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CHEW CHEE KEI, LOCK TIAN JENQ, SOO XIN LU, YIAP FU WEI
COVID-19,
Vaccine and it’s
development process
BIOPROCESS TECHNOLOGY BIO62104
01.
ABOUT COVID-19 & VACCINE
Introduction on COVID-19, Vaccine
and AZD1222 Vaccine
COVID-19 VACCINE
DEVELOPMENT PROCESS
TRADITIONAL VACCINE
DEVELOPMENT PROCESS
COMPARISON
Between Traditional and COVID-19
vaccine development process
03.
02.
04.
AZD1222 Vaccine
Hepatitis B recombinant vaccine
COVID-19 is an infectious disease caused by the
recently found virus known as SARS-CoV-2 (or
coronavirus) which is under the Coronaviridae
family. It was first reported in Wuhan City,
China on December 2019. It is a disease that
affects the human respiratory system.
COVID-19
GLOBAL PANDEMIC DISEASE
(Singhal, 2020)
Presented by: Soo Xin Lu
HIGH FEVERTIREDNESS
DIFFICULTY BREATHINGDRY COUGH
COMMON SYMPTOMS OF COVID-19
The body temperature can
exceed 37.3 Celsius degrees
The body feels completely
tired, without energy
Breathing actually feels
more difficult
Constant coughing without
expelling any mucus
(Singhal, 2020)
Presented by: Soo Xin Lu
This disease can spread from person to
person through small droplets from the
nose or the mouth when the infected
person coughs or exhales
TRANSMISSION ROUTES OF COVID-19
SURFACESPEOPLE
These small droplets land on surfaces,
which means any person that touches
these surfaces and then their eyes, nose
or mouth can become infected
(Singhal, 2020)
Presented by: Soo Xin Lu
VACCINES
What is a vaccine?
- A type of medicine that
trains the body’s immune
system to create
antibodies to fight disease
- Contain killed/weakened
forms of germs that do not
cause the disease or at
risk of its complications
Why is there a need for vaccines?
- To prevent disease
- Protect against many
different diseases such as
pneumonia, cholera,
hepatitis B, influenza,
typhoid etc.
- Critical to the prevention &
control of infectious-disease
outbreaks.
(What is a vaccine, and how do vaccines work?, 2019; Vaccines and immunization, n.d.)
Presented by: Soo Xin Lu
COVID-19 VACCINE
157
As of 1
June 2020
vaccine candidates are
undergoing
development by
academic labs and
industry (and
partnerships thereof).
COVID-19 vaccine candidates:
> live-attenuated vaccines
> inactivated vaccines
> subunit vaccines
> virus-like particles (VLPs)
> viral vectors (replicating
and non-replicating)
> DNA and RNA vaccines
16
vaccine candidates
have entered
clinical testing
(Shin et al., 2020)Presented by: Soo Xin Lu
AZD1222 Vaccine : COVID-19 VACCINE
> formerly known as ChAdOx1 nCoV-19
> Replication deficient viral vectors
> from University of Oxford and Vaccitech
> genetically engineered adenovirus that
causes a common cold in chimpanzees
● Vaccination of AZD1222 hopes to
make the body recognize and develop
an immune response to the Spike
protein that will inhibit SARS-CoV-2
virus from entering human cells and
therefore prevent infection.
● It has been proved to be able to protect
rhesus macaques which have similar
immune systems to human from
developing COVID-19
● Safe and tolerated, cause temporary
side effects, such as temperature,
headache, or a sore arm
Presented by: Soo Xin Lu
Phase 1 and 2 (July 20, 2020):
> single dose cause 4x increase in antibodies
to the SARS-CoV-2 virus spike protein in 95%
of participants one month after injection
Phase 3 clinical trials: late phase (ongoing)
(Baggaley, 2020; Carlson and Reiter, 2020)
Exploratory stage -
● 2-4 years
● Identify natural or synthetic
antigens
Preclinical stage -
● Tissue-culture or cell-culture
systems and animal testing
● Provides rough idea of the
cellular response in humans
● Submit application for clinical
testing
Traditional vaccine development process
(Foley, 2013; Heaton, 2020)
Clinical stage -
● Phase 1 - Testing with small sample of participants, to assess the safety
● Phase 2 - Testing with several hundreds of participants to assess safety and
immunogenicity
● Phase 3 - Testing with several thousands of participants to assess safety, efficacy
Regulatory review and approval -
● Submit application for approval by
governing body
● Once approved, vaccine production is
monitored by governing body
Presented by: Yiap Fu Wei
Traditional vaccine manufacturing process
Upstream processing -
● Antigen is generated in the the
upstream process.
