Transcript Adult Immunizations - MPARX - Maine Pharmacy Association

Kenneth McCall, BSPharm, PharmD
Associate Professor | UNE
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 Surveillance and Vaccines
 Pneumococcal Vaccine Recommendations
 MMR Activity
 HPV9 Vaccine
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
6
2015 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
ACIP Recommendations 2014-15 Influenza Season
 For 2014–15, U.S.-licensed influenza vaccines will contain the same vaccine




virus strains as those in the 2013–14 vaccine.
All persons aged ≥6 months should receive influenza vaccine annually.
When immediately available, LAIV should be used for healthy children
aged 2 through 8 years who have no contraindications or precautions . If
LAIV is not immediately available, IIV should be used.
Persons who care for severely immunosuppressed persons who require a
protective environment should not receive LAIV, or should avoid contact
with such persons for 7 days after receipt, given the theoretical risk for
transmission of the live attenuated vaccine virus.
Persons who report having had reactions to egg involving such symptoms
as angioedema, respiratory distress, lightheadedness, or recurrent emesis;
or who required epinephrine or another emergency medical intervention,
may receive RIV3 if they are aged 18 through 49 years and there are no
other contraindications.
MMWR August 15, 2014 / 63(32);691-697
What is the Healthy People 2020 goal for annual flu
vaccination for adults 65 and older?
0%
100%
0%
0%
100%
2. 90%
3. 70%
4. 50%
1.
12
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?
0%
1. Type B strain in trivalent vaccine
0%
2. Type B strain not in trivalent vaccine
100%
3. Type A H1N1 strain
0%
4. Type A H3N2 strain
Which of the following is the
predominant flu strain of 2014-15?
0%
1. Type B strain in trivalent vaccine
0%
2. Type B strain not in trivalent vaccine
0%
3. Type A H1N1 strain
100%
4. Type A H3N2 strain
20
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
25
Quadrivalent Influenza Vaccines
contain which of the following?
0%
1. Four type A strains
0%
2. Two type A strains, 1 type B, & 1 type C
100%
3. Two type A strains & 2 type B strains
0%
4. Four type B strains
27
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
33
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?
2%
1. 45 yo man with severe egg allergy
95%
2. 27 yo healthy woman
0%
3. 38 yo man with diabetes
2%
4. 54 yo healthy man
2%
5. 19 yo pregnant woman
Which of the following influenza vaccine(s) is/are
preferred for a healthy 7-year-old boy.
0%
1. Fluzone
0%
2. Fluzone ID
100%
3. Flumist
0%
4. Flucelvax
0%
5. 1 and 2
38
 Methods:
 Multicenter, randomized, double-blind controlled study
 HD vaccine (60 mcg of hemagglutinin per strain): N=15,991
 SD vaccine (15 mcg of hemagglutinin per strain): N=15,998
 Adults 65 years and older. Nursing home residents and
immunocompromised persons were excluded.
N Engl J Med 2014;371:635-45
39
Occurrence of laboratory-confirmed influenza following
administration of HD and SD influenza vaccines
350
Number of cases
300
250
301
228
223
200
SD
171
HD
150
100
51
50
9
38
8
0
All Strains
A/H1N1
A/H3N2
N Engl J Med 2014;371:635-45
B
40
Efficacy of HD Vaccine vs. Standard Dose against
Laboratory Confirmed Influenza of Any Type
 Number (%) of cases
 IV3-HD: 228/15,990 (1.4%)
 IV3-SD: 301/15,993 (1.9%)
 Relative Efficacy (95% CI)
 24.2% (9.7% – 36.5%)
 Absolute Efficacy
 0.5%
 Number Needed to Treat
 200
Administration
 Fluzone HD®: 0.5-mL dose
 IM - deltoid
 1 inch, 25 gauge needle
42
Which of the following statements is FALSE when comparing the
efficacy of Fluzone HD to Fluzone in adults 65 years or older?
0%
0%
100%
0%
1. The relative efficacy of Fluzone HD is
24% > than Fluzone
2. The absolute efficacy of Fluzone HD is
0.5% > than Fluzone
3. These results apply to nursing home
patients
4. The NNT is 200 to avoid one additional
case of influenza
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©)
Preferred:
Healthy 2-8 yrs
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.
Pneumococcal Vaccines
 Pneumovax 23®
(PPSV23,
pneumococcal
polysaccharide
vaccine)
• Prevnar 13® (PCV13,
pneumococcal conjugate
vaccine)
ACIP Recommendations on
Pneumococcal Vaccinations in Adults
Pneumococcal vaccine-naïve persons aged > 65 years
*minimum interval between sequential administration of PCV13 and PPSV23 is 8 weeks;
PPSV23 can be given later than 6-12 months after PCV13 if this window is missed.
Persons who previously received PPSV23 at age > 65 years
*minimum interval between sequential administration of PCV13 and PPSV23 is 8 weeks;
PPSV23 can be given later than 6-12 months after PCV13 if this window is missed.
Persons who previously received PPSV23 before
age 65 years who are now aged > 65 years
Rationale & Design of CAPITA:
Community Acquired Pneumonia Immunization Trail in Adults
 Primary Clinical Objective: establish the efficacy of
PCV13 vaccine in the prevention of a first episode of
pneumococcal CAP in community dwelling adults > 65
years.
