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Transcript
VACCINES
PROTECT YOUR HEALTH
AT EVERY AGE
The history, facts, and future of the
most effective and revolutionary
public health intervention
A Legacy of Achievement in Preventing
Pfizer has a long history of researching and developing
Our current research program includes innovative
Smallpox vaccine
developed at the
Company’s Lancaster
County Vaccine Farm.A
1882
1906
The Company
manufactures one
million doses of
smallpox vaccine
per week.B
1915
1941
The Company
introduces
a combined
vaccine for
preventing
diphtheria,
tetanus and
pertussis in
young children.B
1948
1963
First to develop
bifurcated
needle which
subsequently
revolutionizes
smallpox delivery
and leads to
its worldwide
eradication.A
1968
1968
The Company ships
typhoid vaccines as
part of the war effort.A
The diphtheria
antitoxin becomes
the first FDA-licensed
product manufactured
at the Company’s
Pearl River, New York,
facility.B
First to license oral
form of live trivalent
poliovirus vaccine in
the United States.B
First to develop
a heat stable,
freeze-dried
vaccine for
smallpox.A
Reference
Wyeth | BLederle Laboratories | CPraxis Biologics | DLederle-Praxis Biologics | EWyeth Lederle Vaccines and Pediatric | FPfizer |
Pfizer. Pipeline as of November 2012. Available at http://www.pfizer.com/research/product_pipeline/product_pipeline.jsp
A
G
2
Disease1
some of the world’s most important vaccines.
preventative and therapeutic vaccines.
First to license
a conjugatebased vaccine
for Haemophilus
influenzae type b
when HibTITER
is licensed for
toddlers in the
United States.C
1988
1991
First to license
a Haemophilus
influenzae type
b (Hib) vaccine
combined with
DTP in the
United States.D
1993
1999
First to license a
diphtheria, tetanus,
acellular pertussis
(DTaP) vaccine in
the United States.D
First to license a
meningococcal
serogroup C
conjugate
vaccine.E
First to license
a 7-valent
pneumoccocal
conjugate vaccine
[Diphtheria
CRM197 Protein]),
for the prevention
of invasive
pneumococcal
disease caused by
vaccine serotypes
in infants and
toddlers.E
2000
2010
First to license
a 13-valent
pneumococcal
Vaccine, [Diphtheria
CRM197 Protein], for
use in infants and
young children.F
First to license
a 13 valent
pneumoccocal
conjuguate vaccine,
for use in adults 50
years and older.F
2011
Pfizer is currently
investigating vaccines
against Meningitis B
(phase 3); Alzheimer’s
disease (phase 2)
Staphylococcus aureus
(phase 2); Clostridium
difficile colitis (phase 1)
and smoking cessation
(phase 1)G
3
Vaccination is the most effective and economical way of preventing
infectious diseases. Vaccines have led to the control, lower incidence
and even elimination of diseases in Europe that in the past resulted
in death or disability for millions of people.2
– Council of the European Union,
6 June 2011
Table of Contents
• What is a Vaccine?
5
– The Vaccine Revolution
5
– Life-Saving Prevention
6
– Making Vaccines: Science at Its Best
7
• Vaccines: The Key to Protecting Health at Every Age 9
– Adult Vaccination Rates – Why So Low?
9
– As We Get Older, Health Means Wealth
10
• Why Do So Many Myths Persist?
11
– The High Price of Non-Vaccination
12
– Helping Curb Bacterial Multi-Drug Resistance
12
– A Call for Better Public Defense of Vaccines
12
• The Future of Vaccines
13
• Pfizer’s Commitment to Global Health
14
• Appendix
15
– Key Dates in Vaccines History
15
– Terms and Definitions
18
• References
4
21
What is a Vaccine?
A vaccine is a biological preparation which
usually contains a severely attenuated,
weakened or inactivate version of the virus
or bacteria (also called “pathogen”) that
it is meant to prevent. Introducing this
biological preparation into the body prompts
the immune system to combat the specific
although inactive pathogen, and thus prepares
the body to fight it in the future by creating an
“immune memory.” As a result, a vaccinated
person has the tools needed to recognize
and effectively fight off a “live” version of the
pathogen and prevent a potentially deadly
infection.3
The Vaccine Revolution
The world’s first vaccination was performed
by Edward Jenner in 1796 against smallpox.
