This document provides information about newer vaccines for clinical use. It begins with definitions of vaccines and how they work to stimulate the immune system. It then discusses the history of vaccines from Dr. Jenner's smallpox vaccine in 1796 to more recent vaccines for hepatitis A, rotavirus, and HPV. The stages of vaccine development and regulation are outlined. Ideal characteristics of vaccines and causes of mortality in children are also summarized.

1. MAHANTHESHKUMAR G T
1st
M.Sc Biotechnology
Dept of biotechnology
Sahyadri science college,
Shivamogga.

2. NewerNewer
VaccinesVaccines
forfor
Clinical UseClinical Use

3. What is a “What is a “Vaccine”Vaccine”
 The termThe term vaccinevaccine
derives from Edwardderives from Edward
Jenner's 1796 use ofJenner's 1796 use of
the termthe term cow poxcow pox (Latin)(Latin)
variola vaccinævariola vaccinæ,,
adapted from the Latinadapted from the Latin
vaccīn-usvaccīn-us, from, from vaccavacca
cow), which, whencow), which, when
administered toadministered to
humans, provided themhumans, provided them
protection againstprotection against
smallpoxsmallpox

4. Vaccine- DefinitionVaccine- Definition
 A vaccine is any preparation intended toA vaccine is any preparation intended to
produce immunity to a disease byproduce immunity to a disease by
stimulating the production of antibodies.stimulating the production of antibodies.
Vaccines include, for example,Vaccines include, for example,
suspensions of killed or attenuatedsuspensions of killed or attenuated
microorganisms, or products or derivativesmicroorganisms, or products or derivatives
of microorganisms. The most commonof microorganisms. The most common
method of administering vaccines is bymethod of administering vaccines is by
injection, but some are given by mouth orinjection, but some are given by mouth or
nasal spray.nasal spray.

5. Dr Jenner and Cow PoxDr Jenner and Cow Pox
 THE MODERN SCIENCETHE MODERN SCIENCE
OF IMMUNOLOGY HADOF IMMUNOLOGY HAD
ITS BEGINNINGS INITS BEGINNINGS IN
1798 , WHEN THE1798 , WHEN THE
ENGLISH PHYSICIANENGLISH PHYSICIAN
EDWARD JENNEREDWARD JENNER
PUBLISHED A PAPERPUBLISHED A PAPER
IN WHICH HEIN WHICH HE
MAINTAINED THATMAINTAINED THAT
PEOPLE COULD BEPEOPLE COULD BE
PROTECTED FROMPROTECTED FROM
THE DEADLY DISEASETHE DEADLY DISEASE
SMALLPOX BY THESMALLPOX BY THE
PRICK OF A NEEDLEPRICK OF A NEEDLE
DIPPED IN THE PUSDIPPED IN THE PUS
FROM A COWPOX BOIL

6. Historical Picture of VaccinationHistorical Picture of Vaccination

7. Vaccine stimulates ImmuneVaccine stimulates Immune
SystemSystem
 AA vaccinevaccine is a biological preparation thatis a biological preparation that
improves immunity to a particular disease. Aimproves immunity to a particular disease. A
vaccine typically contains an agent thatvaccine typically contains an agent that
resembles a disease-causing microorganism,resembles a disease-causing microorganism,
and is often made from weakened or killed formsand is often made from weakened or killed forms
of the microbe. The agent stimulates the body'sof the microbe. The agent stimulates the body's
immune system to recognize the agent asimmune system to recognize the agent as
foreign, destroy it, and "remember" it, so that theforeign, destroy it, and "remember" it, so that the
immune system can more easily recognize andimmune system can more easily recognize and
destroy any of these microorganisms that it laterdestroy any of these microorganisms that it later
encountersencounters

8. Preparation of VaccinesPreparation of Vaccines
a.a. Live attenuatedLive attenuated organisms which have been passedorganisms which have been passed
repeatedly in tissue culture or chick embryos so thatrepeatedly in tissue culture or chick embryos so that
they have lost their capacity to cause disease, butthey have lost their capacity to cause disease, but
retained an ability to induce antibody response, suchretained an ability to induce antibody response, such
as polio (Sabin), measles, rubella, mumps, yellow fever,as polio (Sabin), measles, rubella, mumps, yellow fever,
BCG, typhoid and plague.BCG, typhoid and plague.
b.b. Inactivated or killedInactivated or killed organisms which have been killedorganisms which have been killed
by heat or chemicals but retain and ability to induceby heat or chemicals but retain and ability to induce
antibody response. They are generally safe but lessantibody response. They are generally safe but less
efficacious than live vaccines and require multipleefficacious than live vaccines and require multiple
doses; e.g. polio (Salk), influenza, rabies and Japanesedoses; e.g. polio (Salk), influenza, rabies and Japanese
encephalitis.encephalitis.

9. Preparation of VaccinesPreparation of Vaccines
c.c. Cellular fractionsCellular fractions:: usually polysaccharideusually polysaccharide
fraction of the cell wall of a disease causingfraction of the cell wall of a disease causing
organism, such as pneumococcal pneumoniaorganism, such as pneumococcal pneumonia
or meningococcal meningitisor meningococcal meningitis
d.d. Recombinant vaccinesRecombinant vaccines: produced by: produced by
methods in which specific DNA sequencesmethods in which specific DNA sequences
are inserted by molecular engineeringare inserted by molecular engineering
techniques, e.g. DNA sequences spliced totechniques, e.g. DNA sequences spliced to
vaccinia virus grown in cell culture tovaccinia virus grown in cell culture to
produces an effective influenza vaccine, andproduces an effective influenza vaccine, and
Hepatitis B vaccine by similar methods.Hepatitis B vaccine by similar methods.

10. Passive ImmunityPassive Immunity
“Vaccination“Vaccination””
Toxoids or antiseraToxoids or antisera: are modified toxins made non-toxic: are modified toxins made non-toxic
to stimulate formation of an antitoxin, such as thoseto stimulate formation of an antitoxin, such as those
produced to protect against toxins of tetanus,produced to protect against toxins of tetanus,
diphtheria, botulism, gas gangrene, snake and scorpiondiphtheria, botulism, gas gangrene, snake and scorpion
venom.venom.
Immune globulinImmune globulin: An antibody containing solution derived: An antibody containing solution derived
from human blood in the form of pooled plasma, usedfrom human blood in the form of pooled plasma, used
primarily for immunity for passive immunization suchprimarily for immunity for passive immunization such
as for immuno-compromised persons e.g. smallpoxas for immuno-compromised persons e.g. smallpox
response groups.response groups.
AntitoxinAntitoxin:: is an antibody derived from serum of animalsis an antibody derived from serum of animals
after stimulation with specific antigens and used toafter stimulation with specific antigens and used to
provide passive immunity in humans.provide passive immunity in humans.

