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Pfizer recently announced that the US FDA has approved TicoVac (tick-borne encephalitis vaccine) for the prevention of tick-borne encephalitis (TBE) in individuals over 1 year old. The press release states that TicoVac is the first TBE vaccine approved by the US FDA. When visiting or living in TBE endemic areas, it helps protect adults and children from the TBE virus.
TBE is a viral infection of the brain and spine, which can be transmitted to humans through the bite of a virus-infected tick. One-third of TBE patients may have long-term effects that last for months or years, including cognitive changes, muscle weakness or permanent paralysis, and in rare cases (0.5-2%) can lead to death. So far, TBE has been found in more than 35 countries in Europe and Asia. Pfizer's TBE vaccine has been used outside the United States for more than 45 years. Since 1976, more than 170 million doses of the vaccine have been distributed.
Pfizer's TBE vaccine is marketed in Europe under the trade names of FSME-immune and TicoVac, and in the United States under the trade name of TicoVac, developed using a "seed" virus similar to the TBE virus found in nature. It can induce 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, after 3 vaccinations, the seroprevalence rate of children aged 1-15 was 99.5%, and the seroprevalence rate of adults >16 years old was 98.7-100%.
Clinical studies have shown that TicoVac is generally well tolerated, and no unexpected adverse events or vaccine-related serious adverse events have been observed. The most common adverse reactions in the two age groups were local tenderness, headache, local pain, fever, restlessness, fatigue, and muscle pain. Real-world studies from Austria show that the vaccine is effective at 96-98.7% for people who have received at least 3 doses of the vaccine.
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