It can be the pathogen itself or it can
be an antigen
generated from a recombinant protein
Downstream processing -
● Antigen is separated from impurities.
This improves product safety and
stability.
● A wide variety of purification
techniques can be used
(Gomez and Robinson, 2018)
Example: Hepatitis B recombinant vaccine
Presented by: Yiap Fu Wei
Phase 1: Clinical safety
testing
➢ Vaccine is given to
small amount of
healthy and
immunocompetent
individuals
➢ To observe immune
response
➢ Test for safety and
appropriate dosage
COVID-19 vaccine development process
Phase 2: Expanded safety
testing
➢ Vaccine is given to
hundreds of
individuals
➢ To confirm:
○ Safeness
○ Immunogenic
○ Amount of
dosage
(Sharma, Sultan, Ding and Triggle, 2020)
Presented by: Lock Tian Jenq
Phase 3: Efficacy
➢ Vaccine is given to thousands of
individual
➢ Half people receive vaccine,
other half receive placebo
➢ Large sample size to reduce
required time for trial
COVID-19 Vaccine
Phase 4: Review and Approval
➢ Clinical trial data submit to
regulatory bodies:
○ U.S. Food and Drug
Administration (FDA)
○ European Medicines
Agency in EU
Phase 5: Manufacturing and Post-
Marketing Surveillance
➢ Continue monitor the vaccine
even after marketed for public
use
➢ Approval for emergency use
(Funk, Laferrière and Ardakani, 2020)
Presented by: Lock Tian Jenq
Oxford vaccine production:
1. Coronavirus surface protein encoded into chimpanzee adenovirus vector
2. Human embryonic kidney (HEK) cells used as mini-factories to produce the vector particles
3. Grown in bioreactor
Manufacturing Process of COVID-19 Vaccine
Downstream Processing
The cells undergo:
● Purification
● Concentration
● Solid-liquid
separation
(filtration and
centrifugation)
(Ketchell, 2020)
(About the Oxford COVID-19 vaccine, 2020)
Presented by: Lock Tian Jenq
COMPARISON
Traditional vaccine development process COVID-19 pandemic development process
Longer development time (approx 6 -20 years) Shorter development time (approx 12-18 months)
Slower Speed and faster
Have gone through small scale clinical trial
materials.
No gone through any small scale clinical trial
materials and straight to manufacturing
Lower risk and more stable as it gone through
different types of pre clinical and clinical trials
before manufacturing
High risks associated with delivering a licensed
vaccine and requires multiple activities to be
conducted at financial risk to developers and
manufacturers and without knowing whether the vaccine
candidate will be safe and effective
Manufacturing scale up to commercial scale after
establishment of clinical proof
Early manufacturing scale-up to commercial scale
before establishment of clinical proof of concept
Presented by: Chew Chee Kei
Comparison between traditional and COVID-19 vaccine
development process
(Lurie, Saville, Hatchett and
Halton, 2020)Presented by: Chew Chee Kei
CONCLUSION
★ COVID-19 is an infectious disease caused by the recently found virus known as
SARS-CoV-2 and can spread from person to person through small droplets
★ Vaccine is a type of medicine that trains the body’s immune system to prevent
and protect from different disease by creating antibodies to fight disease.
★ Due to Covid 19 epidemic , many vaccines candidates are undergoing development
and 16 vaccine candidates have entered clinical testing.
★ AZD1222 Vaccine, train the body to make antibodies to fight the virus. After
going through many clinical trials , it is proved to have 94.7% effectiveness
★ Traditional vaccine development take longer time to manufacture the vaccine as
performs each step in sequence whereas COVID-19 vaccine development take very
short time to manufacture as the production steps are done in parallel
★ Traditional Vaccine is safer to use whereas COVID-19 vaccine development have
higher risk however, COVID-19 vaccine development is able to face emergency
situation.
