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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

10/10/2011 Vaccinology. 1

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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:

[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)

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


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


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


Each host in contact with infected host becomes infected (with a certainprobability)

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Mass Vaccination


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


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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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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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)


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


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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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: 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?


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.


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


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


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


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

10/10/2011 Vaccinology. 7676

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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.

10/10/2011 Vaccinology. 7777

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Immunization Practice Standards

Vaccine management

Informed consent

Administration of vaccine

Documentation

Anaphylaxis management

Reporting of adverse events


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


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


Immunization practice standards

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86 10/10/2011 Vaccinology. 86

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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87 10/10/2011 Vaccinology. 87

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

http://www.cdc.gov/vaccineshttp://www.cdc.gov/vaccineshttp://www.cdc.gov/vaccineshttp://www.cdc.gov/vaccines

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88 10/10/2011 Vaccinology. 88

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


Occupational health issues

R li bl b it

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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

http://www.cdc.gov/vaccineshttp://www.cdc.gov/vaccines

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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


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

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