The document summarizes the development process for COVID-19 vaccines. It notes that vaccine development usually takes years but the pandemic spurred over 100 candidates in rapid development. It outlines the typical stages: exploratory research, pre-clinical testing, clinical trials in three phases, regulatory review, quality control, and approval. The document also provides information on COVAXIN, an approved COVID-19 vaccine in India, including its ingredients, administration method, benefits, side effects, and effectiveness based on clinical trials.

2. COVID-19 VACCINE IN LATE
DEVELOPMENT STAGE
The development of a vaccine against
COVID-19 has taken place in an
unparalled pace. Usually such a process
takes years, but the scope of the
pandemic triggered round the clock
work by thousands of researchers
working over 100 different forms of
vaccine.

3. Before any vaccine can be used widely, it
must go through development and testing to
make sure that its’ effective against the virus
or bacteria and that it doesn’t cause other
problems. The stages of development
generally follow this timeline.

4. 1) EXPLORATORY STAGE
This is the start of lab research to find that
can treat or prevent a disease. It often lasts 2
to 4 years.

5. 2) PRE-CLINICAL STAGE
Scientists use lab tests to learn whether a
vaccine might work. This stage usually lasts 1
to 2 years. Many potential vaccines don’t
make it past this point. But if tests are
successful and the FDA signs off, it’s on to
clinical testing.

6. 3) CLINICAL DEVELOPMENT
This is a three- phase process of testing.
Phase I usually lasts 1 to 2 years and involves
fewer than 100 people. Phase III takes at
least 2 years and includes several hundred
people. Overall the clinical trial process
many stretch to 15 years or more. About a
third of vaccines make it from Phase I to
final approval.

7. 4) REGULATORY REVIEW AND
APPROVAL
Scientists with the FDA and CDC go over the
data from the clinical trials & sign off.

8. 5) QUALITY CONTROL
Scientists and Government agencies in drug
making process and on people who get the
vaccine. They want to make sure it keeps
working safely.

9. VACCINATION IMMUNIZATION
CRITERIA
The vaccination of fronline workers will
help in reducing the societal and economic
impact by reducing COVID-19 mortalities.
The next group will be persons over 50 years
of age and persons under 50 years of age and
persons under 50 years with comorbid
conditions because there is high mortality
in this category

10. ETHICAL PRINCIPLES-
1) Maximize benefits and minimize harms- Respect
and care for people using the best available data
to promote public health and minimize death
and severe illness.
2) Mitigate health inequities- Reduce health
disparities in the burden of COVID-19
vaccination
3) Promote transparency- Make a decision that is
clear, understandable, and open for review of the
decision process.

11. WHAT SHOULD BE MENTIONED TO
VACCINATION PROVIDER BEFORE
GETTING VACCINE
- Are on regular medication for any illness, for how long
and how long and for which conditions, including-
- Have any allergies
- Have fever
- Have a bleeding disorder or are on a blood thinner
- Are pregnant
- Are breast-feeding
- Are immuno-compromised or are on a medicine that
affects immune system
- Have recieved another COVID-19

12. INDICATIONS
COVID-19 vaccine (COVAXIN) has been approved for
restricted use in emergency situation inividuals 18
years of age & older

13. CONTRAINDICATIONS
- Have a severe allergic reaction to any ingredients of the
vaccine)
- Had a severe allergic reaction after a previous dose of
this vaccine
- Currently have an acute infection or fever

14. INGREDIENTS
COVAXIN includes the following
ingredients. COVAXIN contains 6 ug of
whole virion inactivated SARS- CoV-2
antigens 15 ug, 2- phenoxy-ethanol 2.5 mg,
and phosphate buffer saline up to 0.5 ml.
The vaccine (COVAXIN) thus has been
developed by using inactivated/killed virus
along with the aforementioned chemicals.

15. HOW IS THE COVID-19 VACCINE
(COVAXIN) given?
COVID-19 (COVAXIN) will be given as an
injection into the deltoid muscle of the
upper arm. COVAXIN vaccination series 2
doses given 4 weeks apart.

16. BENEFITS OF COVAXIN-
In an ongoing clinical trial, COVAXIN has
been shown to generate immunity following
2 doses given 4 weeks apart. Phase 3 clinical
trial is ongoing in 25,800 participants, with
an interim analysis results showing vaccine
efficacy or 81%.
Hence, it is important to appreciate that
recieving the vaccine does not mean that

17. other precautions related to COVID-19 need to be
followed.

18. SIDE EFFECTS
- Injection site pin/swelling/redness/Itching.
- Headache
- Fever
- Malaise/body ache
- Nausea
- Vomitting
- Rashes

19. COVID-19 VACCINE EFFECTIVENESS
The safety and efficacy data from clinical
trials of vaccine candidates are examined by
Drug regulator before granting the licence
for the same. Hence, all the COVID-19
vaccines that recieve licence will have
comparable safety and efficacy.