For Immediate Release
Office of the Press Secretary
November 1, 2005
Press Briefing on the Avian Flu by Dr. Rajeev Venkayya, Special Assistant to the President for Biological Defense Policy
Via Teleconference
National Strategy for Pandemic Influenza
In Focus: Healthcare
1:45 P.M. EST
DR. VENKAYYA: Thanks very much, Trent. Again, this is Rajeev
Venkayya, from the Biodefense Directorate at the White House Homeland
Security Council. Thanks for joining today. I'd like to give you a
little bit of background on the President's announcement today, and link
between the strategy that he announced and the budget submission that is
going up in parallel, as well as the legislative language that's going
over to the Hill to support the goals of the strategy.
We released today the national strategy for pandemic influenza,
which represents a comprehensive approach that not only the U.S.
government, but we expect that all levels of government, as well as the
private sector, individuals and our international partners will follow
in their efforts on the avian and pandemic influenza front.
There are three pillars to this effort which cut across everything
from the international spectrum, all the way to our domestic efforts,
and from the federal government all the way down to the community.
Those three pillars are preparedness and communication, surveillance and
detection, and response and containment. As you look at the strategy,
which was placed on the White House website at around 10:00 a.m. this
morning, shortly after the President's speech began, you can see very
somewhat detailed descriptions of the specific actions that are mandated
in the strategy. And those actions stretch, again, across the entire
government and across levels of government, and provide principles for
which our international partners we believe should aspire.
We really view this as a threat that cannot be only addressed here
within our borders; we see this as an international threat that
currently resides overseas, but very well, with the passage of time,
could be within our borders, within the animal population, and could
reflect a more imminent threat to our population here with regard to
animal-to-human transmission.
But since it is overseas now, we do think we need to have an
aggressive effort internationally to provide early warning of
human-to-human transmission, as well as a coordinated rapid response
plan that will, on the international stage, contain this to the extent
possible and limit its spread to our borders. We do recognize, though,
that we are -- while we can be hopeful that we will be able to contain
an outbreak overseas, that we can never guarantee this, and so that we
cannot ignore domestic preparedness, and therefore, domestic
preparedness represents the brunt of the budget that was described this
morning.
What I'd like to do is very quickly recap the budget for you at a
high level, and then we can go ahead and open it up for questions.
The budget, itself, has been in the works for several months now.
This overall process began back in the spring and proceeded through the
summer, and led to a draft budget submission that crosses seven
different federal departments, as well as the U.S. Agency for
International Development. Those departments are HHS, Veterans Affairs,
Defense, Agriculture, Interior, Homeland Security, and State, and as I
mention, USAID.
If I can begin, first, with the international budget. We're
looking at a total of $251 million spread across USAID, HHS, Ag, and
State, that is principally directed towards supporting the activities in
the -- that are described in the international partnership, essentially
activities to improve surveillance and early warning, scientific
cooperation, transparency in nations, building up laboratory capacity,
establishing emergency response plans in nations, and building up
general capacity in these regions to not only respond, but also to
produce their own vaccine, and perhaps someday their own antivirals to
deal with the outbreak.
The international budget is also very focused on improving the
relationship between the agriculture sector and the human health sector.
We think that this is an issue that has come up time and time again,
both across countries and in multilateral organizations that deal with
those issues on the human and animal side, but also within countries
where we see that the ag sector is not communicating as well as it,
perhaps, ought to be with the human health sector.
Turning now domestically, we have HHS, VA -- actually, all seven
departments have components of the budget. The lion's share is at the
Department of Health and Human Services, about $6.6 billion. But let me
just quickly touch on what the other departments are contributing here.
First, the Departments of Agriculture and Interior are leading the
way on surveillance, particularly of wild birds, but also of our
domestic bird population here. They already do a fair amount of work in
this area. Those departments have a lot of experience with low-path AI
-- avian influenza -- as well as high-path avian influenza. And they
had been doing surveillance before, but we've asked them to ramp that
up, particularly in light of the concern that avian flu through the
migratory bird population will come into the continental U.S. through
Alaska, over the Bering Straits.
The other departments include the Department of State, health
support for embassy and evacuation contingencies for Asian countries;
the Department of Homeland Security to establish materiel to protect its
first-line workers, particularly the border officials who might be the
first points of contact for a flu that enters our country; and finally,
Departments of Veterans Affairs and Defense are supporting the HHS/CDC
activities in bio-surveillance by improving the quality and quantity and
timeliness of data that's going into the CDC BioSense system. And then,
in the case of the Department of Defense, there's also about $81 million
devoted to purchasing unexpectedly available H5N1 vaccine from Sanofi.