11. Timeline of VaccinesTimeline of Vaccines
 18th century18th century
 1796 First vaccine for smallpox,1796 First vaccine for smallpox,
first vaccine for any diseasefirst vaccine for any disease
 19th century19th century
 1882 First vaccine for rabies1882 First vaccine for rabies

12. Timeline of VaccinesTimeline of Vaccines
 20th century20th century
 1932 First vaccine for yellow fever1932 First vaccine for yellow fever
 1945 First vaccine for influenza1945 First vaccine for influenza
 1952 First vaccine for polio1952 First vaccine for polio
 1954 First vaccine for Japanese1954 First vaccine for Japanese
encephalitisencephalitis
 1957 First vaccine for adenovirus-4 and 71957 First vaccine for adenovirus-4 and 7
 1962 First oral polio vaccine1962 First oral polio vaccine
 1964 First vaccine for measles1964 First vaccine for measles
 1967 First vaccine for mumps1967 First vaccine for mumps

13. Timeline of VaccinesTimeline of Vaccines
 1970 First vaccine for rubella1970 First vaccine for rubella
 1974 First vaccine for chicken pox1974 First vaccine for chicken pox
 1977 First vaccine for pneumonia1977 First vaccine for pneumonia
 1978 First vaccine for meningitis1978 First vaccine for meningitis
 1981 First vaccine for hepatitis B1981 First vaccine for hepatitis B
 1992 First vaccine for hepatitis A1992 First vaccine for hepatitis A
 1998 First vaccine for rotavirus1998 First vaccine for rotavirus

14. World Health OrganisationWorld Health Organisation
ReportsReports
 "Nearly nine million children under 14"Nearly nine million children under 14
years of age die every year fromyears of age die every year from
infectious disease.infectious disease. And at least a thirdAnd at least a third
of them could be saved if existingof them could be saved if existing
vaccines were more widely used, butvaccines were more widely used, but
the rest only if suitable new vaccinesthe rest only if suitable new vaccines
were developedwere developed..."..."

15. Vaccines use in the worldVaccines use in the world
 For the past two decades, in most developingFor the past two decades, in most developing
countries, vaccination restricted only to thecountries, vaccination restricted only to the
initial EPI vaccinesinitial EPI vaccines
 Where-as in most developed countries,Where-as in most developed countries,
several new vaccines such as Hep B, Hib,several new vaccines such as Hep B, Hib,
meningococcal, pneumococcal, weremeningococcal, pneumococcal, were
gradually added to the initial EPI vaccines,gradually added to the initial EPI vaccines,
 Thus widening the gap in protection againstThus widening the gap in protection against
infectious diseases between the rich and theinfectious diseases between the rich and the
poorpoor

16. NewerNewer
VaccinesVaccines

17. Stages of Review and RegulationStages of Review and Regulation
for Devloping Vaccinesfor Devloping Vaccines
 Phase 1 - Safety, immunogenicity (prelim)Phase 1 - Safety, immunogenicity (prelim)
 Phase 2 – Immunogenicity, Safety, DosePhase 2 – Immunogenicity, Safety, Dose
RangingRanging
 Phase 3 – Efficacy, Safety, ImmunogenicityPhase 3 – Efficacy, Safety, Immunogenicity
 BLA – Pre-clinical and clinical data to supportBLA – Pre-clinical and clinical data to support
approval, inspectionapproval, inspection
 Phase 4 – Inspection, Safety, Efficacy, LotPhase 4 – Inspection, Safety, Efficacy, Lot
ReleaseRelease
 BLA-Supplement (post-approval changes)BLA-Supplement (post-approval changes)

18. Stages of VaccineStages of Vaccine
DevelopmentDevelopment
 Vaccine developmentVaccine development
proceeds throughproceeds through
discovery, processdiscovery, process
engineering,engineering,
toxicology and animaltoxicology and animal
studies to humanstudies to human
Phase I, II, and IIIPhase I, II, and III
trials. The processtrials. The process
can take more thancan take more than
10 years, depending10 years, depending
on the disease.on the disease.

19. Stage I DevelopmentStage I Development
 The human trialsThe human trials
focus initially onfocus initially on
safety, involving smallsafety, involving small
groups of peoplegroups of people

20. Stage II of DevelopmentStage II of Development
 Progress toProgress to
moderate-sizedmoderate-sized
"target" populations"target" populations
(persons close to the(persons close to the
age and otherage and other
characteristics forcharacteristics for
whom the vaccine iswhom the vaccine is
intended) tointended) to
determine both safetydetermine both safety
and the stimulation ofand the stimulation of
immune response.immune response.

21. Stage III of DevelopmentStage III of Development
 Finally to large targetFinally to large target
populations topopulations to
establish whether aestablish whether a
vaccine actuallyvaccine actually
prevents a disease asprevents a disease as
intended (efficacy)intended (efficacy)

22. An ideal Vaccine should beAn ideal Vaccine should be
….….
 Good immune responseGood immune response
 Both Cell Mediated Immunity and antibody responses.Both Cell Mediated Immunity and antibody responses.
 Immunity is long livedImmunity is long lived
 Single doseSingle dose
 SafetySafety
 Danger of reversion to virulence, or Severe disease inDanger of reversion to virulence, or Severe disease in
immunocomprisedimmunocomprised
 StabilityStability
 Organisms in the vaccine must remain viable in order to infect andOrganisms in the vaccine must remain viable in order to infect and
replicate in the hostreplicate in the host
 Vaccine preparations are therefore very sensitive to adverseVaccine preparations are therefore very sensitive to adverse
storage conditionsstorage conditions
 Maintenance of the cold chain is very important.Maintenance of the cold chain is very important.
 ExpenseExpense
 Cheap to prepareCheap to prepare

23. Causes of death inCauses of death in
children less than 5 years oldchildren less than 5 years old
ARI
Diarrhea
VPD
Perinatal
Other
19%
20%
20%
13%
The Global Burden of Disease
Murray and Lopez, editors
Total - 12.8 million

25. New approved vaccinesNew approved vaccines
 A number of new vaccines with majorA number of new vaccines with major
potential for controlling infectious diseasespotential for controlling infectious diseases
have just been licensed or are athave just been licensed or are at
advanced stages of development. Amongadvanced stages of development. Among
the illnesses targeted are rotavirusthe illnesses targeted are rotavirus
diarrhoea, pneumococcal disease, anddiarrhoea, pneumococcal disease, and
cervical cancer (as caused by humancervical cancer (as caused by human
papillomavirus), which together kill morepapillomavirus), which together kill more
than a million people each year, most ofthan a million people each year, most of
them in developing countries.them in developing countries.

26. Bacterial Meningitis kills several inBacterial Meningitis kills several in
Developing worldDeveloping world
 Haemophilus influenzae type b (Hib)Haemophilus influenzae type b (Hib)
 30% -50% of bacterial meningitis30% -50% of bacterial meningitis
 PneumococcusPneumococcus
 25- 35% of bacterial meningitis25- 35% of bacterial meningitis
 MeningococcusMeningococcus
 25 - 35% of bacterial meningitis (except25 - 35% of bacterial meningitis (except
during epidemics)during epidemics)

27. Meningococcal MeningtisMeningococcal Meningtis
Threat to AFRICAThreat to AFRICA
 The African "meningitis belt" - which includes allThe African "meningitis belt" - which includes all
or part of 21 countries stretching south of theor part of 21 countries stretching south of the
Sahara desert from Senegal to Ethiopia - is theSahara desert from Senegal to Ethiopia - is the
site of frequent epidemics, usually caused bysite of frequent epidemics, usually caused by
serogroup A meningitis. Over the past decadeserogroup A meningitis. Over the past decade
more than 700 000 cases have been reported.more than 700 000 cases have been reported.
Roughly 10-20 % of persons infected die, andRoughly 10-20 % of persons infected die, and
one out of five survivors is likely to suffer from aone out of five survivors is likely to suffer from a
permanent disability such as hearing loss,permanent disability such as hearing loss,
mental retardation, or paralysis.mental retardation, or paralysis.

