Tick-Borne Encephalitis Vaccine Gains U.S. FDA Approval

New York-based Pfizer Inc. announced late on August 13, 2021, that the U.S. Food and Drug Administration (FDA) has approved TICOVAC™ (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older.

TICOVAC was developed using a master ‘seed’ virus similar to the TBE virus found in nature. It can induce neutralizing antibodies against the natural TBE virus, as the sequence and structure of the virus subtype match those found in nature.

Following the FDA's approval, the U.S. CDC's Advisory Committee on Immunization Practices is expected to discuss recommendations on the safe and appropriate use of TICOVAC.

TICOVAC is the only FDA-approved vaccine to help protect U.S. adults and children against the TBE virus when visiting or living in TBE endemic areas.

Tick-borne encephalitis is a common tick-borne disease in Europe, along with Lyme borreliosis.

“We are proud to deliver the first vaccine to help protect people in the U.S. against TBE if they are traveling to any risk areas,” stated Nanette Cocero, Ph.D., Global President, Vaccines, Pfizer, in a press release.

“This vaccine has helped to protect millions of people in TBE endemic regions since its first approval outside the U.S. 45 years ago."

"The FDA authorization helps to ensure that people from the U.S. are also able to receive this vaccination if needed, reflecting our commitment to provide health for all.”

TBE is a viral infection of the brain and spine, which can be transmitted to humans through the bite of an infected tick.

Although TBE is not endemic in the U.S., it has been identified in more than 35 countries across Europe and Asia. Additionally, the European CDC currently recommends TBE vaccination for people who live in or are traveling to risk areas.

Ticks are abundant in woodlands all across Europe from early spring to late autumn. They live by sucking blood from animals and occasionally bite humans. Ticks themselves do not cause disease, but if a tick is infected with a virus or bacterium, then that pathogen can be transmitted through the tick’s bite and cause disease in humans, says the ECDC.

To learn more, please visit www.Pfizer.com.

Note: Pfizer’s TBE vaccine is marketed under the brand names FSME-Immun® and TicoVac™ in Europe and TICOVAC™ in the U.S. More than 45 years of experience with the Pfizer TBE vaccine exist outside the U.S., and more than 170 million vaccine doses have been distributed since 1976.