Educational Objectives

1
Educational Objectives

• The student should be able to discuss
• Why people should be immunized
• Reasons why immunization programs fail
• Government efforts to insure vaccine safety
• Adverse reactions to vaccines
• Autism and the MMR vaccine controversy
• Ethics and vaccines

2
An immunization-based approach to control
infectious diseases continues to be most
appealing in light of cost effectiveness,
capacity for widespread implementation and
potential for sustained protection from disease.
3

• Vaccines are historys most effective public
  health tool, reducing morbidity and mortality
  associated with infectious diseases.
• A little more than a century ago the US infant
  mortality rate was a staggering 20 and the
  childhood mortality rate before the age of five
  was another 20.
• Vaccines have been so successful that today we
  find ourselves faced with a dangerous complacency
  wherein the necessity for immunization is
  minimized.
• We also find a growing antagonism in our society
  for the vaccination of children as fearful
  parents are bombarded with unsubstantiated facts
  about the dangers of vaccination.

4
Vaccines-Historical Perspective

• 7th century-Indian Buddists drank snake venom to
  protect against snake bite.
• 10th century-variolation to prevent smallpox in
  China and Turkey.
• Early 1700s-variolation introduced into England.
• 1760-70-The Jennerian era.
• 1875-1910-Dawn of Immunological Science.
• 1910-30-Early bacterial vaccines, toxins and
  toxoids.
• 1930-50-Early viral vaccines yellow fever and
  Influenza.
• 1950-1970-The tissue culture revolution
  poliomyelitis, measles, mumps and rubella.
• 1970-1990-Dawn of the molecular era hepatitis B,
  Streptococcus pneumoniae, Hemophilus influenzae
  B.
• Today-Glycoconjugate vaccines, rotavirus
  vaccine, human papilloma virus vaccine and herpes
  zoster vaccine.

5
Vaccine-PREVENTABLE Diseases Anthrax Pneum
ococcal Cervical Cancer Poliomyelitis Diphther
ia Rabies Hepatitis A Rotavirus Hepatitis
B Rubella Haemophilus influenzae type b
Shingles Human Papillomavirus
Smallpox Tetanus Influenza
Tuberculosis Japanese Encephalitis Typhoid
Fever Lyme Disease Varicella Measles Yellow
Fever Meningococcal Monkeypox Mumps Pertussis
6
Impact of vaccination on morbidity
from infectious diseases
7
VACCINES WORK!
8
What happens when you fail to immunize?
9
(No Transcript)
10
Epidemic Infectious Diseases Preventable by
Immunization

• Russia
• 1989-91 55,467 cases of measles with
  11,256 hospitalizations 136 deaths
• 1990 200 cases of diphtheria by 1992-50,000
  cases
• 1993-94 146,000 cases of poliomyelitis
• 1991- childhood immunizations no girls were
• immunized against Rubella, 78
• coverage for Measles, 71 for
• Polio

11
Reasons

• Government anti-immunization policies introduced
  in late 70s
• Nikitin Doctrine journalists
• Idea in pediatric circles that Russian children
  were weak and vaccines could be dangerous for
  them-childhood immunization rates had fallen
  below levels seen in many African countries.
• Lack of expertise in immunology and
  pediatrics-bad vaccines
• War in Afganistan
• Disintegration of the USSR-1991

12
USA

• 1989-1991 Measles epidemic gt55,000 cases,
  11,000 hospitalizations, 136 deaths
• 1992-93-5,000 cases of Whooping Cough

13
Nature of the problem in both instances

• Need to establish herd immunity
• aim is to stop transmission
• requires 95 immune individuals to prevent
  epidemic disease
• even when vaccine has good efficacy, not all
  immunized subjects will develop protective
  immunity
• immunity when induced lasts for a finite period
  of time

14
Why people dont get immunized

• Publics concerns
• too busy
• vaccines cause disease
• vaccine availability and access
• cost and/or access to health care
• immunization schedules
• concerns about vaccine side effects and safety
• perception that diseases have been eradicated
• religious beliefs
• resentment against government interference

15

• Health care providers concerns
• complicated and ever-changing
• immunization schedules
• concerns about vaccine side effects
• concerns about vaccine safety
• concerns about vaccine efficacy
• concerns about reimbursement
• health care provider apathy
• perception that childhood diseases have been
  eradicated
• liability

16
Vaccine Safety Issues
17
Problems with vaccines

• 1935 Lubeck disaster involving BCG immunization.
• 1954 Salk vaccine contaminated with live virus.
• 1960 realized that polio vaccines were
  contaminated with SV40 virus.
• 1976 Swine Flu vaccine and Guillain Barre
  syndrome.
• 1999 Rotashield vaccine and intussuception.
• 2004 Rabies vaccine containing noninactivated
  virus.
• Reemergence of paralytic poliomyelitis caused by
  vaccine strains.

