Special Report: The Pandemic Paradigm: Balancing Commercial Opportunities with Public Health Concerns in the Face of A/H1N1 2009
Decision Resources, Inc, October 2009, Pages: 36
WHO and the European Centre for Disease Prevention and Control (ECDC) are advising countries to prepare for a more severe second wave of A/H1N1 2009 in the winter of 2009-2010. This advisement could be warranted, given that no infectious disease has killed more people in a short period of time than influenza. Without preventive measures—such as vaccines—the current A/H1N1 (“swine flu”) 2009 pandemic could claim more than 1 million lives in the seven major markets we cover. The onus on public health agencies and the pharmaceutical industry, therefore—both now and in the future—is to learn from their past successes and failures to ensure that systems are in place that can quickly identify, prevent, and treat a pandemic virus.
Questions Answered in This Report
Prior to A/H1N1, SARS and H5N1 (“avian flu”) influenza were the first major infectious disease scares of the millennium.
- What lessons did these two events provide?
- How are lessons learned from these infectious outbreaks being applied to the current A/H1N1 2009 situation?
Without preventive measures such as vaccines, A/H1N1 2009 will affect a considerable number of people in the major markets under study.
- How many cases, hospitalizations, and deaths will result if no preventive measures are put in place?
Traditional methods of vaccine production are being challenged by new technologies.
- What are the old technologies and what advantages will the new vaccine technologies have over them?
- What companies are involved in these new technologies?
- How are the emerging vaccines differentiating themselves from one another?
Vaccines for A/H1N1 2009 were approved by the FDA beginning on September 15, 2009.
- Which companies obtained FDA approval for their vaccines?
- Which patient populations are each of these companies permitted to vaccinate?
- Despite these approvals, what obstacles stand in the way of vaccines coming out in the coming months?
Antivirals and diagnostics are useful tools in the A/H1N1 2009 fight, but each technology has room for improvement.
- What are the downsides to antiviral treatments?
- How can diagnostics be improved to assist in current or future pandemics?
- In which situations will certain antivirals be used, and what factors might limit the uptake of antiviral use during this pandemic?
Scope
- Primary research: interviews with three influenza experts.
- Up-to-date Decision Resources epidemiology review of A/H1N1 2009: pandemic versus seasonal influenza, genetic drift versus genetic shift, emerging influenza threats, the current pandemic (cases, hospitalizations, deaths) compared with seasonal flu (cases, hospitalizations, deaths).
- Case studies: history of influenza, severe acute respiratory syndrome (SARS), H5N1 influenza (“avian flu” or “bird flu”).
- Influenza vaccines: development and production processes, current egg-based technologies, current and emerging cell-based technologies, companies with approved or potential A/H1N1 2009 vaccines.
- Antivirals: Tamiflu, Relenza, peramivir.
- Diagnostics: recent FDA A/H1N1 2009 diagnostic approvals, challenges with influenza diagnostics, opportunities and needs for pandemic diagnostics.
Executive Summary
- Strategic Considerations
- Stakeholder Implications
Introduction
Past Influenza Pandemics and Recent Virus Scares: A Historical Perspective
- SARS—the First Pandemic of the Millennium Tests Public Health Readiness
- The Avian Flu: Health Scare Jump-Starts Pandemic Readiness
Current Situation: the A/H1N1 2009 Virus
- Background: Seasonal Influenza
- Genetic Shift and Drift: the Dynamics of the Influenza Virus
- Emerging Influenza Threats
- Pandemic Threat
- Susceptible Populations
- A/H1N1 2009 Pandemic
- - Cases
- - Hospitalizations
- - Deaths
- Pandemic Prevention
Producing Influenza Vaccines: Challenges and Progress
- Egg-Based Methods of Production
- Current Cell-Based Methods
- - Baxter International
- - Solvay Pharmaceuticals
- - Novartis
- Emerging Technologies
- - Protein Sciences
- - Novavax
- - VaxInnate
- DynaVax Technologies
- A/H1N1 2009 Vaccine Development Activities, by Company
- - GlaxoSmithKline
- - Sanofi -Aventis
- - Novartis
- - CSL
- - MedImmune
- - Baxter International
- - Solvay Pharmaceuticals
- - Sinovac
Antivirals
Diagnostics
Outlook: Summary of Lessons Learned and Scenarios Looking Forward
- Lessons Learned
- Possible A/H1N1 2009 Scenarios
- The Probable Scenario
- The Unlikely Scenario
- What About Future Pandemics?
Appendix A: Bibliography
Appendix B: List of Interviewed Physicians
Tables
1. Number of Incident Cases, Hospitalizations, and Deaths Attributable to Seasonal Influenza and A/H1N1 2009 in the Major Markets, 2009/2010
2. U.S. Department of Health and Human Services Grants to Companies for the Development of Cell-Based Influenza Vaccines
Figures
1. Seasonal vs. Pandemic Influenza
2. Creation of Influenza Vaccine Viral Strains Using Reassortment
3. Creation of Influenza Vaccine Viral Strains Using Reverse Genetics
4. Approximate Timeline for Production of Seasonal Influenza Vaccine
5. Sales of Tamiflu and Relenza, 2000-H12009
6. Tamiflu Sales, Seasonal Flu vs. Pandemic Flu, 2005-H12009
- Abbott Laboratories
- AstraZeneca
- Baxter International
- Becton Dickinson
- BioCryst Pharmaceuticals
- CSL
- Dynavax Technologies
- DynPort Vaccine Company
- Focus Diagnostics
- GlaxoSmithKline
- Inverness Medical
- Luminex
- MedImmune
- Mylan
- Novavax
- Novartis Vaccines and Diagnostics
- Prodesse
- Protein Sciences
- Quest Diagnostics
- Quidel
- Roche
- Schering-Plough
- Solvay Biologicals
- Solvay Pharmaceuticals
- Sanofi -Aventis
- Sanofi -Pasteur
- Sinovac
- Teva
- VaxInnate
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