Pfizer and Valneva Work To Deliver Lyme Disease Vaccine as Bella Hadid Shares Health Journey
American model, Bella Hadid, has shared details of her 15-year battle with Lyme disease. The tick-borne disease is now highly endemic in countries including Finland, Germany, the Netherlands, Poland, Sweden and the United States, and continues to spread. Lyme disease represents a high unmet medical need, impacting the lives of many in the Northern Hemisphere.
There is no vaccine for Lyme disease currently available and the only vaccine previously marketed in the United States, LYMERix®, was discontinued by the manufacturer in 2002, citing insufficient consumer demand.
With new treatments clearly needed, we took a look at the two companies working on developing safe and effective options for preventing and treating Lyme disease:
Pfizer (PFE) and Valneva (VALN)
Industry giant, Pfizer, continues to enroll patients in a Phase 3 study evaluating the efficacy, safety and immunogenicity of a Lyme disease vaccine candidate in conjunction with Valneva.
The study aims to enroll approximately 6,000 participants, 5 years of age and older, from Lyme disease-endemic regions in Europe and the United States. The vaccine candidate, VLA15, is a multivalent, protein subunit vaccine that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the bacteria that cause Lyme disease. This vaccine is designed to protect people against North American and European strains of the Lyme disease bacterium.
The Phase 3 study follows the positive evidence from Phase 2 studies, which demonstrated strong immunogenicity in both adults and children, along with acceptable safety and tolerability profiles.
Pfizer expects to submit a Biologics License Application (BLA) to the FDA and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in 2025, pending successful completion of the Phase 3 studies.
About Pfizer
At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world’s premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
About Valneva
We are a specialty vaccine company focused on the development, manufacturing and commercialization of prophylactic vaccines for infectious diseases. We take a highly specialized and targeted approach to vaccine development by focusing on vaccine solutions addressing unmet medical needs to ensure we can make a difference to peoples’ lives. We apply our deep understanding of vaccine science, including our expertise across multiple vaccine modalities, and our established vaccine development capabilities, to develop vaccines against diseases which are not yet vaccine-preventable, or for which there are limited effective treatment options. Today, we are leveraging our expertise and capabilities to rapidly advance a broad range of vaccines into and through the clinic, including candidates against the chikungunya virus and Lyme disease.
