C E N T E R F O R VA C C I N E
I N N O V AT I O N A N D A C C E S S
Advancing new
vaccines against
seasonal and
pandemic
influenza in lowresource countries
Francesco Berlanda Scorza, PhD
Project Director, Influenza Vaccines
Center for Vaccine Innovation and Access
15 November 2016
PATH/Gabe Bienczycki
PATH’s Center for Vaccine Innovation and Access (CVIA)
CVIA’s primary objective is to accelerate the development and introduction of lifesaving essential medicines for
optimal public health impact in the world’s lowest resource settings. We focus on vaccines that protect women
and children from the leading causes of disease and death.
DISEASE AREAS
Enteric and Diarrheal Diseases
rotavirus • enterotoxigenic Escherichia coli • Shigella ssp. • poliovirus
Malaria
Plasmodium falciparum • Plasmodium vivax
Respiratory Infections and Maternal Immunization
pneumococcus • meningococcus • group B streptococcus • B. pertussis • influenza virus •
respiratory syncytial virus
Zoonotic, Emerging, and Sexually Transmitted Infections
human papillomavirus • Japanese encephalitis virus • dengue virus • yellow fever virus • outbreaks
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PATH’s Work on Influenza Vaccines
• CMC and Clinical Trial Technical Support to Influenza Vaccine Manufacturers (2009-2017).
HHS/BARDA.
• Scope: Assistance to DCVMs in the development of seasonal and pandemic vaccines.
• Influenza Vaccine Project (2007-2015). Bill and Melinda Gates Foundation.
• Scope: Advance development of safe, effective, and affordable vaccines suitable for use in infants and
young children.
• Chimeric LAIV-IIV Influenza Vaccine Research. Bill and Melinda Gates Foundation/Mt. Sinai
(2014-2018).
•
Scope: Support chimeric LAIV-IIV prime-boost universal vaccine to be evaluated in a Phase 1 study.
• Chimeric LAIV-LAIV Influenza Vaccine Research: Bill and Melinda Gates Foundation (20162018).
• Scope: Support preclinical studies and manufacture of a second chimeric LAIV.
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Ongoing collaboration with BARDA
Technical support to
influenza vaccine
manufacturers
Goal: To support the
enhancement of regional
sustainable influenza
vaccine production in
emerging countries.
Photo: PATH/Satvir Malhotra
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HHS/BARDA and PATH: Influenza vaccine development
and international capacity building
PRE
Vietnam:
H5N1 (cell based)
India: Seasonal LAIV
Ph. 1
Ph. 2
Ph. 3
PQ
Serbia: Seasonal
split (egg based)
China:
Seasonal LAIV
(egg based)
Vietnam:
Seasonal (split)
H5N1 (whole virus
inactivated)
(egg based)
Brazil:
Seasonal split
PQ
(egg based)
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PRODUCT
HHS/BARDA and PATH: Influenza vaccine development
and international capacity building
Inactivated
Split
Inactivated
whole virus
LAIV
Egg based
Cell based
PLATFORM
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Advancing new vaccines against pandemic influenza in
low-resource countries: Significant challenges
•
CMC: Process Development
• Seed Development
• Intermediate Step Recovery
• Formulation
• Process Yields
• Process Validation
• Analytical Development
• Quality Management Systems
•
Clinical Trial Implementation
• Regulatory Framework
• Ethical Review Process
• Laboratory Challenges
• Lack of Effective Community
Engagement/Recruitment
• Pharmacovigilance
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H5N1 vaccines : Inactivated, whole virion vs. split
(+ adjuvants)
Slide 8
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Conclusions
• No consensus on best in class for influenza A/H5N1 vaccines.
• Cell based approaches offer advantage over egg based, but are not an
established and widely available technology.
• LAIVs offer potential for large scale, cost effective manufacturing on a flexible
platform.
• Whole virus influenza A/H5N1 vaccines are highly immunogenic (both cell
based and egg based).
• Transition from seasonal (H1N1, H3N2 and B, split) to pandemic (H5N1,
whole).
• International support is key for product development in DCVMs.
• Manufacturing process development can be accelerated by process experts.
• Clinical development benefits from a clear regulatory pathway.
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Acknowledgements
•
PATH team members in:
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Hanoi, Vietnam
Beijing, China
Geneva, Switzerland
Seattle, Washington
Washington, DC
IVAC, VABIOTECH, Torlak, BCHT, SIIPL, Butantan
National Institute of Hygiene and Epidemiology
(NIHE) in Vietnam
Pasteur Institute in Vietnam
Supported by a cooperative agreement from
HHS/BARDA.
Learn more: http://sites.path.org/cvia/
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