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1
The VIPS Prioritisation Process:
Methodology and Outcomes
Contents
INTRODUCTION ................................ ................................ ................................ ........................ 3
Rationale for VIPS ................................ ................................ ................................ ...................... 3
VIPS Background and Goal ................................ ................................ ................................ ........ 3
Purpose of this Document ................................ ................................ ................................ ........... 3
STRUCTURE OF VIPS ................................ ................................ ................................ ............... 4
Alliance Working Group ................................ ................................ ................................ .............. 4
Steering Committee ................................ ................................ ................................ .................... 4
Stakeholder Engagement ................................ ................................ ................................ ............ 5
OVERVIEW OF THE VIPS PROCESS ................................ ................................ ....................... 5
Description of Phases and Timeline ................................ ................................ ............................ 5
Scope of Innovations ................................ ................................ ................................ ................... 6
PHASE I ................................ ................................ ................................ ................................ ..... 8
Overview of the VIPS Phase I Evaluation Framework ................................ ................................ . 8
Evaluation of the 24 Innovations in Phase I ................................ ................................ ............... 11
Country Consultation to Inform the Phase I Evaluation ................................ ............................. 11
Technical Notes and Executive Summaries ................................ ................................ .............. 11
Selection of Innovations Shortlisted for Phase II ................................ ................................ ....... 12
PHASE II ................................ ................................ ................................ ................................ .. 13
Overview of the Phase II Evaluation Framework ................................ ................................ ....... 13
Evaluation of the 9 Innovations in Phase II ................................ ................................ ................ 16
Country Consultations ................................ ................................ ................................ ............... 16
Industry consultations ................................ ................................ ................................ ............... 18
Regulator consultations ................................ ................................ ................................ ............. 18
Technical Notes and Executive Summaries ................................ ................................ .............. 18
Selection of Innovations for Final Prioritisation ................................ ................................ .......... 19

May 2019



VIPS Vaccine Product Innovation s and
Comparator s ? list
VIPS scope of innovations

VIPS uses the following definition of product innovation to define its scope: ? completely
new products or adaptations to existing products that provide measurable financial or
programmatic benefits to lower and middle income countries (LMICs), such as
increased coverage and equity (e.g., by overcoming a ?last mile? barrier) or vaccine
effectiveness ?.

The scope of innovations that were assessed was infor med by partner and expert
consultations, with an agreement to define a broad scope to avoid focusing mainly on
?low -hanging fruit? - innovations that are expected to come to market without requiring
incentives - and to include some of the broader vaccine i nnovative features that have
the potential to make an impact in terms of better meeting country programmatic needs
or improving coverage and equity.

In scope:
? Primary vaccine containers (without delivery device): The immediate
receptacle in direct contact with the vaccine as distributed for sale.
? Integrated primary container and delivery technology: A stand -alone
technology used as the primary vaccine container, and to administer a vaccine
by a specific vaccine ad ministration route.
? Delivery technology (not prefilled): A stand -alone technology used to
administer a vaccine by a specific vaccine administration route
? Formulation: The combination of chemical and biological substances used to
produce a final vaccine pr oduct . F or VIPS , formulation innovations will be limited
to those with the objective of improving thermostability and enabling use in
controlled temperature chain (CTC).
? Packaging and safety : Secondary or tertiary packaging for vaccine primary
containers and safety devices for vaccine preparation (not delivery).
? Labelling: Text, symbols, data or other visual cues provided on the primary
packaging of a vaccine or on documents included within the packaging

