Development on Vaccines on COVID-19: Evidences from available literature

1. PROGRESS ON VACCINE DEVELOPMENT
COVID-19
ANIL SIGDEL

2. 01.
VACCINE DEVELOPMENT PROCESS
What are the steps for any vaccine
development?
COVID-19 VACCINE CANDIDATE AND
PROGRESS
What is the current progress
regarding COVID-19 vaccine
development?
DURATION FOR VACCINE DEVELOPMENT
How long will it take to develop
any vaccine?
CONCLUSION
Summarize the key findings
03.
02.
04.
WHAT WILL WE DISCUSS ABOUT?

3. “We cannot say this loudly
enough or clearly enough or
often enough: All countries can
still change the course of this
pandemic”
—DR. TEDROS ADHANOM GHEBREYESUS, WORLD
HEALTH ORGANIZATION’S DIRECTOR GENERAL

4. Vaccines contain the same germs that
cause disease. (For example, measles
vaccine contains measles virus, and Hib
vaccine contains Hib bacteria.) But they
have been either killed or weakened to
the point that they don’t make you sick.
Some vaccines contain only a part of the
disease germ.
VACCINE: THE BASICS
A vaccine stimulates your immune
system to produce antibodies, exactly
like it would if you were exposed to
the disease. After getting vaccinated,
you develop immunity to that disease,
without having to get the disease first.
Source: https://www.cdc.gov/vaccines/vpd/vpd-
vac-basics.html

5. HOW DO VACCINE WORKS?
Source: WHO:

6. VACCINE DEVELOPMENT PROCESS
EXPLORATORY STAGE
PRE-CLINICAL STAGE
CLINICAL DEVELOPMENT
REGULATORY APPROVAL
MANUFACTURING AND QUALITY
CONTROL

7. VACCINE DEVELOPMENT PROCESS
EXPLORATORY STAGE
PRE-CLINICAL STAGE
CLINICAL DEVELOPMENT
REGULATORY APPROVAL
MANUFACTURING AND QUALITY
CONTROL
Involves the study of
disease and its
epidemiology to identify
proper antigens

8. VACCINE DEVELOPMENT PROCESS
EXPLORATORY STAGE
PRE-CLINICAL STAGE
CLINICAL DEVELOPMENT
REGULATORY APPROVAL
MANUFACTURING AND QUALITY
CONTROL
Involves conducting test
on animal subjects to
select the best antigen
formulation.

9. VACCINE DEVELOPMENT PROCESS
EXPLORATORY STAGE
PRE-CLINICAL STAGE
CLINICAL DEVELOPMENT
REGULATORY APPROVAL
MANUFACTURING AND
QUALITY CONTROL
A THREE PHASES PROCESS
PHASE-I: Tests the vaccine in small group
of people (often <100)
PHASE-II: Tests the vaccine on larger
group of people, usually several
hundred to several thousand, to further
characterize its safety and
immunogenicity and confirm
formulations and doses
PHASE-III: Evaluates the
protection and safety in large
groups, usually thousand of
people.

10. VACCINE DEVELOPMENT PROCESS
EXPLORATORY STAGE
PRE-CLINICAL STAGE
CLINICAL DEVELOPMENT
REGULATORY APPROVAL
MANUFACTURING AND
QUALITY CONTROL
All the data collected through the
preceding stages are submitted to the
relevant health authorities for approval.

11. VACCINE DEVELOPMENT PROCESS
EXPLORATORY STAGE
PRE-CLINICAL STAGE
CLINICAL DEVELOPMENT
REGULATORY APPROVAL
MANUFACTURING AND
QUALITY CONTROL
Further trial with higher number of
people and for long time to ensure the
quality. Sometimes called Phase IV
trial.

12. HOW LONG DOES IT TAKE TO DEVELOP A VACCINE?
According to the World Health Organization (WHO) last month, a COVID-19
vaccine is still at least 12 to 18 months away.

13. PROGRESS ON COVID-19 VACCINE DEVELOPMENT
Source: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html

14. PROGRESS ON COVID-19 VACCINE DEVELOPMENT
APPROVED VACCINES: According to New York Times, the two Approved Vaccines
are
CanSinoBIO: APPROVED FOR LIMITED USE
• The Chinese company CanSino Biologics developed a vaccine based on an
adenovirus called Ad5, in partnership with the Institute of Biology at the
country’s Academy of Military Medical Sciences.
• In May, they published promising results from a Phase 1 safety trial, and in July
they reported that their Phase 2 trials demonstrated the vaccine produced a
strong immune response.
• In an unprecedented move, the Chinese military approved the vaccine on June 25
for a year as a “specially needed drug.”
Source: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html

