Greta van Susteren
The United States has invested billions of dollars through Operation Warp Speed,
a Trump Administration initiative to quickly develop a COVID vaccine. The
National Institutes of Health is working closely with pharmaceutical companies
during vaccine development and testing, establishing the COVID-19 prevention
network to recruit volunteers for clinical trials. Since august 2009, Dr.
Francis Collins has directed the National Institutes of Health. He is known for
his extensive work in the field of genetics. I spoke to him about those vaccines
up for approval, who will get them, when will we get the vaccine, and, in the
meantime, what can we do.
Nice to talk to you, sir.
Francis Collins: Nice to talk to you, Greta.
Van Susteren: Well, we Americans know what NIH is and we're very proud of it but
what is NIH?
Collins:The National Institutes of Health, it's the largest supporter of
biomedical research in the world. Basically, everything that the U.S. is doing
in terms of research and academic institutions Institute's and our own
intramural program is funded by the taxpayers through this budget, and I'm the
director that's supposed to make sure it gets spent wisely everything from basic
science to clinical trials. Diabetes, rare diseases, cancer, and of course right
now, COVID-19, and that's what we are all about $42 billion a year.
Van Susteren: For you the research you do a lot, a lot of research, all
research. What does the FDA do the Food & Drug Administration we hear so much
about in terms of the vaccine?
Collins: So, FDA is a sister agency we're both in the Department of Health and
Human Services. FDA's job is to be the regulator and it's to look at some
proposed new approach maybe it's a diagnostic test. Maybe it's a therapeutic,
maybe it's a vaccine and to get all the data together and look at it and decide
if it's going to be safe and effective, so we generally do the research trying
to stimulate this kind of progress to happen and FDA decides whether it's safe
for the public to start to use it in general way.
Van Susteren: All right, so we're waiting breathlessly for these vaccines and
some are farther along like Moderna and Pfizer than others, but once it gets the
green light from the FDA, who decides who will get it first?
Collins: Well, this is a big day for that, basically the CDC has an Advisory
Committee on Immunization Practices, ACIP, and it's their job to look at a
circumstance where you have a vaccine that FDA has decided is safe and effective
at least for emergency use, but there aren't enough doses for everybody to
receive them on day one. So, who gets first in line. That's a big decision, it
will include health care providers because we want them to be safe in their
frontline experience and it will include people at high risk, particularly the
elderly people with chronic illnesses. And that will get played out over the
course of the coming months as more and more doses become available, but of
course trying to protect the most vulnerable people first.
Van Susteren: I'm old enough to know to remember polio vaccine when it first
came out, am is the distance was, how was that distribution decision made? Do
you know?
Collins: I don't know the total details -- initially there was a big trial to
see whether it worked just as we have been doing with COVID-19 with these
vaccine trials involving tens of thousands of people. Once it was decided that
it was working, then there was an issue about how many doses can be made
available and it didn't happen overnight. In fact, it took quite a long time, a
year or two. In this instance, Operation Warp Speed has invested in doing the
manufacturing of vaccine doses, even before we know whether it's one of these
six or more than one of these six vaccines is going to work with the expectation
that if one of them didn't, you'd have to throw those doses away happily now we
have two that look as if they're very likely to win FDA approval in the next
couple of weeks. And there are others just a little bit behind that may get
approved in January, ideally, we may even have multiple different vaccines, each
of which have 10s of millions of doses, and we could really start to reach out
and get immunization to happen to lots of us, not just the most vulnerable
people.
Van Susteren: Well, the vaccines, as I understand, talking to experts, is
coming, very quickly. What has been the role of the U.S. government to sort of
fast track this have gotten rid of some of the red tape or is it provided more
funds or what's the role of the U.S. government?
