Vaccination

Report
Wendy Rosenthal, Pharm.D.
True or False?
Vaccines are among the greatest
achievements of biomedical science
& public health.
Since widespread use of vaccines, the
annual number of cases has fallen by:
 >99%
for diphtheria, measles, poliomyelitis,
rubella, smallpox & Haemophilus influenzae
type B
 >90% for pertussis, tetanus & mumps
 >80% for hepatitis A & B & varicella
 34% for pneumococcal disease
JAMA 2007;298(18):2155-63
 Basics
of Immunity
 Active
immunity produced by vaccine
 Immunity and immunologic memory similar to
natural infection but without risk of disease
Epidemiology and Prevention of Vaccine-Preventable Diseases 9th ed
 Live





attenuated
Weakened form of the original
Must replicate in body to be effective
Generally require one dose
Severe reactions possible
Examples: measles, varicella, intranasal influenza
Epidemiology and Prevention of Vaccine-Preventable Diseases 9th ed
 Inactivated
 Composed for whole viruses or bacteria or
fractions
 Cannot replicate
 Generally require more than one dose
 Antibody titer diminishes over time
 Examples: pneumococcal, HPV, influenza
Epidemiology and Prevention of Vaccine-Preventable Diseases 9th ed
 Vaccine
Adverse Reactions
 Local
Pain, swelling, redness at injection site
 Usually mild & self-limited

 Systemic
Fever, malaise, headache
 Live attenuated vaccines: may produce mild symptoms
after incubation period of 7 – 21 days

 Allergy

Due to vaccine components
Contraindications & Precautions
Condition
Live
Inactivated
Allergy to component
C
C
Severe illness
P
P
Pregnancy
C
V
Immunosuppression
C
V
C=contraindication P=precaution V= vaccinate if indicated
Vaccine
Manufacturer
Vaccine*
Patient
Vaccine*
Provider’s
Office
Distributor
Vaccine*
*Vaccine is transported in a refrigerated or frozen
state, as appropriate (refrigerator 35° - 46°F
(2° - 8°C); freezer 5° F (-15°C) or colder) , using
an insulated container or a refrigerated truck.
Maintain freezer
temperature at
5°F (-15°C) or
colder
Maintain refrigerator
temperature at 3546°F (2-8°C)
*MMR may be stored in either
the freezer or refrigerator
MMR*
Varicella
Herpes Zoster
DTaP, DT, Td
Tdap, Hib,
Hepatitis A,
Hepatitis B, HPV,
Influenza (TIV &
CAIV-T)
IPV, MMR*
Meningococcal
Pneumoccal (PPV & PCV)
http://www.cdc.gov/nip/recs/adult-schedule.htm#chart
 Almost
16 million cases per year in the U.S.
among people <20 years of age
 About 4.5 million per year in the U.S. among
the elderly
 Influenza-related pulmonary and circulatory
deaths


1990–1999: average 36,000
Rates of death/100,000



0.4–0.6 aged 0–49 years
7.5 aged 50–64 years
98.3 aged ≥65 years
JAMA. 2003;289:179–86.
 Single-stranded
 Three



Moderate to severe illness
All age groups
Subtypes determined by surface antigens: hemagglutinin
& neuraminidase
Type B



strains
Type A


RNA virus
Milder diseases
Primarily affects children
Type C

Rarely reported in humans
 Antigenic



Occur only in type A
Drastic changes in hemagglutinin or neuraminidase
Responsible for epidemics & pandemics
 Antigenic



Shift
Drifts
Occur in all three types
Minor change in surface antigens
May result in epidemic
 Contains
surface proteins of virus
strains


Most likely to circulate in the coming winter
Generally two type A and one type B
 Epidemiological
data reviewed and
strains chosen 6–9 months before
distribution
2007 - 2008
vaccine
2008 – 2009
vaccine
A/Solomon
Islands/3/2006 (H1N1)–
like virus
 A/Wisconsin/67/2005
(H3N2) -like virus
 B/Malaysia/2506/2004 like virus


A/Brisbane/59/2007
(H1N1)-like virus
 A/Brisbane/10/2007
(H3N2)-like virus
 B/Florida/4/2006-like
virus
 Trivalent

Fluzone® (Sanofi Pasteur)


Approved for > 18 years of age
FluLaval® (GlaxoSmithKline)


Approved for > 4 years of age
Fluarix® (GlaxoSmithKline)


Approved for > 6 mo of age
Fluvirin® (Chiron)


Inactivated Vaccines (TIV):
Approved for > 18 years of age
Afluria (CSL Limited)

Approved for > 18 years of age
 Cold-adapted

Influenza Vaccine Trivalent :
FluMist® (MedImmune)

