Update 2014 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 ID: 314354
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Slide1
Adult Immunizations
Update 2014
Kenneth McCall, BSPharm, PharmDAssociate Professor | UNEPresident | Maine Pharmacy AssociationSlide2
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.Slide3
Outline
Background & Principles of VaccinationInfluenza VaccinesQuadrivalent inactivatedQuadrivalent live
MammalianHigh DoseIntradermalSlide4
Background &Principles of VaccinationSlide5Slide6
Classification of Vaccines
Live attenuatedWeakened form of the “wild” virus or bacteriaInactivatedWhole viruses or bacteriaFractions of viruses or bacteria
*Epidemiology and Prevention of Vaccine-Preventable Diseases, 12th EditionSlide7
Classification of Vaccines
Live attenuated: Measles, mumps, rubella, varicella, zoster, intranasal influenzaInactivated: hepatitis A, hepatitis B, influenza, pneumonia, diphtheria, tetanus,
pertussis, HPV, meningicoccal*Epidemiology and Prevention of Vaccine-Preventable Diseases, 12th EditionSlide8
8Slide9
2014 Recommended Adult Immunization Schedule, by vaccine and age group
www.cdc.gov/vaccines/schedules/hcp/adult.htmlSlide10
Vaccines that might be indicated for adults based on medical and other indications
www.cdc.gov/vaccines/schedules/hcp/adult.htmlSlide11
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.htmlSlide12
What is the Healthy People 2020 goal for annual flu vaccination for adults 65 and older?
100%
90%70%50%Slide13
Influenza VaccinesSlide14
14Slide15
Influenza Virus Strains
Influenza A virusModerate to severe illnessAll age groupsHumans and other animals
Influenza B virusMilder diseasePrimarily affects childrenHumans onlyInfluenza C virusRarely reported in humansNo epidemics15Slide16
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.Slide17Slide18
US Influenza Vaccines: 2014
Vaccine
Age Group
Dosage
Schedule
Route
Inactivated
, Trivalent Standard Dose
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
Inactivated, Recombinant
Trivalent Standard Dose
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
Live
,
Quadrivalent
Intranasal
2-8 years
0.2 ml
1
or 2
Nasal
9-49 years
0.2 ml
1 dose
NasalSlide19
New Influenza Vaccines: 2013-14
Fluarix ® (GlaxoSmithKline) – inactivated, quadrivalent
vaccineFDA approved December 2012People ages 3 years and olderFluzone® (Sanofi Pasteur) – inactivated, quadrivalent vaccine.FDA approved March 2013People ages 6 months and olderFlumist
®
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
D
oesn’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 contraindicationsSlide20
Which of the following was the predominant flu strain of 2013-14?
Type B strain in trivalent vaccine
Type B strain not in trivalent vaccineType A H1N1 strainType A H3N2 strainSlide21
Inactivated
InfluenzaVaccine (IIV)Quadrivalent Fluarix
® Fluzone®21Slide22
New Influenza Vaccines: 2013-14
Fluarix ® (GlaxoSmithKline) – inactivated, quadrivalent vaccine which contains two type A and two type B strains
FDA approved December 2012People ages 3 years and olderFluzone ® (Sanofi Pasteur) – inactivated, quadrivalent vaccine which contains two type A and two type B strainsFDA approved March 2013People ages 6 months and olderSlide23
Quadrivalent vs. Trivalent:
Local Side Effects
Local Side Effect Fluarix QuadrivalentN=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.Slide24
Quadrivalent
vs. Trivalent:Systemic Side effects
Systemic Side EffectFluarix QuadrivalentN=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.Slide25
Quadrivalent vs. Placebo:
Vaccine Efficacy
Attack Rates (n/N)Vaccine Efficacy
N
N
%
%
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.Slide26
Administration
Fluarix®: 0.5-mL doseIM - deltoid1 inch, 25 gauge needle
26Slide27
Quadrivalent Influenza Vaccines contain which of the following?
Four type A strains
Two type A strains, 1 type B, & 1 type CTwo type A strains & 2 type B strainsFour type B strainsSlide28
Live Attenuated Influenza Vaccine (LAIV)
QuadrivalentFlumist®
28Slide29
New Influenza Vaccines: 2013-14
Flumist® Quadrivalent (MedImmune)– live attenuated vaccine which contains two type A and two type B strains
FDA approved March, 2012People ages 2 through 49 yearsSlide30
Live Attenuated Influenza Vaccine
IndicationHealthy people 2 through 49 years of age
ContraindicationsPregnant womenPeople 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 disordersAnyone with a weakened immune systemSevere egg allergy
30
I pick my nose!Slide31
Immune Response Studies of FluMist
Quadrivalent in Children and AdultsA 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.Slide32
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.Slide33
Summary of solicited adverse reactions observed within 14 days after
FluMist
in Adults 18-49 yearsFluMist Quadrivalent [package insert]. Gaithersburg, MD:
MedImmune
Inc; 2012.Slide34
Administration
Flumist®: 0.1-mL dose in each nostrilIntranasal
34Slide35
Intranasal Administration
Active inhalation (sniffing) by the patient is not requiredSlide36
Which of the following patients is a candidate for the live influenza vaccine?
