested into our R&D efforts.
You recently struck a deal with U.S. authorities regarding your Japanese encephalitis vaccine…
Yes, our Japanese encephalitis vaccine, like all of our products, is highly differentiated. It is the only licensed vaccine against Japanese encephalitis in certain key markets such as the U.S. and Europe. Though the disease is relatively rare, it has a relatively high mortality rate among symptomatic cases, making protection crucial. The U.S. military, which has a significant number of forward-deployed troops in Southeast Asia, has made our vaccine mandatory for all personnel and their families stationed in the region.
This is not the first time we have worked with the U.S. military—they provide us with annual supply contracts, and we have established a strong relationship with them as a trusted partner. We hope to leverage this collaboration for other vaccines, such as our chikungunya vaccine, moving forward.
Yet, given that you are a European company, do you sense the support from European authorities in your endeavors to become a global leader?
Overall, Valneva has received strong support from European authorities. During the COVID-19 pandemic, we developed a vaccine for the UK government and the European Commission, and it was the first COVID-19 vaccine to receive a full marketing authorization in Europe. This work was financially supported by European governments.
While Europe does not have a Biomedical Advanced Research and Development Authority (BARDA) equivalent entity supporting vaccine development, we are in constant dialogue with organizations like HERA (Health Emergency Preparedness and Response), which focuses on outbreak preparedness. We have also benefited from significant R&D funding through tax credits in the European countries where we operate. Furthermore, in Scotland—where our main manufacturing site is located—we receive substantial local support from Scottish Enterprise and other funding institutions. So, in short, we feel well-supported in Europe.
Valneva is presently working on a first of its kind vaccine for Lyme disease, in collaboration with Pfizer. Could you tell us about that partnership and its implications?
From the start, Valneva has focused on developing vaccines for diseases with high unmet medical needs, particularly vector-transmitted diseases. Lyme disease fits this profile perfectly. The disease burden has grown significantly, partly due to climate change, which has expanded the habitat of Lyme-carrying ticks. We began working on a Lyme disease vaccine early in Valneva’s journey, making it one of our longest-running projects.
Early in the program, we realized that late-stage development would be costly, so we partnered with Pfizer, granting them global commercial rights in exchange for financial contributions. We are now in Phase 3 trials, spanning three tick seasons, with the vaccine being tested in Lyme-endemic regions of North America and Europe. Given the vast number of people living in high-risk areas—e.g., 200 million in Europe—a prophylactic solution could have a substantial impact.
You are also developing a vaccine targeting the Zika virus…
Zika is another vector-borne disease we are tackling. The world saw firsthand the devastating effects of Zika infections in pregnant women, particularly the severe birth defects they can cause. Initially, some believed that natural infection would confer lifelong immunity, but we now know that reinfection is possible. Given our expertise in vector-borne diseases, we felt it was important to develop a Zika vaccine.
To our knowledge, we are the only company with an active clinical-stage Zika vaccine program. It is currently in Phase 1, undergoing immunogenicity and safety testing. We expect to see results later this year, and if successful, we hope to advance further. The vaccine would primarily be targeted at women of childbearing age and populations living in high-risk areas such as Asia and South America.
Where do you see Valneva in three years?
Our ambition is to become the leading specialty vaccine company. We want to be the largest independent, fully integrated vaccine company focused on addressing unmet medical needs. With continued commercial success, we aim to expand our R&D efforts and invest in additional vaccine programs that could make a real difference for people’s lives.
We are also exploring vaccines for diseases like Epstein-Barr virus (EBV) and enteric infections such as Shigella. EBV is particularly challenging, but it has potential implications beyond mononucleosis, as it has been linked to multiple sclerosis. Developing a vaccine for it would be a significant achievement. Similarly, Shigella is a major cause of child mortality in low-income countries, and we believe we can play a pioneering role in addressing this neglected disease.