I say "unexpectedly" because Sanofi, through our discussions with them,
has agreed to put off another project they were working on. That freed
up their production lines to produce this vaccine, and the Department of
Defense has purchased them.
Turning, finally, to the Department of Health and Human Services.
As you know from the discussion this morning there is, as I mentioned,
about $6.6 billion there that is spread over vaccine, antivirals,
surveillance activities, state and local preparedness, and general
research and development. On the vaccine front, to accelerate cell
culture technologies, we're looking at a $2.8 billion investment that
includes accelerating the culture, as well as building out search
capacity.
The reason that we're focusing on cell culture capacity here is
because, to use the current technology, which the President, I think
appropriately, described as old-fashioned, based in eggs and flocks of
chickens, is that it's very difficult to have surge when you're talking
about eggs. In other words, in order to ramp up production quickly,
you've got to wait until you have a lot more chickens and eggs to do
that. When you take that in conjunction with the fact that it takes a
lot more vaccine to produce an immune response in a person than we see
with the typical seasonal vaccine, you quickly realize that you would
need a lot of chickens and a lot of eggs sitting around month after
month after month, just waiting for us to use them to produce vaccine.
Cell culture technology, which is, we view, the next wave of
technology that's going to come through the influenza vaccine industry
-- I think the industry shares that view -- allows us to build out
capacity, essentially vats that would be mothballed -- I shouldn't say,
"mothballed" -- they would be used to produce other vaccines, but then
when we needed them, they would be available to quickly divert to
producing large quantities of vaccine. And that's what that $2.8
billion is for.
There's another $1.5 billion that is devoted to producing vaccine
that is created through existing technology; $1.2 billion of that is to
incentivize the vaccine industry to expand the current egg-based
production capacity to produce 20 million courses of vaccine -- "course"
here being defined as two doses of vaccine. So that means 40 million
doses of vaccine. And then we also have additional funds invested at
HHS and at the Department of Defense to buy, again, from the Sanofi
excess capacity.
On the antiviral front, we're looking at an investment of about $1
billion that is going to be spread across two antiviral drugs -- one
called oseltamivir or Tamiflu, the other one called zanamivir or
Relenza. We looked to purchase 24 -- sorry, a total of 44 million
courses for the Strategic National Stockpile as a goal, with an extra 6
million courses that we would use domestically for containment efforts
if we were to have an outbreak of bird-to-human that then became a
human-to-human outbreak -- in other words, the initial spark, if you
will, in a pandemic, domestically. The remainder, we look to the states
to participate in the purchase of, and we would subsidize those
purchases, to get us up to a total of 81 million courses of vaccine
shared between the states and the federal government.
The remainder of the budget is spread across state and local
planning -- $100 million devoted to helping the states to wrap up
activities that they've really undertaken over the past several years.
And that's been funded through just over $5 billion in public health and
medical cooperative agreements through the Department of Health and
Human Services to do preparedness that is all, really, for the most
part, directly relevant to influenza preparedness. It may be, in some
cases, earmarked for smallpox preparedness or general bioterrorism
preparedness or general public health preparedness, but if you look at
the cooperative grant agreement guidance, you'll see that much of that
is actually very relevant to public health preparedness for influenza.
So the $100 million is to help states finish their pandemic
planning efforts and to exercise those efforts. There's also very
critical money in there for risk communication efforts and to expand the
Strategic National Stockpile so that it includes more than, of course,
vaccine and antivirals, but also personal protective equipment,
additional ventilators or breathing machines, and masks, and so on.
With that, let me just stop. I've given you a lot of information.
Actually, one last point, because this question had come up, and that is
a better discrepancy between the speech and the fact sheet. In the
President's remarks, he mentioned that there was -- he was asking for
$583 million for preparedness, and the fact sheet, in fact, said $644
million. That reflects the addition in the fact sheet of two items that
were not referenced in the President's speech. One is an advancement of
general R&D; efforts on human pandemic flu vaccine, both here and in
partnership with Vietnam.
And then secondly, there is an additional $30 million at the
Department of State that I mentioned earlier for their emergency
response to bring personnel back home. So that explains that
discrepancy.
The second question that had come up was the mention in the speech
of $1.2 billion to buy vaccines, when the fact sheet says, $1.519
billion. I mentioned earlier that there were two other vaccine
purchases that are included in that $1.519 billion that are not
reflected in the $1.2 billion, and those are at the Department of Health
and Human Services to buy excess capacity from Sanofi this year, as well
as the Department of Defense, another $81 million.
