Rapid Medical Countermeasure Response to Infectious Diseases Enabling Sustainable Capabilities Through Ongoing Public- and Private-Sector Partnerships: Workshop Summary (2016) / Chapter Skim
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5 Influenza Risk Assessment and Pandemic Preparedness
5 Influenza Risk Assessment and Pandemic Preparedness
Pages 47-62
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From page 47... ...
However, given the enormous geographic diversity, the number of influenza viruses, and the rate of mutations, it is unknown how, when, and where pandemic influenza will emerge. Predictions to date have not been very accurate, and pandemics such as the 2009 H1N1 influenza confounded all preparedness models.
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From page 48... ...
. IRAT is a simple, additive, multiattribute assessment tool to prioritize pandemic preparedness activities.1 Specifically, it evaluates the risk from novel influenza viruses that are circulating in animals.
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From page 49... ...
Risk Management Information from IRAT is used at the HHS Pandemic and Seasonal Influenza Risk Management Meeting (also known as the Flu Risk Management Meeting, or FRMM) 3 to make decisions about influenza strains for inclusion in the pre-pandemic vaccine stockpile, explained Rick Bright, acting director of the Influenza Division at BARDA.
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From page 50... ...
Bright emphasized that the stockpile program and measured response approach have enabled BARDA to gain valuable knowledge about the physical properties of antigens and adjuvants, storage conditions, potency over time, and other information that is needed to manage risk and inform development of the next generation of influenza vaccines. INDUSTRY PARTNERS IN PANDEMIC PREPAREDNESS AND RAPID RESPONSE The national vaccine goals for pandemic influenza preparedness call for pre-pandemic vaccine stockpiles to protect 20 million people as well
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From page 51... ...
There are countless other dynamic pandemic threats, and Mansoura noted that creating a dynamic and strategic stockpile strategy should be considered. Following the 2009 H1N1 influenza outbreak, during which the vaccine supply lagged behind the demand, the President's Council of Advisors on Science and Technology (PCAST)
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From page 52... ...
. Mansoura went on to note that the vaccine industry is among the first responders to pandemic influenza threats, and as a result, manufacturers need to have reliable pandemic plans that need to be exercised to ensure effective performance under pandemic conditions.
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From page 53... ...
Vaughn noted that any plug-and-play rapid technology needs to be repeatedly successful with a variety of disease threats so that regulatory authorities and governments can make decisions in urgent situations to deploy vaccines under an EUA with little or no clinical data. To enhance national preparedness, GSK proposes to embed MCM activities within the pharmaceutical industry's research and development capabilities, Vaughn said.
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From page 54... ...
Mansoura said the ability to leverage a licensed manufacturing platform in a licensed facility provides an enormous enhancement to current capabilities in responding to threats. For example, synthetic vaccine seed technology allows for rapid progress from viral sequence to vaccine manufacturing within days.
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A side benefit of the increased pandemic capacity has been the application of the new technologies to the seasonal influenza vaccine. Domestic manufacturers have been able to provide quadrivalent flu vaccines, highdose vaccines, intradermal vaccines, and egg-free vaccines.
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From page 56... ...
. However, there is a lack of transparency regarding the financing needs, and it is not clear if the pandemic preparedness plan from a decade ago is the basis for the current appropriation.
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Osterholm of CIDRAP noted that now is the time to enlist the support of the business community in pandemic preparedness, and not just government and pharmaceutical industry partners, as the private sector understands how pandemics can impact both their supply chains and the company's workforce. In the push to increase flu vaccination among the general public, public health and the media have created an environment where everyone thinks the current influenza vaccine sufficiently protects the public and does not need improvement, according to Osterholm.
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From page 58... ...
The task is twofold: develop a broader-immunity vaccine for the long term that will provide longer-lasting, broader protection (perhaps also against a potentially pandemic subtype) and simultaneously address the limitations of current vaccines for the short term by developing new platforms for seasonal vaccines.
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From page 59... ...
Rick R Bright Acting Director D of thee Influenza Diivision at BAR RDA Applyiing IRAT to Pandemic P Scen narios Too illustrate a measured reesponse, Brigght described two pandem mic scenarrios involving g a high patthogenicity aavian influennza and a high pathoggenicity influeenza in special populationns. The formeer would havee a rapid, high peak anda then ebbb, and the laatter would hhave a slower, graduaal, lower peaak, and then ebb (see Figgure 5-2)
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From page 60... ...
If the viruus is assessed to be very high risk, a full-scale bu b manufactuured and stored just short of ulk lot could be g the vaccine,, and availablle vaccine woould be ready in finishiing and filling severaal weeks. Davvid Vaughn Head H of Exterrnal Research h and Developpment at GSK K Vaccines Vaaughn explain ned that the H1N1 vacciine developm ment experiennce was veery different from the H5 5N1 experiennce, due to thhe extent of tthe outbreeak and immeediate need fo or MCMs.
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From page 61... ...
. Because of some adverse events reported following the H1N1 adjuvant vaccination of Pandemrix in Europe in 2009, and a link to increased incidence of narcolepsy in children, public concern surrounding the use of adjuvants in flu vaccines also exists.5 Largely because of this, it would not have been possible to license an adjuvanted H1N1 vaccine in the United States in fall 2009, Vaughn said, as no approved flu vaccines in the United States then or now contain an adjuvant.
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