28. Status of vaccine developmentStatus of vaccine development
Polysaccharide vaccines (vaccines made fromPolysaccharide vaccines (vaccines made from
complex sugars taken from the outer coats ofcomplex sugars taken from the outer coats of
the Men bacterium) are currently in use, but arethe Men bacterium) are currently in use, but are
not very effective at protecting young children,not very effective at protecting young children,
do not create long-lasting immunity, and do notdo not create long-lasting immunity, and do not
confer a "herd effect". Because of theseconfer a "herd effect". Because of these
shortcomings, immunization with polysaccharideshortcomings, immunization with polysaccharide
vaccines is usually undertaken only after thevaccines is usually undertaken only after the
onset of an epidemic.onset of an epidemic.

29. Rotavirus DiarrhoeasRotavirus Diarrhoeas
Acute diarrhoea isAcute diarrhoea is
responsible for nearlyresponsible for nearly
1.9 million deaths per1.9 million deaths per
year in children underyear in children under
age five. Rotavirus isage five. Rotavirus is
responsible for asresponsible for as
much as one fourth ofmuch as one fourth of
these casualties, almostthese casualties, almost
all of which occur inall of which occur in
developing countries.developing countries.

30. Status of vaccineStatus of vaccine
development:development:
 RotaRix, a vaccine developedRotaRix, a vaccine developed
by GlaxoSmithKline (GSK),by GlaxoSmithKline (GSK),
against rotavirus diarrhoea isagainst rotavirus diarrhoea is
now licensed in manynow licensed in many
countries. In addition to beingcountries. In addition to being
available on the private marketavailable on the private market
in these countries, it has nowin these countries, it has now
been introduced in the publicbeen introduced in the public
sector immunizationsector immunization
programmes of Brazil, Elprogrammes of Brazil, El
Salvador, Mexico, PanamaSalvador, Mexico, Panama
and Venezuela. . A Phase IIIand Venezuela. . A Phase III
trial is also under way in Southtrial is also under way in South
Africa and Malawi.Africa and Malawi.

31. Merck & Co.’sMerck & Co.’s RotaTeqRotaTeq
 RotaTeq, introduced inRotaTeq, introduced in
2006 for kids aged 22006 for kids aged 2
months, 4 months, and 6months, 4 months, and 6
months, is a highlymonths, is a highly
promising protectionpromising protection
against the highlyagainst the highly
contagious disease –contagious disease –
Rotavirus, says CDC.Rotavirus, says CDC.
 The Centers for DiseaseThe Centers for Disease
Control and PreventionControl and Prevention
(CDC) believes that the(CDC) believes that the
level of protectionlevel of protection
provided by the vaccine isprovided by the vaccine is
much stronger than theymuch stronger than they
originally anticipateoriginally anticipate

32. Pneumococcal diseasePneumococcal disease
and Vaccinationand Vaccination
 Acute lowerAcute lower
respiratory infectionsrespiratory infections
are responsible forare responsible for
close to two millionclose to two million
deaths per year and adeaths per year and a
large proportion oflarge proportion of
these are caused bythese are caused by
StreptococcusStreptococcus
pneumoniaepneumoniae
(pneumococcus).(pneumococcus).

33. PrevenarPrevenar containcontain sevenseven
serotypesserotypes
 A seven-valent conjugateA seven-valent conjugate
vaccine called Prevnarvaccine called Prevnar
(or Prevenar) is designed(or Prevenar) is designed
to act against sevento act against seven
strains of pneumococcalstrains of pneumococcal
disease. It has beendisease. It has been
developed by Wyethdeveloped by Wyeth
Vaccines and is licensedVaccines and is licensed
in the United States andin the United States and
over 70 other countries,over 70 other countries,
but does not include twobut does not include two
serotypes (types 1 and 5)serotypes (types 1 and 5)
that cause a highthat cause a high
percentage ofpercentage of
pneumococcal illness inpneumococcal illness in
developing countries.developing countries.

34. Nine-valent conjugate vaccine aNine-valent conjugate vaccine a
Succesul trial in GambiaSuccesul trial in Gambia
 Wyeth Vaccines has alsoWyeth Vaccines has also
completed evaluation of acompleted evaluation of a
nine-valent conjugatenine-valent conjugate
vaccine, includingvaccine, including
serotypes 1 and 5. Aserotypes 1 and 5. A
Phase III trial of thePhase III trial of the
vaccine involving 40 000vaccine involving 40 000
people was completed inpeople was completed in
South Africa in 2002, andSouth Africa in 2002, and
a Phase III trial with 17a Phase III trial with 17
437 subjects was437 subjects was
concluded in the Gambiaconcluded in the Gambia
in 2004.in 2004.

35. Challenges to identifyChallenges to identify
Pneumococcal infectionsPneumococcal infections
 It can be difficult to establish the extent ofIt can be difficult to establish the extent of
pneumococcal disease as developing countriespneumococcal disease as developing countries
often lack the laboratory facilities, expertise, andoften lack the laboratory facilities, expertise, and
resources to do so. As a result, public healthresources to do so. As a result, public health
decision-makers are often unaware of thedecision-makers are often unaware of the
prevalence of the disease and of the toll itprevalence of the disease and of the toll it
exacts in death and disability. Because of theexacts in death and disability. Because of the
scarcity of data from developing countries, therescarcity of data from developing countries, there
is concern over the appropriate serotypeis concern over the appropriate serotype
valence for developing countriesvalence for developing countries

36. Human papillomavirus (HPV)Human papillomavirus (HPV)
 Sexually transmitted HPV is the majorSexually transmitted HPV is the major
cause of cervical cancer, the mostcause of cervical cancer, the most
common cause of cancer deaths amongcommon cause of cancer deaths among
women in developing countries. Aboutwomen in developing countries. About
5,00 000 cases occur each year, 80% of5,00 000 cases occur each year, 80% of
them in developing countries. Cervicalthem in developing countries. Cervical
cancer kills some 240 000 womencancer kills some 240 000 women
annually.annually.

37. HPV 16 and 18HPV 16 and 18 major typesmajor types
causing Carcinoma cervixcausing Carcinoma cervix
 HPV types 16 and 18 cause around 70%HPV types 16 and 18 cause around 70%
of HPV cervical cancers globally, but theof HPV cervical cancers globally, but the
vaccines in development will not cover thevaccines in development will not cover the
30% of cancers attributed to other HPV30% of cancers attributed to other HPV
types. Because these other types aretypes. Because these other types are
numerous and individually only contributenumerous and individually only contribute
a small percentage, significantlya small percentage, significantly
expanding vaccine coverage against themexpanding vaccine coverage against them
may present technical challenges formay present technical challenges for
manufacturers.manufacturers.

38. Two types of vaccines for HumanTwo types of vaccines for Human
Papilloma virus preventionPapilloma virus prevention
 Bivalent human papillomavirus vaccineBivalent human papillomavirus vaccine
(HPV2) licensed for use in females(HPV2) licensed for use in females
 Either HPV2 or quadrivalent HPV vaccineEither HPV2 or quadrivalent HPV vaccine
(HPV4) used for females ages 19-26(HPV4) used for females ages 19-26
yearsyears
 Quadrivalent human papillomavirusQuadrivalent human papillomavirus
vaccine (HPV4) licensed for use in malesvaccine (HPV4) licensed for use in males
 HPV4 may be administered to males aged 9HPV4 may be administered to males aged 9
through 26 years to reduce their likelihood ofthrough 26 years to reduce their likelihood of
acquiring genital warts.acquiring genital warts.

