Immunization Update 2014

Report
Kenneth McCall, BSPharm, PharmD
Associate Professor | UNE
President | Maine Pharmacy Association
Objectives
 Discuss the gap between current rates and Healthy




People 2020 goals for vaccinations.
Categorize each of the CDC recommended flu
vaccines based upon live/inactivated, route, prep., and
storage.
Discuss the influenza vaccines for 2014 including the
new quadrivalent and mammalian cell vaccines.
Identify vaccine contraindications and recommend
vaccines based upon age and medical history.
Apply ACIP recommendations and FDA approved
indications for the CDC recommended vaccines.
Outline
 Background & Principles of Vaccination
 Influenza Vaccines
 Quadrivalent inactivated
 Quadrivalent live
 Mammalian
 High Dose
 Intradermal
Classification of Vaccines
 Live attenuated
 Weakened form of the “wild” virus or bacteria
 Inactivated
 Whole viruses or bacteria
 Fractions of viruses or bacteria
*Epidemiology and Prevention of Vaccine-Preventable Diseases, 12th Edition
Classification of Vaccines
 Live attenuated:
 Measles, mumps, rubella, varicella, zoster, intranasal
influenza
 Inactivated:
 hepatitis A, hepatitis B, influenza, pneumonia,
diphtheria, tetanus, pertussis, HPV, meningicoccal
*Epidemiology and Prevention of Vaccine-Preventable Diseases, 12th Edition
8
2014 Recommended Adult Immunization
Schedule, by vaccine and age group
www.cdc.gov/vaccines/schedules/hcp/adult.html
Vaccines that might be indicated for adults
based on medical and other indications
www.cdc.gov/vaccines/schedules/hcp/adult.html
2014 Influenza Vaccination Recommendations
 Annual vaccination against influenza is recommended for




all persons aged 6 months or older.
Adults aged 18 to 49 years can receive the recombinant or
mammalian vaccine.
Healthy, nonpregnant persons aged 2 to 49 years without
high-risk medical conditions can receive either intranasal,
live vaccine or inactivated vaccine. Health care personnel
who care for severely immunocompromised persons
should receive inactivated vaccine.
Adults 18 to 64 years can receive either the intramuscular or
intraderm.
Adults 65+ years can receive either the standard-dose or the
high-dose.
www.cdc.gov/vaccines/schedules/hcp/adult.html
What is the Healthy People 2020 goal for annual flu
vaccination for adults 65 and older?
25%
25%
25%
25%
100%
2. 90%
3. 70%
4. 50%
1.
14
Influenza Virus Strains
 Influenza A virus
 Moderate to severe illness
 All age groups
 Humans and other animals
 Influenza B virus
 Milder disease
 Primarily affects children
 Humans only
 Influenza C virus
 Rarely reported in humans
 No epidemics
15
2013-14 Influenza Surveillance
CDC has antigenically characterized 2,110 influenza viruses
 Influenza A 2009 H1N1 [1,657]: 99.9% of the 2009 H1N1 viruses tested were
characterized as A/California/7/2009-like, the influenza A (H1N1) component
of the 2013-2014 Northern Hemisphere influenza vaccine.
 Influenza A (H3N2) [269]: 98.1% of the influenza A (H3N2) viruses tested
have been characterized as A/Texas/50/2012-like, the influenza A (H3N2)
component of the 2013-2014 Northern Hemisphere influenza vaccine.
 Influenza B [184]: 124 (67%) of the 184influenza B viruses tested belong to
B/Yamagata/16/88-lineage and the remaining 60 (33%) influenza B viruses
tested belong to B/Victoria/02/87 lineage.
 Yamagata Lineage [124]: 124 influenza B/Yamagata-lineage viruses were
characterized as B/ Massachusetts/2/1012-like, which is included as an influenza
B component of the 2013-2014 Northern Hemisphere trivalent and quadrivalent
influenza vaccines.
 Victoria Lineage [60]: 60 influenza B/Victoria-lineage viruses were
characterized as B/Brisbane/60/2008-like, which is included as an influenza B
component of the 2013-2014 Northern Hemisphere quadrivalent influenza
vaccine.
