Stakeholder Opinions: Vaccine administration technologies - Beyond needles

Novel vaccine administration technologies have the potential to improve vaccine developers' commercial competitiveness and to increase vaccination safety and convenience. This report assesses key strategies, technologies and products for novel dermal and mucosal vaccine administration. It also provides an overview of opportunities and challenges for the sector and a future outlook.

Report Highlights
Needle-free vaccine delivery into and through the skin is an important focus of vaccine research, with key technologies including intradermal patches, microneedles and needle-free liquid, solid and powder injectors. Recognizing the skin as an important immunologic organ, researchers mainly hope for an improved immune response using this approach.

The largest potential for success of mucosal vaccine delivery lies in oral and intranasal administration, while pulmonary vaccination appears less promising due concerns regarding safety and reliable dosing. Careful selection of suitable indications for mucosal delivery routes will be key to success in this challenging sector.

Antigen stability, safety and efficacy are the key hurdles for novel vaccine administration technologies. In times of restricted healthcare budgets, pricing and manufacturing costs of novel vaccine administration systems need to be kept to a minimum. Only the careful selection of suitable indications will offer a route to commercial success.
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ABOUT DATAMONITOR HEALTHCARE 2
About the Infectious diseases pharmaceutical analysis team 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Strategic scoping and focus 3
Datamonitor insight into the vaccine administration market 3
Related reports 5
Upcoming related reports 5
CHAPTER 2 BRIEF HISTORY OF THE DEVELOPMENT OF VACCINE ADMINISTRATION SYSTEMS 7
Overview of past developments in the vaccine administration sector 7
CHAPTER 3 RATIONALE FOR THE DEVELOPMENT OF NOVEL VACCINE ADMINISTRATION SYSTEMS 10
Unmet needs regarding vaccine administration differ between the developed and the developing world 10
Vaccine delivery through needle / syringe injection is associated with considerable health risks 12
Alternative vaccine delivery technologies could provide better protection through a combined mucosal / systemic immune response 14
Compliance could be improved through painless delivery alternatives 15
Alternative delivery technologies could reduce or eliminate the need for a cold chain 17
Increased ease of use and speed of vaccine delivery is a key achievable for biodefense indications and mass vaccination campaigns 19
From a marketing perspective, vaccine administration could become an advantage in highly competitive segments of the vaccines market 21
CHAPTER 4 CHALLENGES FOR NOVEL VACCINE ADMINISTRATION SYSTEMS 22
The regulatory pathway for novel delivery systems is complicated 23
The oligopoly structure of the vaccines market and the decreasing funding for biotech companies as a result of the economic downturn represent further challenges 24
The limited knowledge of the molecular mechanisms linked to vaccine administration hampers the development of new technologies 27
Cost constraints could dent the commercial opportunity of novel vaccine administration systems 28
Various new technologies are currently in development for vaccine administration 30
CHAPTER 5 DERMAL VACCINE ADMINISTRATION 33
Transdermal vaccine delivery 33
General considerations 33
Transdermal vaccine delivery systems 38
Transdermal patches 38
Key transdermal patch systems in development for vaccine administration 39
Intercell - Transdermal patch technology 40
DBV Technologies - VIASKIN patch 44
Genetic Immunity - DermaPrep 45
Vaxin - patch technology 45
Datamonitor assessment 45
Microneedles 50
Key microneedle-based systems in development for vaccine administration 52
Becton Dickinson - BD Soluvia 53
Cyto Pulse - Easy Vax/Derma Vax 56
3M Drug Delivery Systems - Solid Microstructured Transdermal System (sMTS) 57
Debiotech - Nanoject 59
Nanopass - MicronJet Needle 59
Valeritas - Micro-Trans 60
TheraJect - VaxMAT 60
Zosano Pharma - ZP patch 61
Datamonitor assessment 61
Needle-free solid, liquid or powder injection technologies 65
General considerations 65