A century later, Louis Pasteur developed
the first rabies vaccine. Since then, scientific
research and progress has led to the
development of over 30 vaccines against
some of the most deadly diseases known to
man such as typhoid, polio, and measles.5
Thanks to effective routine childhood
immunisation, diseases with serious outcomes
such as polio, diphtheria or tetanus are now
almost eradicated from the European Union.6
Vaccines have changed
the face of medicine in
just 200 years. Along
with improvements in
sanitation and clean
water, vaccination is now
recognized as the most
successful & effective public
health intervention in the
world for saving lives and
promoting good health.4
– WHO & UNICEF
5
Life-Saving Prevention
Vaccines are an essential component of disease prevention. They are responsible for the global
eradication of smallpox as well as saving over 3 million lives worldwide each year, and millions
more from suffering illness and lifelong disability.5 Vaccines enable people to lead longer,
healthier lives and also help reduce health care costs to both individuals and the broader health
care system by reducing the incidence of vaccine-preventable illness.7 In addition, vaccines help
protect society’s most vulnerable members – including infants, the elderly and groups at risk –
from deadly diseases such as meningitis, pneumonia and measles.
However there is a continuing need to develop vaccines that better address the needs of
specific populations, such as those with weakened immune systems, for whom current vaccine
options may not be suitable.
Vaccines have eradicated some of the world’s deadliest diseases
Comparison of 20th Century Annual Morbidity** and Current Morbidity:
Vaccine-Preventable Diseases8
Disease
Smallpox
Diphtheria
20th Century Annual
Rate of New Cases†
29,005
21,053
Percent Decrease
0
0
100%
100%
Measles
530,217
61
>99%
Mumps
162,344
2,528
98%
Pertussis
200,752
21,291
89%
Polio (Paralytic)
16,316
0
100%
Rubella
47,745
6
>99%
152
0
100%
Congenital Rubella Syndrome
Tetanus
Haemophilus Influenzae
580
8
99%
20,000
270*
99%
Source: JAMA. 2007; 298 (18): 2155–2163.
Source: CDC. MMWR January 7, 2011: 59 (52); 1704–1716.
(Provisional MMWR week 52 data)
†
††
2010 Reported Cases††
* 16 type b and 254 unknown serotype (<5 years of age)
** Morbidity means annual rate of new cases
Comparison of Pre-vaccine Era Estimated Annual Morbidity or
Mortality with Current Estimate: Vaccine-preventable Diseases8
Disease
Hepatitis A
Hepatitis B (Acute)
Pre-vaccine Era
Annual Estimate
2008 Estimate
117,333†
66,232†
11,049
11,269
91%
83%
Pneumococcus (Invasive)
all ages
63,067†
44,000#
30%
<5 years of age
16,069†
4,167##
74%
Rotavirus (Hospitalizations,
<5 years of age)
62,500††
7,500###­
88%
4,085,120†
449,363
89%
Varicella
Source: JAMA. 2007; 298 (18): 2155–2163
††
Source: CDC. MMWR. February 6, 2009 / 58 (RR02): 1–25
#
Source: CDC. Active Bacterial Core surveillance Report;
S. Pneumoniae 2008. http://www.cdc.gov/abcs/survreports/spneu08.pdf
†
6
Percent
Decrease
Source: 2008 Active Bacterial Core surveillance
###
Source: New Vaccine surveillance Network
##
Making Vaccines:
Science at Its Best
Manufacturing vaccines is a complex and highly
technical process that involves stringent quality
and safety procedures. Vaccines are biological
products which are very sensitive to change
and are highly controlled throughout the
manufacturing process.9
The first step in manufacturing a vaccine
is to produce the active component of the
vaccine, which is usually a severely attenuated,
weakened or inactivated version of the virus
or bacteria, rendering it safe to administer to
individuals. Manufacturing processes are then
vaccine-specific.
Conjugate Technology
In the case of Pfizer’s 13 valent pneumococcal
vaccine, thirteen polysaccharides molecules
are manufactured and then bonded or
conjugated with a carrier protein that helps
to elicit an immune response in the immune
system. The process of conjugating 13
serotypes is considerably complex as each
serotype must be made separately in precise
quantities to achieve the correct clinical
immunological response.
• Typically it takes around a year to complete
the full cycle of production and testing
stages for each batch of Pfizer’s 13 valent
pneumococcal vaccine.
• Over 300 separate quality controls tests are
conducted during the production of each
batch of vaccine, to help ensure that Pfizer’s
13 valent pneumococcal vaccine meets the
requirements for purity, potency and safety.
• Scientists perform between 10,000 to 15,000
tests per month on the manufacturing
environment the vaccines are being made.
Vaccines are without questions held to
the single highest standard of safety
than any other biological or drug.
Prof. Dr. Heinz-J. SCHMITT, FIDSA, Senior Director
Scientific Affairs (Vaccines) Europe, Pfizer
7
Pfizer’s Grange Castle Biotechnology Campus is
one of the largest biotech manufacturing sites in
the world. Pfizer recently invested $200 million in
the site to introduce two new processing suites
and expand current production and product
testing capabilities for a number of products
including Pfizer’s 13 valent pneumococcal
conjugate vaccine.10
The stages in the manufacturing process
Activation of the Serotypes
The active components of each of the 13 vaccines
contained in Pfizer’s 13 valent pneumococcal vaccine are
the polysaccharides or large sugar polymers on the surface
of the pathogenic bacterium, Streptococcus pneumoniae.