US Influenza Vaccines: 2014
Vaccine
Inactivated, Trivalent
Standard Dose
Age Group Dosage
Schedule
Route
6-35 mos
0.25 ml
1 or 2 shots
IM
3-8 years
0.5 ml
1 or 2 shots
IM
>9 years
0.5 ml
1 shot
IM
Inactivated, Quadrivalent
Standard Dose
3-8 years
0.5 ml
1 or 2 shots
IM
>9 years
0.5 ml
1 shot
IM
Inactivated, Mammalian
Trivalent Standard Dose
>18 years
0.5 ml
1 shot
IM
18-49 years
0.5 ml
1 shot
IM
Inactivated, Trivalent
High Dose
>65 years
0.5 ml
1 shot
IM
Inactivated, Trivalent
Intra-dermal
18-64 years
0.1 ml
1 shot
ID
2-8 years
0.2 ml
1 or 2
Nasal
9-49 years
0.2 ml
1 dose
Nasal
Inactivated, Recombinant
Trivalent Standard Dose
Live, Quadrivalent
Intranasal
New Influenza Vaccines: 2013-14
 Fluarix ® (GlaxoSmithKline) – inactivated, quadrivalent vaccine
 FDA approved December 2012
 People ages 3 years and older
 Fluzone® (Sanofi Pasteur) – inactivated, quadrivalent vaccine.
 FDA approved March 2013
 People ages 6 months and older
 Flumist® Quadrivalent (MedImmune)– live, attenuated, quadrivalent vaccine
 FDA approved March, 2012
 People ages 2 through 49 years
 Flucelvax® (Novartis)– trivalent inactivated vaccine grown in mammalian cells.
 FDA approved November, 2012
 Adults 18 years and older
 Doesn’t list “severe allergic reaction to egg protein” in the contraindications
 Flublok® (Protein Sciences Corp.) – inactivated, trivalent, recombinant vaccine.
 FDA approved March 2013
 People ages 6 months and older
 Doesn’t list “severe allergic reaction to egg protein” in the contraindications
Which of the following was the
predominant flu strain of 2013-14?
25%
1. Type B strain in trivalent vaccine
25%
2. Type B strain not in trivalent vaccine
25%
3. Type A H1N1 strain
25%
4. Type A H3N2 strain
21
New Influenza Vaccines: 2013-14
 Fluarix ® (GlaxoSmithKline) – inactivated, quadrivalent
vaccine which contains two type A and two type B strains
 FDA approved December 2012
 People ages 3 years and older
 Fluzone ® (Sanofi Pasteur) – inactivated, quadrivalent
vaccine which contains two type A and two type B strains
 FDA approved March 2013
 People ages 6 months and older
Quadrivalent vs. Trivalent:
Local Side Effects
Local Side Effect
Fluarix
Quadrivalent
N=3,015
Trivalent Influenza Vaccine (TIV)
TIV-1
(B Victoria)
N=1,003
TIV-2
(B Yamagata)
N=607
Pain
36
37
31
Redness
2
2
2
Swelling
2
2
1
Fluarix [package insert]. Dresden, Germany: GlaxoSmithKline Inc; 2013.
Quadrivalent vs. Trivalent:
Systemic Side effects
Systemic Side
Effect
Fluarix
Quadrivalent
N=3,015
Trivalent Influenza Vaccine (TIV)
TIV-1
(B Victoria)
N=1,003
TIV-2
(B Yamagata)
N=607
Muscle Aches
16
19
16
Headache
16
16
13
Fatigue
16
18
15
Arthralgia
8
10
9
GI Symptoms
7
7
6
Shivering
4
5
4
Fever ≥99.5°F
2
1
2
Fluarix [package insert]. Dresden, Germany: GlaxoSmithKline Inc; 2013.
Quadrivalent vs. Placebo:
Vaccine Efficacy
Attack Rates (n/N)
N
N
%
Vaccine Efficacy
%
LL
UL
Antigenically Matched Strains
FLUARIX
5,103
49
1.0
66.9
51.9
77.4
placebo
2,549
74
2.9
-
-
-
All Cultured-Confirmed Influenza (Matched, Unmatched, and Untyped)
FLUARIX
5,103
63
1.2
61.6
46.0
72.8
placebo
2,549
82
3.2
-
-
-
Fluarix [package insert]. Dresden, Germany: GlaxoSmithKline Inc; 2013.
Administration
 Fluarix®: 0.5-mL dose
 IM - deltoid
 1 inch, 25 gauge needle
26
Quadrivalent Influenza Vaccines
contain which of the following?