Approved for 2 to 49 years of age
 Inactivated




influenza vaccine
70 – 90% effective among healthy persons <65 yo
30 – 40% effective among frail elderly
50 – 60% effective in preventing hospitalization
80% effective in preventing death
 Cold-adapted


influenza vaccine-trivalent
87% effective in pediatric population
Among healthy adults, 18 – 37% fewer days of
healthcare provider visits
 Persons




at Increased Risk for Complications
Persons aged  50 years
Residents of nursing homes and chronic-care facilities
Adults with chronic heart or lung disorders, including
asthma
Adults with:




Chronic metabolic disease (e.g., diabetes)
Renal dysfunction
Hemoglobinopathies
Immunosuppression (e.g., HIV)
 Persons

Adults with conditions that can compromise
respiratory function or the handling of secretions
or that can increase the risk for aspiration





at Increased Risk for Complications
Cognitive disorders
Spinal cord injuries
Seizure disorders
Other neuromuscular disorders
Women who will be pregnant during the influenza
season
MMWR. 2007
 Persons
Who Can Transmit the Virus to Those
at High Risk
Health care workers
Employees of chronic-care facilities or residences
for persons in groups at high risk
 Persons providing home care to persons in groups
at high risk
 Household members (including children) of persons
at high risk
 Household contacts and out-of-home caretakers of
children aged <2 years


MMWR. 2007
 Healthy


Individuals 2–49 Years of Age
Who wish to decrease their risk of influenza
Who are in close contact with persons at high
risk for influenza-related complications
Influenza vaccination as
personal protection
versus
Immunization for the
greater public good
Which of the following statements is
true regarding the peak month
for influenza?
1.
2.
3.
There has been great variability
over the past 30 years
Peak most commonly occurs in
February
Can peak as late as April & May
 Inactivated

vaccine
Staggered administration based on need



High risk/health care workers– can get as early as Sept, Oct
or Nov is ideal
Nursing homes – October or later
Healthy – November or later
 Cold-adapted

trivalent
Starting in October
 Inactivated

Dose: 0.50 ml IM injection in deltoid
 Cold-adapted




Trivalent
Dose: 0.5 mL intranasally
Half dose to each nostril
No need to inhale
No need to repeat if sneezing or coughing occur
 Soreness
at injection site
 Fever, malaise, myalgia
 Immediate allergic
reaction
 Sneezing or cough
(intranasal)
 Inactivated


vaccine
Egg allergy
History of anaphylactic reaction to components of
the vaccine
 Cold-adapted
trivalent vaccine
Egg allergy
History of anaphylactic reaction to components of
the vaccine
 Aged <2 years or >50 years
 Persons with chronic diseases
 Pregnant women


True or False?
You can contract influenza
from the IM vaccine.
Varicella – Zoster Virus (VZV)
Varicella (Chicken Pox)
Herpes Zoster (Shingles)
 Reactivation
of dormant
varicella zoster virus
 Likelihood for reactivation
related to:
 Age
 Immune
status
90%
of U.S. population has serologic
evidence of varicella
50% of persons who live to age 85
will develop herpes zoster
More than 500,000 cases occur
yearly in U.S.
 Symptoms
 Sharp, stabbing pain & tenderness along the nerve
 Lesions appear 3 – 5 days later





Papules
vesicles
pustules
Heal in 7 – 10 days
Present on only one side of the body
Contagious until dry crusts appear: 5 – 10 days
Pain can occur during the prodrome and/or eruptive
phase
Based on pain research, which of
the following is correct?
1.
2.
3.
Labor pain > HZ pain
HZ pain > labor pain
HZ pain = labor pain
 Serious complications
 Postherpetic neuralgia (PHN)




90% pain-free 1 month after acute attack; 95% pain-free at
3 months & 97% pain-free after 12 months
Incidence & duration directly correlate with patient age
Difficult to treat
Scarring, bacterial superinfection, cranial and motor
neuron palsies, pneumonia, encephalitis, visual
impairment, hearing loss
 Live,
attenuated varicella-zoster virus
 Indication: prevention of HZ in
individuals 60 and older
 Stimulates the patient’s immune system
to reestablish memory cells
 Dose: 0.65 ml subQ
 Advisory
Committee On Immunization
Practices (ACIP) recommendations


Routinely administer to all people 60
years of age and older
This includes those who have had a
previous episode of the disease
What is the potency of Zostavax
compared to Varivax?
Zostavax > Varivax
2. Zostavax < Varivax
3. Zostavax = Varivax
1.
Must
be kept frozen at
-15º C (+5º F)
Reconstitute straight from
freezer and use
immediately
Adverse effects: injection
site reactions
History
of anaphylactic reaction to
gelatin, neomycin, or other
component of the vaccine
Immunodeficiency (leukemia,
lymphomas, other bone marrow or
lymphatic neoplasms, HIV)
Immunosuppressive therapy
Active, untreated tuberculosis
Pregnancy
Efficacy



