-The phase 3 trial
has already started.
It's a trial that will go over
several months
involving 30,000 individuals.
We hope that as the time we get
into the late fall
and early winter,
we will have, in fact,
a vaccine that we can say
would be safe and effective.
-On July 27th, the US began
one of the biggest steps
toward combating novel
coronavirus --
clinical trial phase 3.
-Patients enrolling in any trial
are volunteers.
They're not specifically chosen.
-As I was trying to think,
"What can I do to help
in this pandemic?"
I can't be taking care
of patients,
but I wanted to get involved
in doing something.
I called up and said,
"Can I be part of it?"
-Phase 3 is the last part
of a series of steps
in developing a vaccine,
which has
a standardized procedure.
During the exploratory phase,
heavy research is done
to find an antigen,
a foreign molecule that causes
your body's immune system
to make antibodies
to try to kill it off.
Typically, this antigen
is a weakened
or dead strain
of the virus itself,
and several hundred potential
antigen candidates are found.
Next comes
the pre-clinical phase,
where researchers
use tissue and animals
to test various antigens.
If they don't produce
proper antibodies,
or prove harmful
to the subjects,
the antigen is discarded as
a potential vaccine candidate.
Any antigen candidate
that passes
through pre-clinical phase
then goes through
clinical development,
which itself is split
into three phases.
Phase 1 examines
physical responses to antigens,
phase 2 determines safety
and proper dosing measurements,
and phase 3 applies
those safety measures
to a large scale of patients,
and each phase uses
an increasing amount
of test subjects.
If an antigen passes phase 3,
its developer submits a license
known as a biologics
license application to the FDA.
After approval, it officially
becomes a vaccine,
where it can undergo
an optional fourth phase
to further refine safety before
major drug manufacturers create
and supply it
to the public.
This vaccine-development process
is the standard
for all vaccines
in the United States.
In 1944, the United States
Public Service Act was passed.
It mandated that the federal
government issues licenses
for all biological products,
including vaccines.
But the vaccine process
would be refined in 1954
after Cutter
Laboratories
accidentally distributed
more than 200,000 vaccines
with live polio viruses
to the patients,
causing thousands
to contract polio symptoms
in what became known
as the Cutter Incident.
-I have been involved
in many clinical trials.
Most of the studies
I've done have been
in malaria vaccine development.
With COVID-19, it is affecting
more industrialized nations
than malaria,
but at the same time,
we are seeing the economically
disadvantaged individuals
suffer disproportionately
from COVID-19.
So, this particular Moderna
vaccine trial
has a second vaccination
four weeks after the first.
Over seven days, they would
complete a diary
where they would tell us what
their temperature is every day,
how they're feeling,
if they have any pain
where the injection was given,
if they feel fatigue,
or if they have any muscle pain,
and then they're brought
in three more times
to check their immune response
after that second vaccination.
We're collecting information
on COVID symptoms.
If they're positive, then that
counts as a case for the study.
We have half of our individuals
who get placebo
and half who get the vaccine.
None of the participants
nor the investigators
know who gets what.
It's only the biostatisticians
and actually the pharmacists
who know who gets what.
-If everyone got the vaccine,
you wouldn't really be able
to differentiate
whether it was the vaccine that
was responsible for the outcome,
or whether there were
other underlying factors.
-After a certain number of cases
of COVID-19,
we'll be looking at the data
collected up to that time point
to see
what the efficacy numbers are.
Decisions are made
whether or not
we need to publish results
and let folks know that we have
something that really works well
or if we have something that
doesn't seem to work at all.
-Typical vaccine processes
take around 10 to 15 years
to properly develop.
In COVID-19's case,
reaching phase 3
has just taken a few months,
which is the fastest
the United States
has ever produced
a potential vaccine.
But despite the accelerated
timeline,
scientists assure the public
every possible safety precaution
is being taken.
-We aren't sidestepping
any of the safety parameters
that we normally would look at
as far as vaccine development.
Good for many of the candidates
that are in the pipeline
right now, the safety results
have been promising,
as well as the immune response.
Those two parameters allow us
to accelerate to the next phase
quickly because it's already
been pre-planned and sites
are already ready.
-The federal government
is doing advanced purchases
for the vaccine,
so it is extremely unlikely
that,
at least in the first
round of things,
you're gonna see vaccines
that some people can get
and some people won't.
We brought in someone who is
an expert in supply chain
and distribution,
an army general, General Perna,
that's part of this Operation
Warp Speed
that has been developed.
I think the American public
should be assured
that in the process
of determining
the safety and efficacy,
the proper steps
have been taken.
-If we can do just a little bit
to just help save this world,
save people in this world,
then it's probably the most
important thing I could do --
yeah, I could do.