Now, let me stop, and if there are any questions, feel free to pipe
in.
Q Thanks for taking my question. And I just wanted to get back
to the antivirals. If you could go over the number of treatment courses
again that are going to be purchased at the federal level, and then the
number that are going to be purchased at the state level. I just want
to double-check those numbers. And I have a question for you on that,
which is, could you be setting up a situation here inadvertently, where
you get disparities among the states? In other words, some buy and
others don't buy?
DR. VENKAYYA: Well, to run through the numbers very quickly again
and then to get to your latter question, the goal now for the federal
stockpile is a total of 44 million courses plus an additional 6
[million]. The 44 million courses comes from recommendations of the
National Vaccine Advisory Committee that peered or prioritized the
groups that would receive antiviral therapy.
We would not necessarily -- I want to qualify that by saying that I
think in an actual pandemic, we're not necessarily suggesting that we're
going to strictly follow that list of prioritization. I think there are
a number of different factors that would have to be taken into account,
not the least of which are the characteristics of the virus that is
actually produced in the pandemic.
But the goal now is 44 million courses in the stockpile, plus an
additional 6 million. Why the additional 6 million, that is to handle
two domestic -- attempt to contain two domestic outbreaks of human
illness. In other words, if we have, for instance, a single case that
arrives on a plane in a community and we believe that we have
human-to-human transmission that's now spread to our country -- a spark,
if you will -- we would follow the guidance that comes from scientific
modeling in peer review literature to flood that community with
antivirals -- we're looking at 3 million courses -- in order to attempt
to contain the infection to that region. It is not a strategy that we
can say with certainty will work, but it certainly is something that we
must endeavor to accomplish, because if it does work it can save many
lives and reduce illness significantly.
The remainder, then, 31 million courses we would look to the states
to purchase with a federal government subsidy, and that would take us up
to a total of 81 million courses.
Q Is that roughly a quarter of the population?
DR. VENKAYYA: That's right, that's roughly a quarter of the
population.
Q Yes, please go on.
DR. VENKAYYA: Now, to your point about disparities and state and
local preparedness, I think this is a function of the federalist system
that we have, and that is that we think that the -- the federal
government clearly is shouldering a tremendous amount of the
responsibility of protecting the American population. I want to make
that very clear; we take that very seriously. But I think that we
certainly view preparedness as a shared responsibility. And I wouldn't
limit that to a shared responsibility between the federal and state
government; I would
view it as a shared responsibility across sectors of society, which
includes the private sector and individuals and communities of families.
So this is one example of that, where we look to states to shoulder part
of that responsibility.
Now, what I think we'll see -- and this is per -- Secretary
Leavitt's thoughts is that this will generate discussion in states about
preparedness for influenza. And we think that's important. So we think
that the side benefit will be that we'll stimulate that discussion.
Q Okay, but just a quick follow-up. Don't you think the Feds
could get a better deal on the price than 50 states plus territories
going in on their own and trying to do it?
DR. VENKAYYA: Well, I think that's a good point. And this is why
we would look at this as a partnership. In other words, we would -- I'm
not sure how this would work out, leave it to the attorneys, but I think
that we would look to have the states get the same deal, if you will,
that we're getting, to the extent possible. But, again, I'm not
somebody that negotiates those kinds of deals.
Q Doctor, I was wondering if, in fact, you had a timetable for
how long you anticipate it taking if Congress moved as quickly as you
would like? How soon can these measures be implemented so that -- I
know for this flu season, we would be in trouble if the outbreak hit
this season. But do you anticipate these measures would help for next
flu season? The flu season after that? And how long will it take to
get these antivirals purchased and in hand, knowing that we're behind so
many other countries in line for those orders?
DR. VENKAYYA: To your question about flu seasons, let me just
clarify that. Are you referring to our ability to deal with the annual
flu next season? Or are you talking about if a pandemic hits next
season?
Q If a pandemic hits next season.
DR. VENKAYYA: Well, the answer is it depends on which investment
you're talking about. And these things are going to come in -- the
rewards are going to come in, in phases. There are certain things that
we can do today that are going to make a difference tomorrow. And when
I -- and those are specifically the procurements of additional vaccine
that are using the existing technologies. We've already got egg-based
technology in place, proven technology. It's simply a matter of getting
more eggs and flocks in order to expand our production capacity for the
vaccine that we're already making -- the H5NI vaccine, that is.
A similar statement can be made about antivirals -- the Relenza and
Tamiflu, if you will. Now, I have to say that -- you made a comment
about other countries being well ahead of us -- other countries have put
in their orders, but it's absolutely not the case that all these
countries have received and have in their stockpile the amounts of their
orders. And I think that the timing of that delivery is certainly --
I'm not in a position to share that information, nor do I know it all.
