Pfizer tick-borne encephalitis vaccine TICOVAC gets USFDA okay
New York: Pharma major, Pfizer Inc., has recently 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."
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. 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.
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