Collins: It is astounding what's been done here, Greta, because traditionally it
takes eight to 10 years to develop a vaccine against a new pathogen, this has
been done in less than a year. The U.S. government pulled all of the resources
together to make sure that coordination was happening. operation warp speed made
it possible also to get rid of some of those long delays that oftentimes vex the
process where you go to phase one and then you have to wait many months before
you go to phase two, all of those things were synchronized in an unprecedented
way, but not by doing any compromising at all on safety these will probably be
amongst the most highly tested vaccines ever in terms of their safety and
efficacy and the good news is, the first two that are going to get looked at by
FDA. In the coming weeks, look extremely good with efficacy over 90% which is
better than most of us had dared to hope and safety record that also looks
extremely good so we are in a good place to begin to see how we might get
COVID-19 behind us but it's going to take a lot of months to get there for
everybody.
Van Susteren: I don't want to hope or expect as we another virus coming down the
road, but I assume that it's inevitable so --has the U.S. learned something new
as government learn something like stripped away some of the red tape so that we
can look forward in future times and that will take a shorter time to get a
vaccine than eight or nine years?
Collins: Absolutely. We've learned a lot, and we've documented all along the way
ways that things can be done more efficiently and this. Our accomplishment of
having vaccines that are ready to go into individuals in less than a year is
certainly going to be the norm in the future and maybe we could even do it a
little faster, although it would be pretty hard to go faster than this you just
still have to run the trials and wait and see whether the vaccine works and you
can only speed that up so much, but I do hope and I'm part of this decision and
discussion that's going on right now that we don't slip back into complacency.
Once we get past COVID-19 because there's another pandemic out there. I don't
know whether it's five years from now or 10 years from now or next year, and it
probably could be another coronavirus or it might be an influenza virus. And
this is just the nature of our world and anybody who thinks over over that look
at history, we're not likely to be.
Van Susteren: All right, Moderna, and Pfizer as I understand it, both have
something called the sort of a science behind is something called messenger RNA,
are they very different vaccines are very similar?
Collins: They're quite similar basically messenger RNA is the part of a nucleic
acid that codes for protein. And this is a very clever way to make a vaccine
where you basically synthesize that messenger RNA that has the right information
in it, inject that into Muscle, Muscle goes, Oh I know what to do with messenger
RNA I'll make a protein. And so it does, and it makes the spike protein, which
is the stuff that decorates the coronavirus and those spike proteins, the immune
system says oh no you don't and makes an antibody to them. And it's very quick.
That's why Pfizer and Moderna are the first two out of the gate because the
messenger RNA approach can be started almost immediately upon the time the
viruses isolated. So it is a new approach, it looks extremely promising, it is
going to be transformational I think for vaccines for all kinds of things
because it looks like it's really worked, and this is the first time it's been
taken all the way through to these Phase Three trials and FDA approval.
Van Susteren: One of the issues is gonna be distribution and the Pfizer requires
that the vaccine be kept so called which refrigeration incredible refrigeration.
What, why is it if they're so similar the Moderna and the Pfizer one needs to be
kept so much colder which is going to inhibit some of its distribution?
Collins: Yeah, it's a great question and all our people puzzled if it's so
similar. Moderna can just be kept in a regular freezer and can even be in a
refrigerator for a week and it'll be fine there too. But the Pfizer one, it's
wrapped in a different kind of envelope, it's not just the messenger RNA by
itself it's sort of put into an envelope of lipids and the Pfizer liquid
envelope is very tense sensitive to warming up, which is why it has to be kept
at this minus-94-degrees freezer, which isn't available a lot of places.
Moderna's envelope is less concerned about temperature issues and so it can be
stable in a more forgiving way. Coming along I should say the next set of
viruses next set of vaccines bay by Johnson and Johnson, and by AstraZeneca.
Those are going to be also much more forgiving as far as the temperature
requirements. The so-called cold chain will not be nearly as demanding for those
which will be great, especially for places that don't have a lot of freezer
capacity like some of the low- and middle-income countries that are also going
to need these vaccines.
Van Susteren: Do Astra Zeneca and the Johnson & Johnson have the same messenger
RNA approach to a vaccine are they different vaccines?