Key needle-free injection systems in development for vaccine administration 67
Avant Medical - Guardian 101 Pulse Injection System 68
Bioject - Biojector 2000 69
D'Antonio Consultant International - LectraJet 71
EuroJet Medical - E-Jet 500 71
INJEX - Equidyne Systems - Injex 71
Glide Pharma - Glide SDI 72
PenJet - PenJet injector 74
Pfizer - Powder Injection 74
PharmaJet - PharmaJet System 76
Pulse NeedleFree Systems - HSI-500 77
Valeritas - Mini-Ject 77
Datamonitor assessment 77
CHAPTER 6 MUCOSAL VACCINE ADMINISTRATION 85
Oral vaccine delivery 92
General considerations 92
Oral vaccine delivery systems 93
Live-attenuated pathogens 93
Inactivated pathogens 95
Bacterial/viral vectors 96
Subunit vaccines 97
Plant-derived vaccines 98
Marketed and pipeline oral vaccines 102
Sabin oral polio vaccine 102
Rotarix/RotaTeq 103
Emergent BioSolutions: spi-VEC Technology 107
Aridis Pharmaceuticals: Sublingual wafer technology 107
Vaxart / Barr - adenovirus vector technology 108
Datamonitor assessment 108
Intranasal vaccine delivery 113
General considerations 113
Intranasal vaccine delivery systems 115
Live-attenuated vaccines 115
Viral vectors 115
Split-, subunit- or DNA vaccines 116
Marketed and pipeline intranasal vaccines 118
AstraZeneca: FluMist 121
BioDiem: live-attenuated influenza vaccine 124
Datamonitor assessment 125
Pulmonary vaccine delivery 129
General considerations 129
Pulmonary vaccine delivery systems 131
Marketed and pipeline pulmonary vaccines 133
WHO: aerosol measles vaccine 134
Datamonitor assessment 135
BIBLIOGRAPHY 139
Literature 139
APPENDIX 151
Contributing experts 151
Academic key opinion leaders 151
Industry key opinion leaders 151
Conferences 151
Report methodology 152
About Datamonitor 153
About Datamonitor Healthcare 153
About the Infectious Diseases analysis team 154
Key therapy team members 155
Holger Rovini, Head of Respiratory and Infectious Diseases 155
Hedwig Kresse, Senior Analyst, Infectious Diseases 155
Disclaimer 156
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Table 1: Summary of key vaccine administration technologies in development, 2009 31
Table 2: Key transdermal patch technologies in active development for vaccines, 2009 40
Table 3: SWOT analysis - transdermal patch vaccine delivery systems 49
Table 4: Key microneedle technologies in active development for vaccines 53
Table 5: SWOT analysis - microneedle vaccine delivery systems 64
Table 6: Key needle-free injector technologies in active development for vaccines 68
Table 7: SWOT analysis - needle-free injection vaccine delivery systems 84
Table 8: Key marketed oral vaccines, April 2009 102
Table 9: Key oral pipeline vaccines, April 2009 106
Table 10: SWOT analysis - oral vaccine delivery systems 113
Table 11: Key marketed and pipeline nasal vaccines, March 2009 120
Table 12: SWOT analysis - nasal vaccine delivery systems, 2009 128
Table 13: Comparison of different classes of pulmonary inhaler devices 132
Table 14: Key pipeline pulmonary vaccines, March 2009 134
Table 15: SWOT analysis - pulmonary vaccine delivery systems 138
Figure 1: Key events in the history of vaccine administration 8
Figure 2: Unmet needs in vaccine administration in the developed and developing worlds 11
Figure 3: Drivers and resistors for vaccine administration technology development 22
Figure 4: Overview of the development stage and expected market entry of key physical vaccine delivery technologies, 2009-2019 32
Figure 5: Transdermal vaccine delivery 34
Figure 6: Transdermal patch vaccine delivery 38
Figure 7: Microneedle vaccine delivery 51
Figure 8: Becton Dickinson - BD Soluvia 53
Figure 9: 3M Drug Delivery Systems - Solid Microstructured Transdermal System 58
Figure 10: Nanopass - MicroPyramids 59
Figure 11: Zosano Pharma's ZP patch technology 61
Figure 12: Needle-free injector vaccine delivery 66
Figure 13: Glide Pharma's Glide SDI 73
Figure 14: PharmaJet's liquid jet injector 76
Figure 15: Mucosa-associated lymphoid tissue and aggregates 85
Figure 16: Generation of immunity through mucosal vaccination 86
Figure 17: Advantages and drawbacks of mucosal vaccination 89
Figure 18: Annual sales of RotaTeq versus Rotarix, 2006-08 104
Figure 19: FluMist - vaccine sales in the US, 2004-08 121
Figure 20: FluMist - CDC and private sector costs/dose in the US, 2004-08 123
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