More than 150 coronavirus vaccines are in development across the world—and hopes are high to bring one to market in record time to ease the global crisis. The World Health Organization is also coordinating global efforts to develop a vaccine, with an eye toward delivering two billion doses by the end of 2021. Hello guys , today I am discussing about various stages of vaccine development and types of vaccines already developed by various biotech companies all over the world and their current status in clinical trial till now . Hope , Very early we can get a ideal corona virus vaccine which would be safe and effective to human and also eradicate this disease from the world . For more information please follow these link : https://www.nytimes.com/interactive/2... https://www.precisionvaccinations.com... https://www.who.int/publications/m/it...

1. Vaccine development in Global pandemic
Presented by
Sohini bhattacharjee,M.sc( Microbiology)

2. What is Vaccine?
A vaccine is a biological preparation used to stimulate the production of
antibodies and provide immunity against one or several diseases ,contains a
agents which resembles a disease-causing microorganism and is often made
from weakened or killed forms of the microbe, its toxins, or one of its surface
proteins .

3. How do vaccine work against Covid19 ?
Scientist and researchers worldwide race to develop a vaccine in the fight
against global pandemic (COVID-19 )where main focus is to the so-called
spike protein, which is present in the COVID virus. The spike protein
interacts with ACE2 proteins on human cells, facilitating infection of the
cells, encouraging the virus to replicate and cause disease.
Several vaccines in development are aimed at exposing the body to spike
protein and having the immune system recognize it as an antigen, or foreign.
The immune system then develops a response with specialized white blood
cells that are aimed at either destroying the virus or producing antibodies
that will block infection by the virus when exposed to the real pathogen.
This diagram shows how a Vaccine can develop Cell-mediated
immunity and Humoral immunity against spike protein.

4. Development of New Vaccines
Vaccine development is a long, complex process, often lasting 10-15 years and involving a
combination of public and private involvement.
The general stages of the development cycle of a vaccine are:
● Exploratory stage
● Pre-clinical stage
● Clinical development
● Regulatory review and approval
● Manufacturing
● Quality control

5. Exploratory Stages:
This stage involves basic laboratory research and often lasts 2-4 years. Federally
funded academic and governmental scientists identify natural or synthetic antigens that
might help prevent or treat a disease. These antigens could include virus-like particles,
weakened viruses or bacteria, weakened bacterial toxins, or other substances derived
from pathogens.

6. Pre-Clinical Stage
Pre-clinical studies use tissue-culture or cell-culture systems and animal testing to
assess the safety of the candidate vaccine and its immunogenicity, or ability to provoke
an immune response. Animal subjects may include mice and monkeys. These studies
give researchers an idea of the cellular responses they might expect in humans.
Many candidate vaccines never progress beyond this stage because they fail to
produce the desired immune response. The preclinical stages often lasts 1-2 years and
usually involves researchers in private industry.

7. Clinical Development Stages :
Clinical trials focus on safety and include 20–100 healthy volunteers.
1. Phase 1 :scientists begin to learn how the size of the dose may be related to side effects. If
possible at this early stage, scientists also try to learn how effective the vaccine may be;if no
serious side effects are found in Phase 1, next :
2. Phase 2 :which involves several hundred volunteers. This phase includes studies that may
provide additional information on common short-term side effects and how the size of the dose
relates to immune response.
3. Phase 3 : hundreds or thousands of volunteers participate. Vaccinated people are compared
with people who have receive a placebo or another vaccine so researchers can learn more about
the test vaccine’s safety and effectiveness and identify common side effects.

8. Regulatory review and approval
After a successful Phase III trial, the vaccine developer will submit a Biologics License Application to the FDA.
Then the FDA will inspect the factory where the vaccine will be made and approve the labeling of the vaccine.
After licensure, the FDA will continue to monitor the production of the vaccine, including inspecting facilities
and reviewing the manufacturer’s tests of lots of vaccines for potency, safety and purity. The FDA has the right
to conduct its own testing of manufacturers’ vaccines.

9. Manufacturing and Quality Control Stages
This stage needs well oiled infrastructure of the vaccine producing company and
financial resources to begin the process of manufacturing of the vaccine on a large
scale.

10. FACTORS FOR VACCINE DEVELOPMENT
● Safety (measures the vaccine is safe to give the people)
● Efficacy(measures how well the vaccine protect you from getting sick)
● Duration of immunity ( long time protection is always desirable)
● Doses (single or Multiple )
● Storage (normally vaccine can be stored at 4 degree Celsius but RNA
vaccine require -80 degree Celsius )

11. Stages of
Vaccine
development in
Global
Pandemic.

12. VACCINE DEVELOPMENT IN
PANDEMIC SITUATION .
VACCINE DEVELOPMENT IN NORMAL
CIRCUMSTANCES .

13. STAGES OF VACCINE
DEVELOPMENT FOR
COVID 19 VACCINE
CANDIDATES

14. VACCINE
CANDIDIATES IN
CLINICAL TRIAL
PHASE 3
Recently,3 vaccine candidates are
reached in clinical trial phase 3
according to data.
mRNA-1273
Company : Moderna
AZD1222
(ChAdOx1nCov-19)
Company: Oxford University
COVAXINE
Company : Bharat Biotech

15. VIRUS VACCINES
1.COVAXINE
• First indigenous Vaccine
by Bharat Biotech (India)
3.Inactivated vaccine by
Sinopharm ( China)
2. Inactivated vaccine by
SINOVAC Biotech ( China)

16. VIRAL-VECTOR VACCINES:
Viral vector vaccine by
AstraZeneca And university of
Oxford where
Adenovirus(ChAdOx1)used as viral
vector .
AZD1222
(ChAdOx1nCov-19)

17. NUCLEIC-ACID VACCINES:
mRNA-1273 Moderna
mRNA vaccine
DNA vaccine
RNA vaccine
BIONTECH
FOSUN
Pharma/Pfizer
Zydus Cadilla
Imperial College
of London.

18. PROTEIN-BASED VACCINES:
NOVAVAX (USA)
VAXINE(AUSTRALIA)
COVAX-19, the targeted vaccine has been
developed by company Vaxine and researchers at
Flinders University.

19. • mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated
mRNA-based vaccine that encodes for a full-length, prefusion
stabilized spike (S) protein of SARS-CoV-2.
• mRNA-1273 vaccine was provided as a sterile liquid for
injection at a concentration of 0.5 mg per milliliter. Normal
saline was used as a diluent to prepare the doses administered.
• This vaccine are developed by Moderna (An American Biotech
Company ) and collaboration with NIH(National Institute of
Health)
• This mRNA vaccine use genetic sequence of spike protein not
by working on the virus itself .So this platform provide
advantages in speed and efficiency ,across basic science
,manufacturing and clinical development .
mRNA-1273

20. Thanks!
https://www.nytimes.com/interactive/2020/science/corona
virus-vaccine-tracker.html
https://www.precisionvaccinations.com/vaccines/azd1222-
sars-cov-2-vaccine