FDA accepted the company’s Biologics License Application (BLA) for TicoVac to prevent TBE in individuals aged one year and above
Pfizer World Headquarters in Manhattan, New York. (Credit: Coolcaesar/Wikipedia.)
Pfizer has secured the US Food and Drug Administration (FDA) priority review for its tick-borne encephalitis (TBE) vaccine TicoVac.
The US regulatory agency has accepted the company’s Biologics License Application (BLA) for TicoVac to prevent TBE in individuals aged one year and above.
Pfizer said that TicoVac becomes the first vaccine in the US to help protect adults and children who are visiting or living in TBE endemic areas, if approved.
Pfizer vaccines global president Nanette Cocero said: “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.
“If approved in the U.S., we hope this vaccine will help protect those travelling to or residing temporarily in at-risk locations, potentially including military personnel who are serving overseas.”
Pfizer’s BLA for TicoVac is supported by results from more than 40 years of experience and evidence outside the US.
The US drugmaker assessed the safety and immunogenicity of TicoVac in clinical trials, across two age groups, including 1 to 15 years of age and 16 to 65 years of age.
In the clinical studies, TicoVac was well-tolerated without any unexpected adverse events or vaccine-related serious adverse events reported.
Additional real-world studies demonstrated that the vaccine is 96-99% effective in people who received at least two doses of the vaccine.
Long-lasting immune memory is achieved in people who received two to three doses of the TBE vaccine.
TBE is a viral infection of the brain and spine, transmitted to humans through the bite of an infected tick, and less frequently by ingestion of unpasteurised milk or milk products from infected animals.
Pfizer is marketing its TBE vaccine under the brand names TicoVac and FSME-Immun in Europe, which is an inactivated whole virus vaccine developed using a master seed virus, similar to the natural TBE virus.
The vaccine protects against all known subtypes of the TBE virus in both children and adults, including the European, Siberian and Far Eastern subtypes.