39. GARDASILGARDASIL
 Gardasil, an HPV vaccine recentlyGardasil, an HPV vaccine recently
licensed by Merck, covers four types oflicensed by Merck, covers four types of
HPV, including the cancer-causing typesHPV, including the cancer-causing types
16 and 18 and types 6 and 11 for non-16 and 18 and types 6 and 11 for non-
cancerous genital warts. A secondcancerous genital warts. A second
vaccine, developed by GSK, covers HPVvaccine, developed by GSK, covers HPV
types 16 and 18 alonetypes 16 and 18 alone

40. GARDASILGARDASIL
 GARDASIL is the only human papillomavirusGARDASIL is the only human papillomavirus
(HPV) vaccine that helps protect against 4 types(HPV) vaccine that helps protect against 4 types
of HPV. In girls and young women ages 9 to 26,of HPV. In girls and young women ages 9 to 26,
GARDASIL helps protect against 2 types of HPVGARDASIL helps protect against 2 types of HPV
that cause about 75% of cervical cancer cases,that cause about 75% of cervical cancer cases,
and 2 more types that cause 90% of genitaland 2 more types that cause 90% of genital
warts cases. In boys and young men ages 9 towarts cases. In boys and young men ages 9 to
26, GARDASIL helps protect against 90% of26, GARDASIL helps protect against 90% of
genital warts cases.genital warts cases.

41. How long vaccination is effectiveHow long vaccination is effective
andand
Ideal age for VaccinationIdeal age for Vaccination
 The duration of the immunity conferred by theThe duration of the immunity conferred by the
vaccines is not yet known, and only time andvaccines is not yet known, and only time and
follow up studies will provide this criticalfollow up studies will provide this critical
information... Because HPV is spread by sexualinformation... Because HPV is spread by sexual
contact, and the high-risk years for infection arecontact, and the high-risk years for infection are
roughly from ages 18 to 25, the best subjects forroughly from ages 18 to 25, the best subjects for
vaccination will likely be pre-adolescents orvaccination will likely be pre-adolescents or
adolescents, unlike for traditional vaccinationadolescents, unlike for traditional vaccination
programmes, which are aimed mostly at infantsprogrammes, which are aimed mostly at infants
and pregnant women.and pregnant women.

42. FDAFDA approves Gardasilapproves Gardasil
 In October 2009, theIn October 2009, the
FDA approved theFDA approved the
use of GARDASIL inuse of GARDASIL in
boys and youngboys and young
menmen ages 9 to 26 toages 9 to 26 to
protect against 90%protect against 90%
of genital wartsof genital warts
cases.cases.

43. Meningococcal meningitis AMeningococcal meningitis A
Vaccine (Men A)Vaccine (Men A)
 Polysaccharide vaccines (vaccines made fromPolysaccharide vaccines (vaccines made from
complex sugars taken from the outer coats ofcomplex sugars taken from the outer coats of
the Men bacterium) are currently in use, but arethe Men bacterium) are currently in use, but are
not very effective at protecting young children,not very effective at protecting young children,
do not create long-lasting immunity, and do notdo not create long-lasting immunity, and do not
confer a "herd effect" - that is, do not preventconfer a "herd effect" - that is, do not prevent
spread of the disease in non-vaccinated peoplespread of the disease in non-vaccinated people
through reduction of the carriage of thethrough reduction of the carriage of the
infectious agent by vaccinated people duringinfectious agent by vaccinated people during
epidemicsepidemics
 Because of these shortcomings, immunizationBecause of these shortcomings, immunization
with polysaccharide vaccines is usuallywith polysaccharide vaccines is usually
undertaken only after the onset of an epidemic.undertaken only after the onset of an epidemic.

44. Better Vaccine forBetter Vaccine for
Meningococcal InfectionMeningococcal Infection
 To provide greater and more efficientTo provide greater and more efficient
protection, a public-private effort called theprotection, a public-private effort called the
Meningitis Vaccine Project (MVP) isMeningitis Vaccine Project (MVP) is
developing a Men A conjugate vaccine.developing a Men A conjugate vaccine.
This vaccine is intended to have long-This vaccine is intended to have long-
lasting effect, to create immunity in infants,lasting effect, to create immunity in infants,
and to allow protection to be conferred inand to allow protection to be conferred in
advance through mass immunizationadvance through mass immunization
programmesprogrammes

45. Meningococcal vaccineMeningococcal vaccine
 Meningococcal conjugate vaccine (MCV4) ifMeningococcal conjugate vaccine (MCV4) if
preferred for adults aged 55 years or younger;preferred for adults aged 55 years or younger;
meningococcal polysaccharide vaccinemeningococcal polysaccharide vaccine
(MPSV4) is preferred for adults aged 56 years(MPSV4) is preferred for adults aged 56 years
or older.or older.
 Revaccination with MCV4 after 5 years isRevaccination with MCV4 after 5 years is
recommended for adults previouslyrecommended for adults previously
vaccinated with MCV4 or MPSV4 who remainvaccinated with MCV4 or MPSV4 who remain
at increased risk for infection.at increased risk for infection.

46. Other Vaccines inOther Vaccines in
Meningococcal InfectionMeningococcal Infection
 Other conjugate vaccines, including aOther conjugate vaccines, including a
heptavalent vaccine (DTP Hep B Hib)heptavalent vaccine (DTP Hep B Hib)
covering Sero groups A, and C, are beingcovering Sero groups A, and C, are being
developed by the private sector; and adeveloped by the private sector; and a
tetravalent vaccine has recently beentetravalent vaccine has recently been
licensed by Sanofi-Pasteur in the Unitedlicensed by Sanofi-Pasteur in the United
States and Canada.States and Canada.

47. Zoster vaccineZoster vaccine
 The zoster vaccine licensed in the United StatesThe zoster vaccine licensed in the United States
(ZOSTAVAX®, Merck & Co., Inc.) is a(ZOSTAVAX®, Merck & Co., Inc.) is a
lyophilized preparation of the Oka/Merck strainlyophilized preparation of the Oka/Merck strain
of live, attenuated VZV, the same strain used inof live, attenuated VZV, the same strain used in
the varicella vaccines (VARIVAX®,the varicella vaccines (VARIVAX®,
PROQUAD®). The Oka strain was isolated inPROQUAD®). The Oka strain was isolated in
Japan in the early 1970s from vesicular fluidJapan in the early 1970s from vesicular fluid
from a healthy child who had varicella; the strainfrom a healthy child who had varicella; the strain
was attenuated through sequential propagationwas attenuated through sequential propagation
in cultures of human embryonic lung cells,in cultures of human embryonic lung cells,
embryonic guinea-pig cells, and human diploidembryonic guinea-pig cells, and human diploid
cells (WI-38).cells (WI-38).