Presented by: Chew Chee Kei
References
Baggaley, K., 2020. Oxford University’S Timeline For A COVID-19 Vaccine Is Shorter Than Previous Estimates. [online] Popular Science.
Available at: <https://www.popsci.com/story/health/covid-19-vaccine-oxford-september/> [Accessed 18 November 2020].
Carlson, R. and Reiter, D., 2020. AZD1222 SARS-Cov-2 Vaccine. [online] Precisionvaccinations.com. Available at:
<https://www.precisionvaccinations.com/vaccines/azd1222-sars-cov-2-vaccine> [Accessed 18 November 2020].
Foley, J., 2013. Vaccine Development In The United States. [online] Vaccination Research Group. Available at:
<https://vtechworks.lib.vt.edu/bitstream/handle/10919/79931/Vaccine_Development-information_sheet.pdf?sequence=1&isAllowed=y>
[Accessed 18 November 2020].
Funk, C., Laferrière, C. and Ardakani, A., 2020. A Snapshot of the Global Race for Vaccines Targeting SARS-CoV-2 and the COVID-19
Pandemic. Frontiers in Pharmacology, 11.
Gomez, P. and Robinson, J., 2018. Vaccine Manufacturing. Plotkin's Vaccines, pp.51-60.
Heaton, P., 2020. The Covid-19 Vaccine-Development Multiverse. New England Journal of Medicine, 383(20), pp.1986-1988.
Ketchell, M., 2020. Coronavirus Vaccine Search: How We're Preparing To Make Enough For The Whole World. [online] The Conversation.
Available at: <https://theconversation.com/coronavirus-vaccine-search-how-were-preparing-to-make-enough-for-the-whole-world-
137970> [Accessed 18 November 2020].
Lurie, N., Saville, M., Hatchett, R. and Halton, J., 2020. Developing Covid-19 Vaccines at Pandemic Speed. New England Journal of
Medicine, [online] 382(21), pp.1969-1973. Available at: <https://www.nejm.org/doi/full/10.1056/NEJMp2005630> [Accessed 18 November
2020].
References
Oxford Vaccine Group 2020. 2019. What Is A Vaccine, And How Do Vaccines Work?. [online] Available at: <https://vk.ovg.ox.ac.uk/vk/how-
do-vaccines-work> [Accessed 1 November 2020].
Sharma, O., Sultan, A., Ding, H. and Triggle, C., 2020. A Review of the Progress and Challenges of Developing a Vaccine for COVID-19.
Frontiers in Immunology, [online] 11. Available at: <https://www.frontiersin.org/articles/10.3389/fimmu.2020.585354/full> [Accessed 17
November 2020].
Shin, M., Shukla, S., Chung, Y., Beiss, V., Chan, S., Ortega-Rivera, O., Wirth, D., Chen, A., Sack, M., Pokorski, J. and Steinmetz, N., 2020.
COVID-19 vaccine development and a potential nanomaterial path forward. Nature Nanotechnology, [online] 15(8), pp.646-655. Available
at: <https://www.nature.com/articles/s41565-020-0737-y?elqTrackId=5debe8a10e41435b86d1608376c3e89a> [Accessed 1 November 2020].
Singhal, T., 2020. A Review of Coronavirus Disease-2019 (COVID-19). The Indian Journal of Pediatrics, [online] 87(4), pp.281-286. Available
at: <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7090728/> [Accessed 1 November 2020].
Research.ox.ac.uk. 2020. About The Oxford COVID-19 Vaccine. [online] Available at: <https://www.research.ox.ac.uk/Article/2020-07-19-
the-oxford-covid-19-vaccine> [Accessed 18 November 2020].
Who.int. n.d. Vaccines And Immunization. [online] Available at: <https://www.who.int/health-topics/vaccines-and-immunization>
[Accessed 1 November 2020].
THANK YOU!
