John R. La Montagne Memorial Symposium on Pandemic Influenza Research Meeting Proceedings (2005) / Chapter Skim
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2 Plenary Speakers, Day 1
2 Plenary Speakers, Day 1
Pages 7-52
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From page 7... ...
While much of our attention is focused on the H5N1 virus in Asia, I know very well that it is not the only flu threat we face. Many of the lessons that we learn from it will prepare us for annual influenza as well as for other potentially pandemic influenza viruses that may emerge in the future.
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From page 8... ...
And as part of our commitment to preparedness against the possibility of a pandemic, I am pleased to report that NIH has very recently begun clinical trials of a vaccine specifically designed against the H5N1 strain of avian influenza that is currently circulating in Asia. We have also gone ahead and produced 2 million doses of this vaccine in bulk.
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From page 9... ...
In May, I will also travel to the World Health Assembly, where pandemic influenza preparedness is on the agenda; I am convening a special meeting of health ministers from affected and donor countries to coordinate planning on influenza, followed by a technical meeting of experts the next day. Influenza will continue to be an important topic in all my discussions with my counterparts.
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· Manufacture and clinically test new, inactivated vaccines made from selected novel influenza viruses that have pandemic potential. · Evaluate the effectiveness of using less than 15 micrograms of the current inactivated vaccine.
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"The ability to initiate the tasks outlined above is beyond the responsibility and resources of the NIH or any single government agency. This scope of action requires international organizations and the vaccine and pharmaceutical companies." Acknowledging the need for a coordinated global response, HHS and WHO organized this meeting to refocus our collective efforts on the scientific underpinnings of preparedness.
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From page 12... ...
It doesn't take a scientist to appreciate that the clock is ticking, and that another pandemic is due. We also have some understanding of how antigenic shift occurs in influenza viruses, and why pandemics may emerge.
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From page 13... ...
Does age, ethnicity, nutrition status, or viral strain affect the case mortality rate? We need to address these very important questions about the clinical presentation and outcome of avian influenza through careful epidemiologic, laboratory, and clinical investigations.
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How does the ecology of avian influenza virus affect its mobility to other parts of the world through migratory bird vectors or other movements of people, animals, birds, or fish? Unlike the 2003 isolates, which were homogeneous, these H5N1 influenza viruses now circulating in Asia are expressing some degree of heterogeneity.
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That experience taught us that with the right framework, people can do the seemingly impossible. But SARS was a relatively easy problem compared with the global challenges that an influenza virus strain with a high reproductive number (Ro)
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Julie Louise Gerberding Director Centers for Disease Control And Prevention Current Status of Avian Influenza and Pandemic Threat Presentation To IOM, April 2005 2 3 4 5 6 7 8
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18 PANDEMIC INFLUENZA RESEARCH 17 18 19 20 21 22 23 24 (Slides available on accompanying CD)
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Several manufacturers have expressed interest in becoming licensed to supply flu vaccine to the U.S. market, and, as I will discuss, FDA has defined an accelerated approval mechanism that can help speed their availability to meet this important public health need.
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From page 20... ...
To meet current deficits in capacity and to make licensure of other flu vaccines faster and more efficient, we have turned to our accelerated approval authorities. Accelerated approval can be used to approve a product that provides a meaningful therapeutic benefit for a serious or lifethreatening condition when there is a lack or shortage of available alternative therapies.We determined that influenza vaccines qualify for accelerated approval, as the number of individuals who could benefit and for whom vaccination is recommended far exceeds the current supply.
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From page 21... ...
Conducting the needed clinical studies for candidate pandemic vaccines during the interpandemic period is very important, and real progress is being made here. Studies by the National Institute of Allergy and Infectious Diseases (NIAID)
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From page 22... ...
We need to not only evaluate and standardize assays but also consider new approaches to improve assays of potency, antibodies, and sterility to speed the regulatory and manufacturing processes. Many people have noted that even if we had a decent interpandemic vaccine infrastructure and supply, manufacturing capacity will still most likely be inadequate to meet U.S.
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From page 23... ...
However, in that case we have to address antigenicity and ensure that the immune response elicited to a recombinant protein is indeed a protective one. Other new technologies worth considering include vaccination with potentially crossprotective antigens to build immunity against influenza strains in the population more generally, and live attenuated vaccines, one of which is licensed.
