Transcript Principle of Vaccinology

Principle of Vaccinology
Elham Ahmadnezhad MD. MPH. PhD Student of Epidemiology
Farshid fayyaz Jahani MD. MPH. Specialist in Infectious Disease & Tropical
Medicine
Tehran University of Medical Sciences
10/10/2011
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Brief History of Lecturers
•
Elham & Farshid from Tehran, Iran are couple since 3 years ago (2008).
Farshid graduated from Medical School in Infectious disease and Tropical
medicine’ specialist and Elham now senior student in PhD of Epidemiology.
•
They have common interest in infectious disease epidemiology then
developed some lecturers such as this (Vaccinology).
Hope it’s useful for all target groups.
Our Email:
[email protected]
&
[email protected]
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OUTLINE
 Introduction & Definition
 Vaccination policy option
 Mass Vaccination
 Surveillance System of Vaccination
 Vaccine Development
 Vaccine Evaluation
 Vaccine Safety
 Reporting Immunizations
 Reliable Web sits
 Vaccine Training Course
 Review of National Immunization Coverage
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What is Vaccine
• Dictionary (Dorland 30th edition 2008)
 Attenuated or killed microorganisms or proteins derived from them, administered for
the prevention, treatment, or amelioration of infectious diseases
• Wikipedia
 A vaccine is a biological preparation that improves immunity to a particular disease. A
vaccine typically contains an agent that resembles a disease-causing microorganism,
and is often made from weakened or killed forms of the microbe. The agent stimulates
the body's immune system to recognize the agent as foreign, destroy it, and "remember"
it, so that the immune system can more easily recognize and destroy any of these
microorganisms that it later encounters.
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What is Vaccinology?
• Vaccinology is the science of developing
vaccines to prevent diseases
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Vaccines-Historical Perspective
•
7th century- Indian Buddhists' 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 pneumonia, Hemophilus influenza B.
•
Today- Glycoconjugate vaccines, rotavirus vaccine, human papilloma virus vaccine and herpes zoster
vaccine.
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Aims of Immunisation Programmes
•
•
To protect those at highest risk
(selective immunisation strategy)
or
To eradicate, eliminate or control disease
(mass immunisation strategy)
Currently, it is estimated that vaccination saves the lives of 3 million children a year
•
Eradication
 Infection (pathogen) has been removed worldwide e.g. smallpox
•
Elimination
 Disease has disappeared from one area but remains elsewhere e.g. polio, measles
•
Control
 Disease no longer constitutes a significant public health problem e.g. neo-natal tetanus
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Vaccines Achievements
1
• With sanitation and nutrition, vaccines are hailed as one of the most
important public health achievements of the 20th century.
• The history of vaccinology lends itself to discussion of its progress in terms
of periods or eras, in which new advances were made.
•
Once only targeted against serious childhood diseases, vaccinology has
become a tool for preventing infectious diseases or their complications
and outcomes in all age groups.
• This has seen the number of vaccine-preventable diseases rising to around
26.
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Vaccines Achievements
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• “At the end of the 20th century the US Centers for Disease
Control and Prevention (CDC) cited vaccination as the
number one public health achievement of that century”
• “The elimination in 1977 of smallpox as a human disease
must rank as one of the major achievements of modern
medicine”
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The Ideal Vaccine
• Immunogenic
• Long lasting immunity
• Safe
• Stable in field conditions
• Combined
• Single dose
• Affordable (and accessible) to all
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Categorization of Current Vaccines
• Live attenuated: Viruses (oral polio, measles, mumps, rubella,
yellow fever), Bacteria (BCG, cholera)- Long lasting immunity, very
fragile (cold chain), mutation to pathogenicity
• Killed Vaccines: Viruses (hep. A, Salk polio) Bacteria (pertussis,
cholera)-intermediate immunity, several doses may be required
• Sub-unit vaccines incl: Toxoids: (tetanus, hep b.,occellular vaccines),
Conjugate polysacaride vaccines linked with suitable carrier
proteins (Hib). Also single or polyvalent vaccines.
