FDA Approves Pfizer’s Ticovac

The FDA has approved Pfizer’s Ticovac vaccine for people 1 year of age and older. Ticovac is the only FDA-approved vaccine to help protect U.S. adults and children against the tick-borne encephalitis virus when visiting or living in endemic areas.

In clinical trials, the safety and immunogenicity of the vaccine were assessed across two age groups (1 to 15 years of age and >16 years of age). Clinical studies demonstrated that it was generally well-tolerated with no unexpected adverse events or vaccine-related serious adverse events observed. The most common adverse reactions in both age groups were local tenderness, headache, local pain, fever, restlessness, fatigue, and muscle pain.

Real-world studies from Austria have shown that the vaccine is 96% to 98.7% effective in people who have received at least three doses of the vaccine

Tick-borne encephalitis is a viral infection of the brain and spine that can be transmitted to humans through the bite of an infected tick, specifically the "hard ticks" of the family Ixodidae. To date, it has been identified in more than 35 countries across Europe and Asia, according to the Centers for Disease Control and Prevention.

This virus is a member of the family Flaviviridae of viruses and was initially identified in 1937. Three virus subtypes have been described: European or Western tick-borne encephalitis virus, Siberian tick-borne encephalitis virus, and Far Eastern Tick-borne encephalitis virus.

Pfizer acquired this portfolio of vaccines, including Ticovac, from Baxter in 2014. Outside of the United States, Ticovac has been available since 1976 and is marketed as FSME-Immun/TicoVac.