Some of that is commercial confidential; some of it they just -- we just
don't have. But the bottom line is that we, once Congress approves this
-- presuming they will -- will work diligently with the private sector
to ensure that they are able to deliver what we need as quickly as
possible, and to the extent possible -- do that with domestic production
capacity.
Q But at this point we don't have -- you don't have an estimate
as to how soon those medications could be delivered?
DR. VENKAYYA: Well, I mean I have to tell you it will happen as
fast as possible. I am reluctant to commit to a time frame until we
actually know that this is going to make it through the Congress, and
that we can begin those discussions. Those are procurement-sensitive
discussions, if you will, particularly on the antiviral side.
One last thing I'll point out that could pay out big dividends
soon, and that is the studies that we are proposing in the budget to
look at dose-stretching therapies, or adjuvants, which are materials
that can be administered along with a vaccine that rev up the immune
system, if you will, so that you need less of the vaccine to protect a
person, to make them immune to the virus. If those studies show that we
have effective materials to give with the vaccine, we'll revolve these
rewards much more quickly. In other words, every does we have will go
much further along and we'll be able to treat all the American people
more quickly than we had originally anticipated.
Q So the money that's going for development of cell culture
technology, is that going to the NIH, industry, a mixture of the two?
Also, I'm a little unclear on the -- still on the number of courses for
the antivirals. There's a statement from Senator Schumer today saying
that this plan only covers 7 percent. Are you -- is the 44 million
number covered completely by the money that you're announcing today?
And, lastly, I just wanted to get a sense of the difference between what
the President has talked about today and what HHS is going to be
outlining tomorrow.
DR. VENKAYYA: Okay. So just real quick, the first question was on
whether this is going to NIH, or industry, or both. The second question
was, is the money for the 44 million courses? And the third question
is, how does today's announcement differ from tomorrow's?
Q Right.
DR. VENKAYYA: To your first question about NIH or industry, the
answer is that majority of this is going to be to actually get vaccine
and get capacity on line to produce vaccine. When you say NIH, one of
the thoughts that comes into people's mind is basic science research.
And while basic science research is critically important and we actually
do have part of this budget devoted to developing new vaccines and
antivirals, the majority of the vaccine investment is to get the private
-- to incentivize the private sector to establish the -- to advance the
technology to be able to produce influenza vaccine using cell culture
methods, and to get the production capacity in place to produce vaccine
for the entire American population within months of the recognition of a
pandemic. So the majority of this will be to incentivize industry.
There is money, though, in the budget that is for advanced
development, if you will, which is to bridge that gap between basic
science and the point where you actually have a product that is
licensable, and we have a few hundred million dollars that is -- $200
million, in fact, that is directed to advance development of common flu
vaccines that cover all influenza A strains, so that we don't have to --
someday we'll no longer have to change our vaccine out every year, that
we might have a common vaccine that covers all those strains. And then,
secondly, the advanced development contracts for those dose-stretching
techniques that I mentioned.
On the 44 million -- the $740 million -- there is $740 million that
we're asking for to take us from our current goal of 20 million courses
of vaccine up to a total of 44 million, so it adds 24 million courses to
what we've currently planned for.
And then your third question was about the difference between what
was announced today and what's to be announced tomorrow. What was
announced today is the broad framework for how we think about, prepare
for, and how we plan to respond to pandemic influenza. It is a
comprehensive strategy, and as I mentioned at the beginning of the call,
covers not only many departments in the federal government, it also
covers different levels of government, every different level of
government, and it also includes international efforts. It includes N1
human health efforts and, finally, the role of entities that are outside
the government that the success of our efforts is predicated on. And
those are efforts by the individual, their families and the private
sector.
Today is a broad context, the big picture, if you will. Tomorrow's
effort, or tomorrow's announcement is by HHS and that is going to be
focused on the human health side of the equation -- and, principally,
the domestic human health side of the equation. The HHS plan and
strategy is going to be announced tomorrow and distributed, and the
brunt of that is very specific guidance for state and local health
officials on how to get their -- how to prepare and what they should do
to respond to a pandemic.
So today is the big picture; tomorrow is human health.
Q I had a couple of questions. One is how much of this was
already in the pipeline, administratively, or in legislation in
Congress, versus how much that the President announced today is
brand-new? And then my second question is the waiving of -- or shield
liability for manufacturers essential to all this happening?
DR. VENKAYYA: So when you say "brand-new," the first part of your
question, can you clarify that?
