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Before
it can be made widely available, SpayVac™ must meet FDA requirements.
We anticipate that our goal can be reached in 4–5 years, assuming
that adequate funding (approx. $5 million ) can be secured in a
timely manner and that no serious technical obstacles are encountered.
Good
Manufacturing Practice (GMP)
GMP is intended to assure the “identity, strength, quality,
and purity” from batch to batch of any vaccine. This is a
very demanding requirement, which may require more than $1 million
to achieve. GMP must be in place before any of the pivotal trials
can be undertaken. This will require 1–2 years to complete.
Adjuvant
Adjuvants are agents that are incorporated into vaccines to stimulate
the immune response. The Fallow Deer trials used a SpayVac™
formulation that included Freund’s Complete Adjuvant, a very
powerful agent that is used extensively in research but that cannot
receive regulatory approval. However, the Penn State trials used
SpayVac™ with Adjuvac, an adjuvant developed at the USDA’s
National Wildlife Research Center, which has been previously approved.
Thus, the final formulation to be taken forward to the FDA will
incorporate Adjuvac. |
PZP
Source
Native PZP, used in SpayVac™ and other IC vaccines, has been
routinely obtained as a by-product from slaughterhouses, and this
may continue to be the source of PZP for SpayVac™ in the future.
However, experiments are underway at the University of Georgia to
explore whether recombinant PZP, produced by laboratory bacteria,
could replace native PZP. Should recombinant PZP prove effective,
both regulatory and manufacturing challenges would be greatly reduced.
FDA
Trials
Once a GMP vaccine is available, three types of pivotal trials must
be undertaken:
- Efficacy,
to prove independently that SpayVac™ is highly effective,
- Target-animal
safety, to show that SpayVac™ is not harmful to the animals
that will be treated, and
- Human-food
safety, to establish in laboratory animals that consuming SpayVac™-treated animals by humans
is not harmful.
These
trials can be completed in 2–3 years. |
