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Hi everyone, my name is Michael Perdue. I'm the Director of the Influenza and Emerging Diseases, Division of BARDA
and on behalf of the organizing committee and the co-chairs, I'm very happy to welcome you all to Washington, D.C.
We appreciate you taking the time to come today and I know that some of you are coming from international venues
that have had particular challenges with the weather as we've all been having lately.
Thank you again for coming.
This workshop is entitled a Sustainable Influenza Vaccine Production Capacity Stakeholders Workshop
which is a long name but we believe we have a manageable number of objectives
and we'll cover that later this morning.
But first we are very happy to have with us this morning Dr. Nicole Lurie.
Dr. Lurie is the Assistant Secretary for Preparedness and Response at the
U.S Department of Health and Human Services and prior to that she was senior natural scientist
at Paul O'Neil and professor of Health Policy at the RAND Corporation
and there she directed RAND's public health and preparedness work as well
as RAND's center for population health and health disparities.
She served previously in the federal government as Principal Deputy Assistant Secretary in
HHS. In state government as a medical advisor to
commissioners of Minnesota Department of Health and
in academia as a professor at the University of Minnesota.
Dr. Lurie has a long history in the health services field
primarily in the areas of access to and quality of care, managed care,
mental health prevention, public health infrastructure, preparedness and health disparities.
Among her many roles she also serves as the senior editor for health services research
and on several editorial boards and as a reviewer for numerous journals.
She served on the council and was the President of the
Board of Directors for the Academy Health Services Research
and has been on a number of other national committees.
She is a recipient of numerous awards. Dr. Lurie continues to practice clinical medicine
in Healthcare Safety Net in Washington, DC. And finally, Dr. Lurie has had an enduring
interest in influenza and in influenza vaccination over her career which we are very happy about
that and that we very much look forward to having her thoughts on the workshop
and appreciate you taking the time to be with us. Dr. Luri.
Thanks so much and good morning everyone. I'm delighted to be able to welcome you to
this stakeholders workshop today and to address a topic that I think we
all needed attention before our recent H1N1 adventure.
which is to build on the WHO global pandemic action plan
to increase vaccine supply and to really take a
hard look at sustainable production capacity. I first especially want to recognize and thank Dr. Marie-Paule Kieny
Director of the Vaccine Research Initiative
at the WHO for co-chairing this workshop and for her significant contributions to its
planning and development. Obviously events over the past decade,
beginning with SARS and then H5N1 were critical wake-up calls to the global
community to figure out how we're going to address these
important issues. Obviously we all realized in post-SARS and
in planning for H5N1 that we weren't adequately prepared
and that ensuring global health security is really in all of our mutual interests.
Since then, there have been over three billion dollars put into pandemic preparedness.
And that's really significantly increased our collective capacities.
And certainly have helped in our current H1N1 response.
But our current experience too, it's fair to say, has for sure identified additional gaps.
Both for us here in the US, I suspect for
all of you in your respective countries and for global preparedness in general.
Not only for pandemic influenza but for other kinds of diseases with pandemic potential.
We spent a long time earlier on in our pandemic planning
thinking about some of the major challenges ranging from virus sharing to ensuring that
vaccines and anti-virals were available for those who don't have access to them
and we planned for a specific kind of pandemic.
Well obviously this thing didn't follow the script very well.
and I think we're really lucky that it didn't. Obviously we all know that this started to
Mexico and spread first through the US. We are all planning for a pandemic that might start in
Asia and that didn't happen. But the great part about this is that things like
the virus sharing and open communication
and collaboration were fairly immediate and I think have been sustained and have been global.
As the pandemic progressed, many countries
really stepped up. And President Obama's focus on multi-lateral approaches to better
meet the needs of developing countries has really contributed to a very
substantial effort to donate vaccine or manufacturing capacity to WHO.
And I think the collaboration and work with all of the donor countries and
WHO has been really terrific. But, this certainly has not been enough.
