VACCINES & IMMUNISATION I. M. GEMMILL, MD, CCFP, FRCP(C) Dr. I. M. Gemmill Medical Officer of Health KFL&A Public Health Kingston, Canada Associate Professor

VACCINES & IMMUNISATIONVACCINES & IMMUNISATION

I. M. GEMMILL, MD, CCFP, FRCP(C)

Dr. I. M. Gemmill

Medical Officer of Health KFL&A Public Health

Kingston, CanadaAssociate Professor

Department of Community Health & EpidemiologyDepartment of Family Medicine, Queen’s University

Hosted by Paul [email protected]

A Webber Training Teleclass

OBJECTIVES To describe the value of vaccines in reducing the To describe the value of vaccines in reducing the

morbidity and mortality from communicable diseasesmorbidity and mortality from communicable diseases To describe the various types of vaccines, desirable To describe the various types of vaccines, desirable

qualities in a vaccine, their components and how they qualities in a vaccine, their components and how they workwork

To describe correct storage, handling, administration and To describe correct storage, handling, administration and documentation of immunisationdocumentation of immunisation

To describe the nature of side effects of vaccines and to To describe the nature of side effects of vaccines and to distinguish between real and alleged side effectsdistinguish between real and alleged side effects

To communicate effectively with vaccine recipients and To communicate effectively with vaccine recipients and their parents about the benefits and risks of vaccinestheir parents about the benefits and risks of vaccines

To outline reputable and disreputable sources of To outline reputable and disreputable sources of information on immunisationinformation on immunisation


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COST BENEFIT OF VACCINE

‘‘Vaccination programmes are considered to be the most cost-Vaccination programmes are considered to be the most cost-beneficial health intervention and one of the few that beneficial health intervention and one of the few that systematically demonstrate far more benefits than costs.’systematically demonstrate far more benefits than costs.’

Intervention Cost per Life Year Saved

MMR vaccine for children : < 0$

Mammography > 50 : 810$

Smoking cessation advice (> 1 ppd) : 9800$

Low cholesterol diet (men >20, >180 mg/dl) : 360.000$


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POLIO INCIDENCE 1949-1995


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DIPHTHERIA CASES 1924-1995


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TETANUS DEATHS 1924-1995


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MEASLES INCIDENCE 1924-1995


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RUBELLA CASES 1924-1995


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IMPACT OF VACCINES ON COMMUNICABLE DISEASES IN

CANADA

DISEASE Before vaccine* 2001

Diphtheria 9000 0

Polio 20.000 0

Measles 300.000 33

Rubella 69.000 23

*Number of cases in an outbreak year


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TYPES OF IMMUNISATION

Active immunisation: the formation of antibodies in response to an antigenic

stimulus protection tends to be long-term

Passive immunisation: the administration of preformed antibody, from a

human or animal source, to provide short-term protection against disease

e.g. gamma globulin, specific immune globulin


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QUALITIES OF A GOOD VACCINE

Effective immunogenicity:

induces antibodies in individuals efficacy

reduces disease in populations duration of protection:

need for boosters is limited


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Safe common side effects are mild serious side effects are rare does not cause disease not transmissible to others


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Ease of administration injectable

needle jet injector

nasal spray oral edible


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Stability Freezer stable Fridge stable Stable at room temperature


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Cost Older vaccines cost a few dollars per

dose Newer vaccines enter the market at

60$ per dose or higher Competition brings the price down


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HOW DO VACCINES WORK?

Vaccines cause the immune system to provide protection against disease without causing disease

They stimulate an immune response to provide protective antibodies, memory cells, or both


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NEW VACCINE DEVELOPMENT

Vaccines go through a number of processes: Bench research Animal trials Clinical trials for safety & efficacy Licensure National expert recommendations Field use: private pay or provincial

programme


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VACCINES MANUFACTURING

Vaccines are among the most rigorously controlled medical products:

Production & purification of the desired antigen Inactivation or disruption Sterilisation Packaging & preservatives


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TYPES OF VACCINES

Live vaccines: measles, mumps, rubella varicella yellow fever oral polio vaccine (Sabin) BCG


