MEDGENE'S RHDV2 VACCINE GRANTED CRITICAL LICENSE BY USDA'S CENTER FOR VETERINARY BIOLOGICS

The vaccine targeting the lethal Rabbit Hemorrhagic Disease has successfully passed required efficacy and duration-of-immunity tests

BROOKINGS, S.D., Nov. 2, 2023 /PRNewswire/ -- Medgene, an animal health company that produces highly-targeted platform vaccines, has been granted a Conditional Use License by the United States Department of Agriculture's Center for Veterinary Biologics (USDA-CVB) to further manufacture and distribute its vaccine targeted at Rabbit Hemorrhagic Disease (RHDV2).

"Conditional approval is a testament to the proven safety and efficacy of this important vaccine. Medgene stepped up at a critical time and the rabbit community is more than grateful for the protection and prevention of RHDV2 deaths in our beloved bunnies," stated Dr. Anthony Pilny, Medical Director for the House Rabbit Society.

Once contracted, RHDV2 is usually fatal and affects wild and domestic rabbit populations. RHDV2 is classified as a Foreign Animal Disease by the USDA-CVB, with this recent outbreak first being detected in 2020 in a domestic rabbit in New York City. Since that time, the disease has spread throughout the United States.

RHDV2's virulence and rapid spread prompted the USDA-CVB to grant Medgene's vaccine Emergency Use Authorization following successful testing for reasonable expectation of safety and efficacy in 2021. Additional tests further measuring the vaccine's safety, efficacy and duration of immunity have continued. USDA-CVB's approval of the Conditional Use License is supported by successful satisfaction of full safety, efficacy and duration of immunity criteria.

Medgene's Conditional Use License is especially important for designated State Veterinarians as they are the authority allowing distribution of the vaccine within their respective states.

Dr. Gary Bosch, Executive Vice President of Medgene stated, "(RHDV2) has been heartbreaking for the rabbit community. When RHDV2 first hit, we were grateful to provide some hope against the onslaught of the disease under USDA-CVB's Emergency Use Authorization. Today, we're able to support it with a Conditional Use License. This success is a combined effort between USDA-CVB, state veterinarians, rabbit owners, and the Medgene team."

Medgene CEO, Mark Luecke, added, "We continue to appreciate USDA-CVB's attentiveness to veterinarian and animal owner needs as these emerging diseases present grave threats to animal health. We also appreciate USDA-CVB's recognition of our platform vaccine technologies as important tools in protecting our animals. We must continue to collaborate to improve our country's disease preparedness."

Rabbit owners are encouraged to contact their local veterinarian for more information on RHDV2 and vaccination. 

For information on RHDV2:
https://www.aphis.usda.gov/aphis/maps/animal-health/rhd

For information on Medgene:
https://medgenelabs.com/rabbits

SOURCE Medgene