European Medicines Agency Begins Review of New Lyme Disease Vaccine
European Union (E.U.) officials will begin the study and review process for Pfizer and Valneva’s vaccine targeting Lyme disease, the world’s most common tick-borne illness. There is currently no commercially approved Lyme disease vaccine.1 2 Pfizer, along with French-Swiss pharmaceutical company Valneva say trials have shown 70 percent efficacy in people ages five and older […]
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 […]
FDA, CDC Halt Use of Chikungunya Vaccine in Adults 60+ After Two Deaths Reported
On May 9, 2025, the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention (CDC) recommended a temporary pause in the use of Ixchiq, a live virus vaccine designed to prevent chikungunya virus infection, in adults aged 60 years and older. The recommendation follows reports of serious post-marketing adverse […]
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 […]
Pfizer/BioNTech mRNA Combo Influenza and COVID Shot Efficacy Fails in Trial
Pfizer and BioNTech recently announced that a new mRNA vaccine designed to protect against both COVID-19 and influenza in a single shot faced a major setback after failing to achieve one of its primary goals in a late-stage trial. The “primary goal” missed in the late-stage trials was the ability to effectively prevent influenza B. […]
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 […]