Pasteurella Multocida Vaccine, Avian Isolate.

CFR · 2024-01-01 · US · Title 9

Pasteurella Multocida Vaccine, Avian Isolate, shall be prepared as a desiccated live culture of an avirulent or modified strain of (a) The Master Seed shall meet the applicable general requirements prescribed in § 113.64 and the requirements in this section. (b) Each lot of Master Seed used for vaccine production shall be tested for immunogenicity in each species and for each serotype for which the Master Seed is claimed to give protection. (1) Thirty (2) An arithmetic mean count of colony forming units from vaccine produced from the highest passage of Master Seed shall be established before the immunogenicity test is conducted. The 20 birds to be used as vaccinates shall be inoculated, as recommended on the label with a predetermined quantity of vaccine bacteria. The 10 control birds shall be held separately from the vaccinates. To confirm the dosage calculation, an arithmetic mean count shall be established by conducting five replicate titrations on a sample of the bacterial vaccine used. Only plates containing between 30 and 300 colonies shall be considered in a valid test. (3) Not less than 14 days after vaccination, each of 20 vaccinates and each of 10 unvaccinated controls shall be challenged intramuscularly or by other methods acceptable to the Animal and Plant Health Inspection Service with a virulent (4) Eight or more of the unvaccinated controls must die for the test to be (c) (1) (i) Ten birds of a species for which the vaccine is recommended shall be given the equ

official document · source cfr-2024 · id 9:§ 113.70