Pfizer announced 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 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. Following the FDA approval, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to discuss recommendations on the safe and appropriate use of TICOVAC.
“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,” said Nanette Cocero, Ph.D., Global President, Vaccines, Pfizer. “This vaccine has helped to protect millions of people in TBE endemic regions since its first approval outside the U.S. 45 years ago. This 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., to date, it has been identified in more than 35 countries across Europe and Asia. The European Centre for Disease Prevention and Control (ECDC) currently recommends TBE vaccination for people who live in or are traveling to risk areas.
More than 45 years of experience with the Pfizer TBE vaccine exist outside the U.S., and more than 170 million doses of the vaccine have been distributed since 1976.
Pfizer’s TBE vaccine, marketed under the brand names FSME-Immun and TicoVac in Europe, and TICOVAC in the U.S., is developed using a master ‘seed’ virus that is similar to the TBE virus found in nature. 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.
In clinical trials, the safety and immunogenicity of TICOVAC were assessed across two age groups (1-15 years of age and >16 years of age). In these studies, seropositivity rates were 99.5% in 1-15 year olds and 98.7-100% in adults >15 years following three doses. Clinical studies demonstrated that TICOVAC was generally well-tolerated with no unexpected adverse events or vaccine-related serious adverse events observed. The most common adverse reactions across both age groups were local tenderness, headache, local pain, fever, restlessness, fatigue, and muscle pain. Real-world studies from Austria have shown that the vaccine is 96-98.7% effective in people who have received at least three doses of the vaccine.