immunization update 2017 - intermountainphysician · 2017-11-09 · immunization update 2017 tamara...
TRANSCRIPT
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Immunization Update 2017
Tamara Sheffield, MD, MPA, MPH
November 10, 2017
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• I have no conflicts of interest to disclose
• I will be discussing “off label” use
• I will be discussing an unlicensed vaccine
DISCLOSURE:
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LEARNING OBJECTIVES: PHARMACIST
At the conclusion of this activity, pharmacists should be able to successfully:
• Employ the latest ACIP Immunization Recommendations when delivering services to their clients
• Describe common errors in vaccine delivery and implement strategies to avoid these errors
• Locate tools developed to assist Intermountain vaccine providers in administering vaccines in a clinically appropriate manner
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Impact of Vaccines
Hepatitis B Hep B infections have decreased by 90.6% in US since vaccination initiated in 1982
• Locally contracted – mainly due to injection drug use
• 95% of new cases are imported
• Current focus on diabetics age 19-59 years (only 25% completion of series) – they are coming to your pharmacies for their meds and insulin
Schille S, Presentation at ACIP Oct 19, 2016
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Impact of Vaccines
Community Immunity
Successes
Pneumococcal – PCV7• Vaccinating children protects adults comparing
1997-1999 with 2007-2009Overall 168,000 fewer hospitalizations all ages
• 555/100,000 fewer for children
• 360/100,000 fewer for ages 75-84
• 1300/100,000 fewer for ages 85+
Pneumococcal – PCV13 (approved 2010)• Invasive pneumococcal disease (IPD) rates 33-62%
lower in post vaccination period than in pre-PCV13 child vaccine years (2007-2009) in all age groups
• Rates in seniors have been stable even after introduction of PCV13 in that age group
Griffin MR, NEJM 2013;369:155-63https://idsa.confex.com/idsa/2017/webprogram/Paper64222.html (accessed 10/11/17)
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H= Herd
Immunity
Threshold
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IMMUNIZATION RATES
DM: Diabetes Mellitus; HR: high risk; y/o: years old
Vaccine Group2013 data
(%)2014 data (%) 2015 data (%) % diff from 2014
PneumococcalHR, age 19-64 21.2 20.2 23 2.8
Age ≥ 65 59.7 61.3 63.6 2.3
Tetanus (any)
Age 19-49 62.9 62.6 62.1 -0.5
Age 50-64 64 64.7 64.1 -0.6
Age ≥ 65 56.4 57.7 56.9 -0.9
Tdap ≥ 19 y/o, total 17.2 20.1 23.1 3.1
≥ 65 y/o 11.9 14 16.5 2.5
Hepatitis B
(3 doses)
19-59 y/o, DM 26.3 23.5 24.4 0.8
19-59 y/o, liver
disease29.8 27.4 -2.4
Herpes Zoster ≥ 60 y/o 24.2 27.9 30.6 2.7
MMWR Surveillance Summaries/ February 5, 2016 /Vol. 65 / No. 16. MMWR/ February 6, 2015 / Vol. 64 / No. 4, 95-102. MMWR Surveillance Summaries/ May 5, 2017 / Vol. 66/ No 11, 1–28.
Slide courtesy of Kathy Povilus, Pharm D, BCACP - modified
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Highlighted Topics
• Influenza• Vaccine Errors• 2-Dose HPV• Meningococcal• Future Recs• Zoster
• Yellow fever vaccine access• Intermountain protocols
and resources
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INFLUENZA
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2016-2017 Season
• A:H3N2 predominant
• Had the typical second wave of Type B
• Vaccine well matched to all 4 strains
2017-2018 Season - Trivalent
• A/Michigan/45/2015 (H1N1) pdm09-like –NEW (used in 2017 Southern hemisphere)
• A/Hong Kong/4801/2014 (H3N2)-like
• B/Brisbane/60/2008-like (B/Victoria lineage)
2017-2018 Season – Quadrivalent
• B/Phuket/3073/2013
(B/Yamagata lineage)
Influenza
2016-2017 Season
Chart presented at June 2017 ACIP Meeting
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You have a 75 year old client wishing to receive an influenza vaccine from you. Which vaccine will potentially provide the greatest protection against contracting influenza?
1. Trivalent High-dose
2. Quadrivalent regular dose
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You have a 75 year old client wishing to receive an influenza vaccine from you. Which vaccine will potentially provide the greatest protection against contracting influenza?
1. Trivalent High-dose
2. Quadrivalent regular dose
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Study of high-dose efficacy & Estimation of IIV4 v. IIV3
IIV3-HD compared to IIV3-SD
Age 65 years and older
Lab confirmed influenza of any subtype
24.2% relative efficacy
NEJM 2014; 371:635-645
Quadrivalent Vaccine
• Adds 1 more B type than IIV3
• Type B (0-40% - most years 20-25% of circulating virus)
• Each year 30/70 split of TypeBs circulating
• Then multiply by vaccine efficacy (40-60%)
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You have a 75 year old client wishing to receive an influenza vaccine from you. Which vaccine will potentially provide the greatest protection against contracting influenza?
