World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and...
Transcript of World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and...
![Page 1: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/1.jpg)
Global Vaccine and Immunization Research Forum
Bethesda, USA March 5, 2014
Ph
oto
: WH
O
World Health Organization—Next-Generation Vaccine Delivery Technology Meeting Summary
Darin Zehrung
Senior Technical Officer andPortfolio Leader, Delivery Technologies
PATHVaccine and Pharmaceutical Technologies Group
![Page 2: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/2.jpg)
New and alternative delivery technologies
• Many new technologies are needle-free.
• Some are compatible with existing vaccine formats (e.g., vials or ampoules).
• Others are integrated with formulation (e.g., combination products).
• Improved ease of vaccine delivery, efficacy, cost-effectiveness, and safety are areas of focus.
• Developers include industry, academic, and nonprofit research groups.
Ph
oto
: Ge
org
ia T
ech
Ph
oto
s: P
AT
H
Photo: The Hindu
![Page 3: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/3.jpg)
Potential public health benefits
• Increase vaccine access and coverage—enable community health workers to deliver vaccines.
• Improve immunogenicity.
• Reduce the need for and the number of injections .
• Reduce risk of infections/cross-contamination.
• Reduce potentially dangerous sharps waste.
Gra
ph
ic:
PA
TH
Ph
oto
: WH
O
![Page 4: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/4.jpg)
Potential public health benefits
• Relieve tensions and fears surrounding immunization.
• Reduce drop-out by optimizing schedules.
• Reduce health worker workload—simplified administration and reconstitution (free up time for other tasks).
• Reduce cold chain dependency through improved thermostability (heat and freeze stability).
Ph
oto
: PA
TH
\Üm
itK
arto
glu
Ph
oto
: PA
TH
/De
bra
Kri
ste
nse
nP
ho
to: P
AT
H/D
eb
ra K
rist
en
sen
![Page 5: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/5.jpg)
Meeting background and objectives
• Follow-on to 2013 NUVI meeting. Theme: Innovation in Immunization.
• Objectives:
− Review lessons learned of earlier vaccine technologies.
− Conduct rapid review of existing and future technologies:
� Delivery devices, packaging, and vaccine formulation.
− Provide a vision for the future of vaccine delivery technologies:
� Short-term (within the Decade of Vaccines timeline) and long-term objectives (beyond 2020).
− Determine strategic next steps to guide and enable the development, introduction and uptake of new technologies, to include industry incentives, with potential for public health impact.
![Page 6: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/6.jpg)
• Technology developers (multiple industry, academia – representing 9 universities).
• Vaccine manufacturers (BioFarma, Crucell, GlaxoSmithKline [GSK], Serum Institute of India, Ltd. [SIIL], Sanofi, Merck), Pfizer, Thai Red Cross).
• Public-sector agencies (World Health Organization [WHO], United Nations Children's Fund [UNICEF]), United States Centers for Disease Control[CDC])
• Nongovernmental organizations (Bill and Melinda Gates Foundation [BMGF], PATH, Aeras, Doctors Without Borders/Médecins Sans Frontières International [MSF], Clinton Health Access Initiative [CHAI], GAVI Alliance, Global Good, Intravacc).
• Regulatory authorities (WHO, Brazil, Nigeria, Tanzania, the Netherlands).
Meeting participantsA
ll p
ho
tos:
WH
O
![Page 7: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/7.jpg)
Technology
innovation
Lessons
learned
Public
health
need
Priorities
Challenges
Investment
Trends
Questions and meeting themes
Ph
oto
: PA
TH
\Gab
e B
ien
czyc
ki
Ph
oto
: Bill
& M
elin
da
Gat
es
Fou
nd
atio
nP
ho
to: G
eo
rgia
Inst
itu
te o
f T
ech
no
logy
Ph
oto
: PA
TH
![Page 8: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/8.jpg)
• Autodisable (AD) syringes:
− Providing clear direction to developers is critical.
− Global leadership is essential (WHO, UNICEF).
− A long-term commitment to the technology is necessary.
• Vaccine vial monitors (VVMs):
− Perseverance is key.
− Champions are crucial.
− WHO policies help drive uptake.
− Global effort and long-term financial support required.
• Uniject injection system:
− Demand drives uptake.
− Value proposition analysis is important.
− Regulatory processes must be considered.
− Incentives are necessary.
Lessons learned—technologies
Ph
oto
: Um
itK
arto
ğlu
Ph
oto
: Be
cto
n D
icki
nso
n (
BD
)P
ho
to: B
ect
on
Dic
kin
son
(B
D)
![Page 9: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/9.jpg)
Technologies reviewed and represented
−Disposable-syringe jet injectors
−Intradermal delivery devices
−Electroporation
−Intranasal delivery
−Microneedles
−Aerosol/dry powder inhalation
Delivery devices
−Novel primary containers
−Reconstitution
−Improving packaging materials and reducing volumes
Packaging
−Mucosal delivery
−Solid-dose implants
−Thermostability(heat/freeze)
Formulation
All
ph
oto
s: P
AT
H
![Page 10: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/10.jpg)
Photo: ©Georgia Tech.Photo: ©PATH. Photo: ©PATH.
