FDA Approves Ticovac Vaccine For Tick-Borne Encephalitis

Ticovac is the only FDA-approved vaccine against the TBE virus for individuals visiting or living in TBE endemic areas.

Officials with the FDA have approved Pfizer’s tick-borne encephalitis (TBE) vaccine (Ticovac) for active immunization to prevent TBE in individuals 1 year of age and older, according to a press release from Pfizer. Ticovac is the only FDA-approved vaccine against the TBE virus for individuals visiting or living in TBE endemic areas.

“We are proud to deliver the first vaccine to help protect people in the US against TBE, if they are traveling to any risk areas,” said Nanette Cocero, PhD, global president, Vaccines, Pfizer. “This vaccine has helped to protect millions of people in TBE endemic regions since its first approval outside the US 45 years ago. This authorization helps to ensure that people from the US are also able to receive this vaccination if needed, reflecting our commitment to provide health for all.”

TBE, a viral infection of the brain and spine, can be transmitted to humans through the bite of an infected tick. TBE is not currently endemic in the United States, though it has been identified in more than 35 countries throughout Europe and Asia. One in 3 individuals with TBE experience long-term effects that last months or years, including cognitive changes, muscle weakness or permanent paralysis, and in rare cases, it can be fatal.

Pfizer’s TBE vaccine was developed using a seed virus that is similar to the TBE virus found in nature. The sequence and structure of the virus subtype match those of the natural virus, and as a result, it is able to induce neutralizing antibodies against the natural TBE virus. Clinical trials have determined that the vaccine is safe and immunogenic, having been assessed in patients 1 to 15 years of age and those over 16 years of age. Seropositivity rates were 99.5% in those 1 to 15 years of age and 98.7-100% in adults following 3 doses.

Ticovac has been observed to be generally well-tolerated, with no unexpected adverse events (AEs) or vaccine-related serious AEs observed. The most common AEs across both age groups were local tenderness, headache, local pain, fever, restlessness, fatigue, and muscle pain.

REFERENCE

U.S. FDA approves TICOVAC™, Pfizer’s tick-borne encephalitis (TBE) vaccine [news release]. Business Wire; August 13, 2021. Accessed August 16, 2021. https://www.businesswire.com/news/home/20210813005441/en