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Viral Vaccines
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Bacterial Vaccines
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Target Fungal Vaccines
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Target Parasitic Disease
• Malaria
• Trypanosomiasis
• Leishmaniasis
• Toxoplasmosis
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Selective Vaccination
• Vaccine given specifically to those at increased risk of disease:
• High risk groups
 e.g. Pneumococcal vaccine
• Occupational risk
 e.g. Hepatitis B, influenza
• Travellers
 e.g. Yellow fever, rabies, meningitis
• Outbreak control

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e.g. Hepatitis A. vaccine, measles
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Pipelines for Developing Countries
Much needed vaccines for the developing world
• Malaria
• Tuberculosis
• HIV
• Hookworm
• Dengue
• Enterotoxigenic Escherichia coli
• Shigella
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More Possibilities
• Therapeutic vaccines: Identification of specific tumor
antigens provide immune targets for which immunogenic
vaccines may conceivably be designed. Examples:
 Leukemia
 Breast cancer
 Melanoma
 Prostate cancer
 Colon cancer
• Vaccines against autoimmune diseases
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Similarities between Vaccines and
other Drug
• Vaccines are also medicines
• Potential for adverse effects
• Multiple ingredients
• Potential for interaction with disease and other
medicines
• Also need to comply with standards of safety, efficacy
and quality
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Vaccination Policy Options
?
Eradication Activities
New Vaccine
Introduction
Newer Vaccine
Research and
Development
Outbreak vs. routine
control of epidemic
diseases
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Role of disease burden studies in the development and
introduction of new and underutilized vaccines
Vaccine
Design
Clinical Evaluation
• Study sites
• Vaccination schedules
& Strategies
Vaccine Utilization
• Target groups
• Impact
• Cost-effectiveness
Disease Epidemiology
• Geographical distribution
• Age groups
• Seasonality, risk factors
Disease-Burden Studies
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Mass Vaccination
Objective: Make hosts resistant to infection without
having to experience disease
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Impact of Mass Vaccination Programmes
• Reduce size of susceptible population
• Reduce number of cases
 Reduce risk of infection in population
 Reduce contact of susceptible to cases
 Lengthening of epidemic cycle -> honeymoon
phase
 Increase in mean age of infection
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No Mass Vaccination
Each host in contact with infected host becomes infected (with a certain
probability)
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Mass Vaccination
Outbreak attenuated (or averted) by lack
of susceptible hosts
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Impact of Mass Immunisation Programme
Annual measles notifications & vaccine coverage
Poland 1960-2000
600.0
100
90
Cases/100 000
80
70
400.0
60
300.0
50
40
200.0
30
20
100.0
Immunisation coverage (%)
500.0
10
0.0
0
Year
1964
1969
1974
1979
1984
1989
1994
1999
Year
Vaccination at 12-15 mo
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Vaccination at 6 years
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Cases /100 000
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Surveillance of Vaccine Preventable Disease
• Vaccine uptake
• Vaccine effectiveness
• Serological surveillance
• Adverse events
• Knowledge and attitudes
• Vaccine uptake
• Disease incidence
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Objectives of Surveillance
Vaccine Preventable Diseases
• Pre-implementation
 Estimate burden
 Decide vaccination strategy
• Post implementation
 Monitor impact and effectiveness
• Nearing elimination
 Identify pockets of susceptible
 Certification process
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Disease Incidence
• Main sources of data
 Statutory notification
 Laboratory reporting
 Death registrations
• Other sources
 Hospital episodes
 Sentinel GP reporting
 Paediatric surveillance
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Measles Case Definitions
• Suspect case
 Rash and fever
• Probable case
 Rash, fever, and either: cough, coryza or conjunctivitis
• Laboratory confirmed
• Saliva/serum IgM positive
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Predictive Value of Notified Measles
