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Vaccines The Building Blocks for Immunity
Saumil Patel, Pharm. D., BCPS Pediatric Pharmacotherapy Specialist Tampa General Hospital
57
Pharmacology
Professional
09/03/2013
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Term
Passive Immunity
 Definition
Acquired immunity via:
„« Antibody or immunoglobulin administration
„« Maternal
Maternal-fetal transfer
„« Transfer via breast milk
ƒÞ
Ideal for:
„« persons with active disease or exposure
„« maintenance of immunity of
immunodeficient or immunocompromised
persons
ƒÞ
Immediate immunity
„« Con = temporary immunity
Term
Active Immunity
 Definition

Immunity “activated” via administration of antigens
 Vaccines
 Toxoids

To develop full immunity, requires
 Adequate timing
 Series of vaccines

Results in longer lasting immunity
 May require periodic boosters
Term
Vaccines- Types
 Definition

Various types/forms of vaccines:
 Live
or Inactivated
 Polysaccharide
or conjugate vaccines
 Vaccines
or toxoids
 Vaccines
or immunoglobulins

Type of vaccine = Impact on immunity
 Active vs. passive immunity
 Short vs. long lasting immunity
 Adverse effects
Term
Vaccines
- Attenuated (Live)
 Definition

Pathogens with reduced virulence
 Immune response stimulated

May result in:
 Seroconversion post single dose
 Induced
“infections infections” varying from the mild
to full disease form
 Typically results in lifelong immunity

In pts age > 1 year
Term
Vaccines
– Inactivated (Killed)
 Definition

Either contain inactivated/killed form of whole-agent or subunits of the target pathogen
 In general, safer than live vaccines

Series of booster doses required to maintain a effective long-lasting immunity

Often contain adjuvants
 Chemicals that
↑ effective antigenicity
Term
Vaccines
- Toxoids
 Definition

Inactivated bacterial toxins
 Chemically or thermally modified
 Stimulate antibody
antibody-mediated immunity
 Target toxoids rather than pathogen
 Typically as aluminum salt forms
 Enhance antigenicity

Require multiple doses because they possess few antigenic determinants

ONLY useful for few bacterial diseases
Term
Vaccines
- Conjugates
 Definition

Protein-polysaccharide conjugate

Target = infant immunogenicity
 Stimulate T
T-cell response
  immunity response in infants via
 Memory
cytotoxic T cells
 Memory helper T cells
 Post vaccine exposure = booster effect
 Either via revaccination or natural exposure
Term
Vaccines
- Polysaccharides
 Definition

Plain polysaccharide component
 2 saccharides and 1 phosphate molecules

Stimulate T-cell-independent immune response
 B-cell proliferation and antibody response

Concerns
 Lack of response in age < 2 years
  immune response post repeat dosing
 Minimal impact on nasal carriage of bacteria
Term
Vaccines
- Immunoglobulins
 Definition

Extracted human immunoglobulins

Reserved for:
 Post exposure immunity
 Rabies, Hepatitis B, Measles, Varicella
 Treatment of disease
 Tetanus
 Provision of passive immunity
 Prophylaxis to dz
– CMV Ig prior to BMTCMV BMT
 Prior to travel to high risk/endemic areas

