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Principle of Vaccinology
Elham AhmadnezhadMD. MPH. PhD Student of Epidemiology
Farshid fayyaz JahaniMD. MPH. Specialist in Infectious Disease & TropicalMedicine
Tehran University of Medical Sciences
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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 its useful for all target groups.
Our Email:
&
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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)
Attenuatedor killedmicroorganisms 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 protectthose at highest risk
(selective immunisation strategy)or
To eradicate, eliminate or controldisease
(mass immunisation strategy)
Currently, it is estimated that vaccination saves the lives of3 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 Achievements1
With sanitation and nutrition, vaccines are hailed as one of the most
important public health achievements of the 20th century.
The history ofvaccinologylends 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 Achievements2
At the end of the 20th century the US Centers for Disease
Control and Prevention (CDC) cited vaccination as the
number onepublic 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 orpolyvalent 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
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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Si il i i b V i d
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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 ofsafety, efficacy
and quality
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Vaccination Policy Options
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Eradication ActivitiesNew Vaccine
Introduction
Outbreak vs. routine
control of epidemic
diseases
?
Newer Vaccine
Research andDevelopment
R l f di b d di i h d l d
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Role of disease burden studies in the development and
introduction of new and underutilized vaccines
Disease-Burden Studies
Disease Epidemiology
Geographical distribution
Age groups Seasonality, risk factors
Vaccine
Design
Clinical Evaluation
Study sites
Vaccination schedules
& Strategies
Vaccine Utilization
Target groups
Impact
Cost-effectiveness
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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 numberof cases
Reduce riskof infection in population
Reduce contactof susceptible to cases
Lengthening ofepidemic cycle -> honeymoon
phase
Increase in mean age of infection
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No Mass Vaccination
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Each host in contact with infected host becomes infected (with a certainprobability)
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Mass Vaccination
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Outbreak attenuated (or averted) by lackof susceptible hosts
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Impact of Mass Immunisation Programme
Annual measles notifications & vaccine coverage
Poland 1960-2000
0.0
100.0
200.0
300.0
400.0
500.0
600.0
Year 1964 1969 1974 1979 1984 1989 1994 1999
Year
0
10
20
30
40
50
60
70
80
90
100
Immunisationcoverage
(%)
Vaccination at 12-15 mo Vaccination at 6 years 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 SurveillanceVaccine 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 MeaslesEffect of Change in Incidence
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1
10
100
1000
10000
100000
1000000
Pre-vaccine Low coverage High coverage Near elimination
Numberofcases
0%
20%
40%
60%
80%
100%
PV+
Non-measles Genuine measles
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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 ofpoor coverage
Compare with disease epidemiology
Estimate vaccine effectiveness
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Steps on Vaccine Development1
Recognize the disease as a distinct entity
Identify etiologicagent
Grow agent in laboratory
Establish in animal modelfor disease
Identify an immunologic correlate for immunity to the disease- usually
serum antibody
Inactivate or attenuate the agent in the laboratory- or choose antigens
Preparecandidate vaccine following GOOD manufacturing Procedures
Evaluatecandidate vaccine(s) for ability to protect animals
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Steps on Vaccine Development2
Prepareprotocol(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- Safetyand immugenicity
Phase III trials- Efficacy
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Steps on Vaccine Development3
Submit Product LicensureApplication MCC approval
Advisory Committees review and make recommendations
Marketing Post- Licensure Surveillance for safety and effectiveness
(Phase IV) Long and Complicatedprocess
Usually takes 10-15 years
Manyvaccine candidates fail for every success
Costs: $100- $700million per successful vaccine
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Vaccine Evaluation
Pre-licensingRandomised, Blinded,
Controlled Clinical Trials
Vaccine efficacy:Protective Effect under
Idealised Conditions
RCT: controlled experiments,
simple interpretation
Post-licensingObservational Studies
Vaccine effectiveness:Protective Effect underOrdinary Conditions of apublic health programme
prone to bias, more complexinterpretation
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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
VE (%) = (ARU-ARV) X 100ARUWhere
and
Consequently, VE = 1-RR (preventive fraction)
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ARU
ARU
1ARV
ARU
RR
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0,9 0,2
0,9VE= = 78%
Vaccinated
IV
= 2/10 = 0,2
IU
= 9/10 = 0,9
Unvaccinated
Basic Calculation of VE
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Methods to Assess VE
Pre-licensure: Randomised control trial (RCT)
Post-licensure:Observational/Field investigation
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
10/10/2011 Vaccinology. 43
RelationshipbetweenVE,PPVandPCV
0
0.2
0.4
0.6
0.8
1
0.5 0.6 0.7 0.8 0.9 1
Proportionofpopulationvaccinated
Proportion
ofc
ases
vaccinated
VE=60%
VE=80%VE=90%
VE=95%
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Potential Pitfalls....