Q Well, I mean, I know that, like, I think Bill Frist and maybe
some on the House side had some shield legislation for vaccine makers,
and I know that there's been a number of bills by Republicans and
Democrats that would address little bits and pieces of this. I'm just
not an expert, I'm not a health writer, I'm a politics writer. I don't
know how much of what he said today is out of the blue, versus how much
of what he said today is just kind of wrapping up things that we already
knew about that are already out there.
DR. VENKAYYA: Well, we applaud the efforts that have been underway
in the Congress recently. I think that they're all headed in the right
direction. I think there are a number of -- the Hill has shown great
interest in doing something about this. Let me just rewind the tape a
bit here. We actually went to the Hill in anticipation -- in September
-- in anticipation of taking up this package which we had had in the
works for several months, back in September, in order to, first, before
showing the package, briefing them on the threat, if you will, on what
we need to worry about with regard to avian and pandemic influenza.
Within 18 hours, I think it was, the Hill introduced a $3.9 billion
package to address this. And so I think that it looks like we were
successful, and we applauded those efforts. But as far as whether this
is new -- this is something that we have had in the works for several
months. And then, if you could just repeat your --
Q Let me just clarify that one. The $3.9 billion that they had
already undertaken, is the $7 billion. whatever that the President
announced today on top of that, or is it partially already including
some of the elements that Congress is looking at?
DR. VENKAYYA: This is all brand-new.
Q So if this was all done, plus some of the stuff Congress is
looking at, we'd actually be spending like $11 billion?
DR. VENKAYYA: No, no -- I see, I understand your question. No, I
think that Congress has put forth -- there have been a couple of
proposals that have been put forward to address the avian/pandemic
threat. They have done some of the things, I think put forward some
approaches that we include here. In some cases, they've not included
the approaches that we have included here. This is a comprehensive
package. We wouldn't propose that we do this on top of whatever is on
the Hill right now.
Q There's some crossover, there's some stuff Congress is already
looking at, but they'll probably now look at it in the context of the
President's package?
DR. VENKAYYA: We would hope so.
Q I'm sorry I took up so much time. Just technically, is this
either going to move in the appropriations bills, or as part of budget
reconciliation, or a little bit of both? Is that probably the way it
happens?
DR. VENKAYYA: I have to defer that question. I'm not sure we know
the answer to that yet. It was -- simply because it was just announced
a few hours ago, and I think we need to talk with our colleagues on the
Hill to --
Q -- but hopefully, by Thanksgiving, right about the time
they're trying to wrap up all the money stuff?
DR. VENKAYYA: I think the sooner, the better.
Q Then my second question was, how crucial is the lawsuit shield
to this being effective -- can this actually really work? Can you stop
a pandemic flu from -- can you contain a pandemic flu?
Q DR. VENKAYYA: Well, that's two questions, which is okay. The
liability side of this we think is very important. I mean, I think that
we've -- we rely on the private sector to do a lot of these things in
this country, and the private sector has not responded. In this case,
we've sort of had a guess-timation, if you will, of the vaccine industry
in this country for a few reasons, but the principal one being, in our
view, this issue of liability. And the fact that we, as of today,
recognizing that we have an imminent -- let me rephrase that --
recognizing that we have a threat, an infectious disease threat, and we
only have one vaccine manufacturer that produces, licenses influenza
vaccine domestically represents to us a huge problem. And we need to
fix the climate to allow vaccine manufacturers to get into this business
and stay in the business.
As far as -- and then you had also asked, how much of a threat is
this, really. And to -- that's a broader question that it's impossible
to answer, but I can tell you that we view the risk of a pandemic to be
greater today than it was before 1997, or 2003, when we really saw avian
flu take off. The fact that we now have this new virus that has
developed in birds, that has shown that it can infect people and produce
lethal disease in human beings, and that it shows no signs of stopping
in its progression in birds and in other species around the world, makes
us very, very concerned -- that taken in the context of the fact that
the last three pandemics were caused by viruses that were either
completely bird viruses, as in the case of the 1918 pandemic, or had
parts of bird viruses in the virus that caused the pandemic in 1957 and
1968 makes us -- makes us concerned that this could be the harbinger of
another pandemic.
But we cannot say for certain that this virus is going to be one
that causes a pandemic. That's impossible to say -- which is why
everything that you see in this budget is designed to provide universal
preparedness for influenza, irrespective of which virus poses a pandemic
threat.
Q I actually have more questions, but I know other people do,
too, so I'll wait.
DR. VENKAYYA: Thanks.