25%
1. Four type A strains
25%
2. Two type A strains, 1 type B, & 1 type C
25%
3. Two type A strains & 2 type B strains
25%
4. Four type B strains
28
New Influenza Vaccines: 2013-14
 Flumist® Quadrivalent (MedImmune)– live attenuated
vaccine which contains two type A and two type B strains
 FDA approved March, 2012
 People ages 2 through 49 years
Live Attenuated Influenza Vaccine
 Indication
 Healthy people 2 through 49 years of age
 Contraindications
I pick my nose!
 Pregnant women
 People who have long-term health problems with:






heart disease
kidney or liver disease
lung disease
metabolic disease, such as diabetes
asthma
anemia, and other blood disorders
 Anyone with a weakened immune system
 Severe egg allergy
30
Immune Response Studies of FluMist
Quadrivalent in Children and Adults
 A multicenter, randomized, double-blind study was
performed to assess the immunogenicity of FluMist
Quadrivalent compared to FluMist Trivalent in 2,312
children and adolescents 2 through 17 years of age.
 A multicenter, randomized, double-blind study was
performed to assess the immunogenicity of FluMist
Quadrivalent compared to FluMist Trivalent in 1,800
adults 18 through 49 years of age.
 Conclusion: In both studies, the addition of the
second B strain did not result in immune interference
to other strains included in the vaccine.
FluMist Quadrivalent [package insert]. Gaithersburg, MD: MedImmune Inc; 2012.
Summary of solicited adverse reactions observed
within 14 days after FluMist in Children 2-17 years
FluMist Quadrivalent [package insert]. Gaithersburg, MD: MedImmune Inc; 2012.
Summary of solicited adverse reactions observed
within 14 days after FluMist in Adults 18-49 years
FluMist Quadrivalent [package insert]. Gaithersburg, MD: MedImmune Inc; 2012.
Administration
 Flumist®: 0.1-mL dose in each nostril
 Intranasal
34
Intranasal Administration
Active inhalation (sniffing) by the patient is not required
Which of the following patients is a candidate for the live
influenza vaccine?
20%
1. 45 yo man with severe egg allergy
20%
2. 27 yo healthy woman
20%
3. 38 yo man with diabetes
20%
4. 54 yo healthy man
20%
5. 19 yo pregnant woman
37
New Influenza Vaccines: 2013-14
 Flucelvax® (Novartis)– trivalent inactivated vaccine grown
in mammalian cells rather than chicken embryo cells.
 FDA approved November, 2012
 Adults 18 years and older
 Doesn’t list “severe allergic reaction to egg protein” in the
contraindications
Head-to-Head Comparison:
Flucelvax vs. Placebo
Barrett PN, et al. Lancet 2011;377:751-59
Flucelvax vs. Placebo
Local & Systemic Adverse Reactions
Flucelvax [package insert]. Cambridge, MA: Novartis Vaccines & Diagnostics Inc; 2012.
Flucelvax Compared to Agriflu
Local Adverse Reactions
**Agriflu
Flucelvax [package insert]. Cambridge, MA: Novartis Vaccines & Diagnostics Inc; 2012.
Flucelvax Compared to Agriflu
Systemic Adverse Reactions
**Agriflu
Administration
 Flucelvax®: 0.5-mL dose
 IM - deltoid
 1 inch, 25 gauge needle
43
Which of the following influenza vaccines does not
include “severe egg allergy” as a contraindication?
20%
1. Inactivated quadrivalent
20%
2. Live quadrivalent
20%
3. Inactivated trivalent intradermal
20%
4. Inactivated trivalent high dose
20%
5. Inactivated trivalent mammalian
45
New Influenza Vaccines: 2013-14
 Flublock® (Protein Sciences Corporation)– trivalent
inactivated vaccine grown in insect cells rather than
chicken embryo cells.
 FDA approved November, 2013
 Adults 18 through 49 years of age.
 Doesn’t list “severe allergic reaction to egg protein” in the
contraindications
Vaccine Efficacy against Culture-Confirmed
Influenza in Healthy Adults 18-49 years
Frequency of Local and Systemic Reactions within 7
days of Flublok or Placebo in Adults 18-49 years
Administration
 Flucelvax®: 0.5-mL dose
 IM - deltoid
 1 inch, 25 gauge needle
49
ACIP Recommendations for flu vaccination
of person who report egg allergy.
