Pfizer/Valneva Aim for FDA Approval of mRNA Shot for Lyme Disease
On Mar. 23, 2026, Pfizer, Inc. of New York City, NY and Valneva SE of Saint-Herblain, France announced that they would seek regulatory approval from the U.S. Food and Drug Administration (FDA) for an experimental mRNA (messenger ribonucleic acid) biologic shot against Lyme disease that they have jointly been developing since 2020. The shot, designated […]
CDC’s ACIP Forms Workgroup to Back New Lyme Disease Vaccine and Monoclonal Antibody Products
At an Apr.15-16, 2025 meeting of the U.S. Centers for Disease and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP), it was announced that a workgroup had been formed to further development of a new vaccine for Lyme disease. The first session of the new group will take place in May with a presentation scheduled […]
Novel mRNA Lyme Shots Could Be Released in 2025
Two novel messenger RNA (mRNA) shots for Lyme disease currently in late-stage clinical trials could hit the market as early as 2025, Moderna announced earlier this year. Also in the race to develop the first-ever mRNA product to prevent Lyme disease are Pfizer and Austria-based Valneva, which entered into a collaborative agreement in April 2020 […]
Another Shot at a Vaccine for Lyme Disease
The U.S. National Institutes of Health (NIH) has provided the University of Maryland with a $3.5 million dollar grant to develop a vaccine for Lyme disease.1 Principal investigators Utal Pal, PhD, professor at the Virginia-Maryland College of Veterinary Medicine at the University of Maryland College of Agriculture and Natural Resources and Matthias Schnell, PhD, director […]
Lyme Disease Vaccines: Past and Future
Story Highlights A new Lyme disease vaccine candidate approved by the FDA using the fast track process is currently in its second phase of clinical trials. In 1998, the FDA granted licensure for a Lyme disease vaccine called LYMErix. Following reports of severe adverse reactions to LYMErix, GlaxoSmithKline (formerly SmithKline Beecham) withdrew the vaccine from […]