The first step of the process involves the fermentation or
growth of the organism in large tanks followed by the
purification of the polysaccharide.
Vaccine Conjugation
The polysaccharide is then chemically bound or
conjugated to a special carrier protein to form
a glycoconjugate, and the glycoconjugate is
then purified to a pure substance. Thirteen
different glycoconjugates are manufactured
for Pfizer’s 13 valent pneumococcal vaccine.
Ultrafiltration and Fill
After conjugation, a number of ultrafiltration steps are carried out
for purity and concentration of the product before being filled. At
the filling stage, the product is transferred to individual bags of
conjugate. Each conjugate bag will only hold one serotype. Next,
each of the 13 separate conjugates that represent the 13 serotypes
found in Pfizer’s 13 valent pneumococcal vaccine is combined to
create the vaccine in bulk liquid form in a process called formulation.
Syringe Filling
8
After passing extensive quality control tests
on a manufacturing line, Pfizer’s 13 valent
pneumococcal conjugate vaccine is
dispensed into syringes, in preparation for
final packing labelling and distribution.
Additional quality tests are conducted on the
finished product.
Vaccines: The Key to
Protecting Your Health at Every Age
Amongst adults, vaccine-preventable diseases remain a
significant threat. A 2009 study reported that in the USA,
significantly more adults than children die from vaccinepreventable diseases, such as influenza, pneumococcal
disease, tetanus, diphtheria, pertussis (whooping cough),
each year.11 In Europe, both the burden of vaccinespreventable diseases and vaccination rates amongst older
adults are under-monitored. When data is available, it points
to sub-optimal levels of vaccination rates.
Adults were shown to be
100 times more likely
to die from vaccinepreventable diseases than
children in the USA.12
– Amercian College of Physicians
Adult Vaccination Rates – Why So Low?
90
EU target for Influenza season 2014-15
WHO target 2010
80
Vaccination Coverage (%)
70
60
WHO target 2006
50
40
30
20
Survey 2008
Estonia
Poland
Lithuania
Romania
Slovenia
Iceland
Slovakia
Malta
Hungary
Finland
Portugal
Norway
Denmark
Luxemburg
Ireland
Sweden
Belgium
Italy
Spain
France
The Netherlands
United Kingdom
0
Germany
10
Survey 2009
figure 1: Sub-optimal vaccination coverage for seasonal influenza among the elderly in the EU/EEA countries:
national seasonal influenza vaccination surveys in Europe, January 2008 and July 200913
• FLU: In Europe, most countries do not reach the
targeted rate of 75% vaccination rates for flu – the
most well known and recognized vaccine – for older
adults.
• PNEUMOCCOCAL DISEASES: Immunisation rates for
pneumococcal diseases amongst older adults have
been low, ranging between 20% and 30%. The
UK has had the highest cumulative coverage rate
(over 69%), where active campaigns to promote
pneumococcal vaccination for elderly adults and
younger persons at risk began in 2003.14
In Europe, vaccines coverage
in adults for a variety of
serious vaccine-preventable
diseases remains low13
and unpredictable while
the burden remains high
amongst older adults.
9
15
Cases/100,000
Population
12
9
6
3
0
0–4
5–14
15–24
25–44
Age Group (Years)
Men
45–64
>=65
Women
figure 2: The burden of pneumococcal disease amongst older adults: Notification rates for invasive pneumococcal disease by age and sex in 17 European countries in 2008 (n=12,427)15
These low and inconsistent rates of vaccination among adults have complex root causes but can be
partially explained by the misplaced belief that vaccination is only for the young on the one hand,
and the reliance on risk-based guidelines for adults on the other. Contrary to vaccination guidelines
for young children where specific recommendations are established from birth to age five, adult
vaccination recommendations tend to be patchy and focused on the existence of other diseases,
such as asthma, HIV, or other diseases that affect an individual’s ability to fight off vaccinespreventable diseases.
There is a growing interest and discussion around establishing European best-practice guidelines
which would mimic the model and hence the effectiveness of childhood immunisation schedules.
Such “age-based” guidelines would be more easily understood by both practitioners and patients,
and would be easier to implement than a multitude of risk-based guidelines which require
identifying individuals with specific diseases and usually fail to achieve high coverage levels.14
As We Get Older, Health Means Wealth
Europe’s population is
ageing fast and has the
highest proportion of
“older people (60+)” of all
continents.16
Currently four people of working age support one “retiree”.
By 2050, this ratio will drop to two for every retired person.17
The European Commission estimates that member states
health care spending will increase by approximately 25%
(gross domestic product) in most Member States due to the
growing number of older citizens alone.18 As governments
push back retirement ages to meet this future challenge,
prevention strategies such as adult vaccination programs
have the potential to keep Europe’s senior population active and healthy.