18
Prelicensure Human Studies

• Phases I, II, III trials
• Common reactions are identified
• Vaccines are tested in thousands of persons
  before being licensed and allowed on the market
• Risk/benefit ratio

19
Vaccine Adverse Event Reporting System (VAERS)

• National reporting system
• Jointly administered by CDC and FDA
• Passive (depends on healthcare providers and
  others to report)
• Receives 15,000 reports per year

20
Vaccine Adverse Event Reporting System (VAERS)

• Detects
• new or rare events
• increases in rates of known side effects
• patient risk factors
• Additional studies required to confirm VAERS
  signals
• Not all reports of adverse events are causally
  related to vaccine

21
Vaccine Safety Datalink (VSD)

• Large-linked database
• Links vaccination and health records
• Active surveillance
• 8 HMOs
• 2 of the U.S. population
• Powerful tool for monitoring vaccine safety

22
Vaccine Injury Compensation Program (VICP)

• Established by National Childhood Vaccine Injury
  Act (1986)
• No fault program
• Covers all routinely recommended childhood
  vaccines
• Vaccine Injury Table

23
(No Transcript)
24
Adverse effects due to Vaccines

• Parentally administered vaccines
• Local Effects
• swelling
• pain
• fever
• headache
• malaise
• myalgias
• Systemic effects
• Viable organisms
• Contaminants
• Hypersensitivity to a component of the vaccine
• IgE antibody mediated wheal and flare
• urticaria
• angioedema
• full blown anaphylaxis
• Guillain-Barre Syndrome

25
Relative Incidence of Severe Complications from
Diseases and the Vaccines Used to protect against
these Diseases

• Disease Complication Disease Vaccine Ratio
• Vaccine
• OPV Paralysis 1-5/1000 1/mil 1000
• Measles Encephalitis 1000 1/mil
  1000
• Varicella Cerebellar 4/1000 1/mil
  4000
• ataxia
• Tetanus Death 1/10
  lt1/mil 105

Halsey in the Vaccine Book pg384.
26
SHOULD WE BE IMMUNIZED

• Population basis Frequency of an adverse
  reaction of 1/106 or 0.00001
• On an individual basis 0 or 100
• Immunization results in lessoned disease
  morbidity and mortality

27
Vaccine Negligence-Should My Child be Immunized?
28
(No Transcript)
29
(MMR) Vaccine and Autism

• In 1998 Wakefield et al. proposed an
  association between immunization and autism.
• Wakefield AJ, Murch SH, et al.
  Ileal-lymphoid-nodular hyperplasia, non-specific
  colitis and pervasive develomental disorder in
  children an early report. Lancet 1998
  351637-41.
• Acosta MT, Pearl PL. The neurobiology of
  autism new pieces of the puzzle. Curr Neurol
  Neurosci Rep. 2003 3 149-56.

30
What is Autism?

• Autism is a complex developmental disability
  that typically appears during the first three
  years of life and affects a persons ability to
  communicate and interact with others. Autism is
  defined by a certain set of behaviors and is a
  "spectrum disorder" that affects individuals
  differently and to varying degrees. There is no
  known single cause for autism.
• CDC estimates that 1/150 children have
  autism and developmental disability.

31
Signs of Autism

• Lack of or delay in spoken language?
• Repetitive use of language and/or motor
  mannerisms (e.g., hand-flapping, twirling
  objects)
• Little or no eye contact
• Lack of interest in peer relationships
• Lack of spontaneous or make-believe play
• Persistent fixation on parts of objects

32
What Causes Autism?

• Refrigerator mothers
• Genetic studies in identical and fraternal twins.
• Timing of the development of autism-home movies
  show symptoms present before 1 year of age (prior
  to MMR immunization) and in videotapes of
  children as young as 2-3 months.
• Evidence suggests that autism is likely due to
  abnormalities of the CNS that occur in utero

33
(No Transcript)
34
AMERICAN ACADEMY OF PEDIATRICS WEB SITE

• What Parents Should Know About Measles-Mumps-Rubel
  la (MMR) Vaccine and Autism
• http//www.cispimmunize.org/fam/mmr/a_faq.html
• 28 Aug 03
• ... MMR and Autism Resources ...
  Thehttp//www.cispimmunize.org/fam/mmr/autism.html
  
• 28 Aug 03
• CONFERENCE REPORT ADDRESSES AUTISM AND MMR
  VACCINE
• http//www.cispimmunize.org/resear/autism.html -
  28 Aug 03
• Also see Honey. J Clin Invest. 2008
  May118(5)1586-7.

35
Ethical Concerns Related to Vaccines

• Design and conduct of vaccine research involving
  human subjects.
• Guaranteed access to vaccines that research has
  demonstrated to be safe and effective.
• Tension between public health benefits and
  respect for the autonomy of individuals who may
  refuse mandatory immunization for themselves or
  their children

36
Belmont Report issued by the U.S. National
Commission for the Protection of Human Subjects

• Respect for persons
• Beneficence
• Distributive Justice
• These principles embodied in the
• international guidelines stated in the
• Declaration of Helsinki and other
• international agencies

37
Impact of Bad Publicity and lack of education on
Immunnization Programs

• Misinformation and rumor that polio vaccine
  contained anti-fertility drugs disrupted the WHO
  international immunization program to eradicate
  polio.
• Lack of honesty in poor countries about real
  vaccine-related risks
• Political aspects-risk

38
Future Challenges

• As vaccine preventable diseases become rare,
  public loses awareness of infectious disease
  dangers and the benefits of immunization.
• Physician apathy.
• Anti-vaccine lobbies reduce public confidence in
  immunization.

39
(No Transcript)
40
(No Transcript)
41
How to address the problem of getting people to
be immunized?

• Incentives to make vaccines available
• Advocacy for immunization programs
• Creating public awareness
• Legal protection for vaccine manufactures
  health care providers
• Implementation of compliance laws
• Official public health response to allegations of
  purported vaccine dangers
• Governmental oversight of vaccine manufacture and
  use

42
Sources of Material

• The Vaccine Book. 2005. B. Bloom P-H Lambert
  eds. Academic Press, NY.
• The Pink Book-CDC
• Google -Vaccines, CDC, FDA, WHO
• Any recent text of immunology