PRESENTED BY:
CHEW CHEE KEI 0341035
LOCK TIAN JENQ 0339635
SOO XIN LU 0340684
YIAP FU WEI 0341589

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Covid 19, vaccine and it's development process - Group 1

  • 1. CHEW CHEE KEI, LOCK TIAN JENQ, SOO XIN LU, YIAP FU WEI COVID-19, Vaccine and it’s development process BIOPROCESS TECHNOLOGY BIO62104
  • 2. 01. ABOUT COVID-19 & VACCINE Introduction on COVID-19, Vaccine and AZD1222 Vaccine COVID-19 VACCINE DEVELOPMENT PROCESS TRADITIONAL VACCINE DEVELOPMENT PROCESS COMPARISON Between Traditional and COVID-19 vaccine development process 03. 02. 04. AZD1222 Vaccine Hepatitis B recombinant vaccine
  • 3. COVID-19 is an infectious disease caused by the recently found virus known as SARS-CoV-2 (or coronavirus) which is under the Coronaviridae family. It was first reported in Wuhan City, China on December 2019. It is a disease that affects the human respiratory system. COVID-19 GLOBAL PANDEMIC DISEASE (Singhal, 2020) Presented by: Soo Xin Lu
  • 4. HIGH FEVERTIREDNESS DIFFICULTY BREATHINGDRY COUGH COMMON SYMPTOMS OF COVID-19 The body temperature can exceed 37.3 Celsius degrees The body feels completely tired, without energy Breathing actually feels more difficult Constant coughing without expelling any mucus (Singhal, 2020) Presented by: Soo Xin Lu
  • 5. This disease can spread from person to person through small droplets from the nose or the mouth when the infected person coughs or exhales TRANSMISSION ROUTES OF COVID-19 SURFACESPEOPLE These small droplets land on surfaces, which means any person that touches these surfaces and then their eyes, nose or mouth can become infected (Singhal, 2020) Presented by: Soo Xin Lu
  • 6. VACCINES What is a vaccine? - A type of medicine that trains the body’s immune system to create antibodies to fight disease - Contain killed/weakened forms of germs that do not cause the disease or at risk of its complications Why is there a need for vaccines? - To prevent disease - Protect against many different diseases such as pneumonia, cholera, hepatitis B, influenza, typhoid etc. - Critical to the prevention & control of infectious-disease outbreaks. (What is a vaccine, and how do vaccines work?, 2019; Vaccines and immunization, n.d.) Presented by: Soo Xin Lu
  • 7. COVID-19 VACCINE 157 As of 1 June 2020 vaccine candidates are undergoing development by academic labs and industry (and partnerships thereof). COVID-19 vaccine candidates: > live-attenuated vaccines > inactivated vaccines > subunit vaccines > virus-like particles (VLPs) > viral vectors (replicating and non-replicating) > DNA and RNA vaccines 16 vaccine candidates have entered clinical testing (Shin et al., 2020)Presented by: Soo Xin Lu
  • 8. AZD1222 Vaccine : COVID-19 VACCINE > formerly known as ChAdOx1 nCoV-19 > Replication deficient viral vectors > from University of Oxford and Vaccitech > genetically engineered adenovirus that causes a common cold in chimpanzees ● Vaccination of AZD1222 hopes to make the body recognize and develop an immune response to the Spike protein that will inhibit SARS-CoV-2 virus from entering human cells and therefore prevent infection. ● It has been proved to be able to protect rhesus macaques which have similar immune systems to human from developing COVID-19 ● Safe and tolerated, cause temporary side effects, such as temperature, headache, or a sore arm Presented by: Soo Xin Lu Phase 1 and 2 (July 20, 2020): > single dose cause 4x increase in antibodies to the SARS-CoV-2 virus spike protein in 95% of participants one month after injection Phase 3 clinical trials: late phase (ongoing) (Baggaley, 2020; Carlson and Reiter, 2020)