 Methods: Randomized, placebo controlled trial with
approximately 85,000 subjects.
 Notable Exclusion Criteria:
 Previous vaccination with any pneumococcal vaccine
 Residence in long-term care facility
 Immunodeficiency
Neth J Med. 2008 Oct;66(9):378-83.
PPSV23 (Pneumovax®)
Age
Who receives the vaccine?
≥65 years old
• Vaccination history unclear or never received vaccine before
• Revaccinate: If patient received vaccine before the age of 65
and it has been ≥ 5 years since administration
2-64 years old
•
•
•
•
•
•
Chronic cardiovascular disease (CHF, cardiomyopathies)
Chronic pulmonary disease (COPD)
Diabetes mellitus
Alcoholism
Chronic liver disease
Cerebrospinal fluid leaks
Re-vaccination after 5 years if: (see figure 1 on next slide)
• functional or anatomic asplenia
• Immunocompromising conditions
• Chronic kidney disease
19-64 years old
• Cigarette smokers
• Asthma
ACIP: Pneumococcal. MMWR. http://www.immunize.org/acip/ Accessed 30 July 2014.
Administration
 Pneumovax® & Prevnar®: 0.5 mL dose
 1 inch, 25 gauge needle
 Intramuscular (IM) - deltoid
CDC: Vaccines and Immunizations. Pneumococcal
Disease. http://www.cdc.gov/. Accessed 30 July
What is the Healthy People 2020 goal for pneumococcal
vaccination for adults 65 and older?
0%
100%
0%
0%
100%
2. 90%
3. 70%
4. 50%
1.
A 65-year-old man who is pneumonia vaccine naïve.
What pneumonia vaccine(s) is/are recommended?
2%
1. Pneumovax only
0%
2. Prevnar only
3%
3. Both; Pneumovax prior to Prevnar
95%
4. Both; Prevnar prior to Pneumovax
Which of the following statements about the administration of
influenza and pneumonia vaccines is true?
100%
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?
0%
1. Pneumovax
100%
2. Flumist
0%
3. Prevnar
0%
4. Fluarix
0%
5. Fluzone HD
Pathogen (Common name) Table
Pathogen
Measles
Classification
Virus
Transmission
Respiratory
Mumps
Virus
Respiratory
Complication
Diarrhea
pneumonia
Meningitis
Rubella
Virus
Respiratory
Arthritis
Measles, Mumps, Rubella Vaccination
 All adults born in 1957 or later should have documentation
of 1 or more doses of MMR vaccine unless they have a
medical contraindication to the vaccine, laboratory
evidence of immunity to each of the three diseases, or
documentation of provider-diagnosed measles or mumps
disease.
 A routine second dose of MMR vaccine, administered a
minimum of 28 days after the first dose, is recommended
for adults who
 are students in postsecondary educational institutions;
 work in a health-care facility; or
 plan to travel internationally.
MMR Vaccine Contraindications
 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
high-dose corticosteroids (>20 mg/day of prednisone
or equivalent) lasting two or more weeks
Administration
 MMR: 0.65-mL dose (reconstituted)
 SQ – upper, outer tricep
 5/8 inch, 25 gauge needle
70
Which of the following vaccinepreventable pathogens is a bacteria?
0%
1. Measles
0%
2. Mumps
0%
3. Rubella
100%
4. Pneumococcus
0%
5. Influenza
0%
6. Varicella
http://www.cancer.gov/clinicaltrials/results/summary/2015/gardasil9-0215
Human papillomavirus (HPV) vaccination
 Two vaccines are licensed for use in females, bivalent HPV
vaccine (HPV2 – types 16,18) and quadrivalent HPV vaccine
(HPV9 – types 6,11,16,18,31,33,45,52,58).
 Only one HPV vaccine is licensed for use in males (HPV9).
 For females, either HPV9 or HPV2 is recommended in a 3dose series for routine vaccination at 9 to 12 years of age,
and for those 13 through 26 years of age, if not previously
vaccinated.
 For males, HPV9 is recommended in a 3-dose series for
routine vaccination at 9 to 12 years of age, and for those 13
through 15 years of age, if not previously vaccinated.
Human papillomavirus (HPV) vaccination
 HPV vaccines are not live vaccines and can be
administered to persons who are immunocompromised as a result of infection (including HIV
infection), disease, or medications.
 HPV vaccine can be administered to persons with a
history of genital warts, abnormal Papanicolaou test,
or positive HPV DNA test.
Administration
 Gardasil®/Cervarix®
 IM - deltoid
 1 inch, 25 gauge needle
80
The mother of a 12-year-old boy requests the HPV
vaccination. Select the correct vaccine and series.
100%
 Gardasil®: 3 dose series
0%
 Cervarix®: 3 dose series
0%
 Gardasil®: 2 dose series
0%
 Cervarix®: 2 dose series
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
86
87
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
91
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
92
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.
96
Administration
 Zostavax: 0.65-mL dose (reconstituted)
 SQ – upper, outer tricep
 5/8 inch, 25 gauge needle
98
Which of the following statements about the
administration of influenza and zoster vaccines is true?
100%
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.
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