100%
1.2
2.0
7.9
10.7
80%
15.2
60%
3.4
6.5
11.8
12.3
15.4
16.2
18.5
17.2
21.3
35.0
18.5
32.7
36.9
40%
31.1
15.8
13.0
24.9
23.7
17.1
0%
1950
1975
80+
65–79
2000
50–64
10.5
9.7
14.4
13.3
2025
25–49
15–24
figure 3: Population distribution in EU25 by age group (1950-2050).19
10
28.2
15.5
20%
2050
0–14
– UN
Why Do So Many Myths Persist?
Despite the success of childhood
immunisation programs, and undisputable
evidence that vaccines are safe and effective,
false and misleading information continues
to circulate regarding vaccines in general.
This misinformation leads people to question
the value of vaccines, resulting in a drop
myths
in vaccination rates and new outbreaks of
old diseases. Both the European Centre for
Disease Prevention & Control (ECDC) and the
World Health Organization (WHO) have called
on all stakeholders to partner together to
counter common myths and inaccuracies.20
facts
•“People who get vaccinated for the flu
often wind up getting it.”
•This is false. Certain vaccines can lead to mild symptoms
resembling the disease against which they provide
protection, but those are mainly a consequence of the
immune system gearing up to produce the immune
response.21
•“Vaccines cause side effects, illnesses,
and even death – not to mention
possible long-term effects we don’t even
know about.”
•The vast majority of side effects are minor and temporary,
such as a sore arm or mild fever, and have nothing to do
with the infectious disease against which the immunisation
is directed.22 New vaccines go through a rigorous testing in
development and approval phases in Europe, to make sure
they are safe, effective and of good quality.23 The European
Medicines Agency also monitors any adverse events that
might occur after licensure of the medicine.
•“Vaccine-preventable diseases have been •This is one of the most damaging myths today. Past
virtually eliminated from Europe, so
vaccination programs do not eliminate the need for adults,
there is no need for my child or myself to
young people and children to be vaccinated today. The
be vaccinated.”
indirect protection against disease (also called “herd
immunity”), only results when a sufficient number (from
85% to 95% depending on the disease24) of individuals in
a community are immuned to that disease. For example,
diphtheria requires 85 percent of the population to be
vaccinated, while measles and mumps immunization levels
must approximate 92–96% and 88–92% respectively
before herd immunity becomes effective.25
Routine childhood vaccines effectively
protect between 85% and 95% of
recipients against the targeted diseases.24
– Fine & Mulholland
1111
The High Price of Non-Vaccination
Unfortunately, all of these misperceptions have led some
individuals to avoid vaccinations for either themselves or their
family members, and the cost to individuals and society is
measurable and high.
Bacterial multi-drug
resistance causes 25,000
deaths per year in the EU.31
– ECDC
• New outbreaks of old diseases
While most vaccines-preventable diseases’ prevalence is
being kept at very low levels, recent outbreaks of measles,
and even poliomyelitis, across Europe attest to the fact that these diseases still pose a threat if
vaccination coverage is not kept high.26
• High cost of hospital stays and lost days of work
The annual cost-burden for treating pneumonia alone across Europe is
10 billion Euros mostly due to in-hospital care and lost work days.27
Helping curb bacterial multi-drug
resistance
While some vaccine-preventable diseases can be treated
with antibiotics, over-utilisation of antibiotics leads to drug
resistance, which increases the risk of infectious disease
outbreaks and the potential for widespread illness.29 Since
the mid-1990s the proportion of pneumococci bacteria
resistant to antibiotics has increased in many European
countries from a few percent to 5– 35%.30
These cases are estimated to result in extra healthcare costs
and productivity losses of at least EUR 1.5 billion each year, a
burden likely to increase as numbers rise.31
Encouraging vaccination along with more appropriate use of antibiotics can lower drug resistance
rates by reducing the ability of infectious agents to develop resistance mechanisms.
A Call For Better Public Defense Of Vaccines
Healthcare professionals and public health officials are equally concerned with the rise of antibioticresistant bacteria and the dwindling number of antibiotics that remain to treat infections. Vaccines
information should be part of the development of a European public health communication strategy
that allows European citizens to better understand the value of vaccines, assess their individual risk
in relation to vaccines-preventable illness and manage their own health.
12
12
In 2008, 90% of the people who contracted measles
in EU/EEA countries had not been immunised.28
– ECDC – ECDC
The Future of Vaccines
Future vaccines will not only prevent infectious
diseases, but research is also on-going into
“therapeutic” vaccines to cure such chronic
diseases as diabetes, Alzheimer’s and nicotine
dependence. It’s expected that vaccines will
go beyond their traditional prevention remit
to treat autoimmune diseases and allergic
disorders. In addition, work is also underway
to develop new ways of administering
vaccines like transcutaneousA and orally.
Those medical and technological advances
are void if not coupled with comprehensive
programs to ensure full understanding of the
benefits and safety of vaccines, as well as lifecourse vaccination guidelines to ensure wide
and timely access to these vaccines.
