COVID-19 Vaccines: The End of the Beginning or the Beginning of the End?

GIC Executive Briefing: Analyzing Pandemics COVID-19 Vaccines: The End of the Beginning or the Beginning of the End?

Global Interdependence Center November 5, 2020

Bruce Gellin, MD, MPH

President, Global Immunization Sabin Vaccine Institute

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COVID-19: What Happens Next?

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COVID-19: What Happens Next?

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Understanding the Rules of Immunity Disease • Why are some people protected from disease while others remain healthy?

• Lessons from natural infection applied to vaccine design • Implications of COVID-19 reinfections Vaccination • Why are some vaccines more effective for certain populations than others?

• Why do some vaccines prevent infectious disease transmission?

Population • When is the herd immune? https://www.humanvaccinesproject.org/

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What I worry about with this is it’s being presented as if it’s a major alternative view that’s held by large numbers of experts in the scientific community. That is not true, This is not mainstream science. It’s dangerous. It fits into the political views of certain parts of our confused political establishment.

Francis Collins NIH Director 9

Reinfection: Implications for Vaccination and Herd Immunity

www.thelancet.com/infection Published online October 12, 2020

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VACCIN E

VACCINATIO N

Research Discovery Development Licensing Manufacturing Distribution Recommendations and Use 11

From Vaccine to Vaccination: A Systems View Recognition of public health priorities

Vaccine Manufacture

Vaccine Acceptance

Disease Surveillance Vaccine Development

Vaccine Licensure

Translational research for diffusion of innovation

Vaccine Sales/ Purchase

High Vaccination Rates

Access/ Payment for Vaccination / Reimbursement

Vaccination (Adult, Adolescent and Childhood)

Vaccine Distribution Adverse Event Monitoring

Vaccine Coverage Surveillance

Vaccine Research

Attitudes about vaccination

Develop vaccine recommendations

Vaccine Effectiveness

Communication and Education Strategies

Population health protection against infectious disease in the U.S. and Globally Reduced Morbidity and Mortality from infectious disease in the U.S. and Globally

Vaccine Injury Compensation

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Biology 101: SARS-CoV-2

Washington Post

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COVID-19 Vaccine Technology Platforms

14 Nature Materials 19 (810-812) 2020

Steven Breen -- San Diego Union-Tribune 15

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How Operation Warp Speed Can Be So Speedy

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How Operation Warp Speed Can Be So Speedy • Prior knowledge of the role of the spike protein in coronavirus pathogenesis • Evidence that neutralizing antibody against the spike protein is important for immunity • Evolution of nucleic acid vaccine technology platforms • Development activities conducted in parallel, rather than in sequence, without increasing risks for study participants

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Lurie NEJM May 21 2020

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Vaccine Orders

Wall Street Journal Sept 2, 2020

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Vaccination: Vaccines Don’t Deliver Themselves

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Global vaccine uptake in national schedules 1990-2019 and projections COVID-19

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Planning in the Face of Complex and Evolving Landscape for COVID-19 Vaccines • Possible (initial) approval by FDA’s Emergency Use Authorization • One vs Two doses needed for immunity (separated by 21 or 28 days) • Products not interchangeable • Varying cold chain requirements (refrigerator vs freezer vs ultra-cold) • May require reconstitution (diluent or adjuvant) at point of delivery • Vaccine efficacy and safety to be determined • Potential for different effects in different populations • Use in children and pregnant women • Need for safe (socially distanced) vaccination practices • Communication and education • Vaccine hesitancy, Vaccine skepticism 24

Supply and Demand COVID-19 Vaccination Program:A Phased Approach

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Planning Assumptions: Vaccine Allocation • Final decisions pending re: initial allocation and may be informed by Phase 3 trials (especially efficacy in population subgroups) • State/Jurisdiction allocations will be based on multiple factors: • Critical populations identified by National Academy of Sciences, Engineering and Medicine and Advisory Committee on Immunization Practices • Current local spread/prevalence of COVID-19 • Vaccine supply

• Need to plan for high-demand and low-demand scenarios 26

Framework for Equitable Distribution of COVID-19 Vaccines • Foundational Ethical Principles • Maximum benefit • Equal concern • Dignity, Worth, Value

• Mitigation of health inequities

• Foundational Programmatic Principles • Fairness • Informed by public, data-driven, impartial decision-makers

• Transparency • Evidence-Based • Risk of disease, transmission, societal impact

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Framework for Equitable Distribution of COVID-19 Vaccines

GOAL:

• Reduce severe morbidity and mortality and negative societal impact due to the transmissions of SARS-CoV-2

ALLOCATION CRITERIA: • Risk of acquiring infection • Risk of severe morbidity and death • Negative societal impact • Transmitting infection to others 28

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Who Are Essential Workers?

Total

Percent of industry

55,217,845

100%

Food and agriculture

11,398,233

20.6%

Emergency services

1,849,630

3.3%

Transportation, warehouse, and delivery

3,972,089

7.2%

Industrial, commercial, residential facilities and services

6,806,407

12.3%

Health care

16,679,875

30.2%

Government and community-based services

4,590,070

8.3%

Communications and IT

3,189,140

5.8%

Financial sector

3,070,404

5.6%

Energy sector

1,327,760

2.4%

Water and wastewater management

107,846

0.2%

Chemical sector

271,160

0.5%

Critical manufacturing

1,955,233

3.5%

All essential workers

Economic Policy Institutes (May 2020) https://www.epi.org/blog/who-are-essential-workers-a-comprehensive-look-at-their-wages-demographics-and-unionization-rates/

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Essential Workers: Work from home?

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Who Should Decide? a) b) c) d) e) f) g)

White House CDC Other Federal Agency State Health Department Local Health Department Doctors and Nurses Individuals themselves 33

Who Should Decide?

Citizen Voices: 2005

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How likely are you to get a COVID-19 vaccine as soon as it becomes available?

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IPSOS Survey for World Economic Forum: Conducted July-August 2020

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We don’t have a misinformation problem, we have a relationship problem The misinformation can be deleted, but the underlying distrust that has caused it and allowed it to stick remains • • • • • • •

Dignity Distrust Risk Emotional contagion Choice The power of beliefs over facts The power of stories over data 38

The On-Line Competition Between Pro- and Anti-Vaccine Views Although smaller in overall size, anti-vaccination clusters manage to become highly entangled with undecided clusters in the main online network, whereas pro-vaccination clusters are more peripheral. Our theoretical framework reproduces the recent explosive growth in anti-vaccination views, and predicts that these views will dominat e in a decade.

Nature volume 582, pages230–233(2020)

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Setting Expectations: New Normal isn’t Old Normal “If you get a vaccine into 2021, throughout the year, I believe, by the year 2021, the end of the year, we will be as good back to normal as we possibly can.

That doesn't mean — so, I want to be clear — that you are going to eradicate this virus. The only virus that we have ever eradicated in the history of the planet has been smallpox for humans.”

Dr. Anthony Fauci PBS Newshour 41

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