Select an influenza vaccine for a healthy 37year-old woman with severe egg allergy.
25%
1. Flublok
25%
2. Flumist
25%
3. Fluzone
25%
4. Fluarix
52
 Methods:
 Multicenter, randomized, double-blind controlled study
 HD vaccine (60 mcg of hemagglutinin per strain): N=2,575
 SD vaccine (15 mcg of hemagglutinin per strain): N=1,262
 in adults 65 years of age and older.
J Infect Dis. 2009;200(2):172-80
53
antibody titer level
Comparison of responses to high-dose (HD)
and standard-dose (SD) influenza vaccine
140
700
120
600
100
500
80
400
60
300
40
200
20
100
0
0
SD
A/H1N1
B
J Infect Dis. 2009;200(2):172-80
HD
A/H3N2
54
Comparison of systemic side effects to
HD and SD influenza vaccine
25
Percent
20
15
SD
HD
10
5
0
Fever
Headache
Malaise
J Infect Dis. 2009;200(2):172-80
Myalgia
55
Administration
 Fluzone HD®: 0.5-mL dose
 IM - deltoid
 1 inch, 25 gauge needle
56
Intradermal Influenza Vaccine
 Indication
 Persons 18 through 64 years of age
 Contraindications
 Severe egg allergy
58
Intradermal vs Traditional IM needle Length
30 Gauge Needle and Less Volume
 Methods:
 Multicenter, randomized, double-blind controlled study
 ID vaccine (9 mcg of hemagglutinin per strain) N=1,803
 IM vaccine (15 mcg of hemagglutinin per strain): N=452
 in adults 18 to 60 years of age.
Human Vaccines. 2010;6:346-54.
Seroprotection Rate
Comparison of responses to Intradermal (ID)
and Intramuscular (IM) influenza vaccine
100
100
90
90
80
80
70
70
60
60
50
50
IM 15 mcg
40
40
ID 9 mcg
30
30
20
20
10
10
0
0
A/H1N1
B
A/H3N2
Human Vaccines. 2010;6:346-54.
62
Comparison of systemic side effects to
ID and IM influenza vaccine
35
30
Percent
25
20
IM 15 mcg
15
ID 9 mcg
10
5
0
Fever
Headache
Malaise
Myalgia
Human Vaccines. 2010;6:346-54.
63
Comparison of local side effects to ID
and IM influenza vaccine
90
80
70
Percent
60
50
IM 15 mcg
40
ID 9 mcg
30
20
10
0
Erythema
Swelling
Induration
Pain
Human Vaccines. 2010;6:346-54.
64
Intradermal Injection Technique
1. Remove needle cap
2. Hold microinjection system
between thumb and middle finger

Do not place fingers on the windows
3. Insert needle rapidly perpendicular
to the skin
4. Inject using the index finger
5. Remove needle from the skin and activate the needle
shield by
pushing firmly on the plunger
Which side effect is more common with the intradermal
influenza vaccine than the IM influenza vaccine?
0%
1. Injection site pain
0%
2. Headache
0%
3. Fever
0%
4. Injection site swelling
0%
5. Malaise
Influenza Vaccines and Age Indications
Vaccine
Age Indications
6-23m
2-3y
3-17y
18-49y
Inactivated Trivalent
(Fluzone©, Afluria©, Fluvirin©)
Inactivated Quadrivalent
(Fluarix©, FluLaval©, Fluzone©)
Inactivated Mammalian
Trivalent (Flucelvax©)
Recombinant Influeza Vaccine,
Trivalent (FluBlok©)
Live Quadrivalent
(Flumist©)
Intradermal Trivalent
(Fluzone ID©)
High Dose Trivalent
(Fluzone HD©)
Indicated for those meeting
age requirements and
without contraindications
50-64y
65+y
Influenza Vaccine Indications
Vaccine
Indication
Pregnant
Severe Egg Allergy
Patients with high
risk medical
conditions**
Inactivated Trivalent
(Fluzone©, Afluria©, Fluvirin©)
Inactivated Quadrivalent
(Fluarix©)
Inactivated Mammalian &
Recombinant Trivalent
(FluBlok©, Flucelvax©)
Live Quadrivalent
(Flumist©)
Intradermal Trivalent
(Fluzone ID©)
High Dose Trivalent
(Fluzone HD©)
Indicated for individuals
meeting age requirements.
contraindicated
**Patients with high risk medical conditions:
including immunocompromised, chronic cardiovascular
disease, Diabetes Mellitus, pulmonary disease, or
metabolic disease.
