Public Health Vaccine Planning

at Local, National and

International Levels
Rahul Gupta, MD, MPH, MBA, FACP
Chief Medical & Health Officer
Senior Vice President
March of Dimes
National Press Foundation
August 07, 2020
Objectives

•Past as Prologue – Lessons from Polio

•Current Progress – U.S. and Around the

Globe

•Anticipated Challenges in Launching a

Successful Worldwide Vaccination Campaign
 Our Story
• Paralyzed in the later part of his life by Polio,
President Franklin D. Roosevelt founded the
National Foundation for Infantile Paralysis
(later known as March of Dimes) in 1938

• Funded by March of Dimes, Dr. Jonas Salk

developed the first polio vaccine and then
Dr. Thomas Francis was hired to conduct the
largest drug trial in U.S. history, involving 1.8
million children

• Dr. Francis’s Vaccine Evaluation Center built

the model for future vaccine and clinical
trials after developing the now standard
double-blind placebo controlled process
Past as Prologue – 100 Years Ago
• A viral infection transmitted person to person around
the world

• Community spread driven by asymptomatic carriers

• Social distancing and appropriate handwashing are

considered vital in reducing spread with Board of
Health Nurses on street patrol

• Most dangerous for high-risk populations

• Serious cases require assisted breathing apparatus

• Fatal as well as long term disability in survivors

• Race to develop a vaccine

Current Progress –
U.S. and Around the Globe
 Where are the Developers?

193 candidates in
various stages of
vaccine development

https://www.policycuresresearch.org/covid-19-r-d-tracker
 Manufacturers

https://www.cfr.org/backgrounder/what-world-doing-create-covid-19-vaccine
 Development Progress - Global

https://www.policycuresresearch.org/covid-19-r-d-tracker
 Operation Warp Speed – U.S.

• Operation Warp Speed aims to deliver 300 million doses of a safe,

effective vaccine for COVID-19 by January 2021 as a partnership
among components of the Department of Health and Human
Services, other federal government agencies, and private firms.

• Congress has directed almost $10 billion to this effort through

supplemental funding, including the CARES Act. Congress has also
appropriated other flexible funding to support this effort

https://www.hhs.gov/about/news/2020/06/16/fact-sheet-explaining-operation-warp-speed.html
 Global Funding

Top Government Funders for COVID-19 R&D

Image: Policy Cures Research Key Takeaways

COVID-19 R&D Tracker Analysis 15 July, 2020
https://www.policycuresresearch.org/covid-19-r-d-tracker
Societal Threats
• False information spread via social
media channels

• Arguing government “overreach” as

an “infringement on personal
liberties”

• Increases in other infectious

diseases, such as Measles due to
non-vaccination.

• US saw 1,250 confirmed cases of

Measles, in 31 states by October of
2019 after it was declared
eliminated in the U.S. in 2000
Resurgence of Polio

March of Dimes
Unintended Consequences
Learning from the Past: Issues of Safety,
Distribution, Cost, and Political Will
Domestic
• Parents not adhering to vaccine
schedule due to fear of exposure
Safety • Increases in false information
spread through social media
outlets
• Delivery challenges to providers in
rural areas and patients being
unable to travel great distances
Distribution • Shortages in high population
centers
• Racial/ethnic disparities widen
• Price gouging
• Insurance coverage for the cost of
Cost
immunization
• Ongoing Influenza outbreaks
International
• Shelf stability during transit and storage
• Mistrust of vaccine sources and
international manufacturers
• Political, regional and cultural variations
in views towards vaccines in general
• National hoarding of vaccine supply, or
vaccine shortages
• Social distancing creating challenges
delivering vaccines door to door
• Political instability & conflict impacting
supply chain
• High costs make access to vaccines
inaccessible for those in poverty or with
limited incomes
Anticipated Challenges of Launching a
Successful Worldwide Vaccination
Campaign
Safety Concerns &
The Cutter Incident
• In early 1955, Cutter Laboratories issued a
polio vaccine to the public containing live
polio virus, despite passing internal quality
control checks
• Over 250 cases of Polio, and paralysis were
attributed to this incident
• The Cutter Incident led to vast improvements
in government regulation and oversight of
drug development and manufacturing and
later that year, Polio vaccinations resumed
• Since then, safety concerns surrounding shelf
stability, chemical preservatives and
additives, and potential side effects have
fueled the anti-vax movement
Fitzpatrick M. (2006). The Cutter Incident: How America's First Polio Vaccine
Led to a Growing Vaccine Crisis. Journal of the Royal Society of Medicine, 99(3),
156.
Current Vaccine Confidence

• The United States has seen a decline in

adherence to the recommended childhood
vaccine schedule from 2/3 to fewer than
half within the past decade in some states

• Upwards of 50% of parents and individuals

are expressing concern, hesitancy, and
outright rejection to receiving a COVID-19
vaccine

Bramer CA, Kimmins LM, Swanson R, et al. Decline in Child Vaccination Coverage During the
COVID-19 Pandemic — Michigan Care Improvement Registry, May 2016–May 2020. MMWR
Morb Mortal Wkly Rep 2020;69:630–631
Racial Disparities &
COVID-19 Deaths

Source: https://covidtracking.com/race
Flu Vaccine Rates &
High Risk Populations

Source: http://dx.doi.org/10.15585/mmwr.mm6638a2external icon

A Syndemic in Progress
Global Public Vaccination Campaign
• Safety: New human vaccine platforms;
inadequate preclinical data; lack of detailed
information on protective correlates of Federal &
State
immunity – Should we consider a global Government
vaccine adverse events reporting system
• Defining effectiveness and co-administration: Media Biotech
Which population benefits and how much?
Can flu vaccine be co-administered? Public
Vaccination
• Special Populations: Include pregnant and Campaign
lactating women in clinical trials for vaccines Patient,
and treatments; consider racial/ethnic parity. Advocacy &
Insurers
Provider
• Access: Especially in poorer countries - tiered Groups
pricing strategies; local vaccine development. Big Box
Stores &
• Supply, Ethics and Public Trust: Global Pharmacy
Chains
population of nearly 7.7 billion people at risk.
Developing public’s trust in vaccinations should
precede the development of the vaccine.
 Thank You

RGupta@MarchofDimes.org
@DrGuptaMD