• 17 Aug 2021
• Admin
• News Article

Pfizers Ticovac Vaccine Which Prevent Tick-borne Encephalitis Gets US FDA Approval

Pfizer's TICOVAC™ (tick-borne encephalitis (TBE)) vaccine has been approved by U.S. Food and Drug Administration (FDA) for active immunization to prevent TBE in individuals older than 1 year of age.The TICOVAC™ is the only FDA-approved vaccine that offers protection against the TBE virus in adults and children living or visiting TBE endemic regions. TBE is a virus that can infect the brain and spine, and is spread to humans via tick bites.With US FDA approval, the U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) will discuss recommendations regarding the safe and appropriate use of TICOVAC™. The TBE virus is not endemic in the United States, however it has been identified in more than 35 countries across Europe and Asia to date. For those living in or traveling to risk areas, the European Center for Disease Prevention and Control (ECDC) currently recommends TBE vaccination.On this major development, Nanette Cocero, Ph.D., Global President, Vaccines, Pfizer said “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."She further added, “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.”Pfizer’s TBE vaccine, marketed under the brand names FSME-Immun and TicoVac in Europe, and Ticovac in the US, 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. TBE is also transmitted to humans through the bite of an infected tick, and less frequently by ingestion of unpasteurized milk or milk products from infected animals. It may initially be mistaken for summer flu, but can be a serious condition with possible long-term consequences. One in 3 people can have long-term effects that last months or years including cognitive changes, muscle weakness or permanent paralysis, and in rare cases (0.5-2%; up to 20% in Russia), people may die. TBE can affect people of all ages who come into contact with ticks whenever they do outdoor activities in countries where ticks infected with TBE are prevalent.