113.301—Ovine Ecthyma Vaccine.
Ovine Ecthyma Vaccine shall be prepared from tissue culture fluids or virus-bearing tissues obtained from sheep that have developed ovine ecthyma following inoculation with virulent ovine ecthyma virus. Ovine Ecthyma Vaccine is exempt from the requirements prescribed in §§ 113.27 and 113.300(a), (b), and (c). Each serial shall meet the moisture requirements in § 113.300(e) and the special requirements prescribed in this section. Any serial found unsatisfactory by a prescribed test shall not be released.
(a) Safety tests.
(1)
Bulk or final container samples of completed product from each serial shall be tested for safety as prescribed in § 113.38.
(2)
The prechallenge period of the potency test shall constitute a safety test. If unfavorable reactions attributable to the vaccine occur in either of the vaccinates during the observation period, the serial is unsatisfactory.
(b) Potency test.
Final container samples of completed product from each serial and each subserial shall be tested for potency using susceptible lambs. The vaccine shall be prepared as recommended for use on the label.
(1)
Each of two lambs (vaccinates) shall be vaccinated by application of the vaccine to a scarified area on the medial surface of the thigh and observed each day for 14 days.
(2)
The immunity of the two vaccinates and one or more unvaccinated lambs (controls) shall be challenged in the same manner as for vaccination, using the opposite thigh.
(3)
If typical signs of ovine ecthyma, such as hyperemia, vesicles, and pustules do not develop on the controls during the first 2 weeks following challenge and persist for approximately 30 days, the test is inconclusive and may be repeated.
(4)
If the vaccinates do not show a typical immune reaction, the serial is unsatisfactory: Provided, That, an initial active reaction with hyperemia which resolves progressively and disappears within 2 weeks, may be characterized as a typical immune reaction.