Pfizer Inc. (NYSE:PFE) today announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend Pfizer’s TicoVacTM (tick-borne encephalitis (TBE) vaccine) for active immunization to prevent TBE in individuals 1 year of age and older, in the following U.S. populations:
For persons who travel or move to TBE endemic areas:
- TBE vaccine is recommended for persons who are moving or traveling to a TBE-endemic area and will have extensive exposure to ticks based on their planned outdoor activities and itinerary.
- Additionally, TBE vaccine may be considered for persons traveling or moving to a TBE-endemic area who might engage in outdoor activities in areas ticks are likely to be found. The decision to vaccinate should be based on an assessment of their planned activities and itinerary, risk factors for a poorer medical outcome, and personal perception and tolerance of risk.
For laboratory workers: TBE vaccination is recommended for those with a potential exposure to the TBE virus (TBEV).
“Today’s ACIP recommendation is an important update that offers clear guidance to healthcare providers regarding when a TBE vaccine should be recommended to prevent infection,” said Nanette Cocero, Ph.D., Global President, Vaccines, Pfizer. “We are seeing that travel is opening back up. Those traveling to risk areas in Europe or Asia, whether for leisure or work, including military personnel, or those at risk of exposure to the TBE virus through laboratory work, are now able to have conversations with their healthcare providers about whether vaccination is the right option for them.”.
On August 13, 2021, the U.S. Food and Drug Administration (FDA) approved TicoVac™ for active immunization to prevent TBE in individuals 1 year of age and older.1 TicoVac™ is the only FDA-approved vaccine to help protect U.S. adults and children against the TBEV when traveling or moving to TBE endemic areas. More than 45 years of experience with the Pfizer TBE vaccine exists outside the U.S., and more than 170 million doses of the vaccine have been distributed since 1976.2-4
About TicoVac™ (Tick-borne encephalitis vaccine)
Pfizer’s TBE vaccine, marketed under the brand names FSME-Immun® and TicoVac™ in Europe and TicoVac™ in the U.S., induces protective antibodies against the three most prevalent subtypes of the TBEV circulating globally.5
In clinical trials, the safety and immunogenicity of TicoVac™ were assessed across two age groups (1-15 years and 16 years and above).1 In these studies, seropositivity rates were 99.5% in 1-15 year olds and 98.7-100% in individuals 16 years and above following three doses.*6,7 TicoVac™ has an acceptable safety and tolerability profile for both children and adults. Clinical studies demonstrated that the most common adverse reactions across both age groups were local tenderness, headache, local pain, fever, restlessness, fatigue, and muscle pain.8,9 Real-world studies from Austria have demonstrated 96-99% effectiveness in people who have received at least three doses of the vaccine.10,11
TBE is a rare but serious viral infection of the brain and spine,12 transmitted to humans through the bite of an infected tick,13,14 and less frequently by ingestion of unpasteurized milk or milk products from infected animals.15 There is currently no cure or specific treatment for TBE, but management of symptoms is possible.12 It may initially be mistaken for summer flu,16,17 but can be a serious condition with possible long-term consequences.12,17 1 in 3 people can have long-term effects that last months or years, including cognitive changes, muscle weakness or permanent paralysis,12,15 and in rare cases (0.5-2%; up to 20% in Russia), people may die.18,19 TBE can affect people of all ages who come into contact with TBEV infected ticks whenever they do outdoor activities in countries where ticks infected with the TBEV are prevalent.14,19
U.S. Important Safety Information for TicoVac™
- TicoVac™ should not be given to anyone with a severe allergic reaction (e.g. anaphylaxis) to any component of TicoVac™.
- Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of TicoVac™.
- TicoVac™ may not protect all individuals.
- Some individuals with altered immunocompetence may have a reduced response to TicoVac™.
- TicoVac™ contains albumin, a derivative of human blood, and based on effective donor screening and product manufacturing processes carries an extremely remote and theoretical risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD).
- In clinical studies, the most common adverse reactions in subjects 1 through 15 years of age who received TicoVac™ were local tenderness (18.1%), local pain (11.2%), headache (11.1%), fever (9.6%), and restlessness (9.1%).
- In clinical studies, the most common adverse reactions in subjects 16 through 65 years of age who received TicoVac™ were local tenderness (29.9%), local pain (13.2%), fatigue (6.6%), headache (6.3%), and muscle pain (5.1%).
- Safety and effectiveness have not been established in pregnant women.
Please see full prescribing information for TicoVac™ here.
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