45
yo man with severe egg allergy27 yo healthy woman38 yo
man with diabetes
54
yo
healthy man
19
yo
pregnant womanSlide37
Inactivated
InfluenzaVaccine (IIV)TrivalentMammalianFlucelvax
® 37Slide38
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 olderDoesn’t list “severe allergic reaction to egg protein” in the contraindicationsSlide39
Head-to-Head Comparison: Flucelvax vs. Placebo
Barrett PN, et al. Lancet 2011;377:751-59Slide40
Flucelvax vs. PlaceboLocal & Systemic Adverse Reactions
Flucelvax
[package insert]. Cambridge, MA: Novartis Vaccines & Diagnostics Inc; 2012.Slide41
Flucelvax Compared to Agriflu
Local Adverse Reactions
Flucelvax [package insert]. Cambridge, MA: Novartis Vaccines & Diagnostics Inc; 2012.**
AgrifluSlide42
Flucelvax
Compared to
AgrifluSystemic Adverse Reactions**AgrifluSlide43
Administration
Flucelvax®: 0.5-mL doseIM - deltoid1 inch, 25 gauge needle
43Slide44
Which of the following influenza vaccines does not include “severe egg allergy” as a contraindication?
Inactivated
quadrivalentLive quadrivalentInactivated trivalent intradermal
Inactivated trivalent high dose
Inactivated trivalent mammalianSlide45
Inactivated, Trivalent Recombinant Vaccine
Flublok® 45Slide46
New Influenza Vaccines: 2013-14
Flublock® (Protein Sciences Corporation)– trivalent inactivated vaccine grown in
insect cells rather than chicken embryo cells. FDA approved November, 2013Adults 18 through 49 years of age.Doesn’t list “severe allergic reaction to egg protein” in the contraindicationsSlide47
Vaccine Efficacy against Culture-Confirmed Influenza in Healthy Adults 18-49 yearsSlide48
Frequency of Local and Systemic Reactions within 7 days of Flublok
or Placebo in Adults 18-49 yearsSlide49
Administration
Flucelvax®: 0.5-mL doseIM - deltoid1 inch, 25 gauge needle
49Slide50
ACIP Recommendations for flu vaccination of person who report egg allergy.Slide51
Select an influenza vaccine for a healthy 37-year-old woman with severe egg allergy.
Flublok
FlumistFluzoneFluarix Slide52
High-Dose InactivatedInfluenza Vaccine (IIV)
TrivalentFluzone HD®
52Slide53
Methods:
Multicenter, randomized, double-blind controlled studyHD vaccine (60 mcg of hemagglutinin per strain): N=2,575SD vaccine (15 mcg of hemagglutinin per strain): N=1,262in adults 65 years of age and older.
53J Infect Dis. 2009;200(2):172-80Slide54
Comparison of responses to high-dose (HD) and standard-dose (SD) influenza vaccine
54
antibody titer level
J Infect Dis. 2009;200(2):172-80Slide55
Comparison of systemic side effects to HD and SD influenza vaccine
55
J Infect Dis. 2009;200(2):172-80PercentSlide56
Administration
Fluzone HD®: 0.5-mL doseIM - deltoid1 inch, 25 gauge needle
56Slide57
Intradermal
InactivatedInfluenzaVaccine (IIV)Fluzone Intradermal®Slide58
Intradermal Influenza Vaccine
IndicationPersons 18 through 64 years of ageContraindications
Severe egg allergy 58Slide59
Intradermal vs Traditional IM needle LengthSlide60
30 Gauge Needle and Less VolumeSlide61
Methods:Multicenter, randomized, double-blind controlled study
ID vaccine (9 mcg of hemagglutinin per strain) N=1,803IM vaccine (15 mcg of hemagglutinin per strain): N=452
in adults 18 to 60 years of age.Human Vaccines. 2010;6:346-54.Slide62
Comparison of responses to Intradermal (ID) and Intramuscular (IM) influenza vaccine
62
Seroprotection Rate
Human Vaccines. 2010;6:346-54.Slide63
Comparison of systemic side effects to ID and IM influenza vaccine
63
PercentHuman Vaccines. 2010;6:346-54.Slide64
Comparison of local side effects to ID and IM influenza vaccine
64
PercentHuman Vaccines. 2010;6:346-54.Slide65
Intradermal Injection Technique
Remove needle cap
Hold microinjection system between thumb and middle fingerDo not place fingers on the windowsInsert needle rapidly perpendicular to the skinInject using the index finger Remove needle from the skin and activate the needle shield by
pushing firmly on the plungerSlide66
Which side effect is more common with the intradermal
influenza vaccine than the IM influenza vaccine?