I think all of us really recognize the complexity of the challenges, and the frustrations that
WHO and the donor community have faced in actually getting vaccine to countries and getting countries
ready to be able to have a plan and be able to use it once it arrives on their doorstep.
So that you know, I think, if we have any doubts at all, I think lets us know that just thinking that
the developed world is going to donate vaccine to the developing world is not enough.
That We absolutely have to be sure that countries around the world have the manufacturing capacity
and the skilled work forces to be able to meet their needs and those of their neighbors.
Obviously in an effort to do this, there has been work since about 2006.
The government of Japan, the US Department of Health and Human Services, BARDA,
etc., have provided about thirty-nine million dollars to WHO to work to increase capacity to
produce vaccine in ten developing countries. And we saw the benefits of some of that really
pay off through this. And we are continuing, I think, to work on
efforts to increase manufacturing capacity to technology transfer, train people, this
obviously creates jobs, and expands global partnerships in many, many ways.
The impact of developing independent and sustainable production capacity, could and should have far reaching impact on
the ability of many nations, not only to prevent illness and death from influenza, but to really
serve I hope, as a model for other vaccine preventable diseases and how we think much
more broadly about global, public health response.
To that end, I think sustainable development is certainly one of the three pillars of this administration's
foreign policy agenda, and the US government as well as many others are very strongly committed
to health development. We all recognize, obviously, that good health
is a necessary condition for economic development, global prosperity and global health security.
So this conference and the discussions about sustainable vaccine manufacturing capacity
really could not come at a better time. In the face of our global experience with
H1N1, we all, I think, recognize the set of issues and needs.
The good part is we are all focused right now on doing far better than we have this
time around. This conference also comes at a time of our
own review of medical counter-measures. And, as many of your know, the Secretary has charged
my office with reviewing our entire medical counter-measure enterprise, whether it's
about pandemic vaccines, counter-measures for other kinds of man-made or naturally occurring
threats, really from end-to-end and to make a set of suggestions about how to strengthen
that enterprise. So, that's going on at the same time. And
that very much again touches on many diseases of importance for the developing
world. So that's underway and a preliminary set
of findings will be ready by the end of the first quarter of this year.
And I just want to comment, while this conference is one that really focuses on
getting stuff made. It's also important not to forget that once
you have got the stuff, in this case the vaccine, you actually need
a process to overcome the myriad, legal and logistical barriers to get it to
people. And frankly, for it to be acceptable to people.
In the face of a much more severe public health emergency, we have really been talking a lot
about the fact that in this country we can't have a kind of counter measure that only half the population
10:03 will accept and have confidence in.
And I think we need to do a lot more work to help understand the acceptability
and confidence in vaccines really throughout the world if we are really going to be serious.
So it is not only about the manufacturing capacity and the technology transfer
and the science involved, but it is all that stuff that we talked about on the right hand
side. You know, getting it to country, getting it
into people, having people being really Willing and able to best accept it and use
it. And, you know, if you sort of look at all
the steps in between, what we find every time we take a look at this is
that there is probably a step or two that we didn't recognize needed to happen
in all of our planning. So really careful planning that outlines every
single one of those steps is really important. So we are talking about sustainable manufacturing
capacity let's not forget that it has to get into vials, or into sprayers,
or into whatever it's going to get into.
And that's another one of those kind of rate-limiting steps along the way.
Anyway the goal of this idea, I think, more than this conference,
more than anything else is to get ideas out on the table
So, I want to encourage all of you to be really active, not passive
participants in this discussion. You know consensus is always nice, but it
should not ever be at the expense of group think which I think is sort of all
too easy in settings like this. And so I think that the ideas and out-of-the-box
suggestions you have, and things that have occurred to you from
your wealth of personal and professional experiences will really be
the greatest contributions to our collective understanding and planning
for the future. So, I want to thank you for coming, for your
participation in this conference and I expect it's going to be a very productive
meeting and very much look forward to hearing about not only the thoughts and findings,
but to really working together to charting a way forward and taking some action.
So thanks very much and have a great couple of days.