February 23, 2021: “Pfizer Inc. announced that the U.S. FDA accepted for Priority Review the company’s BLA for TicoVac™, its tick-borne encephalitis (TBE) vaccine for active immunization to prevent TBE in individuals 1 year of age and older.
If approved, TicoVac would be the first vaccine in the U.S. to help protect adults and children who are visiting or living in TBE endemic areas.
In line with Priority Review designation, the FDA will target an action within six months of the application submission date, with the anticipated Prescription Drug User Fee Act (PDUFA) action date expected for August 2021.
TBE is a viral infection of the brain and spine, which is transmitted to humans through the bite of an infected tick.
To date, ticks infected with the TBE virus have been identified in more than 35 countries across Europe and Asia.
The European Centre for Disease Prevention and Control (ECDC) currently recommends TBE vaccination for people who live in or are traveling to these risk areas.
“For many years, our TBE vaccine has helped protect millions of people in Europe from this potentially serious disease. We are proud that today’s U.S. FDA Priority Review acceptance acknowledges the potential value that our vaccine candidate can bring,” said Nanette Cocero, Ph.D., Global President, Vaccines, Pfizer Inc.
“If approved in the U.S., we hope this vaccine will help protect those traveling to or residing temporarily in at-risk locations, potentially including military personnel who are serving overseas.”
The BLA is based on results from more than 40 years of experience and evidence outside the U.S.
In clinical trials, the safety and immunogenicity of TicoVac was assessed across two age groups (1-15 years of age and 16-65 years of age).
In these studies, pooled seropositivity rates were 99-100% in 1-15 year olds and 94-99% in adults >15 years following three doses.*
Clinical studies demonstrated that TicoVac was well-tolerated with no unexpected adverse events or vaccine-related serious adverse events observed.
Subsequent real-world studies have shown that the vaccine is 96-99% effective in people who have received at least two doses of the vaccine, and two to three doses of the vaccine were shown to be sufficient to provide a long-lasting immune memory.
About TicoVac™ (TBE vaccine, whole virus inactivated)
Pfizer’s TBE vaccine, marketed under the brand names TicoVac and FSME-Immun™ in Europe, is an inactivated whole virus vaccine developed using a master ‘seed’ virus that is similar to the TBE virus found in nature.
Therefore, 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.
The vaccine helps provide protection against all known subtypes of the TBE virus in both children (from one year of age) and adults, including the European, Siberian and Far Eastern subtypes.
More than 40 years of experience with the Pfizer TBE vaccine exist outside the U.S., and more than 160 million doses of the vaccine have been distributed since 1976.
About TBE
TBE is a viral infection of the brain and spine, 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.
More than 1 in 3 people can have long-term effects that last months or yearsincluding 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.
Although TBE is not endemic in the U.S., TBE has been reported in more than 35 countries, ranging from Western Europe to Japan.
Currently there is no cure or treatment for TBE, only management of symptoms.
The potential vaccine could help protect people from the U.S. who are traveling to or living in endemic regions.”
https://www.pfizer.com/news/press-release/press-release-detail/us-fda-accepts-priority-review-pfizers-application