Classified as Internal
VIPS Steering Committee members
Members Organisation Role
Alejandro Cravioto Facultad de Medicina Universidad Nacional
Aut?noma de M?xico Professor; SAGE Chair
David Robinson Bill and Melinda Gates Foundation Deputy Director of Vaccine Development and Surveillance,
Chemistry Manufacturing and Controls
Christopher Morgan Jhpiego (from June 2020) and Burnet Institute Senior Technical Advisor (Immunization) and Honorary Senior
Principal Research Fellow
David Kaslow PATH Vice president, Essential Medicines
Jean -Pierre Amorij UNICEF Supply Division Vaccine Technology Specialist
Jerome Kim International Vaccine Institute Director General
Jon Abramson Wake Forest School of Medicine Professor of Pediatric Infectious Diseases
Kelly Moore Vanderbilt University School of Medicine Adjunct Associate Professor of Health Policy
Mark Jit London School of Hygiene and Tropical Medicine Professor, Vaccine Epidemiology
Mark Papania Global Immunization Division, Centers for Disease
Control Medical Epidemiologist
Michael Free Independent Independent Consultant; Senior Advisor Emeritus, PATH
Nora Dellepiane QRB Consultants S?rl Independent consultant
Ramanan Laxminarayan Center for Disease Dynamics, Economics and Policy Director
Ruth Karron John Hopkins University Professor, International Health
Samir Sodha WHO Routine Immunization Officer
Shelley Deeks Public Health Ontario Chief, Health Protection Officer
WHO Immunisation Practices Advisory Committee member Product Development for Vaccines Advisory Committee member

 

VIPS PHASE 2 TECHNICAL NOTE

Microarray patches




30.03.2020
Page 1 of 75
VIPS is a Vaccine Alliance project from Gavi, World Health Organization, Bill & Melinda Gates Foundation, PATH and UNICEF

Microarray patches ( MAPs )

SECTION ONE: Vaccine compatibility and problem statements addressed by the innovations

Technology overview :
MAPs consist of an array of hundreds or thousands of micro -projections on a ?patch?. The projections are coated with, or composed of, vaccine in a dry
formulation. When applied to the skin, the vaccine is delivered into the dermis and/or epidermis, which a re rich in antigen presenting cell (APCs).
Several different formats of MAPs are being developed:
? With, or without, applicators; when present, the applicator can be a separate component or integrated with the MAP. The most advanced MAPs in
development either have no applicator or an integrated applicator. Therefore, MAPs with a separate applicator are not considered in this
assessment;
? Solid micro -projections coated with vaccine;
? Micro -projections formed of vaccine plus biocompatible excipients that dissolve or biodegrade in the skin;
? Hydrogel micro -projections that swell in the skin and act as a condui t for diffusion of the active ingredient from a backing layer (primarily in development for
drug delivery).
In theory, MAPs could be used for administration of any type of vaccine, although there might be some vaccine -specific limitations: it might not be possible to
formulate some vaccines so that they remain potent during the manufacture or storage of MAPs; some vaccines (in particular th ose formulated with an adjuvant)
might have unacceptable levels of local reactogenicity when delivered into the skin; a nd in some cases, MAPs might not have the payload capacity for the vaccine
plus necessary excipients, or it might not be possible to concentrate the antigen sufficiently so that it can be loaded onto the MAP.
Summary of vaccine and innovation compatibility :
Microarray patches ( MAPs ) could potentially be used to deliver any vaccine that is currently administered by injection with needle and syringe (N&S). The
technology does have some features that might however preclude its use with some vaccines, in particular:
1. Reactogenicity: MAPs deliver vaccines to the skin rather than intramuscularly (IM) or sub -cutaneously (SC). The subsequent initial immune response
takes place near the skin surface and is more visible as local reactogenicity, than with IM or SC injections. While this administration route may offer the
potential for dose -sparing for some vaccines, reactogenicity seen with MAP delivery of some ?more -reactogenic? formulations might not be acceptable to
recipients.
The reactogenicity seen with MAP delivery of some ?more -reactogenic? vaccines might not be acceptable to recipients.
The inherent reactogenicity of any of the priority vaccines has NOT been considered in this analysis, and no vaccines have been excluded on this basis.
Reactogenicity due to inclusion of an adjuvant HAS been considered (see below).