The
AVMA Vaccination Study
- continued
VACCINE
LICENSING
Biological agents are regulated by the USDA, not the Food and
Drug Administration, and thus are not subject to those regulations
that address extra label use. Veterinarians can legally use vaccines
in a discretionary manner.
USDA licensing at the full approval level provides a baseline
standard for efficacy, safety, purity, and potency, but the clinical
need (relevancy) or usefulness (applicability) of a product are
not assured by the licensing process. The USDA must approve labels
for biological products. However, current labels frequently contain
revaccination interval recommendations based on historical precedence
and regulation rather than scientific data, may fail to adequately
inform practitioners about the optimal use of the product, and
the testing methods may be inadequate to identify rare but relevant
safety concerns.
Labels on licensed vaccines make different claims and should be
carefully studied when evaluating products. Claims may, for example,
declare the product (a) prevents infection, (b) prevents disease,
or (c) results in a decreased number or a decreased intensity
of clinical signs. Each of these claims represents a different
level of performance outcome that might be important in selection
of a specific vaccine.
USDA-approved products licensed under the conditional approval
process have demonstrated a reasonable expectation of efficacy.
Autogenuous vaccines have no demonstrated efficacy.
1,
2, 3, 4
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