Q Can you give some details of what the incentives are going to
be for vaccine makers, and can you give us a few more details on what
the cell culture preparation is going to be, what exactly you're talking
about -- buy the vats, or what?
DR. VENKAYYA: Well, I think that I need to defer that question
because I think that needs to be figured out. The bottom line is that
we can't have all that detail until we actually sit down with the
manufacturers and have discussions about what can be done and how to do
that.
We do not intend to go off and build factories. Just to be clear,
that's not part of this plan. What we plan to do is get the private
sector to step up -- as they said they would when they met with the
President -- to step up and meet the requirements to protect the
American population. And we just need to figure out the right packages
of incentives to both get the technology to advance, and then have the
production capacity in place to meet the needs. But, unfortunately, at
this point, I can't give you much more detail on that because we don't
have it.
Q So how did you figure out how much money to appropriate to
that area if you don't really quite know what it is you're going to do?
DR. VENKAYYA: Well, I think that was based on -- there have been
efforts to -- there have been RFPs that have gone out on the cell
culture front. And we have a fair amount -- we do have a fair
understanding of what kinds of things the industry -- what kinds of
methods we can use to incent the industry to advance this technology so
this was not done in a vacuum. I guess, what I'm saying is that I can't
tell you that we have a list of incentives that we're ready to put out
there that we're going to use.
Q Can you give us, like, for instance, what kind of thing it
might be -- chocolate sent to their desk every day?
DR. VENKAYYA: That would be an inexpensive approach, and if we
could use that, we would. Unfortunately, I don't think I can give you
much more detail than that right now.
Q I was wondering if you could give me a few more details about
the $1.2 billion -- or $1.12 billion purchase of additional H5N1
vaccine, presumably from Chiron and Sanofi. Over what time frame are
you talking about purchasing this? Would it be in bulk? And I think
previously we were talking about $165 million in purchasing; that would
be 20 million doses. But it seems like a lot more now.
DR. VENKAYYA: Well, the 20 million estimate that was generated
before was based on projections of how much vaccine would be needed to
take care of a population of 20 million individuals. Based on the
clinical trials, we now know that it takes more vaccine than originally
anticipated to vaccinate 20 million people. And so that number --
immediately once we add that data, it went up significantly.
The actual -- I mean the investment, the $1.2 billion in egg-based
capacity and 40 million doses of egg-based vaccine using today's
technology, that will be done using the companies that are already in
the business, that are already doing -- have shown that they can create
licensed vaccine using egg-based technology. And I guess, I can't -- I
can't tell you much more than that. We're going to use the companies
that are already doing it to produce more of what they're already
making. And the difference in price reflects the difference in the
amount of vaccine that it takes to produce an immune response with this
vaccine versus the traditional trivalent vaccine.
Q But no idea how soon this vaccine would be in the storehouse?
DR. VENKAYYA: Well, I think that we're going to start to see this
come online immediately. We're looking to have this in our stockpile by
'08, '09.
Q '08, '09.
DR. VENKAYYA: Wait that would actually -- I would say '09.
Q '09, so the calendar year '09?
DR. VENKAYYA: That I can't tell you.
Q Okay. And then, talking about the antivirals, could you
clarify again that some of it is going to be Tamiflu, some of it is
going to be Relenza? Is that a three-quarter, one-quarter break? And
will this policy permit states or the federal government to purchase
these products from other than the patent holders?
DR. VENKAYYA: The breakdown of Tamiflu and Relenza has not been
determined. I wouldn't want to signal anything on that front.
On the issue of procuring a drug from non-patent holders, I think
that there are a variety of trade considerations there, safety
considerations there that have yet to be determined. The bottom line is
that we don't -- there is no such company out there now, and I think
that -- as of today. And I think that would just have to be addressed
once such companies were actually in existence.
Q With the states having to purchase 40 million on their own to
get this 80 million course goal, I envision the states being somehow in
competition with the federal government over the same production
capacity, which all indications are, are vastly below that level right
now. I'm just wondering how you possibly -- there has got to be a plan.
Can you give a sense of how you would boost that production capacity?
DR. VENKAYYA: No. There clearly is a plan to expand production
capacity. And I just can't give you details on that because these are
things -- this is information that is commercial confidential, and I
just can't speak to what companies might have in store to expand their
capacity.
But to your point, which is I think a very good one, that we don't
want to -- this incentive out there and encouragement for states to
stockpile antivirals and then go out and compete against it, nobody
wants to do that. And we would work with states and companies to make
sure that, in fact, was not happening, that there was an equitable
distribution of any buys that came from the United States across the
nation.
Q One last question because I know a lot of people have them.