48. Zoster virus withZoster virus with
CombinationCombination
 The more recently licensed live,The more recently licensed live,
attenuated Oka-strain VZV vaccineattenuated Oka-strain VZV vaccine
(PROQUAD®) prepared in combination(PROQUAD®) prepared in combination
with measles, mumps, and rubella vaccinewith measles, mumps, and rubella vaccine
(MMRV) is formulated with a broad range(MMRV) is formulated with a broad range
of titers that extend to over 60,000 PFof titers that extend to over 60,000 PF

49. Duration of Efficacy and ofDuration of Efficacy and of
ImmunityImmunity
 Vaccine efficacy for zoster preventionVaccine efficacy for zoster prevention
declined during the first year followingdeclined during the first year following
vaccination, but remained stable throughvaccination, but remained stable through
the remaining 3 years of follow upthe remaining 3 years of follow up
Vaccine efficacy for PHN prevention had aVaccine efficacy for PHN prevention had a
similar pattern, with an initial decline andsimilar pattern, with an initial decline and
subsequent stabilization.subsequent stabilization.

50. Site of Injection is importantSite of Injection is important
 Zoster vaccine should be administered asZoster vaccine should be administered as
a single 0.65-mL dose subcutaneously ina single 0.65-mL dose subcutaneously in
the deltoid region of the upper arm; athe deltoid region of the upper arm; a
booster dose is not licensed for thebooster dose is not licensed for the
vaccine. The vaccine should not bevaccine. The vaccine should not be
injected intravascularly or intramuscularlyinjected intravascularly or intramuscularly
and should only be reconstituted andand should only be reconstituted and
injected using a sterile syringe free ofinjected using a sterile syringe free of
preservatives, antiseptics, and detergents,preservatives, antiseptics, and detergents,
which can inactivate the vaccine virus.which can inactivate the vaccine virus.

51. Vaccines for Hepatitis AVaccines for Hepatitis A
 Hepatitis A vaccines licensed in the UnitedHepatitis A vaccines licensed in the United
States are inactivated, whole-cell virus vaccinesStates are inactivated, whole-cell virus vaccines
that are produced from hepatitis A virus grown inthat are produced from hepatitis A virus grown in
human diploid fibroblast cells. There are 2human diploid fibroblast cells. There are 2
single-antigen vaccines, Vaqta and Havrix, andsingle-antigen vaccines, Vaqta and Havrix, and
a combined hepatitis A/hepatitis B vaccine,a combined hepatitis A/hepatitis B vaccine,
Twinrix (GlaxoSmithKline). The purified virus isTwinrix (GlaxoSmithKline). The purified virus is
then formalin inactivated and adsorbed tothen formalin inactivated and adsorbed to
aluminum hydroxide. Havrix and Twinrix have 2-aluminum hydroxide. Havrix and Twinrix have 2-
phenoxyethanol added as a preservative,phenoxyethanol added as a preservative,
whereas Vaqta is preservative freewhereas Vaqta is preservative free

52. U S adopts to New vaccineU S adopts to New vaccine
 All children who live in the United StatesAll children who live in the United States
should receive hepatitis A vaccine at 1should receive hepatitis A vaccine at 1
year of age (ie, 12–23 months of age) as ayear of age (ie, 12–23 months of age) as a
2-dose regimen. Immunization should be2-dose regimen. Immunization should be
integrated into the routine childhoodintegrated into the routine childhood
immunization schedule and completedimmunization schedule and completed
according to the approved schedulesaccording to the approved schedules
using Havrix or Vaqta hepatitis Ausing Havrix or Vaqta hepatitis A
vaccines. Administration of 2 doses of thevaccines. Administration of 2 doses of the
same hepatitis Asame hepatitis A

53. JapaneseJapanese BB encephalitisencephalitis
 Japanese B encephalitisJapanese B encephalitis
(JE), a mosquito-borne(JE), a mosquito-borne
Arboviral infection, is theArboviral infection, is the
leading cause of viralleading cause of viral
encephalitis in Asiaencephalitis in Asia
Approximately 50,000Approximately 50,000
sporadic and epidemicsporadic and epidemic
cases of JE are reportedcases of JE are reported
annually from theannually from the
People's Republic ofPeople's Republic of
China (PRC), Korea,China (PRC), Korea,
Japan, Southeast Asia,Japan, Southeast Asia,
the Indian subcontinent,the Indian subcontinent,
and parts of Oceania.and parts of Oceania.

54. INACTIVATED JAPANESEINACTIVATED JAPANESE BB
ENCEPHALITIS VIRUS VACCINEENCEPHALITIS VIRUS VACCINE
 An inactivated JE vaccine derived from infected mouseAn inactivated JE vaccine derived from infected mouse
brain has been licensed in Japan since 1954 (24). JEbrain has been licensed in Japan since 1954 (24). JE
vaccine licensed in the United States is produced by thevaccine licensed in the United States is produced by the
Research Institute of Osaka University (Biken) and isResearch Institute of Osaka University (Biken) and is
distributed by Connaught Laboratories Inc. The Bikendistributed by Connaught Laboratories Inc. The Biken
vaccine is the most widely used JE vaccine of its type.vaccine is the most widely used JE vaccine of its type.
 Similar mouse brain derived JE vaccines are producedSimilar mouse brain derived JE vaccines are produced
by other manufacturers in India, Japan, Korea, Taiwan,by other manufacturers in India, Japan, Korea, Taiwan,
Thailand, and Vietnam In the PRC, inactivated andThailand, and Vietnam In the PRC, inactivated and
attenuated JE vaccines are produced in primary hamsterattenuated JE vaccines are produced in primary hamster
kidney cellskidney cells

55. SWINE FLU VACCINESWINE FLU VACCINE

56. H1 N1 old infection and NewH1 N1 old infection and New
ThreatThreat
 H1N1 is a new virusH1N1 is a new virus
that was firstthat was first
detected in peopledetected in people
in April 2009. It wasin April 2009. It was
originally referredoriginally referred
as “swine flu”as “swine flu”
because many ofbecause many of
the genes in thisthe genes in this
new virus werenew virus were
similar to influenzasimilar to influenza
viruses that occur inviruses that occur in
pigspigs..

57. Successful and Safe Vaccine forSuccessful and Safe Vaccine for
H1N1H1N1
 The National Institute of Allergy and InfectiousThe National Institute of Allergy and Infectious
Diseases, part of the National Institutes ofDiseases, part of the National Institutes of
Health, has conducted swine flu clinical trials toHealth, has conducted swine flu clinical trials to
make sure the new swine flu vaccines are safemake sure the new swine flu vaccines are safe
and effective. They were conducted at eightand effective. They were conducted at eight
university research hospitals and medicaluniversity research hospitals and medical
organizations across the United States,organizations across the United States,
including Baylor College of Medicine in Houston,including Baylor College of Medicine in Houston,
Children's Hospital Medical Centre in Cincinnati,Children's Hospital Medical Centre in Cincinnati,
and Emory University in Atlanta.and Emory University in Atlanta.

58. Who should get Vaccinated forWho should get Vaccinated for
H1 N1H1 N1
 CDC recommends influenza vaccinationCDC recommends influenza vaccination
as the first and most important step inas the first and most important step in
protecting against the flu. CDC isprotecting against the flu. CDC is
encouraging anyone who wants to protectencouraging anyone who wants to protect
themselves against 2009 H1N1 to getthemselves against 2009 H1N1 to get
vaccinated, including people 65 years andvaccinated, including people 65 years and
older. While less likely to get sick witholder. While less likely to get sick with
2009 H1N1 than younger people, people2009 H1N1 than younger people, people
65 and older are at high risk of serious65 and older are at high risk of serious
complications if they do become ill.complications if they do become ill.