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TYPES OF VACCINES

Killed vaccines, whole cell: polio rabies hepatitis A

Killed vaccines, particles: pertussis influenza


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TYPES OF VACCINES

Killed vaccines, polysaccharide: meningococcal pneumococcal

Killed vaccines, conjugated: meningococcal pneumococcal haemophilus influenzae


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TYPES OF VACCINES

With live vaccines, a small amount of vaccine virus is administered

The vaccine virus replicates, thereby mimicking the disease process more closely

The protection that they provide is generally therefore longer-lasting and requires fewer total doses

The fact that live virus replicates in this process means that these vaccines have special precautions : Pregnancy People whose immune status is compromised Cold chain must be respected


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TYPES OF VACCINES

With vaccines that are not live, the total dose administered is all that the immune system has to work with

Some vaccines therefore have adjuvants or protein carriers to make them more immunogenic


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COMPONENTS OF VACCINES

Vaccines contain: Antigens to induce an immune response

Vaccines may also contain: Adjuvant: aluminium hydroxide Preservatives: thimerosal Antibiotics: neomycin Other stabilisers: albumin


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VACCINE INDICATIONS

Indications for use are based on epidemiological risk

May be for universal use e.g. pertussis May be for targeted populations e.g. travel,

lifestyle May be for pre-exposure (routine) use May be for post-exposure (outbreak control) use

e.g. hepatitis A Refer to national expert statements for indications,

rather than product monographs


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VACCINE SCHEDULES

Every vaccine has a schedule of administration

The schedule is determined by clinical trial design and post-marketing research

The product monograph is a legal document providing the most conservative approach to vaccine use

Recommendations of expert bodies are the most valid sources for reference for vaccine use


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VACCINE SCHEDULES

Some vaccines have more flexible schedules than others : hepatitis B vaccine vs. conjugated

pneumococcal

Schedules need to accommodate the requirements and precautions for all vaccines that are recommended e.g. timing of live virus vaccines


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IMMUNE MEMORY AND THE NEED FOR BOOSTERS

There are two ways in which vaccines protect: Antibodies are produced that may last for years Memory cells may be produced, that create

antibodies quickly in response to an antigenic challenge

We judge vaccines by antibody, but they may protect through the second mechanism


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Some vaccines need only one dose for lasting protection Conjugated meningococcal vaccine in adults

Most vaccines need more than one dose to be fully effective

Some vaccines need regular boosting throughout life Toxoids: tetanus & diphtheria


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Live virus vaccines may need less doses in general because they mimic the disease process better

Oral polio requires more than one dose because one of the three types predominates with ease dose

Some vaccines just work incredibly well after two or three doses hepatitis A, inactivated polio


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VACCINE ADMINISTRATION

There are several ways to administer vaccines: IM SC (usually live virus vaccines) Oral ID

The route of administration is specific to each vaccine.

It is essential to check and be sure of the route of administration for a given vaccine.


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Technique: Use the right-sized needle (e.g. 1 inch for adult

I.M.) Deltoid for adults and older children Anterolateral surface of the thigh for infants and

young children No gluteal injections Sharp needles only


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Technique: Cleanse the area with alcohol and let it evaporate Separate needle and syringe for each injection Aspirate Practise doing it quickly, so that patients are less

uncomfortable


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VACCINE TIPS

Prophylactic use of antipyretics may decrease minor side effects

Interruption of the recommended schedule does not usually mean restarting (exception: conjugated pneumococcal)

Giving a vaccine after too short an interval is a problem

Recommended vaccine dosage should NEVER be reduced

Prematurity does not affect vaccines schedules


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STORAGE & COLD CHAIN

The storage requirements may vary from vaccine to vaccine

Storage requirements must be respected Some vaccines can undergo one insult without loss but no

insult to the vaccine is preferred Live virus vaccines are generally more susceptible to insult

that others The prime example is fridge failure In general, most vaccines are kept at 2 to 8° C


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IMMUNISATION RECORDS

Every immunisation event should be recorded on the patient’s chart and a record provided to the vaccinee

Immunisations are reportable in some provinces

Provincial systems vary from province to province but are not connected

There is currently no national system to keep track of immunisations


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VACCINE SAFETY MONITORING

Vaccines are probably the best monitored of all medical interventions

The process of licensing vaccines is rigorous (average 2 years)

There is a requirement to report possible AVEs in most provinces

Companies conduct post-marketing surveillance Immunisation Monitoring Programme ACTive (IMPACT) Advisory Committee on Causality Assessment (ACCA)


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VACCINE CONTRAINDICATIONS

The only true contraindication to any vaccine is a previous anaphlylactic reaction or severe hypersensitivity to any component of the vaccine.


