>> The science of vaccinology,
together with the tools of public health,
are the thing that is going to get us out of this.
This will end.
This is not something that's going to be
with us forever.
>> Tell me more; tell me more about vaccines.
>> Researchers and scientists with the
support of the US government are racing
against the clock to develop a vaccine against
the novel coronavirus. >> My name is Dr. Anthony
Fauci and I'm the Director of the National Institute
of Allergy & Infectious Diseases at the National
Institutes of Health in the Department of Health &
Human Services.
What we have here with the coronavirus,
is a virus that's new, that is highly efficient
in spreading from human to human,
and has a relatively speaking,
a considerable degree of morbidity and mortality.
You put all those things together,
and that's the perfect storm.
>> How would a vaccine protect us from the
novel coronavirus?
The virus that causes COVID-19,
known as SARS-CoV-2, is made up of an outer lipid
envelope, inside of which is coiled a single RNA strand.
Once the virus enters the body,
its outer protein spikes attach themselves to
receptors on cells in the lungs.
The spikes allow the RNA strand to slip into
healthy cells and reproduce,
killing the healthy cell, and spewing out multiple
new versions of the virus.
The host's immune system reacts by creating
specific antibodies, and by activating immunity
cells to fight the virus.
A COVID-19 vaccine would provide a protective
shield by stimulating immune response ahead of
any exposure to the virus.
>> One of the great triumphs of medical
science and dealing with infectious diseases,
has been vaccinations.
It has saved hundreds and hundreds and hundreds of
millions of people's lives.
Now you have smallpox eradicated,
polio eliminated, measles in many countries
eliminated, rubella, mumps, hepatitis,
meningitis, all those things.
>> How do scientists develop a new vaccine?
To develop a vaccine, typically research
sponsors begin by selecting a methodology &
developing a candidate, through lab research and
selective humane testing on animals.
With approval from the U.S.
Food and Drug Administration,
clinical trials in humans can begin.
Phase 1 of clinical trials assesses the safety of the
vaccine in a small group of volunteers.
Phase 2, assesses both safety and efficacy of the
vaccine in a slightly larger study group.
And then Phase 3, which is a very large trial,
assesses efficacy in a large population of
subjects against control groups.
>> In the case of the COVID-19 Phase 3 trials,
we're running actually larger trials than usual.
We have 30,000 subjects per trial.
I'm Dr. Moncef Slaoui, Chief Scientific Advisor
to Operation Warp Speed.
When the trials will be completed,
then the FDA will look at the data and assess
whether the vaccines are efficacious and whether
they are safe.
>> I'm Dr. Stephen Hahn, the Commissioner at the US
Food & Drug Administration.
We have the gold standard of safety and
effectiveness for all medical products.
FDA, along with all of our sponsors,
have top of mind the safety of a vaccine.
We will not cut corners, in terms of our assessment
at FDA, of that gold standard,
of safety and effectiveness.
>> How long could it take to develop a COVID-19 vaccine?
Vaccine development can take years,
but there's no set timeline.
In the case of SARS-CoV-2, scientists have a jump on it.
>> So Operation Warp Speed is taking processes that
take years, and compress it into months.
And the way we do that, is by running different
processes in parallel, rather than sequentially.
So for instance, we ramp up manufacturing of the
vaccines while we are running the Phase 3
trials, before we know whether the vaccines are
efficacious or not.
If they turn out to be efficacious and the FDA
approves them, we will use them.
If they are not efficacious,
then we won't use them.
>> Simultaneously, we work with DOD on needed
supplies, so that when a vaccine is ready,
we can administer it widely.
I'm Dr. Robert Kadlec, I'm the Assistant Secretary
for Preparedness and Response at the Dept.
of Health & Human Services.
The FDA can give emergency use authorization or
licensure for promising candidates.
>> From what we know about the initial findings,
we are cautiously optimistic that we will be
able to have a vaccine available by the end of
the calendar year 2020, and the beginning of 2021.
>> What types of vaccines are scientists developing?
>> Operation Warp Speed has invested in a number
of vaccine platform technologies,
such as for instance the novel RNA platform
technology; but also more established technologies
such as protein-based vaccines.
>> Sponsors of vaccines, including the U.S.
government, are looking at a variety of
different platforms.
And I'll use a sports analogy: this is like
taking multiple shots on goal.
We're coming from different directions to
attack the virus.
Hopefully, several of them will be effective.
>> What are some of the reasons for optimism?
>> The overwhelming majority of people who get
infected with this virus, do well and recover.
In other words, their body has made an immune
response that's adequate enough to suppress the
virus, and eliminate it from their body.
That gives us optimism to feel that a vaccine will
induce the kind of response that would mimic that.
And so, protect us.
>> We're marshalling the breadth and depth of
scientific resources to find the safest and most
effective vaccine.
>> I am confident FDA has the scientific expertise
to make the right decision for the American people.
We are laser-focused on the science of vaccines.
>> For the latest information,
please visit www.hhs.gov/coronavirus.