FDA Grants Priority Review to Possibly First TBE Vaccine from Pfizer

The US Food and Drug Administration (FDA) has accepted Pfizer’s regulatory application of tick-borne encephalitis vaccine (TicoVac) for Priority Review.

The expedited pathway for the company’s Biologic License Application (BLA) would mean the vaccine could mean the vaccine could become the first approved in the US for preventing tick-borne encephalitis (TBE) in adults and children aged 1 year and older visiting or living in TBE endemic areas.

The FDA will anticipatedly decide on the application in late August.

A tick-borne viral infection of the brain and spine, TBE can also be transmitted via ingestion of unpasteurized milk or milk products from infected animals. More than one-third of all infected patients experience long-term effects including cognitive changes, muscle fatigue or permanent paralysis, and rarely, death.

Though not endemic in the US, TBE has reported in 35-plus countries around the world, and has no cure.

Marketed as FSME-Immun in Europe, the TBE vaccine is an inactivated whole virus vaccine developed via a master “seed” virus similar to the real-world TBE virus. It has been proven to prevent infection against all known subtypes of TBE in both children and adults, as well as European, Siberian, and Far Eastern subtypes.

Pfizer’s BLA is based on findings from 40-plus years of experience and evidence collected outside the US. TicoVac’s immunogenicity and safety was assessed in clinical trials including 2 age groups: pediatric participants aged 1-15 years old, and older participants aged 16-65 years old. Investigators observed pooled seropositivity rates of 99-100% among the younger vaccine arm, and 94-99% among the older arm, following 3 doses and over a span of 15-plus years.

Additional real-world trials have evidenced the vaccine is 96-99% effective in people who have received ≥2 doses.

In commenting on its proven history in preventing TBE and its potentially unique utility in US administration—including providing prevention for overseas military personnel—Nanette Cocero, PhD, Global President of Vaccines at Pfizer, commended the team’s work toward TBE prophylaxis regulation.

“For many years, our TBE vaccine has helped protect millions of people in Europe from this potentially serious disease,”Cocero said in a statement. “We are proud that today’s US FDA Priority Review acceptance acknowledges the potential value that our vaccine candidate can bring.”