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VACCINE CONTRAINDICATIONS

Contraindications to live virus vaccines: Pregnancy:

although no birth defect has ever been recorded

may have to balance risk versus benefit e.g. Yellow Fever vaccine

Some immunodeficiency states


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VACCINE SIDE EFFECTS

SIDE EFFECTS INCLUDE: Local (at the injection site):

Swelling, induration, tenderness, erythema

Systemic (examples): Fever, rash, arthralgia, myalgia, Severe: anaphylaxis, GBS


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Common side effects are generally milder

Serious side effects are generally rare

Side effects may vary from vaccine to vaccine, based on the components

Some side effects are simply owing to the injection


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Every medical intervention has risks Vaccines are no exception Patients must be informed about risks and

side effects Informed consent for immunisation is a

requirement


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CONDITIONS THAT ARE NOT DUE TO VACCINES:CONDITIONS THAT ARE NOT DUE TO VACCINES:

Chronic fatigue syndrome (hepatitis B vaccine)Chronic fatigue syndrome (hepatitis B vaccine) Multiple sclerosis (hepatitis B vaccine)Multiple sclerosis (hepatitis B vaccine) Autism (MMR vaccine, vaccines containing thimerosal)Autism (MMR vaccine, vaccines containing thimerosal) Ulcerative colitis (MMR vaccine)Ulcerative colitis (MMR vaccine) Brain damage (pertussis vaccine)Brain damage (pertussis vaccine) SIDS (many vaccines)SIDS (many vaccines)


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VACCINE PRECAUTIONS

There are precautions for giving any medical There are precautions for giving any medical intervention, including vaccinesintervention, including vaccines

Precautions are specific to the vaccinePrecautions are specific to the vaccine Example:Example:

Live virus vaccines must be given at the same Live virus vaccines must be given at the same time or with an interval of at least 28 daystime or with an interval of at least 28 days


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VACCINES IN PREGNANCY

Live virus vaccines are contraindicated in pregnancy Live virus vaccines are contraindicated in pregnancy because of the theoretical risk of congenital anomalybecause of the theoretical risk of congenital anomaly

Inadvertent immunisation of a pregnant woman with a live Inadvertent immunisation of a pregnant woman with a live virus vaccine should be reported for monitoring purposesvirus vaccine should be reported for monitoring purposes

Other vaccines may be used safely in pregnancyOther vaccines may be used safely in pregnancy Risk versus benefit must be consideredRisk versus benefit must be considered Some vaccines are indicated in pregnancy :Some vaccines are indicated in pregnancy :

influenzainfluenza


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VACCINE RISK VERSUS BENEFIT

Every vaccine as some small risk attached to itEvery vaccine as some small risk attached to it The benefit of vaccine normally far outweighs any riskThe benefit of vaccine normally far outweighs any risk Sometimes, it is better to respect even a theoretical risk Sometimes, it is better to respect even a theoretical risk

e.g. live virus vaccine in pregnancye.g. live virus vaccine in pregnancy Example: YF vaccine in immunocompromised travellersExample: YF vaccine in immunocompromised travellers If the risk outweighs the benefit, vaccine should not be If the risk outweighs the benefit, vaccine should not be

administered e.g. smallpox vaccineadministered e.g. smallpox vaccine


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COMMUNICATING RISK VERSUS BENEFIT

The advice of a health professional is the most important The advice of a health professional is the most important factor in whether a person receives a vaccinefactor in whether a person receives a vaccine

Clear, simple, concise information must be provided about Clear, simple, concise information must be provided about both the risks and the benefits of vaccines (CMPA policy both the risks and the benefits of vaccines (CMPA policy on pneumococcal & meningococcal vaccines)on pneumococcal & meningococcal vaccines)

Some people may need more detailed explanations than Some people may need more detailed explanations than othersothers

Public health and professional bodies can helpPublic health and professional bodies can help