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From page 24... ...
Finally, we need to consider the risks and benefits of earlier intervention against virulent potential pandemic strains, including potentially integrating them into routine medical and public health preparedness as we do for annual influenza. Can we learn from experiences such as that with swine flu and still meet the challenge of pandemic preparedness?
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PLENARY SPEAKERS 25 Plenary Presentation Slides-Dr. Jesse Goodman
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28 PANDEMIC INFLUENZA RESEARCH (Slides available on accompanying CD)
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I would like to look at medium-term applied research linked to medical and public health interventions, addressing current needs, especially the situation in Asia. I would also like to cover two smaller areas that can make a profound difference in our ability to reduce morbidity and mortality from the next influenza pandemic.
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From page 30... ...
Because a pandemic virus will change very rapidly, we must better understand the factors that influence the genetic and antigenic evolution of influenza viruses. Preparing not only for control and response during a pandemic but also for the research needed to inform policy will require vision, leadership, and the ideas of the participants in the symposium over the next two days.
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From page 31... ...
Such a mechanism for coordinating clinical research, exchanging samples and information can enable affected countries to rely on standardized treatments and research protocols and support effective communication. NIH is supporting an initiative to establish an international clinical research network on emerging infectious diseases in Asia.
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A stockpile could be a complementary tool in a large armamentarium of pandemic interventions, allowing vaccination of certain critical groups before a pandemic virus arrives. A stockpile would also provide an incentive for pharmaceutical companies to invest in a pandemic vaccine, although clinical trials are not complete.
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From page 33... ...
The epidemiology, natural history, and public health risk of emerging avian and mammalian influenza viruses are very difficult to evaluate. Surveillance in animals and constant characterization of viruses would be ideal, as they would allow us to better determine whether these emerging strains pose a public health risk.
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From page 34... ...
That should come next. This meeting is very important in that regard, and will provide us with better insight into priorities for influenza research.
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PLENARY SPEAKERS 35 Plenary Presentation Slides-Dr. Klaus Stöhr
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PLENARY SPEAKERS 39 (Slides available on accompanying CD)
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John's greatest love, as we all know, was influenza research. John had been talking for many years about the dangers not only of seasonal flu but also the potential for a pandemic influenza that we are discussing here.
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From page 41... ...
Basic research provides the fundamental matrix for developing countermeasures. The NIH portfolio includes a substantial effort to understand the pathogenesis of pandemic influenza viruses, including virulence factors, and the transmissibility of H5N1 among different animal species as well as the molecular evolution that allows for the host range to expand.
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From page 42... ...
These cell-culturebased strains are also important because if we confront a virulent influenza strain that might prove lethal to chicken embryos, we can use reverse genetics to splice out the virulence factor. Also, a vaccine that is not grown in eggs is important to individuals who have allergies to egg proteins.
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From page 43... ...
I want to finish by commenting on the fragility of the vaccine enterprise in general, but particularly the influenza vaccine enterprise, and the role of the research enterprise in addressing this fragility. We all were faced with a rude awakening when we discovered the contamination of half of the U.S.
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From page 44... ...
NIAID is also trying to help industry make products that might supplement our normal supply of influenza vaccine -- that is, to obtain the necessary information for as rapid FDA approval as possible. Such efforts are occurring with GlaxoSmithKline's inter-pandemic Fluarix vaccine.
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PLENARY SPEAKERS 45 Plenary Presentation Slides-Dr. Anthony S
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From page 47... ...
PLENARY SPEAKERS 47 Recent Findings · Pathogenicity and Immunogenicity of Influenza Viruses with Genes from the 1918 Pandemic Virus (Proceedings of The National Academies, T Tumepey et al, 2004) · Enhanced Virulence of Influenza A Viruses with the Haemagglutinin of the 1918 Pandemic Virus(Nature, D Kobasa et al., 2004)
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50 PANDEMIC INFLUENZA RESEARCH U.S. Flu Vaccine Supply Halved Health Officials Face Record Shortage as Britain Shuts Down Supplier Associated Press, Oct 2004
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PLENARY SPEAKERS 51 ` Money Plans, March 2005 Intradermal Influenza Vaccination: Can Less Be More?
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From page 52... ...
52 PANDEMIC INFLUENZA RESEARCH (Slides available on accompanying CD)
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