Is there somewhere published a sort of priority list over who should get
what available antivirals are out there first, and for that matter,
vaccines?
DR. VENKAYYA: The prioritization on antivirals, there is a set of
recommendations out there that the National Vaccine Advisory Committee
has put forth. And we have looked at that to establish some of our
baselines, as far as what -- our targets, if you will, for the
stockpile.
I want to be very clear, though, that we are not saying with
certainty -- those are simply guidelines -- we are not saying that those
are the individuals and groups that are going to get antivirals from the
federal stockpile and that that's what we'd recommend for states if a
pandemic begins. That's going to be -- that is being refined, and it
will have to be refined further if and when a pandemic begins.
On the issue of prioritization of vaccine, that is something that
we are currently working on. And I don't have a final answer for you
except to say that this is something that's receiving the highest
attention right now, given that we are -- we do have a nascent vaccine
stockpile currently. But the general guidance is that vaccine needs to
go to those individuals that are at greatest risk for exposure, and
those are the people on the front lines. And the obvious examples are
health care workers, people working at the borders, people that may be
working on aircraft that are coming to and from our country, people that
are working in the agriculture industry -- if you're talking about an
outbreak that arrives here through animals. So those are the kinds of
folks we would look to having that vaccine go out through first.
Q Why is so relatively small a portion of this budget going for
the international cooperation when it seems to me the surveillance and
the help that we could give to foreign countries, specifically the seven
countries that are the focus, would be the first line of defense for
Americans?
DR. VENKAYYA: Well, David, thanks for that question. I think it's
a good one. I wondered that at one point when I was first looking at
the way this budget was playing out. The bottom line is that the -- we
think, first of all, that the international -- we agree with you that
the international piece is critically important in all of our efforts.
What I would say is that $251 million sounds like a small amount of
money in the context of a budget that totals $7.1 billion. I recognize
that. Realize, though, that the lion's share of that budget is devoted
to expanding our countermeasure production capacity, building up our
stockpiles, and advancing the R&D; to produce better countermeasures,
which, by the way, would benefit the entire world.
So it seems small in light of that, but if you look at it against
the other parts of our domestic budget, I think $250 million is a
significant international investment, and I think you'll see that as you
look at what other countries are doing. We here in the United States
had invested $25 million earlier this year as part of the tsunami
supplemental and international efforts, and this is tenfold that. And
it provides significant support to multilateral organizations, such as
the WHO, FAO, OIE, as well as to bilateral support to nations --
affected nations that are particularly challenged by the issues
presented by this.
So I actually don't think it's a small budget. But I agree with
you that it seems small when you match it up against the significant
investment that we have to make, this crash program, if you will, and a
countermeasure development.
Q Thanks for taking my question. I have two questions. Number
one, could you tell us the -- if a pandemic does strike, a part of the
plan is that the administration would have enough vaccine within six
months of a pandemic. But when -- how do we reconcile it with when the
1918 flu swept the Earth, it did most of its -- actually, all of its
killing in the first six months? That's the first question.
Second one, could you give some specifics on the common vaccine, or
the universal vaccine?
DR. VENKAYYA: Well, let me start with the latter one first. The
common vaccine is -- there are a couple of companies out there that are
working on -- actually, more than that -- that are working a vaccine
that would not be strain specific. In other words, it would work
against all H3N2s, and perhaps might even work against H3N2s, as well as
H1N1, as well as, perhaps, H5N1. This is basic R&D; that's currently
underway, and I don't think -- it's something that we're investing in,
but I don't think we're close enough to say that we've got something
that's going to work.
Q What are the companies?
DR. VENKAYYA: I can't get into that on this call simply because I
don't have the list of those, and I don't want to -- I don't want to
just mention the one or two that I'm thinking of and shouldn't miss
anybody.
On the issue of the 1918 pandemic, realize that things are very
different today. That goes without saying, but specifically on the
early warning front, that we have very different ways of looking at --
looking for disease early, both in animals and in humans. We have ways
of following the evolution of the virus, and we now have the benefit of
knowing what happened in 1918 with that virus, the specific genetic
mutations that occurred that contributed to virulence and pathogenicity
and infectiousness and transmit-ability and so on. So we do have
significant tools at our disposal that are going to give us the kind of
early warning of the outbreak that was not available. In other words,
the start point, presumably, today will be upstream of what it was back
in 1918.
The second point is that we have very good infection control
measures, we understand a lot about infection control that we would put
in place immediately. There are a series of things -- the bottom line
is today, as it was back then, the best way to prevent yourself from
getting this infection is to prevent exposure to it. The next best way,
using today's technology, is to have a vaccine in hand. And so there
are a whole host of things that we can do to limit transmission of a
pandemic virus, once it begins, that would further slow the spread.