Effect of Change in Incidence
Non-measles
Genuine measles
100%
100000
80%
10000
60%
1000
40%
100
20%
10
1
0%
Pre-vaccine
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PV+
Number of cases
1000000
Low coverage
High coverage Near elimination
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Surveillance of Vaccine Coverage
• Vaccine distributed
• Vaccine administered
 Sampling population assessment e.g. Cluster
 Total population assessment (administrative)
Number of doses of vaccine given/used
Total (target-)population
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Use of Administrative Coverage Data
• Usually total population
• Monitor trends over time
• Look for pockets of poor coverage
• Compare with disease epidemiology
• Estimate vaccine effectiveness
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Steps on Vaccine Development
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• Recognize the disease as a distinct entity
• Identify etiologic agent
• Grow agent in laboratory
• Establish in animal model for disease
• Identify an immunologic correlate for immunity to the disease- usually
serum antibody
• Inactivate or attenuate the agent in the laboratory- or choose antigens
• Prepare candidate vaccine following GOOD manufacturing Procedures
• Evaluate candidate vaccine(s) for ability to protect animals
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Steps on Vaccine Development
2
• Prepare protocol(s) for human studies
• Apply to MCC for investigational New drug (IND)
approval
• Phase I human trials- Safety and immugenicity,
dose response
• Phase II trials- Safety and immugenicity
• Phase III trials- Efficacy
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Steps on Vaccine Development
3
• Submit Product Licensure Application MCC approval
• Advisory Committees review and make recommendations
•
Marketing Post- Licensure Surveillance for safety and effectiveness
(Phase IV)
• Long and Complicated process
 Usually takes 10-15 years
 Many vaccine candidates fail for every success
 Costs: $ 100- $ 700 million per successful vaccine
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Vaccine Evaluation
Post-licensing
Pre-licensing
Observational Studies
Randomised, Blinded,
Controlled Clinical Trials
Vaccine effectiveness:
Protective Effect under
Ordinary Conditions of a
public health programme
Vaccine efficacy:
Protective Effect under
Idealised Conditions
RCT: controlled experiments,
simple interpretation
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prone to bias, more complex
interpretation
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Efficacy, Effectiveness, Impact and Herd Immunity
•Efficacy is the direct protection to a vaccinated individual as estimated from clinical trial
•Effectiveness is an estimate of the direct protection in a field study post licensure.
•Herd Immunity is an indirect effect of vaccination due to reduced disease transmission.
•Impact is the population level effect of a vaccination programme. This will depend on
many factors such as vaccine coverage, herd immunity and effectiveness.
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Basic Calculation of VE
% reduction in attack rate of disease in vaccinated (ARV)
compared to unvaccinated (ARU) individuals
Where
VE (%) = (ARU-ARV) X 100
ARU
ARU
ARV
 RR
1
and
ARU
ARU
Consequently, VE = 1-RR (preventive fraction)
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Basic Calculation of VE
Vaccinated
IV = 2/10 = 0,2
Unvaccinated
IU = 9/10 = 0,9
0,9 – 0,2
VE =
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= 78%
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Methods to Assess VE
• Pre-licensure:
 Randomised control trial (RCT)
• Post-licensure:
Observational/Field investigation
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Screening method
•
Cohort study
•
Household contact study
•
Case-control study
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Observational study: Screening Method
• Used with Routine Surveillance Data
 Take population vaccine coverage (PPV)
 Compare with coverage in cases (PCV)
VE = 1 - PCV x (1-PPV)
(1-PCV) x PPV
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Observational study: Screening Method
Relationship between VE, PPV and PCV
Proportion of cases
vaccinated
1
0.8
0.6
VE=60%
VE=80%
0.4
VE=90%
VE=95%
0.2
0
0.5
0.6
0.7
0.8
0.9
1
Proportion of population vaccinated
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Potential Pitfalls....
• Case definition;
• Vaccine history;
• Case ascertainment;
• Comparability of vaccinated/unvaccinated groups.