The first decade of this century
has been the most productive
in the history of vaccine
development.32
– WHO
200 candidates in development33
Pandemic influenza
Cervical cancer, vulval and vaginal cancer, Genital warts, Shingles, Rotavirus gastroenteritis
Pneumococcal disease (conjugate vaccine)
Meningococcal C disease (conjugate vaccine)
Hepatitis A
Chickenpox, Whooping cough (acellular vaccine)
Haemophilus influenzae type b
Japanese encephalitis
Hepatitis B
Pneumococcal disease (polysaccharide vaccine)
Rubella
Anthrax
Mumps
Measles
Polio (Oral vaccine)
Polio (Injectable vaccine)
Tickborne encephalitis, Rickettsia typhus
Clostridim difficile
Cytomegalovirus virus
Dengue fever
Ebola virus
Enterotoxigenic Escherichia coli
Herpes simplex
HIV
Malaria
Meningococcal B disease
SARS
Staphylococcus aureus
Tuberculosis
Addiction (Cocaine, Nicotine)
Yellow fever, Influenza
Whooping cough, Tuberculosis, Tetanus
Allergies
Alzheimer’s
Cancer
Multiple sclerosis
Parkinsons
Diphtheria
Plague
Typhoid, Cholera
Rabies
Smallpox
1800
A
Tomorrow
1840
1880
1920 1930 1940 1950 1960 1970 1980 1990 2000 2010
Delivery of vaccine to the skin, via patches for instance.
13
Pfizer’s Commitment to
Global Health
Pneumococcal diseases overwhelmingly
burdens young children and the elderly34,
and kill over 1.6 million people each year –
including approximately 800,000 children
before their 5th birthday35. More than 90% of
these deaths occur in developing countries.36
Through the Advanced Market Commitment
(AMC) program, Pfizer reaffirmed its
commitment to working with the global health
community to accelerate global access to its
vaccines in the world’s poorest countries on an
affordable and sustainable basis.
As of December 2011, Pfizer’s 13 valent
pneumococcal conjugate vaccines is available
in more than 85 percent of countries which
have launched pneumococcal immunisation
programs under the AMC with many
additional launches planned.37
To meet the growing global demand,
Pfizer is investing resources to increase
its manufacturing capabilities and in the
development of a preserved, multidose vial
which, subject to WHO prequalification, is
expected to offer an alternative option for
developing countries.38
For more information on the GAVI Alliance,
visit: http://www.gavialliance.org/
For more information on Pfizer’s vaccines
activities, visit: www.pfizer.com
For more information on vaccines in Europe,
visit:
www.ecdc.europa.eu
http://www.euro.who.int/en/home
http://www.historyofvaccines.org/
Pfizer has pledged to supply
up to 480 million doses of
its 13-valent pneumococcal
conjugate vaccine through 2023
in developing countries, under
the auspices of the Advance
Market Commitment (AMC),
an innovative program piloted
by the GAVI Alliance to enable
affordable access to medicines
by developing countries.39
14
Appendix
Key Dates in Vaccines History
Scientific History of vaccines
Introduction of Vaccines: historical time-line (1796-2004)42
Thucydides
notices that
smallpox
survivors do
not get
reinfected.40
429 BC
*
Chinese
discover
variolation–a
primitive
form of
vaccination
aimed at
preventing
smallpox by
exposing
healthy
people to
tissue from
the scabs
caused by
the disease.40
900 AD
Smallpox
(liveattenuated)
Dr Edward
Jenner, British
physician,
discovers
vaccination40.
The first
smallpox
vaccination is
created.
Vaccination
became
popular
throughout
Europe and,
soon after,
the US41.
Rabies (killedinactivated)*
Cholera
(killedinactivated)*
Typhoid
(killedinactivated)*
Diphtheria
(D) (toxoid)
Pertussis
(Pw), whole
cell (killedinactivated)
Tetanus (T)
(toxoid)
Tuberculosis
(BCG) (liveattenuated).
1796
1885
Yellow
fever (liveattenuated)
Influenza
(killedinactivated)*
Tickborne
encephalitis
(killedinactivated)*
1928
1936
1937
Japanese B
encephalitis
(killedinactivated)
Polio (IPV)
(killedinactivated)
DTPw
Polio (OPV),
oral polio
vaccine (liveattenuated)
DT-IPV
Measles
(M) (liveattenuated)
DTPw-IPV
1945
1955
1958
1961
1963
1966
Mumps (M)
(live-attenuated)
Rubella (R) (liveattenuated)
MMR
Meningococcal disease
(serogroup A –
polysaccharide)
Meningococcal disease
(serogroup C –
polysaccharide)
Meningococcal disease
(serogroups
A&C – polysaccharide)
Pneumococcal
disease (14
serotypes –
polysaccharide)
1967
Replaced by a new vaccine
15
Typhoid (liveattenuated)*
Hepatitis B
(HB) (protein)
Pertussis
acellular (Pa)
1981
Pneumococcal
disease (23
serotypes – polysaccharide)
Varicella-zoster
(live-attenuated)
HB (protein/
recombinant
DNA)
Influenza
(subunit)
Haemophilus
influenzae type
b (Hib)
(polysaccharideprotein conjugate)
Typhoid (polysaccharide)
Hepatitis A (HA)
(killed-inactivated)
DTPw-IPV-Hib
DTPa
HA (subunit,
adjuvanted)
DTPw-HB
HB-HA
DTPa-Hib
DTPa-IPV-Hib
1983
Rotavirus (live
attenuated)
HPV vaccine
approved in
Europe.
