4. Phases of Clinical Trial
Laboratory Stage or pre Clinical
Phase
The new vaccine is tested in animal or
cell studies to determine if it is safe
and effective.
Phase 1
• Small group of healthy people
• Determine safety, efficacy and
dose
Phase 2
• Larger group of healthy people
and some diseased people
• Determine safety and efficacy
Phase 3
• Large group of healthy people
ranging to thousands
• Determine safety and efficacy
Phase 4
• Long term observation among
beneficiaries, after approval and
rolling out the vaccine
5.
6.
7. • Efficacy: These are the results under
ideal and controlled circumstances, such
as in clinical trials.
• Effectiveness: These are the results in
real world after the product is rolled out
to general population.
8. COVISHIELD
• Also known as Oxford-AstraZeneca COVID-19
Vaccine, codenamed AZD1222. Work began in
January 2020.
• Developed by Oxford University partnered with
British Swedish company AstraZeneca.
• On 30 December, 2020 it was approved in UK
vaccination program in UK
9. • In India, Covid vaccination started
among Health Care Workers with
Covishield on 16 January, 2021.
• The vaccine is in Trail phase 3, with
32459 participants, with around 20000
in Vaccine arm and 10000 in placebo
arm.
10. • Dose: 0.5 ml IV on any arm by AD
syringes
• Once opened, multi-dose vials should be
used as soon as practically possible and
within 6 hours when kept between +2
degree C and +25 degree C
11.
12. • This is a viral vector vaccine where the vector used in
chimpanzee adenovirus, ChAdOx1 containing 5 ×
1010 viral particles
• It is found to have 63% efficacy, however if the
interval between doses is 2-3 months it is believed to
have 90% efficacy.
13.
14.
15. COVAXIN
• Bharat Biotech partnered with the National
Institute of Virology and the Indian Council
of Medical Research.
• Inactivated Corona Virus Vaccine
• Authorised for emergency use on January 3
16. • Work started to make the vaccine in
June 2020.
• Phase 3 trial started in October 2020
with around 25,800 participants.
• Trial results later showed the vaccine
has an efficacy of 80.6%.
17.
18.
19.
20.
21. OTHER IMPORTANT VACCINES
• Sputnik V Vaccine is a viral vector vaccine
developed by Gamaleya Research Institute of
Epidemiology and Microbiology in Russia. It has
been cleared to be used in India but it will reach
India as early as May 2021.
22. • Pfizer vaccine is an m-RNA based vaccine
developed by German company BioNTech
partnered by American company Pfizer. It is
being used in Germany, Hungary, UK, USA,
Israel etc.
• It is said to have a 95-100% efficacy against
symptomatic infection.
23. • Moderna vaccine is also a m-RNA based
vaccine developed by United States
national Institute of Allergy and
Infectious diseases (NIAID), the
Biomedical Advanced research and
development authority (BARDA) and
Moderna. It also has an efficacy of 95%.
24. • As of 24/04/2021, 138M doses have
been given in India, 21.4M are fully
vaccinated, which is only about 1.6% of
total population compared to USA
(27.8%), UK (18.1%) and Brazil (5.1%).
25.
26.
27.
28.
29. • Vaccine hesitancy (a delay in acceptance
or refusal of vaccines despite availability
of vaccine services) has 3 domains:
1. Confidence
2. Convenience
3. Complacency
30. • Various studies have shown hesitancy
towards vaccine which results in
resistance towards vaccine.
• A study Edwards et. al in 3000
Australian population showed 29% low
hesitancy, 7% high hesitancy and 6% are
resistant.