U.S. FDA Accepts for Priority Review Pfizer’s Application for TicoVac (Tick-borne Encephalitis Vaccine) - Seite 2

Nachrichtenquelle: Business Wire (engl.)
23.02.2021, 22:30  |  166   |   |   

About TicoVac (TBE vaccine, whole virus inactivated)

Pfizer’s TBE vaccine, marketed under the brand names TicoVac and FSME-Immun in Europe, is an inactivated whole virus vaccine developed using a master ‘seed’ virus that is similar to the TBE virus found in nature.13 Therefore, it is able to induce neutralizing antibodies against the natural TBE virus, as the sequence and structure of the virus subtype match those found in nature.14 The vaccine helps provide protection against all known subtypes of the TBE virus in both children (from one year of age) and adults,1,2,14 including the European, Siberian and Far Eastern subtypes.15,16

More than 40 years of experience with the Pfizer TBE vaccine exist outside the U.S., and more than 160 million doses of the vaccine have been distributed since 1976.7,17

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About TBE

TBE is a viral infection of the brain and spine,4 transmitted to humans through the bite of an infected tick,5 and less frequently by ingestion of unpasteurized milk or milk products from infected animals.4 It may initially be mistaken for summer flu,18,19 but can be a serious condition with possible long-term consequences.4,19 More than 1 in 3 people can have long-term effects that last months or years including cognitive changes, muscle weakness or permanent paralysis,4,19 and in rare cases (0.5-2%; up to 20% in Russia), people may die.20,21 TBE can affect people of all ages who come into contact with ticks whenever they do outdoor activities in countries where ticks infected with TBE are prevalent.4,21

Although TBE is not endemic in the U.S., TBE has been reported in more than 35 countries, ranging from Western Europe to Japan.5 Currently there is no cure or treatment for TBE, only management of symptoms.4 The potential vaccine could help protect people from the U.S. who are traveling to or living in endemic regions.

About Pfizer: Breakthroughs That Change Patients’ Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 170 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at In addition, to learn more, please visit us on and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at

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U.S. FDA Accepts for Priority Review Pfizer’s Application for TicoVac (Tick-borne Encephalitis Vaccine) - Seite 2 Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review the company’s Biologics License Application (BLA) for TicoVac, its tick-borne encephalitis (TBE) vaccine for active immunization to …


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