EIDB Aids Licensure, CDC Recommendations for Tick-borne Encephalitis Vaccine

When a U.S. Army Officer stationed in Germany landed in the hospital a few weeks after a routine morning run, the culprit wasn’t chest pain or a sprained ankle – it was an infectious disease. On a short 5K through the wooded trails near his home, he was bitten by a tick carrying the virus that causes tick borne encephalitis (TBE), a disease that attacks the central nervous system and can result in permanent loss of brain function and even death.

Although a TBE vaccine has been in use in many European countries for more than 30 years, one was not available in the U.S., despite the fact that more than 60,000 U.S. troops are deployed to countries where TBE is both endemic and on the rise. Europe has seen 400% increase in cases in the last 30 years.

To preempt the growing threat of TBE before it impacts soldier health and readiness on a large scale, the U.S. European Command (USEUCOM) called on WRAIR’s EIDB to respond to this gap in force health protection. In less than a year, the EIDB facilitated the creation of an integrated product team within the U.S. Army Medical Research and Development Command (MRDC) to negotiate with vaccine manufacturers, forged collaborations with the Unified Armed Forces of Germany (Bundeswehr) for the study of the disease, and planned research to accelerate U.S. FDA licensure of existing TBE vaccines for use in the United States.

As a result of these efforts, Pfizer worked with MRDC to advance its European vaccine toward FDA licensure in the U.S. And in August 2021, it was announced that the U.S. Food and Drug Administration (FDA) had approved the TicoVac™ TBE vaccine for use in the U.S. in people over the age of one year. TicoVac is the first vaccine available domestically to help protect adults and children who are visiting or living in TBE endemic areas, including deployed soldiers. Last week, the CDC Advisory Committee on Immunization Practices (ACIP) approved new TBEV vaccine recommendations, which will now be taken up by the U.S. DoD.

"This has been an amazing journey, starting with a simple conversation and moving forward to an important and impactful achievement for WRAIR, MRDC" said EIDB Director Dr. Kayvon Modjarrad, who also served in the CDC ACIP working group that developed the TicoVac recommendations." We've played an important part in moving a countermeasure toward approval and availability for all of people in the U.S., but particularly for those who are at highest risk: our military service men and women."