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0:04
Okay,
so what I'd like to turn now
is to the three
pathways available
to actually getting a vaccine
product license, that is,
sending in a biological
licensing application or BLA.
The citations are given.
The first one,
21 CFR 601 Subpart C is,
for lack of a better term,
called the traditional pathway,
the standard pathway.
Subpart E
is the accelerated approval
of biological products
for serious
or life-threatening illnesses.
And Subpart H is relatively new,
and this provides an opportunity
to seek approval
of biological products
when human efficacy studies
are not ethical
or reasonable and this,
dramatically,
is called the "Animal Rule."
I'll be going
over all three of these.
1:03
So the traditional BLA pathway,
again, Subpart C of 21 CFR 601
states that the key goals
are to determine
that the licensed
biological products are safe,
effective and not misbranded.
The regulation sets
standards for safety,
effectiveness and labeling,
which I will discuss,
and requires adequate,
well-controlled clinical trials
for safety and
efficacy assessments,
as you've just seen
I've discussed
in the IND section.
There's a strong preference
for clinical disease endpoints
that is preventing disease
or preventing death
as a result of the interventions
but you'll see where there are
some exceptions to this.