Pfizer's TicoVac Tick-borne Encephalitis Vaccine Receives FDA Priority Review with Efficacy of 96-99%

Pfizer Announces FDA Acceptance of Biologics License Application for TicoVac, a Vaccine for the Prevention of Tick-Borne EncephalitisPfizer announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for TicoVac. This vaccine is indicated for the prevention of tick-borne encephalitis (TBE) in individuals aged one year and older. The press release noted that, if approved, TicoVac would be the first FDA-approved vaccine to help prevent TBE in the United States. The FDA has also granted priority review status to this BLA, with a decision expected by August of this year.

Tick-borne encephalitis (TBE) is a viral infection affecting the brain and spinal cord, transmitted to humans through the bite of infected ticks. To date, ticks carrying the TBE virus have been identified in more than 35 countries across Europe and Asia. In countries where TBE-infected ticks are endemic, the disease can affect individuals exposed to ticks during outdoor activities. TBE can progress to a severe condition; in more than one-third of patients, symptoms such as cognitive changes, muscle weakness, or permanent paralysis may persist for months or even years. In rare cases, it can be fatal. Currently, there is no cure or specific treatment for TBE, and existing therapies are primarily aimed at symptom management.

Pfizer’s TBE vaccine, marketed in Europe under the brand names TicoVac and FSME-Immune, is an inactivated whole-virus vaccine containing virus strains similar to those found in nature. Consequently, it induces neutralizing antibodies against native TBE viruses. The vaccine helps provide protection against all known TBE virus subtypes—including the European, Siberian, and Far Eastern subtypes—in children (aged one year and older) and adults.

This BLA is based on over 40 years of clinical trial evidence from outside the United States. In these studies, the pooled seropositivity rates after three doses were 99–100% in children aged 1–15 years and 94–99% in adults older than 15 years. Clinical studies have demonstrated that TicoVac is 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 individuals who have received at least two doses, and that 2–3 doses are sufficient to induce durable immune memory.

“For many years, our TBE vaccine has helped protect millions of people from this potentially serious disease. The Priority Review designation granted today by the U.S. FDA underscores the potential value that our candidate vaccine can bring,” said Dr. Nanette Cocero, President of Global Vaccines at Pfizer.

Note: This article is intended to introduce medical and health research and does not constitute a recommendation for treatment plans. For guidance on treatment options, please consult a licensed healthcare provider at a reputable hospital.

References:

[1] U.S. FDA Accepts for Priority Review Pfizer’s Application for TicoVac™ (Tick-borne Encephalitis Vaccine). Retrieved February 23, 2021, from https://www.businesswire.com/news/home/20210223006109/en

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