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National Press Foundation

Understanding Vaccines and Health

Kathleen Neuzil, MD, MPH


Director, CVD

July 30, 2019


Mission: Eliminate vaccine-
preventable morbidity and mortality
q Founded 1974 as the first
organized research center in the
School of Medicine
q Large academic enterprise with
CVD Facts
over 30 primary faculty as well
• Foundedas 1974
trainees, research, clinical
• Large research enterprise staff
and administrative with 30
primary faculty

2
Why vaccines? Equity and feasibility

qVaccine delivery
systems designed to
reach every individual
regardless of:
• Socioeconomic status
• Geography
• Age
• Sex
qCurative care limited by
requirement for fixed
structures
3
Why vaccines? Affordability

q Domestic: Vaccines for Children


Program Entitlement program that
guarantees vaccine for all children
in the US until their 19th birthday

q International: Gavi, the Vaccine


Alliance
Subsidizes vaccines in the world’s
poorest countries
Rotavirus vaccine:
$120.00 per dose in U.S.
30 cent co-pay in low
resource countries

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CVD Approach: From Discovery to Impact

Public Health Need/Market Need


Assay & Process Development

Discovery & Preclinical Phase Phase Regulatory


Exploratory Stage Phase I II Policy Financing Launch Delivery
III Approval Phase IV
Stage
Scaling Up Manufacture
• Pathogenesis • Vaccine Design
• Formulation
Quality Controls
• Immune Reponses
• Antigen Discovery • Toxicity
• Animal Model • Proof of Concept in Animal/Human
Challenge

Political Will
Vaccines: A continuum from Discovery to Impact

Vaccines: A Continuum from Discovery to Impact

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CVD research areas
Enteric Diseases CVD has developed and tested vaccines against Shigella
and Enterotoxigenic E. coli, cholera, NTS and others. Leading Typhoid
Vaccine Acceleration Consortium (TyVAC).

Malaria – development and testing of malaria drugs and vaccines and other
interventions; antimalarial drug resistance; malaria transmission.

Influenza and Respiratory Diseases- Clinical trials of seasonal and potential


pandemic influenza vaccines, health modelling and policy.

Emerging Pathogens- Evaluating the safety, immunogenicity and antibody


persistence of Dengue, Ebola, Zika and other vaccines.

Antimicrobial Resistance – Focusing on life-threating infections such as


methicillin-resistant Staphylococcus aureus (MRSA), Klebsiella pneumoniae
and Pseudomonas.
National and international leadership in
vaccine science and policy

• James Campbell: Committee on


Infectious Diseases, AAP
• Karen Kotloff: VRBPAC, FDA;
Multiple WHO TEG on Shigella/ETEC
• Miriam Laufer: WHO malaria
chemotherapy TEG
• Kathy Neuzil: WHO SAGE member;
ACIP (CDC)
• Samba Sow: past Minister of Health,
Mali; former member of Gavi Board
CVD’s global presence: International research

Malaria Research
Program
CVD-Mali (2001)

Mortality among children under five is


unacceptably high (fifth highest in the
world)
Preventing morbidity and mortality is the
driving factor behind every study we do:
ü The Global Enterics Multicenter Study
(GEMS) of moderate-to-severe
diarrhea
ü The Pneumonia Etiology Research
for Child Health Study (PERCH)
ü The Invasive Bacterial Infection Study
ü The Child Health and Mortality
Prevention Surveillance (CHAMPS)
ü Malaria Research Program

Uses data to create political will and


accelerate public health decisions

9
CVD-Mali Impact
Generated evidence to support introduction of
5 new vaccines 2005-2014
ü Hib pentavalent
ü Meningitis A
ü PCV13
ü Rotavirus
ü HPV 2011 (pilot)

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Example: Timeline of NTS vaccine program

2002 2002- 2009 2011 2012 2014 2018


CVD establishes CVD determines Begin Investigation of CVD partners Additional Typbar-TCV™
blood culture that in Mali, NTS development of the with Bharat immunological attains WHO pre-
capabilities at HGT, (S. Typhimurium conjugate and live pathogenesis of Biotech (India) characterization of qual.
Bamako, Mali. and S. Enteritidis) vaccines against iNTS strains. to manufacture NTS conjugates
is the next most invasive S. bivalent NTS performed (e.g., Toxicity studies to
common invasive Typhimurium and conjugate evaluated in infant be performed on
bacterial pathogen S. Enteritidis. (Wellcome animal models). bi/trivalent NTS
after pneumo and Trust). Later conjugate +Typar-
Hib. expanded to TCV™, IND
Develop methods trivalent submitted and
to easily serotype formulation Phase 1 study to
S. Typhimurium with Bharat’s Vi be initiated
and S. Enteritidis. conjugate thereafter.
Tybar-TCV™.
Sow, Kotloff, Sow, Kotloff, Levine, Levine, Galen, Levine, Galen, Levine, Galen,
Levine,
11 Tapia Tapia, Tennant Tennant, Simon Tennant Tennant, Simon Simon, Pasetti Tennant, Simon,
Typhoid: Where are we in 2019?

• Typhoid continues to be a
substantial public health threat.
• Increasing recognition of the
burden in young children.
• Outbreaks of typhoid continue.
• Antimicrobial resistance to the
most effective treatments is on the Percent of population with improved drinking
water sources, 2015.
rise.
• Improvements in water, sanitation,
and hygiene continue to lag in UNICEF and WHO. 2015
many parts of the world.

Source: UNICEF and WHO, 2015.


The Typhoid Vaccine Acceleration consortium (TyVAC)
Mission: To reduce the global burden of typhoid by
accelerating the introduction of typhoid conjugate
vaccines (TCVs), particularly in low resource countries.

COLLABORATING ORGANIZATIONS
A framework for accelerating TCV introduction
Policy milestones impacting TCV introduction

Nov 2017 Feb 2018


Oct 2017 Dec 2017 Mar 2018

Scoping Country introduction


On-going trials and impact studies of TCV

Number vaccinated
• TyVAC Malawi: 28,142
• TyVAC Burkina Faso:
250
Number vaccinated
• TyVAC Bangladesh 61,756
• TyVAC Nepal: 20,015
• Navi Mumbai India: ~ 113,000
• Pakistan (outbreak response): Goal of 250,000
Potential barriers to TCV
introduction
• Insufficient burden data to
assess country need.
• Difficult to apply risk-based
strategy in absence of incidence
data or population risk factors.
• What happens as countries
graduate from Gavi?
• Prioritizing long queue of
vaccines for introduction.
• Vaccine introduction/campaign
fatigue.
Country introduction: A collaborative
effort
• Review and collate burden data for TCV
introduction.
• Participate in national and local
discussion on typhoid data to build
consensus on burden.
• Decision-making and plan of action.
• Gavi application assistance.
• Country-specific materials to support
introduction.
• Post-introduction support.
Training the next generation of vaccinologists
and global health scientists

“The global capability for beginning-to-end vaccine


development has become limited, primarily owing
to a scarcity of human capital necessary to guide
the development of novel vaccines from the
laboratory to the marketplace.”
Thank you!