15. PROGRESS ON COVID-19 VACCINE DEVELOPMENT
Source: https://news.cgtn.com/news/2020-08-17/China-grants-1st-COVID-19-vaccine-patent-to-domestic-
candidateT1hu5rcSek/index.html?fbclid=IwAR1IC3Djk0cmjhDUu8E0Ad6FSnNAHn2d5-4zL1_xZPDWrfwtR4-
V30fn1k8

16. PROGRESS ON COVID-19 VACCINE DEVELOPMENT
APPROVED VACCINES: According to New York Times, the two Approved Vaccines are
Gam-Covid-Vac-Lyo: APPROVED FOR EARLY USE
• The Gamaleya Research Institute, part of Russia’s Ministry of Health, launched a
Phase 1 trial in June of a vaccine they called Gam-Covid-Vac Lyo.
• In July, the chair of the upper house of Russia’s Parliament announced the
country might start vaccine production by the end of the year.
• On Aug. 11, President Vladimir V. Putin announced that a Russian health care
regulator had approved the vaccine, renamed Sputnik V, before Phase 3 trials
had even begun.
• Vaccine experts decried the move as risky. Nevertheless, Tass reported, Vietnam
soon agreed to purchase 50 to 150 million doses.
Source: https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html

17. PROGRESS ON COVID-19 VACCINE DEVELOPMENT
Source: https://timesofindia.indiatimes.com/world/rest-of-world/russia-produces-first-batch-of-
covid-19-vaccine-ministry/articleshow/77563671.cms

18. PROGRESS ON COVID-19 VACCINE DEVELOPMENT
Till August 10, 28 Vaccines are in
clinical evaluation i.e. in human
trials
PHASE III- 6 Vaccines
PHASE II: 12 Vaccines
PHASE 1: 10 Vaccines

19. LANDSCAPE OF C-19 PHASE-III VACCINE
COVID-19 Vaccine developer/manufacturer Vaccine Platform # of
doses
Timing of
doses
Route of
Administration
University of Oxford/AstraZeneca Non-Replicating
Viral Vector
1 - IM
Sinovac Inactivated 2 0,14 days IM
Wuhan Institute of Biological
Products/Sinopharm
Inactivated 2
0, 14 days or
0,21 days
IM
Beijing Institute of Biological
Products/Sinopharm
Inactivated 2
0, 14 days or
0,21 days
IM
Moderna/NIAID RNA 2 0, 28 days IM
BioNTech/Fosun Pharma/Pfizer
RNA 2
0, 28 days
IM

20. WHEN SHALL WE GET THE VACCINE?
Depends up on
• Which Vaccine we will demand for?
→ WHO Approved Vaccine: This will take some time as WHO has not
approved any vaccine till date as treatment of COVID-19.
→ Other Approved Vaccines like vaccine developed in Russia: Some
of the countries irrespective of WHO approval, demand for vaccine. Countries
like Vietnam, Venezuela booked/demand for vaccine.
• When will countries demand for vaccine?
• Who will produce the vaccine and cost of vaccine?
• What will be the role of different development actors like GAVI, Gates
Foundation etc?

21. CONCLUSIONS
• There is rapid progress on COVID-19 vaccine development
• Limited vaccines are approved by authorities for limited use (CanSinoBIO
developed in China and approved to use among soldiers) or early use
(Vaccine developed in Russia)
• However, none of the vaccine have been approved by World Health
Organization.
• Still we need to adapt SMS (Social distancing, use of Mask, and
Sanitizer/handwashing) approach to halt the transmission of COVID-19.

22. REFERENCES
• Institute of Medicine (US) Committee on the Children's Vaccine Initiative:
Planning Alternative Strategies; Mitchell VS, Philipose NM, Sanford JP,
editors.
• Washington (DC): National Academies Press (US); 1993.
• https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-
tracker.html
• https://www.nytimes.com/interactive/2020/science/coronavirus-drugs-
treatments.html
• https://news.cgtn.com/news/2020-04-07/Graphics-How-soon-can-we-get-a-
COVID-19-vaccine--PuPkfQbGxi/index.html
• https://www.who.int/emergencies/diseases/novel-coronavirus-2019
• WHO. Draft Landscape of COVID-19 candidate Vaccines- 10 August 2020
• WHO, Diagnostics and Testing; CORONA Virus update 23; 23rd April 2020
• Source: https://www.cdc.gov/vaccines/vpd/vpd-vac-basics.html
• https://slidesgo.com/theme/covid-19

23. Any Questions
THANK YOU