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Methodological Issues: Case Definition
1
• Lower specificity: Case definition based only on clinical
criteria may result in false-positive diagnoses
ARV
> ARU
VE (%) = (ARU-ARV) X 100
ARU
artificial reduction in VE
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Methodological Issues: Case Definition
2
Changes in MUMPS vaccine effectiveness
ARV
ARU
VE
Case definition
Diagnosis by school nurse
18% (12/67)
28% (77/272)
37%
89
25% (68/272)
52%
Kim Farley et al 1985 AJE
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Methodological Issues: Case Definition
2
Changes in MUMPS vaccine effectiveness
ARV
ARU
VE
Case definition
Diagnosis by school nurse Parotitis > 2 days
18% (12/67)
12% (8/67)
28% (77/272)
25% (68/272)
37%
52%
Kim Farley et al 1985 AJE
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Methodological issues: Vaccine History Ascertainment
• Avoid misclassification of vaccination status
• Equal effort to confirm vaccination status
amongst cases and non-cases
 Vaccination histories should be documented using GP, clinic,
hand-held or computer records
 Persons with missing vaccination records should be excluded
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Vaccine effectiveness: Post licensure monitoring of VE
Post-licensure: maintenance of VE
• Problems in vaccine delivery
 Cold chain failure, schedule violation, n° of doses, vaccine strain substitution
• Epidemiological factors
 Pathogen changes
• Methodological bias
 Selection bias, confounding, chance effects
• Low protective efficacy
 Bad batch, different target population, alternative patterns of use, vaccine
strain used
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Summary of VE
• Multiple sources of data are valuable to
evaluate vaccine programmes
• Source of data and case definitions change
with stage of vaccination programme
• Monitoring VE is integral
• VE can be carefully estimated from routine
data
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Let’s GO An Example
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A Randomized, Controlled Experiment
• 400,000
elementary
school
students
participated in the experiment.
• 200,000 chosen at random from 400.000 in
the treatment group got the vaccine.
• The remaining 200,000 in the control group
did not get the vaccine.
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A Randomized, Controlled Double-Blind Experiment
• The 200,000 children in the control got a fake
vaccination called a placebo.
• The children and their parents were not told if
they got the real vaccine or not.
• Even the doctors and nurses didn’t know; only
the statisticians knew
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Experimental Results
Size
Rate
Treatment
200,000
28
Control
200,000
71
Total
400,000
99
Looks promising but is it significant?
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Analysis: The Devil’s Advocate
• Let’s play the devil’s advocate. Let’s assume
the vaccine has no effect.
• Then the 99 cases of polio were split into the
two groups purely at random.
• Is it very likely only 25 fall in the treatment
group?
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A Probability Model
• Put 400,000 balls in an urn with 99 black and the rest white.
• Draw 200,000 (for the treatment group) and count the
number of black balls.
• What is the chance of a split as extreme or more extreme
than 28 in the treatment group and 71 in the control group.
• About one in a billion
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Calculating Probabilities
• A statistician relies on the theory of probability to
calculate probabilities.
• The number of black balls X in the treatment group
follows the hypergeometric distribution.
•
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 99  399901   400000
 
 

 x   200000  x  200000
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Conclusion: Get vaccinated!
• We must reject the hypothesis that the treatment has no
effect; otherwise we must believe we are incredibly
unlucky.
• We can therefore recommend mass vaccination.
• We also note a vaccination does not prevent polio. Your
best protection is to get vaccinated and encourage
everyone to be vaccinated.
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Vaccine Safety
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Today’s Agenda
• The Good
 The benefits of vaccination
 Ongoing safety monitoring
• The Bad
 Vaccines “rocky” past
 Acceptable risk?
•
And the Ugly
 Wealth of misinformation
 Vaccine refusal
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Vaccines Work
JAMA 2007 298(18)2156-2163
MMWR August 22, 2008 903-913
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Pre-licensure Safety Monitoring1
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Pre-licensure Safety Monitoring2
• Vaccine Adverse Event Reporting System (VAERS)
 Limitations
• Vaccine Safety Datalink (VSD)
 Established in 1990 by CDC and 8 HMOs
 Database on 8.8 million lives
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Safety Monitoring Who looks at all that data?