Collins: They're using a different approach one that has been tried and true and
other situations takes a little longer it basically captures the energy of a
different virus and adeno virus just as a carrier a delivery truck and uses that
also to deliver the coating for this spike protein so it's making the same kind
of response happen in the immune system, but it's getting it in in a different
way. And this is something that's been done successfully for Ebola so we know
this vector system is likely to be safe and effective. The Johnson and Johnson
one also is a single dose which will be very much easier to manage whereas
Pfizer and Moderna requires two doses one on day one and other one three or four
weeks later, it's a little more complicated to set that up, we'd love it if we
had at least one of these that was just one dose and you're done.
Van Susteren You know I read early on, I've been following this virus like
everybody else is that there was a possibility or some discussion about six
months ago about a bridge vaccine which would be polio or TB, that if you got
that vaccine the live vaccine that it would rev up your immune system,
essentially, and fight out fight off COVID. Was there ever any sort of thought
or did NIH look at that was that just a bridge it's like health care workers in
the short run?
Collins: We did look at that, we have a group called active ACTA IV accelerating
coronavirus therapeutic interventions and vaccines and they surveyed the entire
landscape of opportunities for therapeutics and vaccines and they looked at
this, they thought if we had nothing else, there might be a little enhancement
of your immune response sort of in a general way by one of these other vaccines,
but compared to the specific vaccine that we now see in front of us, the effect
would probably not be nearly as powerful so we decided to focus on what really
was needed something that would be 95% effective as opposed to a general benefit
that might give you a few percentages of improvement but wasn't really going to
change the course of this pandemic in such a big way as what we need right now.
Van Susteren When I get, when I've got a tetanus vaccine I've since then. Over
the years had to get boosters. Do you anticipate that with or can't you tell now
whether if you get this vaccine that at some period, sometime in the future you
need a booster.
Collins: I wish we knew more about that, because this is a new virus, we really
don't know how durable, your immunity is going to be, we don't know for people
who got the COVID-19 infection naturally, could they get it again if we knew
more about that we have some sense about whether the vaccine would last for
years and years. It's going to take some time to tell. it might be that the
virus also mutates over time and ultimately new version appears that the vaccine
and your natural immunity don't quite work anymore. So we might have to have not
just a booster but a slightly redesigned the vaccine to cover whatever this
coronavirus is trying to do to us. Those are all uncertainties in the best of
all worlds. This will last a very long time, I'm guessing boosters are probably
going to be needed. I just hope they aren't too frequent tetanus we could live
with a 10-year timeline if that's what it takes, but we just don't know.
Van Susteren I spoke to Dr. Fauci who works at NIH, several times and very
early on and we were talking about vaccines and he said he would be very hopeful
with a with a protection of 50, and that he was thrilled with 70. Now we're
reading you know 94,95 ish, is that you know the flu isn't that good the flu
vaccine doesn't do that well- with this with this new approach messenger RNA can
we expect that we'll relook at like flu vaccines or is it just a completely
different category, and that we can sort of up the protection there?
Collins: I think it's not so much the technology for the vaccine. it's the
nature of the actual virus. influenza has this nasty ability to change its coat,
every year in a very substantial way. And no matter how clever your vaccine is
if the virus is like completely changed its appearance the vaccine won't give
you immunity anymore so I don't think we'll be able, through this approach to
solve the influence issue there may be other ways to do that by a Universal
influenza vaccine. We just seem to be fortunate though that coronavirus is
particularly susceptible to the vaccine. I didn't dare to hope that we'd end up
with efficacy over 70%, and to see these first two coming through at 95% is
incredibly exciting and provides a great deal of hope that we will be able to
get through the next few months and be able to put this in the rearview mirror,
but we've got a long way to go.
Van Susteren With the influence of changing its code so to speak so often, in
looking at the coronavirus with the virus that you saw last February, March is
at the same virus you were looking at now or is it likewise trying to change its
code.