The third thing I would say is that we do have containment
strategies that we have -- we're talking about with our international
partners, so that wherever this begins we do think that while we may not
be able to stop it in its tracks, that we will have a very good shot at
slowing, limiting or otherwise containing its spread to that area, or
slowing its arrival here to the U.S.
And the fourth thing I would say is that everything that we're
talking about with regard to ramping up production is phased. In other
words, it's not like you go six months without any vaccine and then all
of a sudden, boom, you've got enough for the whole population. This is
something that would begin -- the production would begin immediately and
you would get vaccine online over the course of months.
And then the final thing I'll say is that the whole point of having
a standing stockpile of 20 million courses of vaccine against the most
likely pandemic producing strain of virus is so that we do have
something that's ready to go at time zero when we recognize that a
pandemic virus has emerged.
Q One follow-up. How do we plan, specifically, to require
transparency with the countries we're working with?
DR. VENKAYYA: Well, we -- I can't say we "require," that makes it
sound legal, but it's strongly encouraged. Now, the international
partnership that was announced on September 14th has a set of core
principles, one of which is transparency, timely reporting, scientific
cooperation and so on. And if you want to be a country that's part of
the partnership, you have to demonstrate that you -- and we are putting
in place with our partner nations ways to track implementation of these
measures -- you have to be willing to sign up to those principles.
Eighty-eight countries have signed up to the principles of the
international partnership, including many, many affected nations. And
so while we can't "require," because that sounds like it's a legal
instrument, we can strongly encourage, and we can also bring to bear all
of the diplomatic pressure of our international partners, the other 88
nations that are part of this, to make sure that those nations do the
right thing if something develops within their borders.
I'll take one more, then we'll wrap it up.
Q You mentioned earlier about the responsibility of all sectors,
including the private sector. I'm just curious about your thoughts of
whether there is any preparedness going on in the private sector, other
than the drug and vaccine industry.
DR. VENKAYYA: I think there is. But I think that the private
sector is interested in having guidance on this issue. And we're going
to provide it from the people that do it best -- the health experts
working in concert with people to understand the private sector, so that
a business, a private sector entity will know what it needs to be
thinking about with regard to pandemic preparedness and what specific
measures it can take to be prepared.
Let me just elaborate briefly on that. The bottom line is that
while a pandemic is not like a hurricane, it doesn't knock down
telephone polls and destroy roads, it does produce severe absenteeism,
such that a business could be attempting to function with only 60
percent of its employees, or 50 percent of its employees in place.
Well, that, if it's not managed properly, can result in the same thing
as a hurricane, by preventing the people that need to maintain the
infrastructure, take them out of the equation, if you will, so that you
can't deliver fuel, you can't maintain your telecom networks. We worry
about that a lot. And we think that people in the private sector,
businesses, need to be thinking about how they can maintain their
essential functions in the face of a 30-percent to 50-percent
absenteeism which might last a few weeks.
And there are things that businesses can do. First of all,
businesses can prioritize what those essential services are. Secondly,
they can determine staffing plans that would allow them to make sure
that they can maintain those essential services in the face of
absenteeism. Thirdly, they can take specific measures to reduce
infection transmission in the workplace, and there is a whole list of
things that the CDC and I and others could tell you about that would
facilitate that.
And fourthly, they can put systems in place so that even if people
have to stay at home because they are either ill or because they have to
take care of a family member who is ill, or because the public health
officials are just saying you should stay home, companies can put in
place mechanisms for people to work from home. And if they're not
working from home, if they're coming to work, well, maybe it doesn't
make sense to have your shift change happen all at once, maybe you ought
to stagger those shift changes. And once people are at work, maybe they
shouldn't meet in rooms, maybe they ought to just meet by phone. All of
these things and many others are steps that a business could take to
prepare for a pandemic influenza.
And by the way, every single one of those things I just mentioned
will also help any business during the annual flu season when we know
businesses already suffer some degree of absenteeism that affects their
bottom line. And so we think that there is a critical role for the
private sector, as well as critical infrastructure entities to play in
preparedness. And we intend to fully engage as we move forward with
this pandemic planning process.
MR. DUFFY: Okay, we're going to have to stop it there. The Doctor
has run out of time. Again, I'm Trent Duffy. You can reach me for any
further questions through the White House Press Office which is
202-456-2580. And we'll be around, as well as other folks in HHS to
answer other questions.
Thanks, again. Bye.
END 2:34 P.M. EST
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