Which of the following influenza vaccine(s) is/are
appropriate for a healthy 16-year-old boy.
20%
1. Fluzone
20%
2. Fluzone ID
20%
3. Fluzone HD
20%
4. Flucelvax
20%
5. 1 and 2
Which of the following influenza vaccines is NOT
indicated for a 72-year old woman?
25%
1. Inactivated trivalent IM vaccine
25%
2. Inactivated quadrivalent vaccine
25%
3. Inactivated high dose vaccine
25%
4. Inactivated trivalent intradermal vaccine
A 35-year-old woman requests an annual flu shot. She
has ulcerative colitis and is taking Prednisone 40 mg QD.
Which flu vaccine(s) is/are appropriate?
14%
1. Influenza intradermal vaccine
14%
2. Influenza intramuscular vaccine
14%
3. Influenza high dose vaccine
14%
4. Flumist nasal spray 0.2 ml nasal
14%
5. Either 1 or 2
14%
6. Either 2 or 3
14%
7. Either 2 or 4
2014 ACIP Recommendations for
Pneumococcal Vaccination in Adults
Immunocompromised?
no
Age > 65?
no
Lung, liver,
kidney,
heart
disease,
diabetes,
smoking,
nursing
home?
yes
yes
Previously received
Pneumovax?
no
Administer
Pneumovax
yes
no
Vaccine not
recommended
Administer
Prevnar
followed by
Pneumovax
8 weeks later
yes
Administer
Prevnar one
or more
years after
last
Pneumovax
2014 ACIP Recommendations on
Revaccination with Pneumovax in Adults
Age > 65?
Renal disease,
Immunocompromised?
no
yes
Vaccine not
recommended
no
yes
no
Previous
Pneumovax > 5
years ago?
no
yes
Vaccine not
recommended
Previous Pneumovax
> 5 years ago and prior
to age 65?
Vaccine not
recommended
Administer
Pneumovax
yes
Administer
Pneumovax
Administration
 Pneumovax® / Prevnar ® : 0.5-mL dose
 IM - deltoid
 1 inch, 25 gauge needle
81
A 54-year-old man is immuno-compromised due to
asplenia. No prior pneumonia vaccination. What
pneumonia vaccine(s) is/are recommended?
25%
1. Pneumovax only
25%
2. Prevnar only
25%
3. Both; Pneumovax prior to Prevnar
25%
4. Both; Prevnar prior to Pneumovax
A 67-year-old woman has a history of type 2 diabetes.
No prior pneumonia vaccination. What pneumonia
vaccine(s) is/are recommended?
25%
1. Pneumovax only
25%
2. Prevnar only
25%
3. Both; Pneumovax prior to Prevnar
25%
4. Both; Prevnar prior to Pneumovax
Which of the following statements about the administration of
influenza and pneumonia vaccines is true?
0%
1. Same day, opposite arm, separate syringe
0%
2. Same day, same arm, mixed in 1 syringe
0%
3. Must be separated by at least 7 days
0%
4. Must be separated by at least 4 weeks
Which of the following vaccines is a live vaccine?
20%
1. Pneumovax
20%
2. Flumist
20%
3. Prevnar
20%
4. Fluarix
20%
5. Fluzone HD
88
89
Clinical Presentation of Herpes Zoster1–3
Herpes Zoster Rash Follows a Dermatomal Distribution
© Phototake.
© Phototake.
© Dr. P. Marazzi / Photo Researchers, Inc.
Prodrome
Acute HZ Rash
Evolution of Rash
Complications?
Abnormal Skin Sensations
Headache
Photophobia
Malaise
Unilateral Dermatomal Rash
Maculopapules/Vesicles
Altered Sensitivity to Touch
Unbearable Itching
Cessation of New Vesicles
Pustulation
Scabbing
Cutaneous Healing
Neurologic
Cutaneous
Ophthalmic
Visceral (rare)
Pain (varying severity)
“Aching”, “burning”, “stabbing”, “shock-like”
1. Oxman MN. In: Arvin AM et al, eds. Varicella-Zoster Virus: Virology and Clinical Management. Cambridge, UK: Cambridge
University Press; 2000:246–275.
