PaxVax’s chikungunya vaccine receives US FDA fast track designation

PaxVax, a leading independent specialty vaccine company, has received Fast Track designation from the US Food and Drug Administration (FDA) for its vaccine for the prevention of disease caused by the chikungunya virus.

About Chikungunya: 

• Chikungunya represents a significant public health need and can cause headache, muscle pain, and skin rashes, with severe, often debilitating, joint pain that can persist for years, especially in adults.
• The virus spreads through mosquito bites and can often cause large outbreaks.
• A recent study by the US Centers for Disease Control and Prevention (CDC) indicates that the number of people getting infected with diseases transmitted by tick, flea and mosquito bites, such as chikungunya, has more than tripled in the US in recent years. There are no licensed vaccines for chikungunya prevention and no specific treatments.

Regulatory Note: 

• The FDA’s Fast Track program is designed to facilitate the development and expedite the review of therapies and vaccines for serious or life-threatening conditions to address unmet medical needs, with the intention to accelerate availability of products.
• “This Fast Track designation is another positive step for the development of our chikungunya vaccine, in addition to our recent Phase 2b initial patient enrollment, and is a clear recognition of the serious unmet need,” said Lisa Danzig, MD, chief medical officer of PaxVax. “This is another example of the capabilities of our technology platform and our steadfast commitment to developing specialty vaccines that protect against overlooked infectious diseases as mosquito-borne diseases continue to increase due to air travel and warmer weather.”

The vaccine was licensed from the National Institute of Allergy and Infectious Diseases (NIAID) at National Institutes of Health (NIH). PaxVax recently announced the enrollment of the first patient in its Phase 2b dose-finding trial of the chikungunya virus-like particle (VLP) vaccine, building upon a phase 2a study by the NIH with 400 subjects. The Phase 2b study is in the process of enrolling 400 subjects to evaluate multiple dosing regimens. PaxVax expects the results in early 2019.