Good afternoon everybody and thank you Governor.
I'd like to start today by talking about vaccines themselves,
how do they do what they do? I would like you to think of the vaccine as forcing a
practice session on the immune system. It's a scrimmage. It's a chance to
get exposed to this virus
so that the body is ready should it become attacked
or come in contact with that that virus itself.
To give the body this sneak peek
we take a protein, one component of the virus,
and present it to the immune system, and that way the immune system
can get used to it, see it, understand it. For the COVID-19 disease,
the protein is called the spike protein and it sits
on the surface of this virus. It's important that we build this
vaccine, that we do it in a way that assures that it works, and that it's safe.
And the FDA has a number of rules that are in place so that when we develop a
vaccine we're following it step by step, looking
very closely at its safety and how well it works. You'll see that we
typically think of three phases in the in the development of a vaccine:
phase one, phase two, and phase three. The first phase involves a small number
of patients, 20 to 100 at most,
and it's really trying to determine what the right dosing is
for the the vaccine itself. How much of this spiked protein
vaccine is needed to get the immune system ready in its practice
session. Once the first phase is done, we're ready
to take it to the phase two, in which a larger number of people are
now going to be tested, looking again at the safety and
that the way the immune system responds to this vaccine.
Common safety events might be found when you're in the phase 2
trial. This can involve hundreds of patients,
but really, we're really still just looking at questions
of how the immune system seems to be responding
to this vaccine, this protein that has been
presented to it. Finally the real show begins and that's the phase three trials.
With the phase three three trials, we're enrolling
tens of thousands of people into these trials,
and these are being done in communities where this disease
is present. And here we're looking to see, does this vaccine actually do what it's
supposed to do? Does it prevent these illnesses, and does
it reduce the severity of these illnesses? And so
you can see why you need many thousands of people
to be involved in the phase three trial. The other very important information
we're getting from phase three trials is about the safety of the vaccines. So
persons enrolled are given specific cards they take home,
where they write down if they have redness of their
arm, if they develop fever. People are followed very closely.
If they go on to develop symptoms, they're followed and tested for COVID
vaccine, or virus, excuse me. If indeed they have those symptoms. So
the phase three trials are really the big ones that lead to the final
decision to license a vaccine. Next slide, please.
Now I've talked a lot about the importance of presenting
the spike protein to our immune systems. How do we do that with these new
vaccines? In general, vaccines can either be
the protein itself presented to the immune system,
or more recently developed genetic material,
or genetic code for the protein which is presented
to our immune system. With the current vaccine trials underway,
we're using new technologies that actually
present the genetic material to our immune systems.
And there are two broad categories that are being done right now.
You'll see it called MRNA, which stands for Messenger
RNA, which is simply the genetic material that one translated
creates a protein, the spike protein from the COVID-19 disease.
Another way of getting that genetic material into the body
is to take a common cold virus, the adenovirus in this case,
take out its ability through genetic engineering
to replicate or grow, insert the genetic material
for the spike protein, and then administer an adenovirus
modified vaccine which then enters into our immune systems cells, and
again produces the spike protein. These spiked
protein vaccines are presented to a variety of
immune cells, and in that process, our immunity is built.
Next slide. There are four large phase three trials now underway.
Two of them use the MRNA technologies where the genetic material
is in a protective envelope, and administered in the vaccine.
And two of them are in these adenovirus vector vaccines. Moderna
and Pfizer are both in the phase three trials for the MRNA
vaccines. Remember too, that in phase 3, we need large numbers,
so there's 30,000 volunteers in each of these two studies.
The two adenoviral studies, one done by Oxford Biomedica,
and by Jansen are also underway. And the number of participants
range between 40,000 and 60,000. This has been an important time, an
amazing time for vaccine science. Over the last
10 years, These new technologies of using direct
genetic materials has led to an ability
to quickly produce a vaccine and bring it out
to be for for use. In times past, it would have taken decades to go from phase one
to final licensure, but the platforms that have been built where you simply
need to now put in the genetic material is allowing
us to build these new vaccines in record time. Here in Colorado, we have
the opportunity to participate in vaccine trials. I know
that the Lieutenant Governor's sister is one. We have other staff in our
executive level group who are also participating
through our local universities in these vaccine trials.
We still though have to be patient because it will be a number of months
yet before these vaccines are readily available.
In the meantime, we can all do what we need to do to best protect ourselves,
the people we love, the health care workers that we depend upon.
We need to wear our masks, wash our hands, stay six feet apart,
avoid mass gatherings, and if we're at risk for severe illness, to stay
home. Thank you very much.