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MYTHS ABOUT VACCINES

Common myths about vaccines:Common myths about vaccines: Vaccines don’t really workVaccines don’t really work Vaccines aren’t safeVaccines aren’t safe We don’t need vaccines because the diseases are rareWe don’t need vaccines because the diseases are rare There are too many anThere are too many anttiigensgens given to children now given to children now Vaccines weaken the immune systemVaccines weaken the immune system A healthy lifestyle is all one needs to prevent infectionA healthy lifestyle is all one needs to prevent infection There is an industry conspiracy to poison children for There is an industry conspiracy to poison children for

profitprofit


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ANTI-VACCINATIONISTS

There is a small group of zealots who are opposed to vaccineThere is a small group of zealots who are opposed to vaccine

They believe that vaccines are unsafe and subscribe to They believe that vaccines are unsafe and subscribe to conspiracy theories about themconspiracy theories about them

They are willing to spread untruths about vaccines publiclyThey are willing to spread untruths about vaccines publicly

They may cause damage to public programmes :They may cause damage to public programmes : hepatitis B in Manitoba, Francehepatitis B in Manitoba, France


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There are many books published and web There are many books published and web sites maintained by the anti-vaccine factionsites maintained by the anti-vaccine faction

Many have respectable names and purport to Many have respectable names and purport to be authoritativebe authoritative

Some are supported by health Some are supported by health paraprofessionalsparaprofessionals


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Web sites to checkWeb sites to check : : Vaccine Risk Awareness Network

http://64.41.99.118/vran/membership/contact_us.htm

National Vaccine Information Centrehttp://www.909shot.com/

Children of God for Lifehttp://www.cogforlife.org/

Dr. Joseph Mercola

http://www.mercola.com/article/vaccines/death.htm


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RELIABLE VACCINE WEB SITES

Web sites to check : Canadian Public Health Association

http://www.immunize.cpha.ca/english/links.htm

Public Health Agency of CanadaPublic Health Agency of Canada

http://www.phac-aspc.gc.ca/dird-dimr/immunization_e.html

United Kingdom Department of Healthhttp://www.immunisation.nhs.uk/


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RELIABLE VACCINE WEB SITES

Web sites to check :

World Health OrganisationWorld Health Organisation

http://www.who.int/vaccines/

Centres for Disease Control & PreventionCentres for Disease Control & Prevention

http://www.cdc.gov/nip/


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VACCINES ARE NOT JUST FOR KIDS

People have the impression that vaccines are People have the impression that vaccines are primarily for childrenprimarily for children

While vaccines do prevent disease in children, there While vaccines do prevent disease in children, there are many vaccines that adults need:are many vaccines that adults need: Routine : tetanus, diphtheria, pertussisRoutine : tetanus, diphtheria, pertussis Lifestyle : hepatitis A & BLifestyle : hepatitis A & B Travel : YF, typhoid, hepatitis A, etc.Travel : YF, typhoid, hepatitis A, etc.


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VACCINES ARE NOT JUST FOR KIDS

Other occupations :Other occupations : Health care provider : hepatitis B, MMR, influenzaHealth care provider : hepatitis B, MMR, influenza Vets : rabies. hepatitis AVets : rabies. hepatitis A Zookeepers: hepatitis A vaccineZookeepers: hepatitis A vaccine Staff of some institutions: hepatitis A & BStaff of some institutions: hepatitis A & B Prison guards : hepatitis BPrison guards : hepatitis B Lab workers : many vaccinesLab workers : many vaccines Military : many including anthrax, plagueMilitary : many including anthrax, plague


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The Next Few 2006 TeleclassesThe Next Few 2006 Teleclasses

April 20 Secrets from the CBIC Test Committee… A free teleclass

April 27 Evaluation and Comparison of Quality Management Systems - ISO, Six Sigma, Baldridge, Toyota Production Model… with Dr. Tammy-Sue Lundstrom

May 16 Product Evaluation and Selection… with Robert Garcia (A British Teleclass)

For the full teleclass schedule – www.webbertraining.comFor the full teleclass schedule – www.webbertraining.com

Documents

VACCINES & IMMUNISATION I. M. GEMMILL, MD, CCFP, FRCP(C) Dr. I. M. Gemmill Medical Officer of Health KFL&A Public Health Kingston, Canada Associate Professor