Anthrax Spore Vaccine—Nonencapsulated.

CFR · 2024-01-01 · US · Title 9

Anthrax Spore Vaccine—Nonencapsulated shall be a live spore suspension prepared from nonencapsulated variants 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 shall be tested for immunogenicity as follows: (1) Forty-two susceptible guinea pigs from the same source each weighing 400 to 500 grams, shall be used as test animals (30 vaccinates and 12 controls). (2) An arithmetic mean spore count of vaccine produced from the highest passage of the Master Seed shall be established before the immunogenicity test is conducted. The guinea pigs used as vaccinates shall be injected as recommended on the label with a predetermined number of vaccine spores. To confirm the dosage, five replicate spore counts shall be conducted on a sample of the vaccine dilution used. (3) Fourteen to fifteen days postvaccination the vaccinates and controls shall each be challenged with not less than 4,500 guinea pig LD (4) If at least 10 of the 12 controls do not die from (5) If at least 27 of 30 of the vaccinates do not survive the 10-day postchallenge observation period, the Master Seed is unsatisfactory. (6) An Outline of Production change shall be made before authority for use of a new lot of Master Seed shall be granted by Animal and Plant Health Inspection Service. (c) (1) (2)

official document · source cfr-2024 · id 9:§ 113.66