Background Analysis: US FDA Advisory Committee to Discuss Chikungunya Vaccine Development – NOV 8, 2019 (VRBPAC)

Announcement

The US FDA has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting for Friday, November 8, 2019. The committee will discuss and make recommendations on the development of Chikungunya vaccines.

Indication Background

Chikungunya virus (CHIKV) is a mosquito borne virus. Within days of CHIKV exposure, most people (i.e., approximately 80%) will experience symptoms of fever and joint pain. Other possible symptoms include muscle pain, headache, weakness, and rash. These symptoms can become severe and disabling, sometimes necessitating hospitalization. Treatment typically involves rest, fluid intake and pain management. Patients can usually recover within one week of treatment, however, chronic joint inflammation and rheumatic disorders, as well as rare neurologic complications, have also been reported. The fatality rate is below 1%.

Product Background

There are currently no licensed Chikungunya vaccines.

Regulatory Background

US Regulatory Background

The purpose of the upcoming VRBPAC meeting is for the FDA to obtain recommendations on the development of Chikungunya vaccines. Of note, the Agency recently incentivized the development of Chikungunya vaccines and treatments when they announced that sponsors of applications for the prevention or treatment of Chikungunya may be eligible to receive Tropical Disease Priority Review Vouchers if their applications are approved by the FDA (Agency/Docket number: FDA-2008-N-0567, announced on August 24, 2018). A priority review voucher (PRV) entitles its bearer to a priority review of a future application for a product that would not otherwise qualify for priority review. In addition, PRVs are transferable and can be sold to other organizations.

Global Considerations

On November 29, 2018, the World Health Organization (WHO) convened experts to discuss methodological issues and agree on principles in the design, conduct and analysis of Phase 2b/Phase 3 clinical trials to evaluate Chikungunya vaccines. A meeting report has been made available at the following link: https://www.who.int/blueprint/what/norms-standards/meeting-report.pdf?ua=1 .

What’s Next?

Tarius will send a Briefing Summary after briefing materials are posted to FDA’s website (typically within 2 days of the meeting). This report will provide a summary of the FDA briefing materials.

Tarius will send a Results Wire soon after the meeting. This report will include the voting outcomes, if applicable, and key outcomes of the discussion.

METADATA: Sponsor: none Drug Name: none Drug Class: vaccine Indication: Chikungunya

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DISCLAIMER: The information in this document is for informational purposes only. The SAC Tracker Background Analysis contains information from publicly available sources, including FDA, sponsor, scientific, and clinical websites. Tarius A/S assumes no liability for any inaccurate or incomplete information, or for any actions taken in reliance thereon. © Tarius A/S. All rights reserved.