1. Trivalent high-dose
2. Trivalent adjuvanted
3. Quadrivalent Recombinant
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You have a 75 year old client wishing to receive an influenza vaccine from you. Which vaccine will potentially provide the greatest protection against contracting influenza?
1. Trivalent high-dose
2. Trivalent adjuvanted – Don’t know
3. Quadrivalent Recombinant –Interesting new study
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Study of Recombinant Influenza Vaccine (RIV4)
RIV4-HD compared to IIV4 (standard dose)
Age 50 years and older
PCR lab-confirmed influenza of any subtype during a mismatch season
RIV4 attack rate = 2.2% IIV attack rate = 3.2%
30% lower probability of influenza like illness with RIV4 than with IIV4
Sanofi has purchased Protein Sciences – maker of RIV (Flublok)
NEJM 2017; 376:2427-36
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How about Egg Allergy?
ACIP 2016-2017 Recs• Remove egg allergy chart• 30 minute wait down to 15
minute• All products can be used
including LAIV**• Be able to recognize and treat
severe allergic reactions (all allergy symptoms except hives)
**CDC has recommended against providing LAIV (FluMist®) for the 2017-2018 season
MMWR; August 26, 2016;65(5);1-54
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Influenza Vaccines
Available Products
Age Type Trade Name Manufacturer
6 mo + IIV4 Fluzone® Sanofi
6 mo + IIV4 FluLaval® GSK/ID BIo
2-49 years LAIV FluMist®** AstraZeneca
3 years + IIV4 Fluarix® GSK
4 years + ccIIV4 Flucelvax® Seqirus
5 years + IIV3 Afluria® Seqirus
5 years + IIV4 Afluria® Seqirus
18 years + RIV4 FluBlok® Protein Science
18-64 years IIV4 Fluzone®
IntradermalSanofi
65 years + IIV3 Fluzone® High-dose
Sanofi
**CDC has recommended against providing LAIV (FluMist®) for the 2017-2018 season
MMWR; August 26, 2016;65(5);1-54Updated for 2017 - unpublished
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FluLaval for Infants
Approved by FDA
FluLaval QuadrivalentTM (IIV4)
New age indication, 6 through 35 months
Different dose than pediatric Fluzone
• FluLaval = 0.5 mL
• Fluzone = 0.25 mL
2017 CPT code determined by dose, not age
• 90686 0.5mL syringe (all ages)
• 90688 0.5mL MVD (all ages)
• 90685 0.25 mL syringe (6-35 mo)
• 90687 0.25 mL MVD (6-35 mo)
FluLaval Package Insert
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Afluria QIV
Approved by FDA
as safe and effective
Indicated for age 5+ years (as of 8/31/17)
Studies on going for age 6 months to 5 years
Concerns about fevers and febrile seizures in young children in the TIV formulation (Australia)
Resolved fever concern with change in manufacturing process
• Increased use of TDOC (deoxycholate) splitting agent in both QIV and TIV
• Reduce lipids connected to mRNA fragments
• Lipids = fevers
Afluria TIV also approved by ACIP down to 5 years
• Previously ACIP limited it to ages 9 years + because of fevers
• FDA approval has always been 5 years +Grohskopf presentation, ACIP June 2017
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FluMist (LAIV)
Concerns of Efficacy
• Heat stability
• HA activation pH
• Replicability
Grohskopf presentation, ACIP June 2016
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Documents to assist vaccine providers
Influenza Immunization Plan
Plan Summary (1pg. 2 side)
• Table of start and stop times
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National Vaccine Administration Errors
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2017-02/errors-01-shimabukuro.pdf
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Vaccine Errors Wrong dose or vaccine for age• Influenza (0.25mL/0.5mL)
• DTaP/Tdap
• Hep A – adult and ped
• Kinrix/ProQuad
Wrong interval between doses
Wrong diluent
Temperature excursions
Keeping up with guidelines: New ACIP recommendations 3X per year
Storage: Multiple products, diluent not with vaccine, labels,
Similar names and colors
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Vaccine ErrorsOne dose for Influenza vaccine (0.5mL)
Use single dose syringes rather than multi-dose vials
Scan vaccine bar code prior to administering – iCentra prompts
Refer to USIIS forecast before administering
“Registry Import” button
Keep diluent connected to vaccine
iCentra removed “General” influenza choice when ordering
Strategies to avoid errors
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9vHPV 2-Dose
Original 3-dose recommendation
Originally recommended as 3-dose series
Any product (2valent, 4valent, 9valent)
Interval = 0, 2 months, 6 months
For the prevention of cervical, vulvar, vaginal, and anal cancers, precancerous or dysplastic lesions (HPV Types 16, 18, 31, 33, 45, 52, 58) and genital warts (HPV Types 6, 11)
MMWR, August 29, 2014, Vo1 63, #RR05
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9vHPV 2-Dose
New ACIP Rec
Evidence
1 trial of 9vHPV (girls and boys 9-14 v. females 16-26 yo)
• >97.9% seroconverted to all 9 serotypes
• Non-inferiority criteria met for seroconversion and GMTs
• GMTs significantly higher for all 9 serotypes in 2-dose 9-14 yo than 3 dose 16-26 yo
6 additional trials of 4vHPV, 2vHPV –immunogenicity non-inferior in 9-14 yo
MMWR 2016;65(49);1405-8.