Injection site painHeadacheFeverInjection site swellingMalaise Slide67
Influenza Vaccines: SummarySlide68
Influenza Vaccines and Age Indications
Vaccine
Age Indications6-23m
2-3y
3-17y
18-49y
50-64y
65+y
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 Slide69
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. Slide70
Which of the following influenza vaccine(s) is/are appropriate for a healthy 16-year-old boy.
Fluzone
Fluzone IDFluzone HDFlucelvax
1 and 2Slide71
Which of the following influenza vaccines is NOT indicated for a 72-year old woman?
Inactivated trivalent IM vaccine
Inactivated quadrivalent vaccineInactivated high dose vaccineInactivated trivalent intradermal
vaccineSlide72
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?
Influenza
intradermal vaccineInfluenza intramuscular vaccineInfluenza high dose vaccineFlumist nasal spray 0.2 ml nasal
Either 1 or 2
Either 2 or 3
Either 2 or 4Slide73
Pneumococcal Vaccine
PPSV23 / Pneumovax® PCV13 / Pnevnar®Slide74Slide75Slide76Slide77Slide78Slide79
2014 ACIP Recommendations for Pneumococcal Vaccination in Adults
Immunocompromised?
yes
no
Previously received Pneumovax?
yes
no
Administer
Prevnar
one or more years after last Pneumovax
Administer
Prevnar
followed by Pneumovax 8 weeks later
Age
>
65?
yes
no
Administer Pneumovax
Lung, liver, kidney, heart disease, diabetes, smoking, nursing home?
yes
no
Vaccine not recommendedSlide80
2014 ACIP Recommendations on Revaccination with Pneumovax in Adults
Age
> 65?
yes
no
Previous Pneumovax
>
5 years ago and prior to age 65?
no
Administer Pneumovax
Vaccine not recommended
Renal disease,
Immuno
-compromised?
yes
no
Administer Pneumovax
Previous Pneumovax
>
5 years ago?
Vaccine not recommended
yes
yes
no
Vaccine not recommendedSlide81
Administration
Pneumovax® / Prevnar ® : 0.5-mL doseIM - deltoid1 inch, 25 gauge needle
81Slide82
A 54-year-old man is immuno
-compromised due to asplenia. No prior pneumonia vaccination. What pneumonia vaccine(s) is/are recommended?
Pneumovax onlyPrevnar onlyBoth;
Pneumovax
prior to
Prevnar
Both;
Prevnar
prior to
PneumovaxSlide83
A 67-year-old woman has a history of type 2 diabetes. No prior pneumonia vaccination. What pneumonia vaccine(s) is/are recommended?
Pneumovax
onlyPrevnar onlyBoth; Pneumovax prior to Prevnar
Both;
Prevnar
prior to
PneumovaxSlide84
Which of the following statements about the administration of influenza and pneumonia vaccines is true?
Same day, opposite arm, separate syringe
Same day, same arm, mixed in 1 syringeMust be separated by at least 7 daysMust be separated by at least 4 weeksSlide85
Which of the following vaccines is a live vaccine?
Pneumovax
FlumistPrevnarFluarixFluzone
HDSlide86
Questions and DiscussionSlide87
Herpes Zoster VaccineZostavax
®Slide88
88Slide89
89Slide90
Clinical Presentation of Herpes Zoster
1–3
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)
Prodrome
Acute HZ Rash
Evolution of Rash
Complications?
Pain (varying severity)
“Aching”, “burning”, “stabbing”, “shock-like”
Oxman
MN. In: Arvin AM et al, eds.
Varicella
-Zoster Virus: Virology and Clinical Management
. Cambridge, UK: Cambridge University Press; 2000:246–275.
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.
© Phototake.
© Dr. P. Marazzi / Photo Researchers, Inc.
Herpes Zoster Rash Follows a
Dermatomal
Distribution
© Phototake. Slide91Slide92
Zoster Vaccination Rates are Low
1–3
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.
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 infection
4
% Vaccinated (cumulative) in Individuals Aged ≥60 Years
Year
7%
10%
14%
2008
2009
2010
0
5
10
15
20
25
30
35
40
45
50
15.8%
2011
2010
2009
2008Slide93
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
.