2. Weaver BA. J Am Osteopath Assoc. 2007;107(suppl 1):S2–S7. 3. Harpaz R et al. MMWR Morb Mortal Wkly Rep. 2008;57(RR-5):1–30.
Zoster Incidence by Age Group1
12
Number of Cases
Rate per person-years
1,800
10
1,600
1,400
8
1,200
1,000
6
800
4
600
400
Rate per 1,000 Person-Years
Number of Cases of Zoster (n = 9,152)
2,000
2
200
0
0
0-14
15-29
30-39
40-49
50-59
60-69
70-79
80+
Age
1. Insinga RP et al. J Gen Intern Med. 2005;20:748–753.
55
Zoster Vaccination Rates are Low1–3
50
% Vaccinated
in
(cumulative)
Individuals Aged ≥60
Years
45
40
35
30
25
20
15
14%
7%
15.8%
10%
10
5
2008
2008
2009
2009
2010
2011
0
Year

More than 99.5% of US adults ≥40 years of age have serologic
evidence of previous infection of varicella zoster virus; therefore,
all older adults are at risk of zoster infection4
1. Centers for Disease Control and Prevention (CDC). cdc.gov/vaccines/stats-surv/nhis/2009-nhis.htm. Accessed January 19, 2011. 2. Centers for Disease Control
and Prevention (CDC). Morbid Mortal Wkly Rep. 2012;61(4):66–72. 3. Centers for Disease Control and Prevention (CDC). MMWR. 2013;62(4):61–76. 4. Harpaz R et
al. Morbid Mortal Wkly Rep. 2008;57(RR-5):1–30.
Zoster Vaccine Indication
 ACIP recommends routine vaccination of all persons aged
>60 years with 1 dose of zoster vaccine.
 NEW FDA LABELING: “ZOSTAVAX is a live attenuated
virus vaccine indicated for prevention of herpes zoster
(shingles) in individuals 50 years of age and older.”
 Persons who report a previous episode of zoster and persons
with chronic medical conditions can be vaccinated unless
those conditions are contraindications or precautions.
 Zoster vaccination is not indicated to treat acute zoster.
Zostavax® [package insert]. Whitehouse Station, NJ: Merck; April 2011.
Recommendations of the Advisory Committee on Immunization Practices (ACIP)
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5705a1.htm?s_cid=rr5705a1_e
93
Vaccine Contraindications
 Allergy to neomycin or any vaccine component
 Pregnancy
 Immunocompromised status
 AIDS or other clinical manifestations of HIV, including
persons with CD4+ T-lymphocyte values <200 per mm3
 malignant neoplasms affecting the bone marrow
 chemotherapy or radiation within the last 3 months
 Persons on immunosuppressive therapy, including highdose corticosteroids (>20 mg/day of prednisone or
equivalent) lasting two or more weeks
94
Efficacy of ZOSTAVAX® (Zoster Vaccine Live) on Incidence of
Herpes Zoster in Adults Aged 60 Years
Based on the results of the Shingles Prevention Study
(SPS)a
OVERALL LOWER
INCIDENCE OF ZOSTERa
RESULTS BY AGE GROUPS (YEARS)
60–69
in subjects
70–79
in subjects
[95% CI: 28–52]
334
122
Placebo ZOSTAVAX
(n=10,356) (n=10,370)
Number of Zoster Cases
[95% CI: 56–71]
Number of Zoster Cases
18%
51%
 80
in subjects
[95% CI: –29–48; NS]
261
156
Placebo ZOSTAVAX
(n=7,559) (n=7,621)
47
Placebo
(n=1,332)
 60
[95% CI: 44–58]
Number of Zoster Cases
in subjects
41%
Number of Zoster Cases
64%
642
315
37
ZOSTAVAX
(n=1,263)
Placebo ZOSTAVAX
(n=19,247) (n=19,254)
CI=confidence interval; NS=not significant.
aIn the Shingles Prevention Study, efficacy was evaluated in a placebo-controlled, double-blind clinical trial of ZOSTAVAX.
38,546 subjects 60 years of age or older were randomized to receive a single dose of either ZOSTAVAX (n=19,270) or placebo
(n=19,276) and were monitored for the development of zoster for a median of 3.1 years (range, 31 days to 4.90 years).