2004
16
2006
Influenza
(subunit,
adjuvanted)
DTPa
Meningococcal disease
(serogroup
C–
polysaccharide-protein
conjugate)
HA-Typhoid
(polysaccharide)
dTaP-IPV
DTPa-IPV-HB
DTPa-IPV-HBHib
Pneumococcal disease (7
serotypes –
polysaccharide-protein
conjugate)
Pseudomonal
disease (8
serotypes –
polysaccharide-protein
conjugate)
Influenza
(live-attenuated)
Meningococcal disease
(serogroups
ACW – polysaccharide)
1997
1999
2000
2001
2003
Pandemic
Influenza
vaccine
approved in
Europe.
pneumoccocal
conjugate
vaccine,
13-valent,
licensed in
Europe for
infants and
young children.
2009
2009
pneumoccocal
conjugate
vaccine,
13-valent,
licensed in
Europe for
adults 50+.
2011
Epidemiological, social & political history of Vaccines
1700s
Variolation
spreads
around
the world.
At this
time,
smallpox
was the
most
infectious
disease in
Europe,
killing
up to
one-fifth
of those
infected in
numerous
epidemics.
Variolation
caused
mild
illness but,
although
it occasionally
caused
death,
smallpox
rates were
lower in
populations that
tried it.40
Sep.
20102011
measles
outbreak in
Europe.45
1870s
Violent
opposition to
vaccination.
People
found it
hard to
believe
that it
really
worked.
They
also felt
that it
took
away
people’s
civil
liberties,
particularly now
that
it was
compulsory.40
1956
WHO
launches
global
drive to
eradicate
smallpox.40
Sep.
2010
2010
Member
States in
the WHO
European
Region
set themselves
2015
as new
target for
eliminating measles and
rubella.46
Reemerging cases
of Polio in
Europe.47
1974
Launch of
the World
Health Organization’s
Expanded
Program on
Immunisation (EPI),
including
six vaccines,
covering
diphtheria,
tetanus,
whooping
cough,
measles,
polio, and
tuberculosis. Before
1974, only
5 per cent
of children
were vaccinated
against
these
diseases.
Today over
70 per cent
are vaccinated.43
1980
Smallpox
eradicated
from
the
world.40
1988
WHO
launches
global
drive to
eradicate
polio by
the year
2000.41
1999
2000
WHO
set up a
Global
Advisory
Committee
on Vaccine
Safety,
made up
of independent
experts, to
respond
promptly,
efficiently,
and with
scientific
rigour, to
rumours
and
reports
related to
vaccine
safety.44
Global
Alliance
for Vaccines and
Immunisation
established to
strengthen routine
vaccinations and
introduce
new and
underused vaccines in
countries
with a per
capita
GDP of
under
US$1000.
GAVI
is now
entering
its second
phase of
funding,
which
extends
through
2014
17
Terms and Definitions
Adjuvants: A substance (e.g. aluminum salt)
that is added during production of a vaccine
to increase the body’s immune response to a
vaccine.48
Antibody: A protein found in the blood that is
produced in response to a foreign substance
(e.g., bacteria or viruses) invading the body.
Antibodies protect the body from disease by
binding to these organisms and destroying
them.48
Antigens: Foreign substances (e.g., bacteria
or viruses) in the body that are capable of
causing disease. The presence of antigens in
the body triggers an immune response, usually
the production of antibodies.48
Attenuated Vaccine: A vaccine created by
reducing the virulence of a pathogen but still
keeping it ‘live’ so as to ensure an immune
response. The aim is to render the living agent
harmless or less virulent.49
Conjugate vaccine: A vaccine in which
two compounds (usually a protein and
polysaccharide) are joined together to
increase a vaccine’s effectiveness. Conjugate
vaccines include certain pneumococcal and
meningococcal vaccines.50
Herd immunity: Indirect protection against
disease that results from a sufficient number
(from 85 to 95% depending on the disease24)
of individuals in a community having
immunity to that disease. Herd immunity does
not apply to diseases such as tetanus, that are
not spread via person-to-person contact.51
Immunogen: A substance able to provoke an
immune response. “Immunogenicity” refers
to an immunogen’s ability to provoke such a
response under particular circumstances.51
Immunotherapeutic vaccines: vaccines
designed to treat against conditions beyond
the infectious diseases or cancer arena. Most
of the candidates are still in early-stage
development and their underlying scientific
bases require additional investigation:
Smoking cessation52, Alzheimer’s disease;
18
Allergies; Diabetes; Atherosclerosis
Hypertension53; Multiple Sclerosis .
