This document discusses a class on vaccines for COVID-19. It covers topics like vaccine development, current candidate vaccines, challenges with vaccine distribution, and how vaccines are being assessed for safety, effectiveness, costs and production feasibility. Over 100 vaccine candidates are in development using platforms like DNA, RNA, viral vectors and inactivated viruses. Efforts like Operation Warp Speed are coordinating development of nucleic acid, viral vector and protein subunit vaccines. Distribution challenges include vaccine production, storage and logistics, number of doses required, and overcoming vaccine nationalism and hesitancy.

1. EVE 198-COVID-19 (Mass) Testing
COVID-19 Mass Testing Course (EVE198, Fall 2020)
Class 8 - Vaccines

2. EVE 198-COVID-19 (Mass) Testing

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NY Times Article
• Politics, Science and the Remarkable Race for a Coronavirus Vaccine

8. EVE 198-COVID-19 (Mass) Testing
EVE198 Class 8: Vaccines
• Vaccines and Immunology
• COVID19 Vaccine Development
• COVID19 Vaccine Current Candidates
• COVID19 Vaccine Delivery

9. EVE 198-COVID-19 (Mass) Testing
EVE198 Class 8: Vaccines
• Vaccines and Immunology
• COVID19 Vaccine Development
• COVID19 Vaccine Current Candidates
• COVID19 Vaccine Delivery

10. EVE 198-COVID-19 (Mass) Testing

11. EVE 198-COVID-19 (Mass) Testing
EVE198 Class 8: Vaccines
• Vaccines and Immunology
• COVID19 Vaccine Development
• COVID19 Vaccine Current Candidates
• COVID19 Vaccine Delivery

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Vaccine Development Protocols
https://www.frontiersin.org/articles/10.3389/fphar.2020.00937/full
Development of the “ideal” vaccine for COVID-19 depicted by
concentric circles converging to the target. Normally, development
occurs in three discrete phases: Research and Development (R&D)
involving platform selection, designing targets (e.g. whether that
might be selection of an RNA sequence and decisions on nucleoside
substitutions, lipid nanoparticle (LNP) formulation, etc, or decisions
on how to create a live-attenuated viral preparation) and preclinical
testing in vitro in cell culture and in vivo in animals. For SARS-CoV-2
R&D, some of the animal models used are transgenic mice that
overexpress the Spike-binding protein ACE-2, Syrian hamsters,
ferrets, and non-human primates (NHPs). If encouraging results are
apparent in the preclinical phase (indicated by various parameters in
green boxes), the candidate vaccine is taken to the second phase,
which consists of testing in human volunteers in three stages of
clinical trials (Phase I, Phase II, and Phase III). These may be
concatenated to expedite approval (e.g. Phase II/III). Due to the
pandemic nature of COVID-19, both these outer concentric phases are
being pursued simultaneously under expedited approvals with
potential for emergency use authorizations. If, and only when, vaccine
safety and efficacy is achieved in human volunteers, the logistical
operations become the major hurdles to ensure worldwide
distribution in a coordinated and inter-connected manner
(manufacturing, supply chain distribution, storage, etc.). Vaccine
candidates that do not achieve satisfactory results in clinical trials,
due to various factors shown in the red boxes, will be dropped from
further development. ADE, antibody-dependent enhancement;
ADCC, antibody-dependent cellular cytotoxicity; CDC,
complement-dependent cellular cytotoxicity; VAERD,
vaccine-associated enhanced respiratory disease; AE, adverse event.

15. EVE 198-COVID-19 (Mass) Testing
Vaccine Development Time Line
https://www.frontiersin.org/articles/10.3389/fphar.2020.00937/full

16. EVE 198-COVID-19 (Mass) Testing
EVE198 Class 8: Vaccines
• Vaccines and Immunology
• COVID19 Vaccine Development
• COVID19 Vaccine Current Candidates
• COVID19 Vaccine Delivery

17. EVE 198-COVID-19 (Mass) Testing
Vaccine Development Platforms
https://www.frontiersin.org/articles/10.3389/fphar.2020.00937/full
Vaccine candidates in development
for SARS-CoV-2. (A) For our
analyses, we have divided potential
vaccines into 7 (seven) main
platforms (DNA, RNA,
Protein-based, Viral vector-based
(non-replicating), Viral
vector-based (replicating), Virus
(inactivated), and Virus (live,
attenuated). An additional “Other”
category for those platforms where
there is uncertainty from described
sources is also included but not
shown. The platforms are
represented by various simple
drawings. LNPs, lipid
nanoparticles. (B) Numbers of
vaccine candidates in development
late May 2020, depicted in pie
chart format, in each platform.
Sources include: The Milken
Institute, WHO, BioCentury, and
our own investigations.
Categorization of platforms differs
slightly in each source.

18. EVE 198-COVID-19 (Mass) Testing
Operation Warp Speed
• US Government Funding and Coordination Effort
• Focus on three categories of vaccine development
• Nucleic acid - Moderna; Pfizer/BioNTech
• Viral vector - AstraZeneca; Jannsen
• Protein subunit - Novovax, Sanofi/GSK
• Note - others in development outside of any connection to
“Operation Warp Speed”

19. EVE 198-COVID-19 (Mass) Testing
How To Assess Candidates?
• Effectiveness
• Safety
• Costs
• Producibility

20. EVE 198-COVID-19 (Mass) Testing
How To Assess Candidates?
• Effectiveness
• Safety
• Costs
• Producibility
The ability to assess both of these issues was massively accelerated by
the rapid spread of the virus

21. EVE 198-COVID-19 (Mass) Testing
EVE198 Class 8: Vaccines
• Vaccines and Immunology
• COVID19 Vaccine Development
• COVID19 Vaccine Current Candidates
• COVID19 Vaccine Delivery

22. EVE 198-COVID-19 (Mass) Testing
Vaccine Distribution Challenges
• Production
• Distribution (Storage, Logistics, Cost)
• Delivery (number of doses, mechanism of delivery)
• Vaccine Nationalism
• Vaccine Hesitancy

23. EVE 198-COVID-19 (Mass) Testing
Vaccine Distribution Challenges
• See Initial Batch Of COVID-19 Vaccines Will Go To States Based On
Population, Not Risk