Webinar Series on Demystifying Phases in Clinical Trials & COVID-19 Updates organized by Institute for Clinical Research (ICR), NIH Speaker: Dr. Cheah Wee Kooi, Physician & Geriatrician, Head of Medical Dept & Clinical Research Centre, Taiping Hospital More information please visit: https://clinupcovid.mailerpage.com/resources/r0x8r9-webinar-series-on-demystifying-cl

1. COVID-19 Vaccine Trials:
Why we still need them?
Dr Cheah Wee Kooi
Physician and Geriatrician
Head of Medical Department and Clinical Research Centre
Taiping Hospital, PERAK

2. Disclaimer
•This slide was prepared for the Webinar Series Demystifying
Clinical Trials & COVID-19 Updates session on 14th July
2021, by Dr. Cheah Wee Kooi, Physician and Geriatrician at
Taiping Hospital, Malaysia.
•This is intended to share within healthcare professionals, not
for public.
•Kindly acknowledge “Clinical Updates in COVID-19
http://www.nih.gov.my/covid-19” should you plan to share
the information obtained from this slide with your
colleagues.

3. Contents
• Why vaccine trials are needed?
• Requirement from trial participants

4. What is a vaccine?
• Vaccination is a simple, safe and effective way of
protecting people against harmful diseases,
before they come into contact with them.
• It uses your body’s natural defences to build
resistance to specific infections and makes your
immune system stronger.

5. What is a vaccine?
• Vaccines train your immune system to
create antibodies, just as it does when
it’s exposed to a disease.

6. What is a vaccine?
• However, because vaccines contain only killed or
weakened forms of germs like viruses or bacteria
• They do not cause the disease or put you at risk
of its complications.

7. What is a vaccine?
• Most vaccines are given by an injection, but some
are given orally (by mouth) or sprayed into the
nose.

8. Why is vaccine trials needed
• Safety
• Efficacy

9. Clinical trials
Pre-clinical
Animal
studies
Phase 1
Safety
Phase 2
Efficacy
Safety
Phase 3
Efficacy
Safety
FDA
Review &
Approval

11. Emergency authorization
• At least 2 months of safety data
• Short term efficacy is proven

12. Global vaccination

13. COVID-19 vaccine doses per 100 people
(27 June 20201)

14. 5 Vaccines Approved for Use in Malaysia

15. Current Vaccine trials in Malaysia
• Institute of Medical Biology Chinese Academy of Medical
Sciences (IMBCAMS): (Inactivated, Vero Cell)
• Kangtai Biological Products. Co. Ltd. : (Inactivated, Vero Cell)
Few more in pipelines

16. Efficacy vs Effectiveness
• Efficacy is the degree to which a vaccine prevents disease,
and possibly also transmission, under ideal and controlled
circumstances – comparing a vaccinated group with a
placebo group.
• Effectiveness meanwhile refers to how well it performs in
the real world.

17. How well and safe a vaccine works
depend on many factors
• Randomization and blinded
• Base rate bias: “half of infected, vaccinated” vs “half of
vaccinated, infected”

18. Why do we still need trials?
• Longer-term safety and duration of protection.
• Waning of vaccine-induced protection
• Evaluate additional vaccines to meet worldwide needs.

19. Why not convert to observational?
• Bias in effectiveness and safety data
• Risk behaviour may change
• Unrelated events that occur by chance after vaccination
may be incorrectly attributed to the vaccine

20. Safety ensured for participants
• Independent review board
• Researchers need qualification, training and experience
• Adequate resources
• Medical care of participants
• Continue to monitor for effectiveness and safety data

21. Requirements from trial participants
● Stay safe, continue to comply with advice given by the
authorities
● Timely report of new symptoms to the research team
● Continue to follow with the research requirements
○ 12 months from the last inoculation
○ Not receiving any other vaccines during the research period

22. ● Volunteers are altruistic.
● Your safety is top priority.
● The data you generate today
will bring the world one step
closer to end the pandemic.