Encephalomyelitis Vaccine, Eastern, Western, and Venezuelan, Killed Virus.

CFR · 2024-01-01 · US · Title 9

Encephalomyelitis Vaccine, Eastern, Western, and Venezuelan, Killed Virus, shall be prepared from virus-bearing cell culture fluids. Each serial or subserial shall meet the requirements prescribed in this section and the general requirements prescribed in § 113.200, except those in § 113.200(d). Any serial or subserial found unsatisfactory by a prescribed test shall not be released. (a) (1) Each of at least ten 6 to 12 hour old chickens shall be injected subcutaneously with 0.5 ml of the product and the chickens observed each day for 10 days. (2) If unfavorable reactions attributable to the product occur in the chickens during the observation period, the serial is unsatisfactory. If unfavorable reactions not attributable to the product occur, the test is a No Test and (b) (1) For this test, a guinea pig dose shall be one-half the amount recommended on the label for a horse and shall be administered as recommended for a horse. Each of 10 healthy guinea pigs (vaccinates) shall be injected with two guinea pig doses with an interval of 14 to 21 days between doses. Two additional guinea pigs from the same source shall be held as controls. (2) Fourteen to 21 days after the second injection, serum samples from each vaccinate and each control shall be tested by a plaque reduction, serum neutralization test using Vero 76 cells. (3) If the control serum samples show a titer of 1:4 or greater for any fraction, the test is a No Test for that fraction and may be repeated: (4) If two or th

official document · source cfr-2024 · id 9:§ 113.207