U.S. Travelers Get New Vaccine Option

ACIP recommendation provides new option for protection against tick- borne encephalitis (TBE) for U.S. travelers

Over the past four decades, the world has seen many changes—from varying heads of states to technological advances, new cultural phenomena to global crises. One constant in this time has been Pfizer’s tick-borne encephalitis (TBE) vaccine, FSME-Immun®/TicoVac™. In 1976 the vaccine was first introduced to the pharmaceutical market in Austria, with over 170 million doses of the vaccine having been distributed since launch.1,2

In 2022, following an approval by the U.S. Food and Drug Administration (FDA) in 2021, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices’ (ACIP) voted to recommend* TicoVac for active immunization to prevent TBE in U.S. populations one year of age and older who travel or move to TBE endemic areas and will have exposure to ticks, and laboratory workers with potential exposure to the TBE virus (TBEV).

Two travellers at picnik table

Spending time outdoors may put you at risk of tick bites.

The burden of TBE

TBE is a rare infection involving the central nervous system, affecting the brain and spine.3 It can lead to serious and complicated long-term consequences, including cognitive changes, muscle weakness or permanent paralysis.3,4

There is currently no cure or specific treatment for TBE, only management of symptoms.5 Therefore, it’s important to help protect against TBE if spending time outdoors in an area where there is a risk of being infected with the TBE virus.

These areas where there is a risk of TBE are increasing as geographical reach of TBE is expanding.5 To date, TBE has been reported in more than 36 countries, from across Western Europe to parts of Asia, meaning that U.S. citizens traveling to or living in these regions may be at risk of TBE if bitten by a tick.5

Providing a new option for protection

Following discussions amongst the TBE Vaccine Work Group and a detailed analysis of extensive data from more than 20 years of evidence of use from outside the U.S., ACIP voted to recommend TicoVac for specific groups of at-risk individuals in February 2022. These included:

  • Persons who are moving or traveling to a TBE-endemic area and will have extensive exposure to ticks based on their planned outdoor activities and itinerary
  • Persons traveling or moving to a TBE-endemic area who might engage in outdoor activities in areas ticks are likely to be found may consider vaccination (where the decision to vaccinate should be based on an assessment of their planned activities and itinerary, risk factors for a poorer medical outcome, and personal perception and tolerance of risk)
  • Laboratory workers with a potential exposure to the TBE virus (TBEV)

"This recommendation clearly demonstrates our ongoing commitment to patients, helping ensure that a vaccine with 46 years of heritage continues to be made available to new groups of at-risk individuals. This vote is important as it provides clear guidance for healthcare providers on when a TBE vaccine should be recommended to prevent infection, supporting conversations between patients and healthcare providers about whether vaccination is the right option for them,” said Alejandro Cane, VP, US/IDM Vaccines and Antivirals Medical and Scientific Affairs Lead, Pfizer.

As the world opens up again in the wake of COVID–19, this ACIP recommendation* means that U.S. individuals who are traveling or moving abroad to TBE-endemic areas in Europe or Asia, potentially including military personnel and their families, or those at risk of virus exposure through laboratory work have access to another option to help protect themselves.

Ensuring that broader populations have the option to help protect themselves from a potentially serious infection whilst traveling forms part of Pfizer’s ongoing commitment to helping address tick-borne diseases.

* ACIP recommendations are provisional until published in the Morbidity and Mortality Weekly Report (MMWR).

  1. Pfizer. Data on file. 2021 FSME-IMMUN® doses
  2. Barrett PN. Tick-borne encephalitis virus vaccines, p 773–88. In: Plotkin SA, Orenstein WA, PA O, (ed). Vaccines. Sixth edition. Elsevier Saunders; 2013, Philadelphia, PA
  3. Lindquist L, et al. Tick-borne encephalitis. The Lancet. 2008;371(9627):1861-71
  4. Kaiser R. Tick-borne encephalitis. Infect Dis Clin North Am. 2008;22(3):561-75.
  5. Dobler G, Erber W, Bröker M, Schmitt HJ, eds. The TBE Book. 5th ed. Singapore: Global Health Press; 2022. Available from https://tbenews.com/tbe/(link is external). Accessed: November 2022.