Efficacy of ZOSTAVAX® (Zoster Vaccine Live) on Incidence of PHN
in Adults Aged 60 Years Who Developed Zoster Post-Vaccination
Based on the results of the Shingles Prevention Study
(SPS)a
% of Zoster Cases
With PHN
30
Placebo
39%b
20
ZOSTAVAX
(95% CI: 7–59)
10
12.5
8.6
0
Number of PHN Cases
Number of HZ Cases
80
642
27
315
Overall
The benefit of ZOSTAVAX in the prevention of PHN can be primarily
attributed to the effect of the vaccine on the prevention of herpes zoster.
HZ=herpes zoster; PHN=postherpetic neuralgia.
aPHN was defined as herpes zoster-associated pain rated as ≥3 on a 10-point scale and occurring or persisting at least 90 days after
rash onset.
Efficacy of ZOSTAVAX® (Zoster Vaccine Live) on Incidence of
Herpes Zoster in Adults Aged 50–59 Years
Based on the results of the ZOSTAVAX Efficacy and Safety Trial
(ZEST)1,a
Number of Zoster Cases
70%
in subjects
50–59
[95% CI: 54–81]
99
30
Placebo
(n=11,228)
aStudy Design
ZOSTAVAX
(n=11,211)
for ZEST: In the ZOSTAVAX Efficacy and Safety Trial, efficacy was evaluated in a placebocontrolled, double-blind study of ZOSTAVAX. 22,439 subjects 50 to 59 years of age were randomized to receive
a single dose of either ZOSTAVAX (n=11,211) or placebo (n=11,228) and were monitored for the occurrence of
shingles for a median of 1.3 years postvaccination (range, 0 to 2 years).
1. Schmader KE et al. Clin Infect Dis. 2012;54:922–928.
Storage and Handling
 zoster vaccine must be stored frozen
 The vaccine must be discarded if not used within 30
minutes after reconstitution.
 New labeling: Zostavax may be stored and/or
transported at fridge temp for up to 72 hours prior to
reconstitution. Any unused vaccine at fridge temp
should be discarded.
Zostavax® [package insert]. Whitehouse Station, NJ: Merck; April 2011.
98
Administration
 Zostavax: 0.65-mL dose (reconstituted)
 SQ – upper, outer tricep
 5/8 inch, 25 gauge needle
100
Which of the following statements about the
administration of influenza and zoster vaccines is true?
0%
1. Same day, opposite arm, separate syringe.
0%
2. Same day, same arm, mixed in 1 syringe.
0%
3. Must be separated by at least 7 days.
0%
4. Must be separated by at least 4 weeks.
RR is a 70-year-old woman with COPD. She has no allergies. Her meds
include albuterol, Pulmicort and Spiriva. She has an 80-pack-year
history of smoking. She quit smoking 5 years ago. Her last pneumonia
shot was 8 years ago. Which vaccine(s) is/are appropriate for her?
11%
1. Pneumovax 0.5 ml IM
11%
2. Influenza SD shot 0.25 ml IM
11%
3. Influenza HD shot 0.5 ml IM
11%
4. Flumist nasal spray 0.1 ml in each nostril
11%
5. Zostavax 0.65 ml SQ
11%
6. Both 1 and 2
11%
7. 1, 2 and 5
11%
8. 1, 3 and 5
11%
9. 1, 4 and 5
Pathogen (Common name) Table
Pathogen
Tetanus
(lockjaw)
Diphtheria
Pertussis
(whooping cough)
Classification
Gram + Bacteriatoxin
Gram + Bacteriatoxin
Gram – Bacteria
Transmission
Wound
Complication
Respiratory failure
Respiratory
Myocarditis/Neuritis
Respiratory
Pneumonia
Comparison of 20th Century and current
US Morbidity of VPDs
Diseases
20th Century
2010 Reported
Annual Morbidity Cases
Percent Decrease
Smallpox
29,005
0
100%
Polio (paralytic)
16,316
0
100%
Measles
530,217
61
>99%
Mumps
162,344
2,528
98%
Pertussis
200,752
21,291
89%
Diphtheria
21,053
0
100%
Rubella
47,745
6
>99%
Congenital Rubella
Syndrome
152
0
100%
Tetanus
580
8
99%
20,000
270
99%
Haemophilus
influenzae
New FDA Approval – July 8, 2011
 US FDA has expanded the age indication for Boostrix®
vaccine to prevent tetanus, diphtheria, and pertussis
(whooping cough) to people ages 65 and older.