Examples
 Cytomegalovirus Ig (CMVIG)
 Hepatitis A Ig
 Hepatitis B Ig (HBIG)
 Rabies Ig (RIG)
 Synargis (RSV
RSV- IGIV)
 Tetanus Ig (TIG)
 Varicella zoster Ig (VZIG)
Term
Immunization Schedule - Traditional mainstays
 Definition
 DTP
 MMR
 Hepatitis B
 Hib
 Pneumococcal
 Influenza
Term
Immunization Schedule - Recent additions
 Definition
 Meningococcal
 Hepatitis A
 Tdap
 Varicella
 HPV
 Rotavirus vaccine
Term
DTaP
 Definition
Inactivated bacterial
Diphtheria/Tetanus/Pertussis
Term
Tdap
 Definition
Inactivated bacterial
Diphtheria/Tetanus/Pertussis
Term
TD/DT
 Definition
Inactivated bacterial toxoids
Diphtheria/Tetanus/Pertussis
Term
Td
 Definition
Inactivated bacterial toxoids
Diphtheria/Tetanus/Pertussis
Term
TT
 Definition
Inactivated bacterial toxoids
Diphtheria/Tetanus/Pertussis
Term
Diphtheria/Tetanus/Pertussis Target
 Definition
 Diphtheria
 Corynebacterium diptheriae
 Tetanus
 Clostridium tetani
 Pertussis
 Bordetella pertussis
Term
Diphtheria
 Definition
 Toxin mediated illness
 Myocarditis, neuritis, thrombocytopenia,
respiratory failure, and death
Term
Tetanus
 Definition
 Transmission via environment
 Interrupts neurotransmitters
 Muscle spasms, lockjaw, CNS complications
Term
Pertussis
 Definition
 Variable severity and prognosis
 Cyclic pattern
- epidemic nature
 Disease progression
 Catarrhal phase
 Paroxysmal phase
aroxysmal  Convalescent phase
 Progressive flu like s/sx leading to classic
whooping cough
Term
Current vaccines - Diphtheria
 Definition
 DTaP
– 5 dose series in infant early childhood
 10 year immunity
 Tdap
 Minimum age 10 years for Boostrix
®
 Minimum age 11 years for Adacel
®
 DT
– pediatric strength booster
 Td
– adult strength booster - every 10 years
 Unimmunized adult
- 3 dose series
Term
Current vaccines - Tetanus
 Definition
Tdap
 Tetanus & diphtheria toxoids & pertussis
vaccine
 Minimum age = 10 years
 Td
 Tetanus/diphtheria
toxoid
 Adult formulation
 TT
 Tetanus
toxoid
 May be used for adults or children
Term
Current vaccines - Pertussis
 Definition
 Single dose booster (post DTaP series)
 2008 recommendations:
 ALL age 11
11-12 years
 Catch
Catch-up dose for ages 13 13-18 years
 For all ages > 18 years previously vaccinated with
Td
 With a suggested 5
5-year gap between the
Tdap and Td
Term
Haemophilus influenzae type b (Hib)
 Definition

Vaccine Type
 Inactivated bacterial, conjugate

Target
 Haemophilus influenzae (type b b)

Disease clinical manifestations
 Pneumonia, meningitis, sepsis, etc
 High infant/pediatric mortality
 Post vaccination era, 99%
 in disease
Term
Haemophilus influenzae type b (Hib) Current vaccines
 Definition
Conjugate vaccine introduced in 1995
 Primarily for children under age of 5 years
 Natural immunity if > 5 years
 3-dose childhood primary vaccination series
 Single dose for high risk groups
with partial
or unvaccinated status
 Leukemia or malignant neoplasms
 Anatomic or functional asplenia
 Immunocompromised conditions
Term
Hepatitis A
 Definition

Vaccine Type
 Inactivated viral

Target
 Hepatitis A virus (HAV)

Disease clinical manifestations
 Most common hepatitis prior to 2004
 Fatigue, loss of appetite, N/V, abdominal pain
 Dark urine, clay
clay-colored BM
 Joint pain, jaundice
Term
Hepatitis A Current vaccines
 Definition
 2013 Recommendation:
 2 dose vaccination series
 Dose # 1 at 1 yr (dose = 0.5 mL)
 Dose # 2
six months after first dose (dose = 1 mL)
 Certain high
high-risk adolescents
Term
Hepatitis B
 Definition
Vaccine Type
 Inactivated viral (recombinant)

Target
 Hepatitis B virus (HBV)
epatitis 
Disease clinical manifestations

Flu-like s/sx

Dark urine, jaundice

Hepatomegaly, liver failure

Hepatocellular carcinoma and death
Term
Hepatitis B Current vaccines
 Definition
 2 main vaccine manufacturers
 3 vaccine formulations
 Pediatric formulations
 Adults formulations
 Dialysis formulations
 Dose volumes defer
 Formulations sometimes NOT interchangeable
Term
Human Papilloma Virus (HPV)
 Definition
Vaccine Type
 Inactivated viral