Efficacy with respect to incidence of zoster was
63.9% among those 60 – 69 yo compared with 37.6%
in those 70 years and older
Reduced incidence of postherpetic neuralgia by
67%
Duration of time patients experienced pain was
significantly lower in those who received the
vaccine
N Engl J Med 2005:352;2271-84
DNA
tumor virus
Skin virus
 About 40 genital types
 15 to 18 of these associated
with cancer
Sexually
transmitted disease
 Intercourse
 Genital, oral & skin to skin
contact
HPV Types
Manifestations
Low-grade cervical changes
High-Risk Types 16, 18, High-grade cervical changes
31, and 45
Cervical cancer
Anogenital and other cancers
Benign low-grade cervical
changes
Low-Risk Types 6 and 11
Condylomata acuminata
(Genital warts)
HPV
Normal
Cervix
Infection
HPV-
Progression
Precancer
Infected
Clearance Cervix
Regression
Mild Cytologic and/or
Histologic Abnormalities
Invasion
Cervical
Cancer
 HPV



80 – 90% of infections resolve in 2 years
Average duration of infection 9 – 13 months
Unclear if eradicated or latent
 HPV



“clearance”
“persistence”
10 – 20% of infections persist
Major risk factor for cancer
Clearance & persistence are age related
 6.2
million new cases of sexually transmitted HPV
occur in the U.S. each year
 20 million people in the U.S. currently have a
detectable genital HPV infection
 50% of sexually active men and women acquire
genital HPV infection at some point in their lives
 $1.6 billion in direct annual medical costs for
treating symptoms of genital HPV infection
What % of women tested positive for HPV
DNA within 12 months of intercourse
with FIRST male sex partner?
5%
2. 13%
3. 28%
4. 42%
1.
1
million new cases annually; two thirds in
women
 Present in 15% of general population
 Transmitted during vaginal or anal sex with
infected partner
 Can
spontaneously disappear without
treatment
 May remain unchanged or increase in size
and/or number
 Treatment options



Provider applied topical medications
Patient applied topical medications
Freezing, laser and surgical excision
 Recurrence
rates of 30-40%
 Indication:
Approved for use in females aged 9
to 26 for prevention of the diseases caused by
HPV types 6,11,16 & 18:



Cervical cancer
Genital warts
And the following precancerous or dysplastic lesions:

Cervical adenocarcinoma in situ (AIS)
Cervical intraepithelial neoplasia (CIN) grade 2 & 3
Vulvar intraepithelial neoplasia (VIN) grade 2 & 3
Vaginal intraepithelial neoplasia (VaIN) grade 2 & 3

Cervical intraepithelial neoplasia (CIN) grade 1



 HPV
types 16 & 18 account for 70% of all
cervical cancers
 HPV types 31,33,35,39,45,51,52,56,58,&59
account for an additional 20%
 Gardasil provides cross-protection reducing
incidence for precursor lesions by 38%

45% protection with types 31 &45
 Advisory
Committee On Immunization Practices
(ACIP) recommendations



Routinely administer to all girls when they are 11 – 12
years old
Immunize females 13 – 26 who have not previously
received the vaccine
At their discretion, physicians could vaccinate girls as
young as 9
Administration
 Given
as 3 separate IM injections over 6
months



1st dose: at elected date
2nd dose: 2 months after 1st dose
3rd dose: 6 months after 1st dose
 Available
in single-dose vial or prefilled
syringe
 No dilution or reconstitution necessary
Conclusions

Vaccine was well tolerated



from pivotal trials
No differences between its ADRs and the placebo
Most common complaints: pain at injection site & headache
There was complete protection against persistent HPV
types 16 & 18 infection and associated cervical lesions
in the fully vaccinated cohort
Obstet Gynecol 2006;107:18-27
Lancet Oncol 2005;6:271-8
 Pain,
swelling & erythema at injection site
 No serious reactions have been reported
 Contraindicated for persons with history of
immediate hypersensitivity to yeast or any
vaccine components
True or False?
Once a female has received the
complete Gardasil vaccine series
she no longer needs routine PAP
smears.
 90,000
Americans die of vaccinepreventable infections every year
 Most visited health care providers in the
year preceding their deaths but were not
vaccinated
 Influenza and pneumonia are the fifth
leading cause of death for Americans 65
 Most American adults are inadequately
vaccinated
www.cdc.gov; www.healthypeople.gov
Am J Health Syst Pharm 2003;60:1371-1377
 Advocate


Motivating people to be vaccinated
Screen for needed vaccines and refer
 Facilitator

Hosting others who vaccinate
 Immunizer

Administering vaccines
As of August 2007
In the typical American household, which
family member has the most accurate
& up-to-date immunization record on
file?
1. The parents
2. The children
3. The pets

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