Collins: It's pretty much the same. It's an RNA virus, it does change its
spelling when it gets copied and there's lots of bad virus out there that has
the chance to change its spelling and we've seen two or three instances where
there's a new version that maybe has a little bit of an advantage maybe it's a
bit more infectious and so that new version starts to rise up in its frequency
so far nothing that we're alarmed about in terms of affecting the likelihood
that the vaccine is going to work, but we have to watch that closely and again
over the course of many years it's possible, a new a new version might arise
that the vaccine doesn't work very well for and then we'd have to redesign the
vaccine.
Van Susteren You know I'm old enough to remember landed on the moon that was
such a huge game changer, you know, for the United States, I likewise see this I
mean moving so quickly in a vaccine something that is, you know, that is
terrorizing the world I mean it really is quite extraordinary isn't it.
Collins: It is, Greta, and you know 2020 has been just a terrible year for so
many people with the suffering and death of this terrible pandemic with economic
distress it's caused. And I must say, for science, it has been a challenge like
one we've really not quite had to deal with before for life science, and it is
really wonderful to see the way science has come forward. All of the partners in
industry and academia and government, working together in an unprecedented way
not worrying too much about who's going to get the credit to make these things
happen at a scale and a timetable that was unimaginable before and I hope that's
being noticed and I hope a lot of young people watching that might have the same
reaction they did when we went to the moon saying, That looks like fun. I want
to be part of that too because we have a lot more science to do in the future.
Van Susteren Well I guess we could use more help from the people who are
watching the science I think it stopped congregating in huge, you know, huge
herds of people, because you know this is all hands on deck, sort of, so to
speak.
Collins: Yeah. And that is something to really keep in mind even though we are
seeing this promise of a vaccine that's going to get us through this, it will be
many months before we have enough people in the community immunized that we
could stop worrying about transmission. So for the coming months. People need to
double down on those careful measures -- wearing your mask watching your
distance washing your hands those three W's more important than ever, and nobody
should imagine that this is about somebody else and not about them even a young
person who imagines that they're pretty immortal and even if they get this
virus, they're going to be fine and they could be the next super spreader. and
if you care about the people around you, your neighbors your parents, your
grandparents, then it's got to be up to you to all of us to take that
responsibility seriously. We have holidays coming where the risks are going to
go up, if people relax their guard. I'm not going to have Christmas with my
family this year first time didn't have Thanksgiving with my family this year
either first time, but it's the way that we all have to wrap our arms around
responsibility for 2020, as a year of, we got to get through this. And we got to
get through it together.
Van Susteren And I suspect that NIH is also working on treatments, new
therapies to to fight this to the for the person who does get COVID.
Collins: We are indeed and that's an intense part of how I'm spending my time
and we've made some real progress there. We have the drug remdesivir, which is
an antiviral that helps people who are quite sick in the hospital. We have
dexamethasone a steroid that also helps people who are the sickest of the sick
in the ICU. And we have monoclonal antibodies developed from people who've
survived COVID-19 basically purifying their antibodies that help them recover
and giving them to other people, showing real promises, especially if you give
those early to high risk individuals, and we have other trials that are going on
right now that may very well yield up other immunosuppressives or antivirals
that can add to this compared to where we were back in February and March where
we didn't have much of anything we've now got quite a menu of therapeutics and
survival has certainly improved for people who get very sick with this but it's
still a very serious disease we've lost 275,000 people. And this is a scary few
months that we're looking at with wintertime, and with the vaccine not yet as
widely available as it will be by the summer.
Van Susteren you talked about Remdesivir the other antiviral is to reduce the
viral load, you get those when you get to the hospital, and you're very sick.
When I get the flu. I call the doctor calls in a prescription for something
called Tamiflu and I get a pill and could just go to the drugstore sir I headed
off at the past before I get so sick to the hospital is are there efforts being
made to make these antivirals, not when you get real sick and end up in hospital
but to back it up when you first get sick?
