U.S. FDA Approves Pfizer’s TicoVac for Prevention of Tick-Borne Encephalitis in Individuals Aged 1 and Older

Pfizer recently announced that the U.S. FDA has approved TicoVac (tick-borne encephalitis vaccine) for the prevention of tick-borne encephalitis (TBE) in individuals aged 1 year and older. The press release noted that TicoVac is the first TBE vaccine approved by the U.S. FDA. It helps protect adults and children from the TBE virus when visiting or living in TBE-endemic areas.

TBE is a viral infection of the brain and spinal cord that can be transmitted to humans through the bite of infected ticks. One-third of TBE patients may experience long-term effects lasting months or years, including cognitive changes, muscle weakness, or permanent paralysis, and in rare cases (0.5–2%), it can be fatal. To date, TBE has been identified in more than 35 countries across Europe and Asia. Outside the United States, Pfizer's TBE vaccine has been in use for over 45 years, with more than 170 million doses distributed since 1976.

Pfizer's TBE vaccine, marketed under the brand names FSME-immune and TicoVac in Europe and TicoVac in the United States, was developed using a "seed" virus similar to the TBE virus found in nature. It induces neutralizing antibodies against the natural TBE virus.

Clinical trials evaluated the safety and immunogenicity of TicoVac in two age groups (1–15 years and >16 years). In these studies, following three doses, the seropositivity rate was 99.5% in children aged 1–15 years and 98.7–100% in adults aged >16 years. Clinical studies demonstrated that TicoVac 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 injection site tenderness, headache, injection site pain, fever, irritability, fatigue, and myalgia. Real-world studies from Austria have shown that the vaccine is 96–98.7% effective in individuals who have received at least three doses.

References:

[1] U.S. FDA Approves TICOVAC™, Pfizer’s Tick-Borne Encephalitis (TBE) Vaccine. Retrieved August 14, 2021, from https://www.businesswire.com/news/home/20210813005441/en

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