•
•
•
•
Institute of Medicine (IOM)
Part of the National Academy of Science
Non-profit, non-governmental organization, volunteer
Provide the CDC, NIH and congress on data interpretation on matters of
bio-medical science
IOM Vaccine Safety Reports – The “Gold Standard” in vaccine safety
analysis
 MMR and Autism (2001)
 Thimerosal and Neurodevelopmental Disorders (2001)
 Multiple Immunizations and Immune Dysfunction (2002)
 HepB Vaccine and Demyelinating Neurological Disorders (2002)
 SV40 Contamination of Polio Vaccine and Cancer (2002)
 Influenza vaccines and Neurological Complications (2003)
 Vaccines and Autism (2004)
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The Bad
• The Cutter IPV incident (1955)
• Vaccine associated paralytic polio
• Swine flu vaccine and GBS (1976-7)
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The Cutter Incident
• 1950s Jonas Salk pioneering work with IPV
• 5 companies stepped forward to manufacture IPV
after licensure
• Cutter (the smallest) made a bad batch
 100,000 children injected with live virus
 70,000 got mild polio
 200 were permanently paralyzed
 10 died
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Vaccine-Associated Paralytic Polio
(VAPP)
• OPV is a live attenuated virus
• 1 out of 2.4 million doses
VAPP
• 1997 a IPV/OPV schedule
• 2000 an all IPV schedule recommended
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“Swine Flu” vaccine of 1976-1977
• Increased risk of Guillain-Barré syndrome (GBS)
• Risk period was 6-8 weeks after vaccine and most
>25 yrs of age
• Incident of 1 per 100,000
• Above the background rate of 0.87 per million
persons in a 6 week period
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“Acceptable” Risk?
• Local side effects
 Swelling, redness
• Systemic side effects
 Fever, pain, allergic reaction
• MMR and Thrombocytopenia
•
MMR(V) and febrile seizures
•
Adolescent vaccines and syncope
•
Guillain-Barré and MCV4
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MMR & Thrombocytopenia
• Yes
• 1 in 40,000 at 12-23 months
• Less common than after natural disease
Journal of Autoimmunity 2001 16: 309-18
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MMR(V) & Febrile Seizures
• 10% develop fever after 1st MMR dose
• Febrile Seizure Risk
4 cases / 10,000 doses
MMR + V
9 cases / 10,000 doses
MMRV
MMWR 2008 57: 258-60
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Syncope and Adolescent Vaccines
MMWR May 2, 2008 / 57(17);457-460
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Guillain-Barré Syndrome and MCV4
• MCV4 (Menactra®) licensed in Jan 2005
•
Sept 2005 alert by FDA/CDC:
 2.5 million doses
 5 cases of GBS in month following vaccine (VAERS data)
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and the Ugly
• Wealth of misinformation
MMR and Autism
Mercury poisoning
Vaccines overwhelming the immune system
• Vaccine refusal
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Reporting Immunization Requirements
• Documenting administration of vaccine
• Documenting record of immunization
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Reporting immunization requirements: Documenting
administration of vaccine Content
• Name and address of vaccine
• Medicare number
• Date of birth and gender
• Date of administration
• Name and lot number of vaccine
• Name of immunizer
• Other data as required
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Reporting immunization requirements: Documenting
administration of vaccine Content-Lot Number
3 lot numbers on packaging:
 On antigen carton
 On adjuvant carton
 On shoe box
Document lot number
on shoe box.
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Immunization Practice Standards
•
Vaccine management
•
Informed consent
•
Administration of vaccine
•
Documentation
•
Anaphylaxis management
•
Reporting of adverse events
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Immunization practice standards: Vaccine
management-Storage and handling of vaccine
• Cold chain system
• Control procedure/mechanism/equipment
Vaccine fridge
Dialer and data logger
Vaccine coolers
Cold and warm marks or minimum-maximum
thermometers
• Cold chain breach
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Immunization practice standards Informed
consent
• Parental consent required for individuals
• less than 16 years old
• Risk vs. benefits (of receiving vaccine or not)
• General info about vaccine and potential side effects
• Ensure info is well understood
• Allow opportunities for questions
• Assess health with screening questions
• Document informed consent
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Immunization practice standards
Informed consent
Screening Questions (Examples)
•
Is unwell today?
