Oral rabies Vaccine wildlife baits ONRAB
Waiver type - Procurement: Nonavailability
Agency: ANIMAL AND PLANT HEALTH INSPECTION SERVICE (12K3) • Product Service Code (PSC) : 6505 | Last Modified: 05/17/2023
Procurement Summary
This acquisition is for wildlife baits containing oral rabies vaccine (ORV). The Government proposes to purchase up to 7,500,000 (approximately 2,084 boxes) units of the Ultralite bait containing the ORV ONRAB. Each Ultralite bait contains 1.8±0.1 ml of ONRAB vaccine (titer of not <109.5 cell culture infectious dose 50% [CCID50]/ml) in an elongated plastic blister pack that is coated with an attractant-bait matrix.
Waiver Rationale Summary
The Center for Veterinary Biologics, Ames, Iowa must approve all potential rabies vaccine manufacturers to confirm their products complies with the regulatory processes. There are no US made end products known to the CVB or available on the market. The ONRAB bait produces higher levels of rabies antibody seroconversion. ONRAB was identified as a candidate for testing, in part, because this oral vaccine demonstrated higher levels of rabies antibody seroconversion in raccoons than the oral vaccine currently in use in the United States in two cross border comparison studies. In addition, it has produced favorable control in raccoons and, in some cases, skunks in Canada.
No
Yes
Consistent with Policy
DRUGS AND BIOLOGICALS
325414 - Biological Product (except Diagnostic) Manufacturing
05/10/2023
12639523Q0108
Post-solicitation
Between 2 and 3 years
Individual Waiver
ANIMAL AND PLANT HEALTH INSPECTION SERVICE