2. Introducti
on
• What is a vaccine?
• Ingredients in the vaccine
• How are vaccines developed?
• Steps in vaccine development
• Regulatory bodies and regulatory of drug
development
• Types of vaccine
• Covid-19 vaccine trials by Number
• Strategies for building vaccine confidence in
facility or system
• Benefits & Side effects of Covid -19 vaccine
• Summary
• Reference
3. This Photo by Unknown Author is licensed under CC BY
• A type of medicine .
• Trains the body's immune system to create
antibodies to fight disease.
What is a vaccine ?
• To prevent disease
• Protect against many different diseases
such as covid-19, pneumonia, cholera,
hepatitis B, influenza, typhoid etc.
• Critical to the prevention & control of
infectious-disease outbreaks.
Why is there a need for vaccines?
4. Ingredients In The Vaccine
Antigen
• All vaccines contain an active component (the
antigen) which generates an immune response, or
the blueprint for making the active component.
• May be a small part of the disease-causing
organism weakened or inactive form.
Preservatives
• Preservatives prevent the vaccine from becoming
contaminated once the vial has been opened, if it
will be used for vaccinating more than one person.
• Some vaccines don’t have preservatives because
they are stored in one-dose vials and are discarded
after the single dose is administered.
5. Stabilizers
• Stabilizers prevent chemical reactions from occurring within the
vaccine and keep the vaccine components from sticking to the
vaccine vial.
Surfactants
• Surfactants keep all the ingredients in the vaccine blended. They
prevent settling and clumping of elements that are in the liquid
form of the vaccine. They are also often used in foods like ice
cream.
Residuals
• Residuals are tiny amounts of various substances used during
manufacturing or production of vaccines that are not active
ingredients in the completed vaccine.
Diluent
• A diluent is a liquid used to dilute a vaccine to the correct
concentration immediately prior to use. The most commonly
used diluent is sterile water.
Adjuvant
• Some vaccines contain adjuvants.
• An adjuvant improves the immune response to the vaccine.
• The adjuvant may be a tiny amount of aluminum salts (like
aluminum phosphate, aluminum hydroxide or potassium
aluminum sulphate).
Ingredients In The Vaccine
6. How Are Vaccines Developed?
• Every vaccine must go through extensive and rigorous testing to
ensure it is safe before it can be introduced in a country’s vaccine
programme.
• Each vaccine under development must first undergo screenings
and evaluations to determine which antigen should be used to
invoke an immune response.
• This preclinical phase is done without testing on humans. An
experimental vaccine is first tested in animals to evaluate its safety
and potential to prevent disease.
• If the vaccine triggers an immune response, it is then tested in
human clinical trials phases.
7. Steps In Vaccine Development
• Pre-clinical studies
Vaccine is tested in animal studies for efficacy and safety, including challenge studies.
• Phase I clinical trial
Small groups of healthy adult volunteers receive the vaccine to test for safety.
• Phase II clinical trial
Vaccine is given to a larger group of people to observe its safety and ability to generate an
immune response.
• Phase III clinical trial
Vaccine is given to thousands of people and tested for efficacy and safety.
• Phase IV post marketing surveillance
Ongoing studies after the vaccine is approved and licensed, to monitor adverse events and to
study long-term effects of the vaccine in the population.
8. •The process of testing, developing and marketing of medicines has to regulated to protect the
interests of the public.
• Major regulatory bodies include the Food & Drug Administration (FDA) in the US and the European
Medicines Agency (EMA) in Europe.
•These bodies have various functions
Drug regulatory authorities often have other important functions including:
•Pharmacovigilance .
•Regulating clinical trials.
•Regulating herbal and homeopathic medicines.
•Inspecting and maintaining standards of drug development and manufacture.
Regulatory Bodies And Regulatory Of Drug
Development
9.
10. A coronavirus disease 2019 (COVID-19) vaccine can prevent you from
getting COVID-19 or from becoming seriously ill or dying.
Messenger RNA (mRNA) vaccine.
• A mRNA vaccine is made using mRNA that
gives your cells instructions for how to make the
spike protein found on the surface of the
COVID-19 virus. After vaccination, your immune
cells begin making the spike protein and
displaying them on cell surfaces. This causes
your body to create antibodies that can fight the
COVID-19 virus.
• Pfizer-BioNTech and the Moderna COVID-19
vaccines use mRNA.
Types of vaccine
11. Viral vector vaccine
• A viral vector vaccine is made when genetic
material from a COVID-19 virus is inserted into a
unrelated, harmless virus. When the viral vector
gets into your cells, it delivers genetic material
from the COVID-19 virus that gives your cells
instructions for how to make the spike protein
found on the surface of the COVID-19 virus.
Once your cells displace the spike proteins on
their surfaces, your immune system creates
antibodies that can fight the COVID-19 virus.
Vaccines - The Janssen/Johnson & Johnson,
AstraZeneca.
Types of vaccine
16. • Encourage senior leaders to be vaccine champions.
• Host discussions where personnel at different levels can provide
input and ask questions.
• Share key messages with staff through emails, breakroom
posters, and other channels.
• Provide information and resources to healthcare teams about
COVID-19 vaccines, how they are developed and monitored for
safety, and how teams can talk to others about the vaccines.
• Talk to non-medical staff about the importance of getting
vaccinated.
• Make the decision to get vaccinated visible and celebrate it.
Photo credit: https://timesofindia.indiatimes.com/india/pm-modi-takes-2nd-
dose-of-covid-vaccine-at-aiims-delhi/articleshow/81961509.cms
Strategies for building vaccine confidence in facility or system
17. • COVID-19 vaccination will help keep you from getting
sick from COVID-19.
• Wearing masks and social distancing help lower your
chance of getting the virus or spreading it to others, but
these measures are not enough.
• The combination of getting vaccinated and following
GOI's recommendations to protect yourself and others
will offer the best protection from COVID-19.
• The more people who get vaccinated, the faster we can
get back to our normal lives.
What are the benefits of getting a COVID-19 vaccine?
18. • Serious side effects from vaccines, including
the COVID-19 vaccine, are rare-
• Side effects are normal signs that your body
is building protection.
• The most common side effects are minor
and include:
• Tiredness
• Headache
• Pain at the injection site
• Muscle and/or joint pain
• Chills
• Nausea and/or vomiting
• Fever
Do the COVID-19 vaccines have any side effects?
19. • The vaccines do not contain the live virus that causes COVID-19.
• This means that you can't catch COVID-19 from the vaccine.
Can I get COVID-19 from the COVID-19 vaccines?
20.
21. Summary
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 (Glycoprotein 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.