Inactivated vaccine: A type of vaccine
in which the vaccine pathogen (a viral or
bacterial) is killed or otherwise altered so that it
cannot cause infection, but can still provoke an
immune response.51
Pathogen: A microorganism capable of
producing a disease (e.g., bacterium or virus).54
Prophylactic vaccine: A biological preparation
intended to prevent individuals from
contracting given diseases.
Therapeutic vaccines: vaccines which intend
to treat chronic infections by inducing immune
responses that suppress infection, even when
the host has been unable to create those
responses naturally.52
Selected vaccines-preventable
diseases:
Diphtheria
Diphtheria is an acute disease caused by
toxin-producing strains of Corynebacterium
diphtheriae bacteria, that is known to colonise
mucous membranes.55 Diphtheria affects
people of all ages, but most often it strikes
unimmunized children. In 2,000, 30,000 cases
and 3,000 deaths of diphtheria were reported
worldwide.56
Haemophilus influenzae type b infection
Haemophilus influenzae serotype b (Hib) is the
most common cause of bacterial meningitis
in children aged two months to five years, in
those countries where suitable vaccination
programmes are not in place.55 Hib is estimated
to cause millions of cases of serious disease
worldwide and hundreds of thousands of
deaths each year among young children.57
Hepatitis A: Hepatitis A is a liver disease
caused by the hepatitis A virus (HAV). Hepatitis
A can affect anyone.58
Hepatitis B: is a serious disease caused by
a virus that attacks the liver. The virus, which
is called hepatitis B virus (HBV), can cause
lifelong infection, cirrhosis (scarring) of the
liver, liver cancer, liver failure, and death.59
human papillomavirus (HPV), HPV is a
common infection: over three quarters of
sexually active women are estimated to
be infected at least once in their lifetimes.
Persistent infection with oncogenic HPV types
can cause cervical cancer in women and
anogenital cancers in both sexes.60
Influenza (seasonal): Influenza (the flu)
is a contagious respiratory illness caused by
influenza viruses. It can cause mild to severe
illness, and at times can lead to death. Some
people, such as older people, young children,
and people with certain health conditions, are
at high risk for serious flu complications.61
Measles: Measles is highly infectious vaccinespreventable disease caused by morbillivirus.
The disease is transmitted via airborne
respiratory droplets, or by direct contact
with nasal and throat secretions of infected
individuals.55 Measles is one of the leading
causes of childhood mortality, leading to
about 240,000 deaths worldwide each year.62
Meningococcal infection: Meningococcal
infection is caused by Neisseria meningitidis,
a bacterium with human carriers as the
only reservoir.55 Meningococcal group C (or
Meningitis C) is one of the 6 groups of the
bacteria Neisseria meningitides which can
cause meningitis and septicaemia.
Mumps: Mumps is an acute illness caused by
the mumps virus. It is characterised by fever
and swelling of one or more salivary glands.55
Mumps is mostly a mild childhood disease. It
most often affects children between five and
nine years old.63
Pertussis: Pertussis is an acute bacterial
infection of the respiratory tract caused by the
bacterium Bordetella pertussis. The disease
is characterised by a severe cough.55 Pertussis
(whooping cough) is an important cause of
infant death worldwide and continues to be a
public health concern even in countries with
high vaccination coverage. Estimates from
WHO suggest that, in 2008, about 16 million
cases of pertussis occurred worldwide, 95% of
which were in developing countries, and that
about 195,000 children died from the disease.64
Pneumococcal infection: [Pneumococcal
Disease (PD) describes a group of illnesses
caused by the bacterium Streptococcus
pneumoniae (S. pneumoniae), also called
pneumococcus, and can include invasive
infections such as meningitis, bacteremic
pneumonia as well as noninvasive infections
such as non-bacteraemic pneumonia and
acute otitis media.65 According to a WHO 2004
estimate, PD is the leading cause of vaccinepreventable death in children younger than
5 years of age worldwide.66 The proliferation
of resistant strains of S pneumoniae and other
pathogens in the past 15 years threatens the
successful treatment of CAP67 Pneumoccocus
vaccine is deemed underused by the WHOEurope Office.68
Poliomyelitis: Polio is caused by polioviruses,
classified into types 1, 2 and 3. Humans are
the only reservoir of infection. Transmission
occurs via the oral-faecal route or contact
with saliva.55 Polio is a highly infectious and
sometimes fatal disease, which invades the
nervous system and can cause paralysis in a
matter of hours. The disease usually affects
children under 5 years of age. In June 2002,
all 53 countries in the WHO European Region
were certified polio free. Since then, the region
has experiences several episodes of wild
poliovirus importation but sustained effort of
immunisation and disease surveillance helps
maintain the Region’s polio-free status.69
Rubella: Rubella is a mild febrile rash illness
caused by rubella virus. It is transmitted from
person to person via droplets (the virus is
present in throat secretions). It affects mainly,
but not only, children and can often lead to
serious and sometimes fatal complications
in the fetus when an unprotected woman
acquires the infection early in pregnancy.
