FDA Gives Nod to Pfizer’s Tick-Borne Encephalitis Vaccine

 

The U.S. Food and Drug Administration (FDA) has approved Pfizer’s tick-borne encephalitis (TBE) vaccine TICOVAC to prevent TBE in people aged 1 year and older. This approval makes TICOVAC the only FDA-backed vaccine in the U.S. to protect people of all ages against the virus when visiting or living in TBE endemic regions.

TBE, a viral infection, is transmitted to humans via an insect bite. The infection, which affects the brain and spine, has been reported in over 35 countries across Asia and Europe but is not known to be endemic in the states.

Recommendations from the European Centre for Disease Prevention and Control (ECDC) state that people who live or are traveling to endemic regions should receive TBE vaccination. Currently, experience with Pfizer’s TBE vaccine has been documented outside the U.S. for more than 45 years. Additionally, more than 170 million vaccine doses have been delivered to people since 1976.

“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 Pfizer’s global president of Vaccines, Nanette Cocero, Ph.D., in a statement. “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.”

The vaccine is marketed in Europe as FSME-Immun and TicoVac and in the U.S. as TICOVAC. The company says the vaccine was developed with “a master ‘seed’ virus that is similar to the TBE virus found in nature” and is capable of inducing “neutralizing antibodies against the natural TBE virus.”

Clinical trials have assessed the safety and immunogenicity of the Pfizer TBE vaccine across patients aged 1 to 15 years as well as patients older than 16. Seropositivity rates after three doses were 99.5% in patients between 1 and 15 years and 98.7% to 100% in people older than 15 years. These studies also found TICOVAC was generally well-tolerated and corresponded with no unexpected side effects or serious adverse events related to the vaccine.

Pfizer said after the FDA approval that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will soon discuss recommendations on the appropriate use of TICOVAC based on the available clinical evidence.

On Thursday, the FDA also gave the amended Emergency Use Authorization for Pfizer and BioNTech’s COVID-19 vaccine, which allows a third booster shot for patients who are immunocompromised. The amendment specifically targets patients who have been diagnosed with illnesses considered “equivalent” to immunocompromising conditions as well as those who have received a solid organ transplant.

News of the amendment arrive in the midst of rising cases attributable to the Delta variant. The CDC is also set to discuss additional recommendations for COVID-19 vaccine boosters in immunocompromised patients. These recommendations are expected sometime today.

Amendments made to Pfizer and Moderna’s COVID-19 vaccine administration schedules were made after the FDA reviewed data that showed a booster shot, administered six months following the second dose, could offer increased protection for the immunocompromised. Additionally, the FDA states that people who are in close physical contact with these patients should also receive a booster shot.