59. FDA approved H1 N1 vaccinesFDA approved H1 N1 vaccines
 The U.S. Food and Drug Administration an has
approved four vaccines against the 2009 H1N1
influenza virus
 The vaccines are made by CSL Limited,The vaccines are made by CSL Limited,
MedImmune LLC, Novartis Vaccines andMedImmune LLC, Novartis Vaccines and
Diagnostics Limited, and sanofi pasteur Inc. AllDiagnostics Limited, and sanofi pasteur Inc. All
four firms manufacture the H1N1 vaccines usingfour firms manufacture the H1N1 vaccines using
the same processes, which have a long recordthe same processes, which have a long record
of producing safe seasonal influenza vaccineof producing safe seasonal influenza vaccine

60. Influenza A (H1N1) 2009
Monovalent Vaccine
 INDICATIONS AND USAGE
 Influenza A (H1N1) 2009 Monovalent
Vaccine is an inactivated influenza virus
vaccine indicated for active immunization
of persons 4 years of age and older
against influenza disease caused by
pandemic (H1N1) 2009 virus .

61. DOSAGE AND
ADMINISTRATION
 Based on currently available information the
vaccination regimen is as follows:
 Children 4 through 9 years of age: Two 0.5-
mL intramuscular injections approximately 1
month apart Children 10 through 17 years of
age: A single 0.5-mL intramuscular injection
 Adults 18 years of age and older: A single 0.5-
mL intramuscular injection

62. Hepatitis B vaccination included inHepatitis B vaccination included in
several Vaccination Programmeseveral Vaccination Programme
 Hepatitis B vaccines are effective and safe. UpHepatitis B vaccines are effective and safe. Up
to 95% of vaccinated individuals form effectiveto 95% of vaccinated individuals form effective
antibodies when they get the vaccine and areantibodies when they get the vaccine and are
protected from hepatitis B. In healthcareprotected from hepatitis B. In healthcare
workers, high-risk public safety workers, dialysisworkers, high-risk public safety workers, dialysis
patients, and sexual partners of infectedpatients, and sexual partners of infected
persons, a blood test for antibodies ispersons, a blood test for antibodies is
recommended after vaccination to ensure thatrecommended after vaccination to ensure that
the person produced antibodies. For the fewthe person produced antibodies. For the few
who do not form antibodies, revaccination maywho do not form antibodies, revaccination may
improve response, especially in infantsimprove response, especially in infants

63. Licensed Vaccines That Are Not BeingLicensed Vaccines That Are Not Being
UsedUsed
WidelyWidely
 New/Improved:New/Improved:
 •• Hib: PRP-conjugatesHib: PRP-conjugates
 •• Pneumococcus: PS-conjugatesPneumococcus: PS-conjugates
 •• Cholera: inactivatedCholera: inactivated
 •• Rotavirus: live, attenuatedRotavirus: live, attenuated
 •• Typhoid: Vi, Ty2laTyphoid: Vi, Ty2la
 •• Pertussis: AcellularPertussis: Acellular
 •• HAV: InactivatedHAV: Inactivated
 •• Group A Meningococcus: PS-conjugatesGroup A Meningococcus: PS-conjugates
 •• Rabies: Cell-culture basedRabies: Cell-culture based
 •• Varicella: Live-attenuatedVaricella: Live-attenuated

64. Progress to prevent H PyloriProgress to prevent H Pylori
H. pyloriH. pylori is among commonest bacterial infectionsis among commonest bacterial infections inin
humans, and may be be transmitted by water and oralhumans, and may be be transmitted by water and oral
fecal spread.fecal spread.
Genomics may helpGenomics may helpunderstanding the pathogenesis ofunderstanding the pathogenesis of
H. pyloriH. pylori infectioninfection and development of new therapies,and development of new therapies,
includingincludingH. pyloriH. pylori–specific antimicrobial agents and–specific antimicrobial agents and
vaccinesvaccines
EnormousEnormousprogress in studying the virulence factors ofprogress in studying the virulence factors of
H. pyloriH. pylori and their variation, but not yetand their variation, but not yet used in clinicalused in clinical
practicepractice
Px and Rx vaccination have been successfulPx and Rx vaccination have been successful in animal models, butin animal models, but
the translation to human vaccine remainsthe translation to human vaccine remains difficultdifficult
These developments willThese developments will be needed to prevent and treat thisbe needed to prevent and treat this
infection in areasinfection in areasof the world where there is a high prevalence ofof the world where there is a high prevalence of
chronic infectionchronic infection

65. New Vaccine StrategiesNew Vaccine Strategies
Vaccine developmentVaccine development
 Purified (Subunits) Antigens vaccinePurified (Subunits) Antigens vaccine
e.g. Hepatitis B, Haemophilus influenzae.g. Hepatitis B, Haemophilus influenza
type b, RSV, Rotavirus, foot-and-mouthtype b, RSV, Rotavirus, foot-and-mouth
diseasedisease
 Conjugate vaccines e.g. meningitis,Conjugate vaccines e.g. meningitis,
pneumoniapneumonia
 Recombinant antigen vaccines e.g.Recombinant antigen vaccines e.g.
Hepatitis B, malariaHepatitis B, malaria

66. Vaccine trails for HIVVaccine trails for HIV
preventionprevention

67. HIV Vaccine ApproachesHIV Vaccine Approaches
Protein subunit
Synthetic peptide
Naked DNA
Inactivated Virus
Live-attenuated
Virus
Live-vectored Vaccine

68. Challenges in HIV Vaccine ResearchChallenges in HIV Vaccine Research
• Viral Genetic DiversityViral Genetic Diversity:: HIV is notHIV is not
just one specific virus.just one specific virus.
• Immune ProtectionImmune Protection:: We don’t knowWe don’t know
what immune responses arewhat immune responses are
needed, or how strong they need toneeded, or how strong they need to
be.be.
• Neutralizing AntibodyNeutralizing Antibody:: Difficult toDifficult to
generate broadly neutralizinggenerate broadly neutralizing
antibodies.antibodies.
• Vaccine TestingVaccine Testing:: Slow process, verySlow process, very
expensiveexpensive

69. ……but on the Brightsidebut on the Brightside……
 Precedent from other systemsPrecedent from other systems:: SuccessSuccess
against other viral infectionsagainst other viral infections
 Precedent from animal studies:Precedent from animal studies: Long-Long-
term control of infection in vaccinatedterm control of infection in vaccinated
monkeysmonkeys
 Immune control of HIV-1Immune control of HIV-1:: InfectedInfected
individuals control infectionindividuals control infection
 Vaccine TrialsVaccine Trials:: In progressIn progress

70. Status of HIV VaccineStatus of HIV Vaccine
DevelopmentDevelopment
 Over 60 Phase I/II trials of 30 candidateOver 60 Phase I/II trials of 30 candidate
vaccinesvaccines
 United States, Thailand, South Africa,United States, Thailand, South Africa,
BrazilBrazil
 One Phase III trialOne Phase III trial
 VaxGen gp120 protein subunit vaccineVaxGen gp120 protein subunit vaccine

71. CDC collaborating the researchCDC collaborating the research
on Vaccine for HIV infectionon Vaccine for HIV infection
 CDC played an important role in the trialsCDC played an important role in the trials
(VAX003 and VAX004) that evaluated the(VAX003 and VAX004) that evaluated the
efficacy of gp120-based vaccine candidates.efficacy of gp120-based vaccine candidates.
VaxGen, which also sponsored the trials. CDCVaxGen, which also sponsored the trials. CDC
sponsored a series of behavioural andsponsored a series of behavioural and
biomedical studies linked to the VAX004 efficacybiomedical studies linked to the VAX004 efficacy
trial in North America and was part of thetrial in North America and was part of the
consortium that conducted the VAX003 trial inconsortium that conducted the VAX003 trial in
Thailand. Although the vaccine candidates failedThailand. Although the vaccine candidates failed
to prevent HIV infection, the successful conductto prevent HIV infection, the successful conduct
of these trials proved that large HIV vaccineof these trials proved that large HIV vaccine
efficacy trials were possible, even in developingefficacy trials were possible, even in developing
countries.countries.

