FDA Accepts for Priority Review Pfizer’s Application for TicoVac (Tick-borne Encephalitis Vaccine)
Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review the company’s Biologics License Application (BLA) for TicoVac, its tick-borne encephalitis (TBE) vaccine for active immunization to prevent TBE in individuals 1 year of age and older. If approved, TicoVac would be the first vaccine in the U.S. to help protect adults and children who are visiting or living in TBE endemic areas. In line with Priority Review designation, the FDA will target an action within six months of the application submission date, with the anticipated Prescription Drug User Fee Act (PDUFA) action date expected for August 2021.
TBE is a viral infection of the brain and spine, which is transmitted to humans through the bite of an infected tick. To date, ticks infected with the TBE virus have been identified in more than 35 countries across Europe and Asia. The European Centre for Disease Prevention and Control (ECDC) currently recommends TBE vaccination for people who live in or are traveling to these risk areas.
“For many years, our TBE vaccine has helped protect millions of people in Europe from this potentially serious disease. We are proud that today’s U.S. FDA Priority Review acceptance acknowledges the potential value that our vaccine candidate can bring,” said Nanette Cocero, Ph.D., Global President, Vaccines, Pfizer Inc. “If approved in the U.S., we hope this vaccine will help protect those traveling to or residing temporarily in at-risk locations, potentially including military personnel who are serving overseas.”
The BLA is based on results from more than 40 years of experience and evidence outside the U.S. In clinical trials, the safety and immunogenicity of TicoVac was assessed across two age groups (1-15 years of age and 16-65 years of age). In these studies, pooled seropositivity rates were 99-100% in 1-15 year olds and 94-99% in adults >15 years following three doses. Clinical studies demonstrated that TicoVac was well-tolerated with no unexpected adverse events or vaccine-related serious adverse events observed. Subsequent real-world studies have shown that the vaccine is 96-99% effective in people who have received at least two doses of the vaccine, and two to three doses of the vaccine were shown to be sufficient to provide a long-lasting immune memory.