9 C.F.R. § 113.213 Pseudorabies Vaccine, Killed Virus.
Title 9 - Animals and Animal Products
Pseudorabies Vaccine, Killed Virus, shall be prepared from virus-bearing cell culture fluids. Only Master Seed which has been established as pure, safe, and immunogenic shall be used for preparing seeds for vaccine production. All serials of vaccine shall be prepared from the first through the fifth passage from the Master Seed. (a) The Master Seed shall meet the applicable general requirements prescribed in §113.200. (b) The immunogenicity of vaccine prepared from the Master Seed in accordance with the Outline of Production shall be established by a method acceptable to Animal and Plant Health Inspection Service. Vaccine used for this test shall be at the highest passage from the Master Seed and at the minimum preinactivation titer provided in the Outline of Production. (c) Test requirements for release. Each serial and subserial shall meet the applicable general requirements prescribed in §113.200 and the special requirements provided in this paragraph. Any serial or subserial found unsatisfactory by a prescribed test shall not be released. (1) Safety. Vaccinates used in the potency test in paragraph (c)(2) of this section shall be observed each day during the prechallenge period. If unfavorable reactions occur, including neurological signs, which are attributable to the vaccine, the serial is unsatisfactory. If unfavorable reactions occur which are not attributable to the vaccine, the test is inconclusive and may be repeated. If the test is not repeated, the serial is unsatisfactory. (2) Potency. Bulk or final container samples of completed product shall be tested for potency as follows: (i) Ten pseudorabies susceptible pigs (five vaccinates and five controls) shall be used as test animals. The animals shall be at the minimal age recommended for vaccination. Blood samples shall be drawn and individual serum samples inactivated and tested for neutralizing antibody. (ii) A constant virus-varying serum neutralization test in cell culture using 50 to 300 TCID50 of virus shall be used. Pigs shall be considered susceptible if there is no neutralization at 1:2 final serum dilution. Other tests of equal sensitivity acceptable to Animal and Plant Health Inspection Service may be used. (iii) The five pigs used as vaccinates shall be administered one dose of vaccine as recommended on the label. If two doses are recommended, the second dose shall be given after the interval recommended on the label. (iv) Fourteen days or more after vaccination, blood samples shall be drawn and individual serum samples inactivated and tested for pseudorabies virus neutralizing antibody by the method used to determine susceptibility. (v) Test interpretation. If the controls have not remained seronegative at 1:2, the test is inconclusive and may be repeated. If at least four of the five vaccinates in a valid test have not developed titers of at least 1:8, and the remaining vaccinate has not developed a titer of at least 1:4, the serial is unsatisfactory, except as provided in paragraph (c)(2)(vi) of this section. (vi) Virus challenge test. If the results of a valid serum neutralization test are unsatisfactory, the vaccinates and controls may be challenged with virulent pseudorabies virus furnished or approved by Animal and Plant Health Inspection Service. The animals shall be observed each day for 14 days postchallenge. If four of five controls do not develop central nervous system signs or die, the test is inconclusive and may be repeated. In a valid test, if two or more of the vaccinates develop clinical signs or die, the serial is unsatisfactory. [50 FR 434, Jan. 4, 1985. Redesignated at 55 FR 35562, Aug. 31, 1990, as amended at 56 FR 66784, 66786, Dec. 26, 1991]
Title 9: Animals and Animal Products
PART 113—STANDARD REQUIREMENTS
Killed Virus Vaccines
§ 113.213 Pseudorabies Vaccine, Killed Virus.