93
Recommendations of the Advisory Committee on Immunization Practices (ACIP)
http://
www.cdc.gov/mmwr/preview/mmwrhtml/rr5705a1.htm?s_cid=rr5705a1_e
Zostavax
®
[package insert]. Whitehouse Station, NJ: Merck; April 2011.Slide94
Vaccine Contraindications
Allergy to neomycin or any vaccine componentPregnancyImmunocompromised 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 high-dose corticosteroids (>20 mg/day of prednisone or equivalent) lasting two or more weeks
94Slide95
Efficacy of ZOSTAVAX
® (Zoster Vaccine Live) on Incidence of Herpes Zoster in Adults Aged
60 YearsBased on the results of the Shingles Prevention Study (SPS)a
RESULTS BY AGE GROUPS (YEARS)
Placebo
(n=10,356)
ZOSTAVAX
(n=10,370)
Number of Zoster Cases
64
%
in subjects
60–69
[95% CI: 56–71]
Placebo
(n=7,559)
ZOSTAVAX
(n=7,621)
Number of Zoster Cases
41
%
in subjects
70–79
[95% CI: 28–52]
Placebo
(n=1,332)
ZOSTAVAX
(n=1,263)
Number of Zoster Cases
18
%
in subjects
80
[95% CI: –29–48; NS]
334
122
261
156
47
37
Placebo
(n=19,247)
ZOSTAVAX
(n=19,254)
Number of Zoster Cases
51
%
in subjects
60
[95% CI: 44–58]
OVERALL LOWER
INCIDENCE OF
ZOSTER
a
642
315
CI=confidence interval; NS=not significant.
a
In 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).Slide96
Efficacy of ZOSTAVAX
® (Zoster Vaccine Live) on Incidence of PHN in Adults Aged
60 Years Who Developed Zoster Post-Vaccination 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.0
Overall
Number of PHN Cases
80
27
8.6
12.5
10
20
30
% of Zoster Cases
With PHN
39%
b
Number of HZ Cases
642
315
(95% CI: 7–59)
ZOSTAVAX
Placebo
HZ=herpes zoster; PHN=postherpetic neuralgia.
a
PHN 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.
b
Age-adjusted estimate based on the age strata (60–69 and ≥70 years of age) at randomization.
Based on the results of the Shingles Prevention Study (SPS)
aSlide97
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
a
Study Design for ZEST:
In the ZOSTAVAX Efficacy and Safety Trial, efficacy was evaluated in a placebo-controlled, 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.
99
30
Placebo
(n=11,228)
ZOSTAVAX
(n=11,211)
Number of Zoster Cases
70
%
in subjects
50–59
[95% CI: 54–81]Slide98
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.98
Zostavax
®
[package insert]. Whitehouse Station, NJ: Merck; April 2011.Slide99Slide100
Administration
Zostavax: 0.65-mL dose (reconstituted)SQ – upper, outer tricep5/8 inch, 25 gauge needle
100Slide101
Which of the following statements about the administration of influenza and zoster vaccines is true?
Same day, opposite arm, separate syringe.
Same day, same arm, mixed in 1 syringe.Must be separated by at least 7 days.Must be separated by at least 4 weeks.Slide102
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?
Pneumovax 0.5 ml IMInfluenza SD shot 0.25 ml IM
Influenza HD shot 0.5 ml IM
Flumist
nasal spray 0.1 ml in each nostril
Zostavax
0.65 ml SQ
Both 1 and 2
1, 2 and 5
1, 3 and 5
1, 4 and 5 Slide103
Tetanus, Diphtheria, Pertussis
Boostrix®Adacel®Slide104
Pathogen (Common name)
Table
PathogenClassificationTransmissionComplicationTetanus
(lockjaw)
Gram +
Bacteria-
toxin
Wound
Respiratory
failure
Diphtheria
Gram +
Bacteria-
toxin
Respiratory
Myocarditis
/Neuritis
Pertussis
(whooping cough)
Gram
– Bacteria
Respiratory
PneumoniaSlide105
Diseases
20
th Century Annual Morbidity2010 Reported CasesPercent 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%
Haemophilus influenzae
20,000
270
99%
Comparison of 20
th
Century and current
US Morbidity of VPDsSlide106
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.Slide107
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), andhealth-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
.Slide108
Administration
Boostrix®/Adacel®: 0.5-mL doseIM - deltoid1 inch, 25 gauge needle
108Slide109
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?
Pneumovax 0.5 ml IMInfluenza SD shot 0.5 ml IMInfluenza HD shot 0.5 ml IM
Flumist
nasal spray 0.1 ml in each nostril
Zostavax
0.65 ml SQ
Tdap
0.5 ml IM
1, 2 and 5
1, 3 and 5
1, 2, 5 and 6 Slide110
Questions and DiscussionSlide111
Pathogen (Common name)
Table
PathogenClassificationTransmissionComplicationInfluenza (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
hepatitisSlide112
Adult Vaccine Table
Vaccine
Vaccine TypeRoute / ReconstituteSeriesStorageInfluenza IIV
Inactivated
IM / No
1
x
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
,
MenveoMenomune (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