FDA Grants First Drug Approval for Uncommon Sleep Disorder
August 12, 2021
Mirena Receives Expanded Approval for Contraception
August 13, 2021
TicoVac Wins U.S. FDA Approval to Prevent Tick-Borne Encephalitis
August 13, 2021 – TicoVacTM (tick-borne encephalitis vaccine), manufactured by Pfizer, has received FDA approval to provide active immunization to prevent tick-borne encephalitis (TBE) in individuals who are at least one year old. It is the first vaccine to be FDA approved for this indication.
A viral infection that affects the brain and spinal cord, TBE is transmitted to humas through the bite of infected ticks and, less often, through the consumption of unpasteurized milk or milk products from infected animals. Early symptoms may resemble the flu, but approximately one-third of all patients who contract TBE may experience long-term complications such as muscle weakness, cognitive changes, and permanent paralysis. In some cases, TBE can be fatal.
TicoVac has been in use outside of the United States since 1976. In real-world studies in Austria, the vaccine has been 96% to 98.7% effective against TBE.
Under the recommended dosing, a full course of immunization requires three doses administered via intramuscular injection. The second dose is given up to three months after the first, while the third dose should be administered 5-12 months following the second dose. A booster dose can be given three or more years following completion of the primary immunization series if an individual is expected to have ongoing exposure or re-exposure to the TBE virus.
Launch and pricing plans are not yet available.