  • 9. Exploratory stage - ● 2-4 years ● Identify natural or synthetic antigens Preclinical stage - ● Tissue-culture or cell-culture systems and animal testing ● Provides rough idea of the cellular response in humans ● Submit application for clinical testing Traditional vaccine development process (Foley, 2013; Heaton, 2020) Clinical stage - ● Phase 1 - Testing with small sample of participants, to assess the safety ● Phase 2 - Testing with several hundreds of participants to assess safety and immunogenicity ● Phase 3 - Testing with several thousands of participants to assess safety, efficacy Regulatory review and approval - ● Submit application for approval by governing body ● Once approved, vaccine production is monitored by governing body Presented by: Yiap Fu Wei
  • 10. Traditional vaccine manufacturing process Upstream processing - ● Antigen is generated in the the upstream process. It can be the pathogen itself or it can be an antigen generated from a recombinant protein Downstream processing - ● Antigen is separated from impurities. This improves product safety and stability. ● A wide variety of purification techniques can be used (Gomez and Robinson, 2018) Example: Hepatitis B recombinant vaccine Presented by: Yiap Fu Wei
  • 11. Phase 1: Clinical safety testing ➢ Vaccine is given to small amount of healthy and immunocompetent individuals ➢ To observe immune response ➢ Test for safety and appropriate dosage COVID-19 vaccine development process Phase 2: Expanded safety testing ➢ Vaccine is given to hundreds of individuals ➢ To confirm: ○ Safeness ○ Immunogenic ○ Amount of dosage (Sharma, Sultan, Ding and Triggle, 2020) Presented by: Lock Tian Jenq
  • 12. Phase 3: Efficacy ➢ Vaccine is given to thousands of individual ➢ Half people receive vaccine, other half receive placebo ➢ Large sample size to reduce required time for trial COVID-19 Vaccine Phase 4: Review and Approval ➢ Clinical trial data submit to regulatory bodies: ○ U.S. Food and Drug Administration (FDA) ○ European Medicines Agency in EU Phase 5: Manufacturing and Post- Marketing Surveillance ➢ Continue monitor the vaccine even after marketed for public use ➢ Approval for emergency use (Funk, Laferrière and Ardakani, 2020) Presented by: Lock Tian Jenq
  • 13. Oxford vaccine production: 1. Coronavirus surface protein encoded into chimpanzee adenovirus vector 2. Human embryonic kidney (HEK) cells used as mini-factories to produce the vector particles 3. Grown in bioreactor Manufacturing Process of COVID-19 Vaccine Downstream Processing The cells undergo: ● Purification ● Concentration ● Solid-liquid separation (filtration and centrifugation) (Ketchell, 2020) (About the Oxford COVID-19 vaccine, 2020) Presented by: Lock Tian Jenq
  • 14. COMPARISON Traditional vaccine development process COVID-19 pandemic development process Longer development time (approx 6 -20 years) Shorter development time (approx 12-18 months) Slower Speed and faster Have gone through small scale clinical trial materials. No gone through any small scale clinical trial materials and straight to manufacturing Lower risk and more stable as it gone through different types of pre clinical and clinical trials before manufacturing High risks associated with delivering a licensed vaccine and requires multiple activities to be conducted at financial risk to developers and manufacturers and without knowing whether the vaccine candidate will be safe and effective Manufacturing scale up to commercial scale after establishment of clinical proof Early manufacturing scale-up to commercial scale before establishment of clinical proof of concept Presented by: Chew Chee Kei
  • 15. Comparison between traditional and COVID-19 vaccine development process (Lurie, Saville, Hatchett and Halton, 2020)Presented by: Chew Chee Kei
