08 May FDA Fast Tracks Development of PaxVax Vaccine for Chikungunya
MedicalResearch.com Interview with:
Dr. Danzig
Lisa Danzig, MD
Chief Medical Office
PaxVax
MedicalResearch.com: Would you briefly explain what is meant by Chikungunya infection? Whom does it primarily affect? How is it transmitted and what the complications?
Response: Chikungunya is caused by the chikungunya virus (CHIKV), an arthropod-borne virus (arbovirus) spread by infected mosquitos.
Infection with chikungunya virus results in severe, often debilitating joint pain in infected patients, known as arthralgia. Symptoms can include intense discomfort in joints, such as the wrists, fingers, ankles, and feet, in the knees and in the hips or shoulders. Those affected can also frequently suffer from headaches, fever, and severe muscle pain, rashes on the torso and limbs and swelling in one or more cervical lymph nodes. Individuals who are at a higher risk for contracting chikungunya include infants, elderly and those with chronic conditions.
The virus is a small, spherical, enveloped, positive-strand RNA virus. The virus is transmitted by the Aedes aegypti and Aedes albopictus mosquito, which originated in Africa, first spreading to Asia and recently expanding to the western hemisphere. Outbreaks are rapid and widespread. In February 2005 a major outbreak of chikungunya occurred in the islands of the Indian Ocean after which over 1.9 million cases have been reported in India, Indonesia, Maldives, Myanmar and Thailand.
Chikungunya spread has been identified in 45 countries in the Americas alone with more than 1.7 million suspected cases reported to the Pan American Health Organization since 2015, increasing the incidence of the disease and risk to U.S. travelers. In 2016 there were approximately 60,000 cases of chikungunya across India. Beyond the Indian subcontinent, the Caribbean, Central America and South America, inhabitants and travelers visiting sub-Saharan Africa and Southeast Asia are also at risk.
MedicalResearch.com: What are the main findings of the PaxVax studies to date? What is meant by Fast Track designation?
Response: At this point, PaxVax has initiated 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 National Institutes of Health (NIH) with 400 subjects. The Phase 2b study will enroll 400 subjects to evaluate multiple dosing regimens. PaxVax expects results in early 2019.
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 product
MedicalResearch.com: What should readers take away from your report?
Response: Chikungunya represents a significant unmet public health need. Currently, there are no licensed vaccines for chikungunya prevention or treatment. The development of this chikungunya vaccine has potential to serve as a much needed medical and public health intervention.
MedicalResearch.com: Is there anything else you would like to add?
Response: A study by the U.S. Centers for Disease Control and Prevention (CDC) was published recently, indicating 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 U.S. in recent years. There is an increasingly important sense of urgency to protect everyone from these mosquito-borne illnesses.
MedicalResearch.com: Is there anything else you would like to add?
Response:
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Citation: Press Release
FDA Grants PaxVax Fast Track Designation for its Chikungunya Vaccine
Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.
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Last Updated on May 8, 2018 by Marie Benz MD FAAD