Microneedles
![Page 11: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/11.jpg)
Intradermal delivery
Photos: Star SyringePhotos: West Pharmaceutical Services
![Page 12: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/12.jpg)
Photo: ©PharmaJet. Photo: ©PATH. Photo: ©PATH.
Disposable-syringe jet injectors
![Page 13: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/13.jpg)
Photo: ©LMA.
Ph
oto
: ©Th
e H
ind
u.
Photo: ©Serum Institute of India, Ltd.
Intranasal spray/atomizers
![Page 14: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/14.jpg)
Aerosolization/nebulizers
Photos: ©World Health Organization
![Page 15: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/15.jpg)
Dry-powder inhalers
Photos: ©AktivDry.
![Page 16: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/16.jpg)
Photo: ©LyoTip.
Photo: ©Aktivax.
Photo:©Eulysis.
Ph
oto
:Du
oje
ct
Ph
oto
: Lyo
go
Reconstitution
![Page 17: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/17.jpg)
Ph
oto
s/gr
aph
ics:
©R
om
me
lag.
Blow-fill-seal
![Page 18: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/18.jpg)
Ph
oto
s/gr
aph
ics:
©M
ed
ical
Inst
ill(M
ED
Inst
ill)
Preservative-free packaging
![Page 19: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/19.jpg)
Photo: ©Ichor Medical Systems, Inc.
Photo: ©Ichor Medical Systems, Inc.
Photo: ©Ichor Medical Systems, Inc.
Photo: ©Inovio Pharmaceuticals Inc.
Electroporation
![Page 20: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/20.jpg)
Photo: ©Glide Pharma Photo: ©Glide Pharma Photo: ©Bioneedle
Solid-dose/dissolvable needles
![Page 21: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/21.jpg)
New vaccine technologies—key input
A bold, transformative vision must be generated, incorporating technology and industry trends.
Public sector must define needs and objectives—problem
statement—eliminate conflicting messages.
Regulatory process and requirements must be established at global and country level—guidance documents?
Improved cost benefit analysis is required to assess new technologies—to include systems costs. Who pays and who benefits?
![Page 22: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/22.jpg)
New vaccine technologies—key input (cont.)
Lessons learned are critical to capture both successes and challenges.
Developers need feedback and guidance—Vaccine Presentation and Packaging Advisory Group (VPPAG) expansion?
Country input is critical (design/prioritization/procurement).
Incentive structures are needed to push and pull promising ‘game changer’ technologies forward—advance market commitments (AMCs), other mechanisms?
![Page 23: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/23.jpg)
Meeting participant poll results:Vision of the future of immunization
Integrated combination products available to be used by
community health workers (85 percent).
No more manual reconstitution of vaccines (69 percent).
Significantly improved thermostability of new EPI vaccines (66
percent).
No more needles to administer vaccines (53 percent).
Combining vaccines at the point of delivery (49 percent).
![Page 24: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/24.jpg)
Proposed next steps—strategy and evidence base
Develop vision and goals for the next decade(s).
Identify champions to move the process forward.
Develop a forum for device developers to seek feedback from
VPPAG—initiate guidance documents.
Establish cost-benefit analysis criteria and thresholds from a system perspective—vaccine-specific investment cases?
![Page 25: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/25.jpg)
Proposed next steps—strategy and evidence base (cont.)
Support the formation of associations of vaccine device developers, academia, and vaccine manufacturers.
Conduct a comprehensive assessment on the vaccine delivery technology needs of developing countries—the user perspective is key.
Set up country sites (e.g., WHO Collaborating Centers) for new technology field evaluations.
Prepare for a future SAGE discussion on new vaccine delivery technologies.
![Page 26: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/26.jpg)
Proposed next steps—regulatory
Develop guidance on the regulation of combinations of devices and vaccines with regulators—enable harmonization and maintain flexibility.
Hold follow-up meetings: Device-specific, regulatory (devices and vaccines) meetings to include key stakeholders.
Consider facilitated country registration procedures for WHO-prequalified vaccines and recommendation for delivery with specific devices.
![Page 27: World Health Organization—Next-Generation Vaccine Delivery … · 2014-03-28 · New and alternative delivery technologies • Many new technologies are needle- free. • Some](https://reader034.fdocuments.net/reader034/viewer/2022043008/5f9729e9c9bad20a213f22bf/html5/thumbnails/27.jpg)
Thank you!
Darin Zehrung
Senior Technical Officer & Portfolio Leader, Delivery TechnologiesVaccine and Pharmaceutical Technologies Group [email protected]
Carsten Mantel
Priority Area LeaderNew Vaccines and InnovationsExpanded Programme on Immunization (EPI)Dept. of Immunization, Vaccines and Biologicals (IVB)World Health [email protected]