  • 16. CONCLUSION ★ COVID-19 is an infectious disease caused by the recently found virus known as SARS-CoV-2 and can spread from person to person through small droplets ★ Vaccine is a type of medicine that trains the body’s immune system to prevent and protect from different disease by creating antibodies to fight disease. ★ Due to Covid 19 epidemic , many vaccines candidates are undergoing development and 16 vaccine candidates have entered clinical testing. ★ AZD1222 Vaccine, train the body to make antibodies to fight the virus. After going through many clinical trials , it is proved to have 94.7% effectiveness ★ Traditional vaccine development take longer time to manufacture the vaccine as performs each step in sequence whereas COVID-19 vaccine development take very short time to manufacture as the production steps are done in parallel ★ Traditional Vaccine is safer to use whereas COVID-19 vaccine development have higher risk however, COVID-19 vaccine development is able to face emergency situation. Presented by: Chew Chee Kei
  • 17. References Baggaley, K., 2020. Oxford University’S Timeline For A COVID-19 Vaccine Is Shorter Than Previous Estimates. [online] Popular Science. Available at: <https://www.popsci.com/story/health/covid-19-vaccine-oxford-september/> [Accessed 18 November 2020]. Carlson, R. and Reiter, D., 2020. AZD1222 SARS-Cov-2 Vaccine. [online] Precisionvaccinations.com. Available at: <https://www.precisionvaccinations.com/vaccines/azd1222-sars-cov-2-vaccine> [Accessed 18 November 2020]. Foley, J., 2013. Vaccine Development In The United States. [online] Vaccination Research Group. Available at: <https://vtechworks.lib.vt.edu/bitstream/handle/10919/79931/Vaccine_Development-information_sheet.pdf?sequence=1&isAllowed=y> [Accessed 18 November 2020]. Funk, C., Laferrière, C. and Ardakani, A., 2020. A Snapshot of the Global Race for Vaccines Targeting SARS-CoV-2 and the COVID-19 Pandemic. Frontiers in Pharmacology, 11. Gomez, P. and Robinson, J., 2018. Vaccine Manufacturing. Plotkin's Vaccines, pp.51-60. Heaton, P., 2020. The Covid-19 Vaccine-Development Multiverse. New England Journal of Medicine, 383(20), pp.1986-1988. Ketchell, M., 2020. Coronavirus Vaccine Search: How We're Preparing To Make Enough For The Whole World. [online] The Conversation. Available at: <https://theconversation.com/coronavirus-vaccine-search-how-were-preparing-to-make-enough-for-the-whole-world- 137970> [Accessed 18 November 2020]. Lurie, N., Saville, M., Hatchett, R. and Halton, J., 2020. Developing Covid-19 Vaccines at Pandemic Speed. New England Journal of Medicine, [online] 382(21), pp.1969-1973. Available at: <https://www.nejm.org/doi/full/10.1056/NEJMp2005630> [Accessed 18 November 2020].
  • 18. References Oxford Vaccine Group 2020. 2019. What Is A Vaccine, And How Do Vaccines Work?. [online] Available at: <https://vk.ovg.ox.ac.uk/vk/how- do-vaccines-work> [Accessed 1 November 2020]. Sharma, O., Sultan, A., Ding, H. and Triggle, C., 2020. A Review of the Progress and Challenges of Developing a Vaccine for COVID-19. Frontiers in Immunology, [online] 11. Available at: <https://www.frontiersin.org/articles/10.3389/fimmu.2020.585354/full> [Accessed 17 November 2020]. Shin, M., Shukla, S., Chung, Y., Beiss, V., Chan, S., Ortega-Rivera, O., Wirth, D., Chen, A., Sack, M., Pokorski, J. and Steinmetz, N., 2020. COVID-19 vaccine development and a potential nanomaterial path forward. Nature Nanotechnology, [online] 15(8), pp.646-655. Available at: <https://www.nature.com/articles/s41565-020-0737-y?elqTrackId=5debe8a10e41435b86d1608376c3e89a> [Accessed 1 November 2020]. Singhal, T., 2020. A Review of Coronavirus Disease-2019 (COVID-19). The Indian Journal of Pediatrics, [online] 87(4), pp.281-286. Available at: <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7090728/> [Accessed 1 November 2020]. Research.ox.ac.uk. 2020. About The Oxford COVID-19 Vaccine. [online] Available at: <https://www.research.ox.ac.uk/Article/2020-07-19- the-oxford-covid-19-vaccine> [Accessed 18 November 2020]. Who.int. n.d. Vaccines And Immunization. [online] Available at: <https://www.who.int/health-topics/vaccines-and-immunization> [Accessed 1 November 2020].
  • 19. THANK YOU! PRESENTED BY: CHEW CHEE KEI 0341035 LOCK TIAN JENQ 0339635 SOO XIN LU 0340684 YIAP FU WEI 0341589