72. Difference between a preventive
HIV vaccine and a therapeutic
HIV vaccine?
 Therapeutic HIV vaccines are designed to
control HIV infection in people who are
already HIV positive Preventive HIV
vaccines are designed to protect HIV
negative people from becoming infected
or getting sick. This fact sheet focuses on
preventive HIV vaccines.

73. Malaria Vaccines inMalaria Vaccines in
ProgressProgress

74. Vaccine trails in MalariaVaccine trails in Malaria
 More than a dozenMore than a dozen
vaccine candidatesvaccine candidates
are now in clinicalare now in clinical
development, anddevelopment, and
one, GlaxoSmithKlineone, GlaxoSmithKline
Biologicals’ RTS,S, isBiologicals’ RTS,S, is
in Phase III clinicalin Phase III clinical
testing—the firsttesting—the first
malaria vaccinemalaria vaccine
candidate to advancecandidate to advance
third stage of testingthird stage of testing

75. Phase III trial in MalariaPhase III trial in Malaria
 Phase III trial of thePhase III trial of the
world’s most clinicallyworld’s most clinically
advanced malariaadvanced malaria
vaccine candidate wasvaccine candidate was
launched in Kisumu,launched in Kisumu,
Kenya, in July 2009,Kenya, in July 2009,
under the auspices of theunder the auspices of the
Kenya Medical ResearchKenya Medical Research
Institute (KEMRI)/CDCInstitute (KEMRI)/CDC
Research and PublicResearch and Public
Health Collaboration.Health Collaboration.

76. Vaccine Candidate—Vaccine Candidate—
GlaxoSmithKline BiologicalGlaxoSmithKline Biological
 The vaccine candidate—GlaxoSmithKlineThe vaccine candidate—GlaxoSmithKline
Biological' (GSK Bio) RTS,S—is the first of theBiological' (GSK Bio) RTS,S—is the first of the
current generation of malaria vaccines tocurrent generation of malaria vaccines to
warrant Phase III testing on this scale. Thewarrant Phase III testing on this scale. The
vaccine has a promising safety profile, was morevaccine has a promising safety profile, was more
than 50% effective in reducing episodes ofthan 50% effective in reducing episodes of
clinical malaria in children 5 to 17 months old inclinical malaria in children 5 to 17 months old in
earlier testing, and can be administered togetherearlier testing, and can be administered together
with the package of vaccinations routinely givenwith the package of vaccinations routinely given
to African children.to African children.

77. Very young taken for trails in view ofVery young taken for trails in view of
High mortality and MorbidityHigh mortality and Morbidity
 Phase III trial willPhase III trial will
demonstrate how thedemonstrate how the
vaccine performs in twovaccine performs in two
groups of children—onegroups of children—one
aged 6 to 12 weeks and aaged 6 to 12 weeks and a
second aged 5 to 17second aged 5 to 17
months—in differentmonths—in different
transmission settingstransmission settings
across a wide geographicacross a wide geographic
region in Africa.region in Africa.

78. Malaria Vaccine possible in nextMalaria Vaccine possible in next
few yearsfew years
 In Phase II testing,In Phase II testing,
the vaccine reducedthe vaccine reduced
cases of malaria incases of malaria in
young children 5 to 17young children 5 to 17
months by 53%. Ifmonths by 53%. If
Phase III results arePhase III results are
as good, the vaccineas good, the vaccine
could be fullycould be fully
available in the next 5available in the next 5
- 10 years.- 10 years.

79. DNADNA VaccinesVaccines

80. DNA VaccinesDNA Vaccines
 DNA vaccines are atDNA vaccines are at
present experimental,present experimental,
but hold promise forbut hold promise for
future therapy sincefuture therapy since
they will evoke boththey will evoke both
Humoral and Cell-Humoral and Cell-
mediated immunity,mediated immunity,
without the dangerswithout the dangers
associated with liveassociated with live
virus vaccines.virus vaccines.

81. What are DNA VaccinesWhat are DNA Vaccines??
From Scientific American,
July 1995

82. MakingMaking DNADNA VaccinesVaccines
 The gene for an antigenic determinant of aThe gene for an antigenic determinant of a
pathogenic organism is inserted into a plasmid.pathogenic organism is inserted into a plasmid.
This genetically engineered plasmid comprisesThis genetically engineered plasmid comprises
the DNA vaccine which is then injected into thethe DNA vaccine which is then injected into the
host. Within the host cells, the foreign gene canhost. Within the host cells, the foreign gene can
be expressed (transcribed and translated) frombe expressed (transcribed and translated) from
the plasmid DNA, and if sufficient amounts ofthe plasmid DNA, and if sufficient amounts of
the foreign protein are produced, they will elicitthe foreign protein are produced, they will elicit
an immune responsean immune response

83. Genetic Engineering a great toolGenetic Engineering a great tool
in developing newer vaccinesin developing newer vaccines
 It is possible, using genetic engineering, toIt is possible, using genetic engineering, to
introduce a gene coding for an immunogenicintroduce a gene coding for an immunogenic
protein from one organism into the genome ofprotein from one organism into the genome of
another (such as vaccinia virus). The organismanother (such as vaccinia virus). The organism
expressing a foreign gene is called aexpressing a foreign gene is called a
recombinant. Following injection into the subject,recombinant. Following injection into the subject,
the recombinant organism will replicate andthe recombinant organism will replicate and
express sufficient amounts of the foreign proteinexpress sufficient amounts of the foreign protein
to induce a specific immune response to theto induce a specific immune response to the
protein.protein.

84. Genetically EngineeredGenetically Engineered
Vaccines a future toolVaccines a future tool
 DNA vaccinationDNA vaccination is a technique for protectingis a technique for protecting
an organism against disease by injecting it withan organism against disease by injecting it with
genetically engineered DNA to produce angenetically engineered DNA to produce an
immunological response. Nucleic acid vaccinesimmunological response. Nucleic acid vaccines
are still experimental, and have been applied toare still experimental, and have been applied to
a number of viral, bacterial and parasitic modelsa number of viral, bacterial and parasitic models
of disease, as well as to several tumour models.of disease, as well as to several tumour models.
DNA vaccines have a number of advantagesDNA vaccines have a number of advantages
over conventional vaccines, including the abilityover conventional vaccines, including the ability
to induce a wider range of immune responseto induce a wider range of immune response
types.types.