Case definition;
Vaccine history;
Case ascertainment;
Comparability of vaccinated/unvaccinated groups.
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Methodological Issues: Case Definition1
Lower specificity: Case definition based only on clinical
criteria may result infalse-positive diagnoses
ARV > ARU
VE (%) = (ARU-ARV) X 100
ARU
artificial reduction in VE
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Methodological Issues: Case Definition2
Changes in MUMPS vaccine effectivenessCase definition
Diagnosis by school nurse
ARV 18% (12/67) 89
ARU 28% (77/272) 25% (68/272)VE 37% 52%
Kim Farley et al 1985 AJE
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Changes in MUMPS vaccine effectiveness
Case definition
Diagnosis by school nurse Parotitis > 2 days
ARV 18% (12/67) 12% (8/67)
ARU 28% (77/272) 25% (68/272)
VE 37% 52%
Kim Farley et al 1985 AJE
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Methodological Issues: Case Definition2
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Methodological issues: Vaccine History Ascertainment
Avoid misclassification of vaccination status
Equal effort to confirm vaccination statusamongst 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 toevaluate vaccine programmes
Source of data and case definitions change
with stage of vaccination programme
Monitoring VE is integral
VE can be carefully estimated from routinedata
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Lets 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 groupdid 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 didnt know; only
the statisticians knew
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Experimental Results
Looks promising but is it significant?
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Size Rate
Treatment 200,000 28
Control 200,000 71
Total 400,000 99
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Analysis: The Devils Advocate
Lets play the devils advocate. Lets 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
200000
400000
200000x x
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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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Todays 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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S f t M it i
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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
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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-Barr 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-Barr 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 Risk4 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-Barr 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
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Reporting Immunization Requirements
Documenting administration of vaccine
Documenting record of immunization
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Reporting immunization requirements: Documentingadministration of vaccine Content
Name and address ofvaccine
Medicare number
Date of birth and gender
Date ofadministration
Name and lot number ofvaccine
Name ofimmunizer
Other data as required
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Reporting immunization requirements: Documentingadministration 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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I i ti ti t d d V i
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Immunization practice standards: Vaccinemanagement-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
79
Immunization practice standards Informed
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Immunization practice standards Informedconsent
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 standardsInformed 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 standardsAdministration of vaccine
Intramuscular injection
IM in vastus lateralis
(Birth to 18 months)
IM in deltoid
(18 mths and over)
10/10/2011 Vaccinology. 82Source : http://www.health.gov.nl.ca/health/publications/immunization/S4/
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Immunization practice standardsAdministration 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
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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
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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
CDC Unit faxes form to PHAC
Refer to NB Immmunization Handbook
Immunizers: informclients to call PH ifsevere or unusual
reactions in the 4weeks following
vaccination.
Immunization practice standards Reporting AEFI -
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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
Immunization practice standards
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Immunization practice standardsReporting 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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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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Occupational health issues
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Reliable web sites
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CDC Vaccines and Immunization
Contact Information Telephone 800.CDC.INFO
Email [email protected]
Website
www.cdc.gov/vaccines
Vaccine Safety
www.cdc.gov/od/science/iso
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Promote Epidemiology Training & Research
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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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R f
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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 practicesan intro uctory primer. Vaccine 23 (2005):
20952103
NB Immunization Handbook, sections IV-III, IV-IV
http://www.who.int/immunization_monitoring/routine/EPI_coverage_survey.pdfhttp://www.who.int/immunization_monitoring/routine/EPI_coverage_survey.pdf