Target
 Coverage = 4 types of HPV
 2 types that cause 70% of cervical cancers
 2 types that cause 90% of genital warts

Disease clinical manifestations
 Most common sexually transmitted
infection
in the US
 > 6 million NEW infections/year
Term
Human Papilloma Virus (HPV) Current vaccines
 Definition

Current vaccines
 Gardasil
 Quadrivalent (types 6, 11, 16, 18)
 Licensed for
males and females 9 through 26
years.
 Cervarix
– Bivalent
 Bivalent (types 16, 18)
 Licensed for females 10 through 26 years
 Added as a recommendation in 2007
 3 dose schedule (at 0, 1 to 2, 6 months)

Recent concerns/controversies
 Safety of the vaccines
 Long
Long-term effects
 Moral objectives and perceived
 risk of
promiscuity in adolescents
 Need for long
long-term boosters
 Cost (3
3-dose series ~ $360)
 Especially for males
Term
Influenza
 Definition
Vaccine Type
 Inactivated
influenza vaccine (IIV IIV)
 Live -attenuated influenza vaccine (LAIV)

Target
 Vaccine based off projected
“problematic problematic”
serotypes for 2013 2013-14 season
 2013
2013-14 influenza vaccine antigens:

A/California/7/2009 (H1N1)-like

A/Victoria/361/2011 (H3N2) – like

B/Massachusetts/2/2012–like (new)

B/Brisbane/60/2008-like
Disease clinical manifestations
 Common
“flu flu” like s/sx
 Fever/chills/cough/sore throat/HA
 Runny or stuffy nose
 Muscle/body aches or fatigue
 Vomiting and diarrhea
 Severe illness
 Pneumonia
 Life
Life-threatening complications
 Death
Term
Influenza Current vaccines
 Definition
ACIP recommendations
 Inactivated Influenza Vaccine
(IIV IIV) *

Trivalent = preferred

Injection(3 types) -match age with vaccine product
 Live
Live-attenuated influenza vaccine (LAIV)

Intranasal

Quadrivalent

For age ≥ 2 to 49 years

Do NOT use in high risk group
General vaccine criteria

ALL children ≥ 6 months of age

Postpartum and breastfeeding moms

ALL household and caregivers

ALL healthcare personnel

MUST immunize HIGH risk pts

asthma/chronic lung/cardiac conditions

SCD, DM and immunosuppression

neurologic conditions (new)
Age-based dosing

Age 5 months and less

Do NOT administer vaccine

Age 6 months to 8 years

See dosing algorithm (next slide)

Dose for age 6-35 months = 0.25 mL

Dose for age ≥ 36 months dose = 0.5 mL

Age 9 years and greater

0.5 mL
Term
Measles
 Definition
Vaccine Type
 Live attenuated viral

Target
 Measles rubeola

Disease clinical manifestations

Rash all over the body

Red eyes, rhinorhea, fever, cough

Severe forms = pneumonia, encephalitis
Term
Mumps
 Definition
Vaccine Type
 Live attenuated viral

Target

Mumps virus

Disease clinical manifestations

Reactive inflammatory processes

Lymphadenopathy and jaw swelling

Testicles (occasional sterility)

CNS

Deafness and brain damage
Term
Rubella
 Definition
Vaccine Type
 Live attenuated viral

Target
 Rubella virus

Disease clinical manifestations

Rash (German measles)
 F, malaise, lymphadenopathy, and URI s/sx
 Joint pain
Term
MMR Current vaccines
 Definition

M-M-R II (MMR)