85. DNA Vaccines areDNA Vaccines are 33rdrd
Generation vaccinesGeneration vaccines
 DNA vaccines areDNA vaccines are third generationthird generation
vaccinesvaccines, and are made up of a small,, and are made up of a small,
circular piece of bacterial DNA (called acircular piece of bacterial DNA (called a
plasmid) that has been geneticallyplasmid) that has been genetically
engineered to produce one or two specificengineered to produce one or two specific
proteins (antigens) from a micro-organism.proteins (antigens) from a micro-organism.
The vaccine DNA is injected into the cellsThe vaccine DNA is injected into the cells
of the body, where the "inner machinery"of the body, where the "inner machinery"
of the host cells "reads" the DNA andof the host cells "reads" the DNA and
converts it into pathogenic proteins.converts it into pathogenic proteins.

86. Advantages of DNA VaccinesAdvantages of DNA Vaccines
Over Other Types of VaccinesOver Other Types of Vaccines
 cheaper and easier to producecheaper and easier to produce
 safersafer
 can elicit antibody and cellular immunecan elicit antibody and cellular immune
responsesresponses
 stable at a broad range of temperature (nostable at a broad range of temperature (no
cold-chain requirement)cold-chain requirement)
 can be designed and produced by geneticcan be designed and produced by genetic
engineering to have only the desired antigensengineering to have only the desired antigens
or antigenic sequences (epitopes) in theor antigenic sequences (epitopes) in the
vaccinevaccine

87. The New GMO Swine FluThe New GMO Swine Flu
Corn FlakesCorn Flakes
 Iowa State UniversityIowa State University
researchers are puttingresearchers are putting
flu vaccines into theflu vaccines into the
genetic makeup of corn,genetic makeup of corn,
which may somedaywhich may someday
allow pigs and humansallow pigs and humans
to get a flu vaccinationto get a flu vaccination
simply by eating cornsimply by eating corn
or corn products.or corn products.

88. WHO Initiative for VaccineWHO Initiative for Vaccine
Research (IVR)Research (IVR)
 The WHO Initiative for Vaccine ResearchThe WHO Initiative for Vaccine Research
was established in 2001 to streamline thewas established in 2001 to streamline the
various vaccine research andvarious vaccine research and
development projects being carried out bydevelopment projects being carried out by
different departments of WHO (includingdifferent departments of WHO (including
the Special Programme for Research andthe Special Programme for Research and
Training in Tropical Diseases: TDR) andTraining in Tropical Diseases: TDR) and
UNAIDS.UNAIDS.

89. Importance Of Vaccines ForImportance Of Vaccines For
AdultsAdults
 Most effective strategies for preventingMost effective strategies for preventing
illnessillness
 Deaths from VPD still occurDeaths from VPD still occur
 Viewed as routine for children andViewed as routine for children and
travelers but not for adultstravelers but not for adults
 Make immunizations integral part ofMake immunizations integral part of
patient carepatient care

90. Why we should supportWhy we should support
vaccinationvaccination
 We don't vaccinate just to protect our children.We don't vaccinate just to protect our children.
We also vaccinate to protect our grandchildrenWe also vaccinate to protect our grandchildren
and their grandchildren. With one disease,and their grandchildren. With one disease,
smallpox, we "stopped the leak" in the boat bysmallpox, we "stopped the leak" in the boat by
eradicating the disease. Our children don't haveeradicating the disease. Our children don't have
to get smallpox shots any more because theto get smallpox shots any more because the
disease no longer exists. If we keep vaccinatingdisease no longer exists. If we keep vaccinating
now, parents in the future may be able to trustnow, parents in the future may be able to trust
that diseases like polio and meningitis won'tthat diseases like polio and meningitis won't
infect, cripple, or kill children.infect, cripple, or kill children.

91. Vaccine ControversiesVaccine Controversies
 The public health benefits of vaccinationsThe public health benefits of vaccinations
are exaggerated. Critics of vaccinationare exaggerated. Critics of vaccination
policy point out that the mortality rates ofpolicy point out that the mortality rates of
some illnesses were already dramaticallysome illnesses were already dramatically
reduced before vaccines were introduced,reduced before vaccines were introduced,
and claim that further reductions cannotand claim that further reductions cannot
immediately be attributed to vaccines.immediately be attributed to vaccines.
 Secondary and long-term effects on theSecondary and long-term effects on the
immune system from introducingimmune system from introducing
immunogens directly into the bloodstreamimmunogens directly into the bloodstream
are not fully understood.are not fully understood.

92. Vaccine ControversiesVaccine Controversies
 Vaccinations contain chemicalVaccinations contain chemical
components that are known to becomponents that are known to be
toxic, such as formaldehyde,toxic, such as formaldehyde,
aluminum in various compounds,aluminum in various compounds,
acetone, glyceride, ethylene glycol,acetone, glyceride, ethylene glycol,
and neomycin when injected in largeand neomycin when injected in large
enough quantitiesenough quantities

93. Can some vaccines causeCan some vaccines cause
Cancers ?Cancers ?
 Some researchersSome researchers
hypothesizehypothesize
possible linkspossible links
between thebetween the
increasingincreasing
incidence of cancerincidence of cancer
and use ofand use of
vaccines,vaccines,
suggesting links tosuggesting links to
the way vaccinesthe way vaccines
may alter the cellsmay alter the cells
in our bodies.in our bodies.

94. Vaccine developmentVaccine development
A Complex ResearchA Complex Research
 Vaccine development for emerging and re-Vaccine development for emerging and re-
emerging diseases is a complex issueemerging diseases is a complex issue
 There are many mechanisms already in place toThere are many mechanisms already in place to
help deal with the development of preventivehelp deal with the development of preventive
vaccines for emerging and re-emergingvaccines for emerging and re-emerging
diseasesdiseases
 Close communication between the Sponsor andClose communication between the Sponsor and
the Agency will hopefully aid in more efficientthe Agency will hopefully aid in more efficient
product developmentproduct development

95. Vaccines Can Contain DangerousVaccines Can Contain Dangerous
Ingredients Not Adequately Reported toIngredients Not Adequately Reported to
the Publicthe Public ??

96. Public do challenge the safety ofPublic do challenge the safety of
Several VaccinesSeveral Vaccines

97. Anti-vaccine lobbyistsAnti-vaccine lobbyists
 Not everybody believes that vaccines are goodNot everybody believes that vaccines are good
 Despite the ridiculousness of anti-vaccineDespite the ridiculousness of anti-vaccine
arguments, there are significant and influentialarguments, there are significant and influential
followersfollowers
They can bring untold damage to immunizationThey can bring untold damage to immunization
programs and cause diseases and deathsprograms and cause diseases and deaths
 •• Recent examplesRecent examples
 –– Northern Nigeria and polioNorthern Nigeria and polio
 –– MMR and measles in UKMMR and measles in UK
 –– Hepatitis B in IndiaHepatitis B in India

98. All the New Vaccines are UnderAll the New Vaccines are Under
Scanner by Health Authorities andScanner by Health Authorities and
Social ActivistsSocial Activists

99. Luc MontagnierLuc Montagnier on Vaccine foron Vaccine for
AIDSAIDS
 Our goal is not toOur goal is not to
completely eradicate thecompletely eradicate the
infection - that would beinfection - that would be
very difficult - but tovery difficult - but to
produce a vaccine thatproduce a vaccine that
will prevent not infectionwill prevent not infection
but disease. I think this isbut disease. I think this is
more possible.more possible.

It's clear thatIt's clear that
prevention will never beprevention will never be
sufficient. That's whysufficient. That's why
we need a vaccine thatwe need a vaccine that
will be safe.will be safe.

100. Are we getting the VaccinesAre we getting the Vaccines
inin TIMETIME

101. Questions?Questions?