Collins: Yes, there are efforts of that sort, so far, none of those antivirals
have yet been approved for outpatients. remdesivir is an intravenous drug which
makes it not so convenient for people who are not in the hospital, what is
approved for outpatients what I mentioned a minute ago. these monoclonal
antibodies from Lilly and from regeneron, which while they're in somewhat
limited supply can absolutely greatly help people who are at high risk, just got
diagnosed get the monoclonal in the first three days after symptoms, and you can
greatly reduce the likelihood that person ends up in the hospital.
Van Susteren Is dexamethasone so the last question I have is dexamethasone,
which is the steroid, which is what you get in the hospital and when when you've
really been when you've got a huge problem -would prednisone which is a steroid
that is prescribed by pill. Would that be at all helpful in in minimizing the
risk of how sick you get or not?
Collins: It's all about timing, Greta, and these steroids are basically keeping
your immune system from overreacting and causing more damage than help and that
is often what seems to happen with the sickest people in the ICU, who've
developed really bad lung disease and other systemic problems. At that point the
virus is almost gone but the immune system is going crazy. And by dialing it
back sort of turning down the thermostat for your immune system you can help
people survive. On the other hand, you need your immune system early in the
course of a viral infection you want it to be out there cracking down that virus
and taking care of it so it's probably a bad idea to give prednisone or
dexamethasone to somebody who's early in the course save that for the people who
are laid in the course and are still really sick, and you may help them.
Van Susteren Because under the theory that your immune system you don't want to
tell your immune system not to work. What you want to do is what, when you get
to the point where the virus is gone is you don't want your immune system to
overwork and give you another problem and that's when the steroid comes in to
tell your immune system stop. Right?
Collins: Exactly, exactly. And we're looking at some other immune suppressive
that might be even more specific than dexamethasone, which is a pretty broad
acting anti-inflammatory drug. Maybe there's a more subtle directed way to do
this that would even be better and that's under study right now, several trials.
Also, one more thing here in that space. We know that those people who are
really sick also developed a problem with too many blood clots in the lungs,
clots in small vessels. And so using an anticoagulant to actually thin the blood
may also help people survive and that's another big study that's underway right
now it looks pretty promising.
Van Susteren Which is so interesting because older people tend to be on those
types of drugs for heart, you know, medication so that they some of them are
already on that.
Collins: That's right, they may be somewhat protected ironically against the
worst aspects of COVID-19 if they're already in the blood thinner, but a lot of
people aren't, and those folks may need one if they're in that very serious
circumstance where blood clotting is starting to be part of the problem.
Van Susteren Well, as Dr. Birx told me is you can't get the virus if you don't
go near it. So, you know, keep your hands clean masks and stay out of groups,
you know, that's, you know, stay away from people.
Collins: Absolutely, especially indoors where we know the spread is so easy and
unfortunately that means a lot of family gatherings which tend to be indoors
with people eating and not wearing masks and I'm fearful that with this holiday
season upon us. People will be too careless about that. We are not out of the
woods here, we have a very challenging few months ahead, and the best things we
can do while cheering for the science and waiting for our turn to get the
vaccine is to practice those three W's absolutely wear your mask, watch your
distance wash your hands.
Van Susteren What about surfaces boxes that come to the house, you know people
who come into your house and we may not be near, but they touch the surface.
Collins: You know, we worried more about that early on, I am there is some
possibility of viral spread there, but it does not seem to be a major effect so
at my house we stopped wiping off all the boxes that came to the front door.
After seeing some of the data that's probably a very low risk, compared to all
of the other things which is basically these droplets, that are being expressed
by all of us when we speak. Certainly, when we sing. All of those things where
that's the most likely place to catch this illness.
Van Susteren Doctor thank you very much and thanks to NIH and you know for, you
know, I think the world's very grateful for all the work that all of you do.
Collins: Well, it's a privilege to be able to be the guy trying to manage this
effort with such an amazing team of dedicated scientists and we are going to get
through this and science is going to be a big reason why.
Van Susteren Thank you, sir.
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