FDA Grants Fast Track Designation to Chikungunya Vaccine

May 4, 2018

The U.S. FDA has granted Fast Track designation to PaxVax for development of its vaccine for prevention of the chkungunya virus.

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PaxVax for development of its vaccine for prevention of the chkungunya virus.

The designation comes on the heels of the initiation of Phase 2a and Phase 2b studies conducted by the National Institute of Health (NIH), each of which enrolled 400 subjects, to evaluate safety and efficiency, and multiple dosing regimens, respectively.

The vaccine was licensed from the National Institute of Allergy and Infectious Diseases (NIAID) at NIH, and PaxVax expects study results in early 2019.

Chikungunya virus is an arthropod-borne RNA virus (arbovirus), and is closely related to other viruses in Africa, South America and Australia that cause similar symptoms. The virus is vectored by the Aedes aegypti mosquito, which can also transmit yellow fever, Zika and dengue viruses.

The virus was first discovered in sub-Saharan Africa, but has variants that spread throughout tropical areas of the world.

“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 in a press release. “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.”

Earlier this week, the CDC announced that the number of people being transmitted diseases by ticks, fleas and mosquitos, such as chikungunya, has tripled in the U.S. in recent years, making this update particularly timely.

“It is exciting to see this vaccine candidate moving forward with Fast Track designation as this is an extremely debilitating disease with the potential for causing serious long term sequelae,” said Eva Harris, PhD Professor, Division of Infectious Diseases and Vaccinology and Director, Center for Global Public Health, University of California, Berkeley. “As there are currently no therapies or vaccines available for treatment or prevention of chikungunya, we are in desperate need for a medical and public health intervention.”

VLP vaccines are non-infectious multi-protein structures that mimic the organization and conformation of naturally occurring viruses, but lack the viral genome. Additionally, the chikungunya VLP vaccine sustains natural epitopes to mimic natural infection.

Because VLP vaccines are non-infectious, they avoid safety concerns during production or use. Furthermore, the chikungunya VLP vaccine maintains natural epitopes to mimic natural infection and derives high immunogenicity.

For more from the FDA, follow Rare Disease Report on Facebook and Twitter.


x