•
Has history of severe life-threatening allergy to
 Eggs
 Previous dose of the vaccine; or
 Any of its components
•
Past history of Guillain Barre Syndrome
•
Has disease or treatment lowering immunity
•
Has severe bleeding disorder
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Immunization practice standards
Administration of vaccine
Intramuscular injection
IM in vastus lateralis
(Birth to 18 months)
IM in deltoid
(18 mths and over)
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Source : http://www.health.gov.nl.ca/health/publications/immunization/S4/
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Immunization practice standards
Administration of vaccine
Post-vaccination
• Check
 For bruising, redness, swelling
 Client for any adverse event
• Instruct client
 To wait 15 minutes
 Of possible side effects and what to do
 To call if adverse event in next 4 weeks
 Need for a second dose
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Immunization practice standards Documentation
•
Consent
form:
Pandemic
H1N1
Influenza
Immunization
•
Client immunization record
•
Adverse event following immunization
•
CSDS – as directed
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Immunization practice standards Anaphylaxis
management
•
Assess and manage ABCs
•
Call for help
•
Administer epinephrine
•
Call 115
•
Repeat dose as needed
•
Document and share clinical info
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Immunization practice standards
Reporting AEFI Current surveillance process
• AEFI form to be completed by PH or physician
• Form submitted to RMOH
• PH enters data in CSDS and sends form to CDC
Unit
Immunizers: inform
clients to call PH if
severe or unusual
reactions in the 4
weeks following
vaccination.
• CDC Unit faxes form to PHAC
• Refer to NB Immmunization Handbook
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Immunization practice standards Reporting AEFI Enhanced severe AEFI surveillance
• AEFI form to be completed by physician
• May be completed by PH when reported to PH first
• Form submitted to RMOH
• PH enters data entered in CSDS and sends form to CDC Unit
• Refer to GNB website for reporting process, case definition and form
http://www.gnb.ca/0053/h1n1/audience_professionals-e.asp
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Immunization practice standards
Reporting AEFI Enhanced severe AEFI surveillance
Weekly active AEFI reporting
• Internal medicine specialist and neurologists will submit weekly count of
cases meeting case definition of 8 conditions along with DOB and name
to CDC Unit via special email address.
• CDC Unit will send the information to MOH.
• Timely data to be used be regional PH to ensure complete reporting of
AEFI.
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Immunization practice standards
Occupational health issues
• Used injection material
 Handling
 Disposal
 Sharp containers
 Where to place
 When to replace
 How to dispose of
• Needle stick injury – refer to RHA policy
• Use of personal protective equipment and infection control measures
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Reliable web sites
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CDC Vaccines and Immunization
Contact Information
• Telephone
• Email
800.CDC.INFO
[email protected]
• Website
www.cdc.gov/vaccines
• Vaccine Safety
www.cdc.gov/od/science/iso
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Promote Epidemiology Training & Research
• WHO Advanced Training Course on Immunology, Vaccinology,
and Biotechnology Applied to Infectious Diseases
• Liaison with epidemiology training programmers
 INCLEN, FETP, EPIET
• WHO Collaborating Centers
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References
•
Geoffrey A. Weinberg and Peter G. Szilagyi. Vaccine Epidemiology: Efficacy, Effectiveness ,and the Translational Research Roadmap. The
Journal of Infectious Diseases 2010; 201 (11): 1607 -1610
•
European Program for Intervention Epidemiology Training. Principle of Vaccinology. 2008
•
EPI coverage survey, WHO. Available at: http://www.who.int/immunization_monitoring/routine/EPI_coverage_survey.pdf. Access date:
10.10.2011
•
Geert Leroux-Roels, Paolo Bonanni, Terapong Tantawichien,Fred Zepp. Understanding Modern Vaccines: Perspectives in Vaccinology
Vaccine development. Volume1/ Issue1/ 115-150
•
Thomas D. Szucs. Health economic research on vaccinations and immunization practices—an intro uctory primer. Vaccine 23 (2005):
2095–2103
•
NB Immunization Handbook, sections IV-III, IV-IV
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