ProQuad (MMRV) – includes Varicella

Minimum age = 1 year

Exception = outbreak containment

2 vaccine series4 to 6 years

1st dose at 12 to 15 months

2nd dose at 4 to 6 years
Term
Meningococcal Vaccine
 Definition

Vaccine Type
 Inactivated bacterial

Target
 Neisseria meningitidis

Disease clinical manifestations
 Meningitis and sepsis
 Highest risk
= infants & teenagers
 Commonly result in localized
“out breaks breaks”
 College freshmen dormitories
 Crowded living spaces
Term
Meningococcal Vaccine Current vaccines
 Definition
Menectra
®
 Meningococcal
conjugate vaccine (MCV4)

Route = IM
 1° target vaccination group
 Age 11 to 18 years routine vaccination
 Other target vaccination groups
 Age Range 9 to 23
months
 Complement component deficiency
 Age 2 to 10
years AND age 19 to 55 years
 Complement component deficiency
 Functional or anatomic asplenia

Menveo®
 Meningococcal
conjugate vaccine (MCV4)

Route = IM
 1° target vaccination group
 Age 11 to 18 years routine vaccination
 Other target vaccination groups
 Age 2 to 10
years AND age 19 to 55 years
 Complement component deficiency
 Functional or anatomic asplenia

 Menomune
®
 Meningococcal
polysaccharide vaccine (MPSV4)

Route = SC
 Target vaccination groups
 Age 56 years and older
 If given in error to age 2 to 55 years, then follow
follow-
up with conjugate booster
Term
Pneumococcal Vaccine
 Definition
Vaccine Type
 Inactivated bacterial

Target
 Streptococcus pneunomiae

Disease clinical manifestations
 Highest risk = < 2 years and > 65 years
 URI, sinusitis, AOM, pharyngitis, pneumonia
 Bacteremia, meningitis, and sepsis
Term
Pneumococcal Vaccine Current vaccines
 Definition
 2 types of vaccines
 Pneumococcal Conjugate Vaccine (PCV13)
 Prevnar
®
 Pneumococcal Polysaccharide Vaccine (PPSV23)
 Pneumovax
®
 Caution: NOT interchangeable
Term
Pneumococcal Conjugate Vaccine (PCV)
 Definition
Current PCV covers 13 serotypes

Significant  invasive pneumococcal dz

1° target vaccination group
 Age 23 months and less
 Routine childhood vaccination series
 4 dose series

Other target vaccination groups
 Age 24 to 59 months
 SCD, splenic dysfunction, HIV, chronic illnesses
and immunocompromised
Term
Pneumococcal Polysaccharide Vaccine (PPSV23)
 Definition

Current PPSV covers 23 serotypes

1° target vaccination groups
 Age
≥ 65 years (ever
 Age 2 to 64 years
 CHF, cardiomyopathy, DM, liver dz
 Functional or anatomic asplenia
 Asthma, CLD, smokers
 Cochlear implants
 HIV, leukemia, lymphoma
 CRF or nephrotic syndrome
Term
Rotavirus
 Definition

Vaccine Type
 Live viral

Target
 Rotavirus

Disease clinical manifestations
 Leading cause of gastroenteritis in infants
 Dehydration
 Hospitalizations
 Death


Rotashield – With drawn from the market in 1999 (intussusceptions)

RotaTeq: pentavalent, oral vaccine
 3 doses at 2, 4 and 6 months of age

Rotarix: monovalent, oral vaccine
 2 dose vaccination series (6 months apart)
 Dose #1 at 6 to 14 weeks
 Dose #2 at 14 to 24 weeks
Term
Varicella A
 Definition

Vaccine Type
 Live viral

Target
 Varicella
Varicella-zoster virus

Disease clinical manifestations
 Chicken pox and cellulites
 Sever dehydration
 Pneumonia and encephalitis
Term
Varicella A Current vaccines
 Definition
 Series changed to include total of 2 doses

Dose #1 at age 12-18 months

Dose #2 at 4-6 yrs
 2008 recommendations are:

2 doses for unvaccinated child < 13 years (with a 3 month interval)

2nd dose for previously vaccinated child with 1 dose (with a 3 month interval)
Term
Immunocompromised
 Definition

