JUDY WOODRUFF: Some of the federal government's
top health officials are suggesting a vaccine
for COVID could be sent out in less than two
months. It would be done through a special
emergency authorization of the Food and Drug
Administration.
But, as Amna Nawaz tells us, the accelerating
speed of this process is raising questions.
AMNA NAWAZ: That's right, Judy.
In fact, the CDC confirmed it has notified
public health officials in all 50 states and
five large cities to prepare for potential
vaccine distribution. That would be for some
higher-risk people as early as late October
or early November.
But there are a number of concerns about developing
and distributing a rushed vaccine, especially
when the president himself has been promising
one.
Dr. Michael Mina is assistant professor of
epidemiology, immunology and infectious diseases
at Harvard's School of Public Health. He's
also a member of the Center for Communicable
Disease Dynamics.
He joins me now from Boston.
Dr. Mina, thanks for being with us.
We should point out to people, the normal
vaccine process takes years. It's been dramatically
accelerated during the pandemic. And the firms
that are developing a vaccine are already
in phase three of the trials, which is the
final phase before they are supposed to seek
FDA approval.
So, how would an emergency authorization change
the timeline and the process?
DR. MICHAEL MINA, Harvard's School of Public
Health: Well, essentially, what happened is,
having the emergency use authorization as
the goal to actually get this vaccine approved
gives the FDA and gives the manufacturers
of the vaccines quite a bit more room to accelerate
the overall design and study of these.
So, what we have seen, for example, is an
overlapping of the different phases, phase
one, phase two and phase three, that normally
don't overlap in nearly the same way that
we have seen.
And this has compressed the time window considerably,
by years, essentially, to actually get this
vaccine, potentially over the first hurdle,
to get it out into the public domain.
AMNA NAWAZ: But with an emergency authorization,
does it reduce the number of hurdles it has
to go through? Does it lower the standards
in any way?
DR. MICHAEL MINA: Well, ideally, it would
not lower the standards, nor necessarily reduce
the actual -- the overall hurdles that it
needs to get through.
It certainly allows for the evaluation to
be accelerated in many ways. Now, of course,
there's been concerns about whether or not
it might be getting approved too quickly and
sort of rushed through. And that is not necessarily
a function of the EUA in this case. It's -- that
might be more -- those concerns are really
being driven, I think, more from some of the
confusion that's happened at the political
level.
But the EUA is still intended to keep safety
first and foremost, try to evaluate for efficacy
as well as possible before these vaccines
really get out to market.
AMNA NAWAZ: So, if you're further accelerating
the process, what are the potential risks
of that?
DR. MICHAEL MINA: Yes, well, the risks certainly
are to -- if these are not necessarily recruiting
and evaluating as many people as they might
otherwise look at, what we are concerned with,
for example, as we're talking about safety,
is that phase one and two are really designed
around safety, to make sure that people aren't
getting harmed by the vaccine.
We didn't see any real serious safety signals
during phase one and two of this, but these
were also -- these were accelerated. And there
is a chance that, when these really move out
to phase three and then out to post-market,
we could end up seeing what we have been think
of as kind of fringe effects.
What happens at the edges of the distribution?
If you have a bulk of people, for example,
getting slight fevers, there's always a concern
that in a rare number of people that those
fevers could become more serious in terms
of adverse effects.
And so we haven't really had the protocols
set up and the time to really rigorously evaluate
those pieces. So that is a risk, I would say.
AMNA NAWAZ: Let me ask you about some of the
higher-risk communities that they say the
vaccine could be deployed to first.
We know that the front-line health care workers,
essential workers, national security people
also among the high-risk groups so far. You
can talk about Black and brown communities
and Native Americans. We know they have been
disproportionately affected in the pandemic.
You look at the COVID-19 death rate, it's
higher for Latinos, higher for Native populations,
more than two times higher for Black Americans
than for white Americans.
Is there a concern that the government will
have trouble convincing these communities
that have already lost faith in them for failing
to help them during the pandemic, convincing
them to willingly accept a vaccine?
DR. MICHAEL MINA: I think there's a lot of
concern around that.
The vaccine, unfortunately, has been polarized.
And this certainly is -- it's been polarized
by politics. The whole virus and our response
to this virus has become polarized.
And I think any time we're infusing so much
divisiveness into what needs to be a concerted
effort, in this case, to keep people healthy,
to suppress the virus from transmitting at
the population level, to get people to trust
that the FDA and the CDC and the federal government
are doing their due diligence to keep people
safe, whether it's from the virus or from
the vaccine, I am -- it's not surprising that
there is so much concern and confusion that's
abounding in the general public.
AMNA NAWAZ: Dr. Mina, before we go, I want
to ask you to address a claim the president
himself has made and now others are picking
up.
There is this idea that the COVID-19 death
toll is overstated that is now circulating,
that hospitals are misreporting COVID-19 diagnoses
for reimbursement incentives. Is there any
evidence or truth to that?
DR. MICHAEL MINA: No, this is all misunderstanding,
whether intentional or unintentional.
These -- it is very common. By the time somebody
dies from an infection, many things can go
wrong during that course in the hospital.
And so it's actually very rare that, when
somebody dies in a hospital, that they have
a single cause of death necessarily written
on their death certificate.
And so this piece of information has kind
of been picked up and completely misconstrued.
For example, somebody dying of COVID who also
has diabetes, for example, well, we know that
diabetes is a risk factor for severe infections
with COVID, but you still are dying of this
virus, even if you have diabetes.
So, diabetes will make its way onto the certificate
perhaps, but it's not the thing that's killing
you. So, I think that this has been, unfortunately,
another piece that's been politicized. It's
been taken up by people who want to project
a message that this virus isn't something
to take seriously.
And that is -- it's an unfortunate state of
affairs that we are even having to have this
conversation.
AMNA NAWAZ: And we appreciate the clarification.
That is Dr. Michael Mina from Harvard's School
of Public Health.
Thanks so much for your time.
DR. MICHAEL MINA: Well, thanks very much.