 Boostrix® is the first vaccine approved to prevent all
three diseases in people 65 and older.
 Adacel® is approved for persons 11 through 64 years.
Boostrix® [package insert]. Rixensart, Belgium: GlaxoSmithKline; July 2011.
Adacel® [package insert]. Swiftwater, PA: Sanofi Pasteur Inc.; February 2012.
Tetanus, diphtheria, and pertussis (Td/Tdap) Vaccination
 Administer a one-time dose of Tdap to adults younger than age
65 years who have not received Tdap previously or for whom
vaccine status is unknown to replace one of the 10-year Td
boosters.
 Tdap is specifically recommended for the following persons:
 pregnant women more than 20 weeks’ gestation,
 adults, regardless of age, who are close contacts of infants younger
than age 12 months (e.g., parents, grandparents, or child care
providers), and
 health-care personnel.
 Tdap can be administered regardless of interval since the most
recent tetanus or diphtheria containing vaccine.
 Pregnant women not vaccinated during pregnancy should
receive Tdap immediately postpartum.
 Adults 65 years and older may receive Tdap.
Administration
 Boostrix®/Adacel®: 0.5-mL dose
 IM - deltoid
 1 inch, 25 gauge needle
108
AB is a 52-year-old woman with hypertension. She has no allergies. Her meds
include amlodipine 10 mg PO QD. She smokes 1 PPD. Her newborn grandson lives
with her. Which vaccine(s) is/are appropriate for her?
11%
1. Pneumovax 0.5 ml IM
11%
2. Influenza SD shot 0.5 ml IM
11%
3. Influenza HD shot 0.5 ml IM
11%
4. Flumist nasal spray 0.1 ml in each nostril
11%
5. Zostavax 0.65 ml SQ
11%
6. Tdap 0.5 ml IM
11%
7. 1, 2 and 5
11%
8. 1, 3 and 5
11%
9. 1, 2, 5 and 6
Pathogen (Common name) Table
Pathogen
Classification
Transmission
Complication
Influenza (flu)
virus
Respiratory
Pneumonia
Pneumococcus
Gram + Bacteria
Respiratory
Meningitis/Bacteremia
Varicella (chicken pox)
virus
Respiratory
Bacterial infection
Zoster (shingles)
virus
Latent varicella
Neuralgia
HPV (genital warts)
virus
Sexual contact
Cervical cancer
Meningococcus
Gram - Bacteria
Respiratory
Invasive disease
Tetanus (lockjaw)
Gram + Bacteria-toxin
wound
Respiratory failure
Diphtheria
Gram + Bacteria-toxin
Respiratory
Myocarditis/Neuritis
Pertussis (whooping cough)
Gram - Bacteria
Respiratory
Pneumonia
Measles
virus
Respiratory
Diarrhea, pneumonia
Mumps
virus
Respiratory
Meningitis
Rubella
virus
Respiratory
Arthritis
Hepatitis A
virus
Fecal-oral
Acute/chronic hepatitis
Hepatitis B
virus
Blood-serous fluids
Acute hepatitis
Adult Vaccine Table
Vaccine
Vaccine
Type
Route /
Reconstitute
Series
Storage
Influenza IIV
Inactivated
IM / No
1x annually
Fridge
Flumist
Live
Intranasal / No
1x annually
Fridge
Pneumovax
Inactivated
IM or SQ / No
1-2 doses
Fridge
Zostavax
Live
SQ / Yes
1 dose
Freezer
Gardasil (HPV4)
Cervarix (HPV2)
Inactivated
IM / No
3 doses
Fridge
Td
Inactivated
IM / No
1 q 10 years
Fridge
Tdap
Inactivated
IM / No
1x, then Td
Fridge
Varivax
Live
SQ / Yes
2 doses
Freezer
MMR
Live
SQ / Yes
1-2 doses
Fridge or Freezer
Menactra, Menveo
Menomune (MPSV4)
Inactivated
IM / No
1-2+ doses
Fridge
Havrix, Vaqta
Inactivated
IM / No
2 doses
Fridge
Recombivax-HB
Engerix-B
Inactivated
IM / No
3 doses
Fridge

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