Should NOT receive LIVE vaccines

May receive:
 Inactivated vaccines
 Immunoglobulins

Household contact:
 MMR, influenza, varicella, and rotavirus
vaccines are recommended
 Should
NOT receive oral polio vaccine
Term
Oncology Population
 Definition

Inactivated vaccines or Toxoids = Yes

Immunoglobulins = Yes (when necessary)

Live Vaccines = NO
 OK to give MMR to close contacts
 OK to give live vaccines to leukemia patients
3 months post last chemotherapy cycle
 Zoster vaccines at least 2 weeks prior
 Influenza vaccine 2 weeks prior or in
between cycles
Term
HIV Population
 Definition

Inactivated vaccines = Yes

Immunoglobulins = Yes (when necessary)

Live Vaccines
 MMR, Varicella, and Zoster
 should be considered for
asymptomatic or
mildly symptomatic pts
 ONLY if CD4 counts are > 200/mm
mm3
 NO to LAIV
Term
Solid Organ Transplant Population
 Definition

Best to immunize prior to transplantation

Post transplant
 NO live vaccines
 Life long immunosuppressive regimens
  response to hepatitis B vaccine
 Unpredictable response to most vaccines
Term
Stem Cell Transplant Population
 Definition

Re-immunize post transplantation
 Influenza vaccines
– 6 months post
 Inactivated vaccines
– 12 months post
 PPSV23
 Hib
 Some live vaccines
– 24 months post
 MMR
Term
Live Vaccines & Corticosteroids
 Definition

Administer if:
 Topical corticosteroids
 Physiologic maintenance doses
 Low to moderate doses
 Less than 2 mg/kg/day
or 20 mg/day

With high dose steroids:
 Course < 14 days = after end of course
 Course
≥ 14 days = wait 1 month
Term
Pregnancy
 Definition

Most vaccines = pregnancy category C

AVOID live vaccines
 Defer to postpartum
 Use immunoglobulins (when necessary)

Influenza = Must-have

Postpartum must-have = TdaP
 Passive protection to infant against pertussis
Term
Barriers to Immunizations
 Definition

Vaccine safety
 Problems associated with immunization
 Mild toxicity most common
 Risk of anaphylactic shock
 Residual virulence from attenuated viruses
 Allegations that certain vaccines cause autism,
diabetes, and asthma
 Research has not substantiated these allegations


Contraindications
 Anaphylactic rxn to vaccine or components
 Severe
febrile illness
 Severe
immunodeficiency (Live vaccines)
 Pregnancy (Live vaccines)

Misconceptions of contraindications:
 Mild acute illness (Fever)
 Concurrent antibiotic therapy
 Pregnancy & breastfeeding


Low socioeconomic status
 Lack of education/understanding

Concerns of potential AEs
 Pain/discomfort
 Nerve damage
 Injection site infection
 Guillain
Guillain-Barr Barré Syndrome (GBS)
 Autism
Term
Vaccines and GBS
 Definition

GBS:
 1° cause = idiopathic
 2° causes = surgical and immunizations

Possible association with:
 Influenza vaccine
 Tetanus toxoid
toxoid-containing vaccines
 MCV4 vaccine
 HPV vaccine
Term
Autism and Vaccines
 Definition

Data with methyl mercury causing brain damage and developmental disorders

Thimerosal (ethyl mercury)

AAP & IOM review = conclude no association

No evidence of harm

US vaccines now virtually mercury-free
Term
Role of Pharmacists
 Definition

Understand the role of vaccines

Understand immunization schedules

Pharmacist’s role has evolved recently

Administration certification (optional):
 Influenza vaccine
 Pneumococcal vaccine

Criteria for certified administers:
 License = active + in good standing
 Complete Florida Board of Pharmacy
approved immunization administration
certification program
 SOP protocol under a MD supervision
 Maintain liability insurance
 Obtain approval from their employer
 Maintain CPR certification

Upon certification:
 Register with Florida SHOTS
(state registry of immunization information)
 Report immunizations administered to
Florida SHOTS
 Pharmacy must designate a certified
pharmacist to maintain the Florida SHOTS
account
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