Humans are the only reservoir of infection.55
Rotavirus: Rotavirus infection affects nearly
all the children of the world. It causes about
25% of all diarrhoeal illnesses in children
under 5, and is a major cause of morbidity
and mortality globally. According to WHO
estimates, more than 10,000 children under
19
5 die each year in the WHO European Region
due to rotavirus infection. WHO/Europe
works with Member States to accelerate the
introduction of rotavirus vaccine into their
national immunisation programmes, and
to establish a regional surveillance network
to collect local data on disease burden and
monitor the impact of vaccines.70
Shingles (Herpes Zoster): Shingles is a
painful localized skin rash often with blisters
that is caused by the varicella zoster virus
(VZV), the same virus that causes chickenpox.
Shingles most commonly occurs in people
50 years old or older, people who have medical
conditions that keep the immune system
from working properly, or people who receive
immunosuppressive drugs.71
Smallpox: Smallpox is a serious, contagious,
and sometimes fatal infectious disease caused
by the variola virus and characterized by
extensive rash and higher fever.72 The global
eradication of smallpox was certified in 1980.73
Tetanus: Tetanus is an often fatal disease,
which is present worldwide, and affects people
of all ages but is particularly common and
serious in newborn babies. It is a consequence
of a toxin produced by the bacterium
Clostridium tetani. The main reservoirs of the
bacterium are herbivores, which harbour the
bacteria in their bowels (with no consequences
for them) and disseminate the “spore form”
of the bacteria in the environment with their
faeces.55 WHO estimated that neonatal
tetanus killed about 180,000 babies in 2002.74
Varicella infection (chickenpox): Chickenpox
is caused by the varicella-zoster virus (VZV),
which also causes shingles. The virus spreads
through the body into the skin causing rashes
to appear.55
Yellow Fever: Yellow fever is caused by
the yellow fever virus, which is carried by
mosquitoes. It is endemic in 33 countries in
Africa and 11 countries in South America.75
Other diseases against which
Pfizer is investigating vaccines:
Alzheimer’s disease: a degenerative disease,
which slowly and progressively destroys
brain cells, affecting memory and mental
20
functioning.76 In 2010, 9.95 million individuals
were suffering from Alzheimer in Europe and
35.6 million people worldwide.77 Predictions
show the number will double over the next
20 years.78 Alzheimer also has an economic
cost for society, which has been estimated at
US$604 billion worldwide in 2010, comprising
the cost of informal care, direct cost of social
care, and the direct cost of medical care.79 This
huge burden of disease is yet unaddressed as
neither a preventative nor a curative treatment
exist to date. Pfizer is currently investigating a
vaccine in phase 2.80
Staphylococcus aureus: ‘Staphylococcus
aureus is an opportunistic bacterial pathogen
associated with asymptomatic colonization
of the skin and mucosal surfaces of normal
humans. It is the most frequently isolated
bacterial pathogen from patients with hospitalacquired infections. Before the introduction
of antimicrobials in the 1940s, the mortality
rate of S. aureus invasive infection was about
90%. The initial success of antibiotherapy was
rapidly countered by the successive emergence
of penicillin-resistant, then methicillin-resistant
S. aureus (MRSA) strains, and since 2002 by
that of vancomycin-resistant strains.81 ’Pfizer is
currently investigating a vaccine in phase 2.
Meningitis B: Meningitis is an infection of the
meninges, the thin lining that surrounds the
brain and spinal cord, caused by the bacteria
Neisseria meningitidis group B, one of 6 groups
of bacteria which cause disease.82 ‘Serogroup B
accounts for up to 80% of meningococcal
disease in European countries such as UK,
Norway, The Netherlands, Germany and
Denmark.’83 Pfizer is currently investigating a
vaccine in phase 3.80
Clostridium difficile colitis: is a bacterium
that causes inflammation of the colon, known
as colitis. People who have other illnesses
or conditions requiring prolonged use of
antibiotics, and the elderly, are at greater risk
of acquiring this disease. The bacteria are shed
through feces.84 Pfizer is currently investigating
a vaccine in phase 1.80
Smoking Cessation: Pfizer is currently
investigating a vaccine for smoking cessation
in phase 1.80
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VAC/2013/001/1
Date of preparation: April 2013.