Connect to THE FUTUREof Vaccine Development

TYPES OF VACCINES

INACTIVATED VACCINES

Vaccines save millions of lives and are one

of the most e�ective weapons in the battle

against deadly and crippling diseases. As

part of the scientific community working on

novel vaccines, you are connected to a

legacy that began with breakthroughs in

the 18th century and continues to break

the boundaries of precision medicine.

Here is the story of vaccine science, a

story that is still being written today.

Vaccines are biologics, designed to

induce an immune reaction when

administered to the human body.

Pathogens are killed/inactivated with heat, chemicals, or radiation

before being administered to the body to provoke an immune response.

They contain a simulated, inactivated, or attenuated

form of a disease-causing pathogen, germ, part of a

germ, or toxin in formulations that work with patients’

natural immune systems to protect against future

viruses and combat disease.

Vaccine-originated immunity is one of the most

e�ective ways to protect human life, yet viruses

and disease-causing germs are always evolving,

making the development and improvement of vaccines

an ongoing and constant e�ort.

Scholars believe an understanding of inoculations has existed for more than 2,000 years.

What we know for sure is that major pandemics of smallpox, whooping cough, typhoid,

and other infectious diseases across the 16th and 17th centuries led to a major surge in

vaccine research from the 18th century onward.

Thermo Fisher Scientific connects your viral vaccine workflow end-to-end with

our trusted solutions and technology to design, develop, test, and produce

your vaccine swiftly, e�ciently, and safely.

Connect your vaccine research from discovery to commercialization and make your own mark on the story of vaccine development, with Thermo Fisher Scientific.

thermofisher.com/biotechvaccines

LIVE-ATTENUATED VACCINES

A weakened form of the disease-causing germ is used to

initiate a strong and long-term immune response within patients.

TOXOID VACCINES

Disease-causing toxins made by the germ are administered. This provokes

an immune response to the toxins and parts of the germ that lead to disease.

SUBUNIT, RECOMBINANT, POLYSACCHARIDE, AND CONJUGATE VACCINES

A specific disease-causing piece of the germ like its protein,

sugar, or capsid is separated out to create an immune response

to that particular part.

NUCLEIC ACID VACCINES

DNA, plasmid, and mRNA vaccines result in the endogenous generation

of viral proteins that mimic antigens produced during natural viral infection.

A BRIEF HISTORY OF VACCINE ADVANCES

1853

Pasteur produces the first rabies vaccine and introduced the term "vaccination"

First inactive vaccine is successfully developed for diphtheria by Gaston Ramon

Scientists discover new types of vaccines: subunit, recombinant, polysaccharide, conjugate, pneumococcal, and meningococcal

SARS-CoV-2 represents the biggest global challenge for vaccine development todayPolio vaccine is

invented by Jonas Salk and distributed worldwide

1923

1945

1952

1965

1970s

1995

The first influenza vaccines are approved and produced for military use

Vaccine developments include measles and smallpox, leading to the eradication of smallpox by 1980

Havrix, an inactive vaccine against hepatitis A virus, is developed and licensed

English doctor Edward Jenner observes milkmaids’ immunity to smallpox if they already contracted cowpox

1796

Louis Pasteur produces the first laboratory-developed vaccine to treat chicken cholera

1879 2016

Measles is declared eliminated from the Americas; however, lower rates of vaccination lead to outbreaks years later

20201885

Vaccinations are made mandatory in the UK

Target discovery

Identify pathogen and

conduct genetic/proteomic

analysis to design vaccine.

It is important to look for

solutions that enable

speed and accuracy and

maximize throughput.

Antigen identification and selection

Synthesize, characterize,

and optimize candidate

antigens. Consider

cost-e�ective and scalable

solutions to accelerate

transition from research to

clinical trials and production.

© 2020 Thermo Fisher Scientific Inc. All rights reserved.

All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.

Process and analytical development

Identify materials,

equipment, analytical

methods, and process

conditions that support

scalable vaccine

production. Consider

whether you need

standard or customized

solutions to enable

scale-up of processes.

Clinical studies/trials

Conduct patient testing

to track success rates

and help ensure vaccine

safety, data integrity,

and reproducibility. Look

for partners who can

provide rapid genotyping

solutions for e�ective

patient stratification, and

who can o�er global

clinical trial support.

Commercial production

Consistent, reliable,

contaminant-free

development of a stable

vaccine requires raw

materials that meet

regulatory requirements

for cGMP production,

and QA/QC testing.

VACCINE DEVELOPMENT CHALLENGES

VIRAL VACCINE DEVELOPMENT WORKFLOW

Competitive biopharmaceutical

industry

Changes in the virus: genetic

mutations and new strains can mean

constant redevelopment

Harder to develop,

standardize, and produce than

other biologics

New antigens require novel, complex cell substrates

Vaccines have specific

biochemical and biological properties

Scale-up, clinical study, trial, testing,

and validation are arduous

Early-phase success rate

typically <10%

High cost / high risk; initial outlay can exceed $1 billion

over 12+ years

VACCINE DEVELOPMENTMILESTONES

Research and discovery

Natural or synthetic antigens that

could prevent or treat a disease are

identified during basic lab research.

These include virus-like particles,

weakened viruses, bacteria,

weakened bacterial toxins, or other

pathogen-derived substances.

Licensing 1–2 years

If trials are successful, a

biologics license is approved

following factory inspections,

labeling, and potency and

purity tests by the issuing

institution. Manufacture can

now begin.

Clinical studies/trials

A proposed vaccine must be tested

within the human body during Phase 1,

2, and 3 clinical trials to assess:

• Patient safety

• Immunogenicity

• Proposed dosage, schedule of

immunizations, and method of delivery

• Side e�ects

• E�cacy of disease prevention,

infection prevention, and

antibodies produced

Pre-clinical studies

A tissue or cell culture and

animal testing phase assesses

the safety and immunogenicity

of a proposed vaccine. Possible

human cell responses, safe

dosage levels, and vaccine

administration methods are

also evaluated.

Apply for approval

After pre-clinical studies, an

application will be made to

regulatory bodies and the

institutions responsible for

authorizing clinical trials.

1

2

3

4

5

VACCINES, UNPACKED