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9vHPV 2-Dose
New Recommendation
A 2-dose series of HPV vaccine will be appropriate if:
• Initiate first dose before age 15 years
• If patient is healthy (not immunocompromised)
• If separation of doses is 6 months (5 months minimum interval)
Series can include doses of 2vHPV, 4vHPV or 9vHPV
HPV recommended for females 9 to 26 years, males 9-21 years, high risk males 22-26
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MeningococcalACYW
Menomune MPSV has been discontinued
Give high-risk adults age 56 years and older MenACYWconjugate vaccine
High risk:• Complement component deficient• Anatomic or functional asplenia• Microbiologists exposed• HIV• Outbreaks• Travel
MMWR, March 22, 2013 Vol 62. #RR02 – addresses off-label use
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Meningococcal B New 2-Dose
Approved for low risk, BUT----
Still not a general recommendation (Category B)
2 doses for both products• Bexero – (0, 1 month)• Trumenba (0, 6 month)
Category B - Individual shared clinical decision, allows for insurance coverage (ACA)
• Series may be administered to age 16 through 23 years for short-term protection against most strains of serogroup B meningococcal disease
Not Category A because of low incidence of disease, lack of efficacy and safety data
No herd protection----
High risk and outbreak – still need 3 doses of Trumenba (0, 1-2 mo, 6 mo)
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Meningococcal B
High Risk, age 10 years and older
Category A recommendation
Those at high-risk may receive 2 doses of
• Bexero – (0, 1 month)
But must still receive 3 doses of
• Trumenba (0, 1-2 months, 6 month)
High risk includes:
• Asplenia (anatomic)
• Asplenia (functional, such as sickle cell)
• Complement component deficiency
• Microbiologists exposed
• Outbreak
MMWR May 19, 2017:66(19);509-513
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SHINGLES- HERPES ZOSTER
Background:• Caused by varicella zoster virus (VZV)o Exclusively human pathogen that affects approx. 98% of US adult population
o Reactivation of Chickenpox infection
• Herpes Zoster (“shingles”) is a localized and painful cutaneous eruptiono Vesicular rash across dermatomes of the involved sensory nerve roots
o 1 in 3 persons will develop shingles in their lifetime
• Post Herpetic Neuralgia (PHN) is a common complication of zoster o Can occur up to 6 months after rash and can last months to years
o Impacts quality of life (sleep, work, activity), contributes to social withdrawal and depression
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“SHINGRIX” – HERPES ZOSTER SUBUNIT VACCINE (HZ/su)
Investigational herpes zoster subunit vaccine for prevention of herpes zoster and post herpetic neuralgia in adults ≥ 50 years
• Unique ingredient components designed to enhance CD4+ T-cell-mediated immune responses and improve vaccine efficacy:
oAntigen: varicella zoster virus (VZV) glycoprotein E
oAdjuvant system: AS01B adjuvant
• Two dose series, separated by 2 months
• Manufactured by GlaxoSmithKline
Lal H, et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. NEJM 2015;372:2087-96 Cunningham AL, et al. Efficacy of the herpes zoster subunit vaccine in adults ≥70 years of age. NEJM 2016;375:1019-1032
Colindros R. Investigational Herpes Zoster Adjuvanted Subunit (HZ/su) Vaccine: Efficacy in People 70 years and Older. Presented at: ACIP 2016. 2016 Oct 19.
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ZostavaxEfficacy
Merck
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ZOE-50 TrialHZ/su
NEJM May 28 2015
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ZOE-70 Trial HZ/su
NEJM Sept 15 2016
13,900 participants, mean age 75.6 years
Efficacy
• Age 70-79 (90.0%)
• Age 80 + (89.1%)
• All (89.8%)
Pooled ZOE-50 and ZOE-70 (91.3% efficacy)
• Postherpetic neuralgia (88.8%)
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Zoster CandidateHZ/su
Safety• No difference from placebo in Severe Adverse
Events• Local reaction – pain, redness, swelling – 9.1%
Of those who had a first dose Grade 3 reaction • 91.4 % received 2nd dose (local reaction)
• 89.2% received 2nd dose (systemic reaction)
Efficacy and persistence of protection out to 9 years so far• Cellular and humoral immune responses:
3.4 fold titers sustained from years 4 to 9
Safety and Duration of Protection
Colindres, R Presentation at ACIP Feb 2017
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COMPARISONZostavax® Shingrix®
Live vaccine Inactivated vaccine
Indication Recommended for prevention of
shingles in patients ≥ 50 YOAApplied for FDA-approval for prevention
of shingles in patients ≥ 50 YOA
Dosing schedule 1 injection 2 injections, 2-6 months apart
Efficacy for HZ 51.3% 91.3%
Efficacy for PHN 66.5% 91.2%
Duration of HZ efficacy 31.9% after 7 year follow up 87.9% at 4 year follow up
Other notes2 doses may decrease compliance and
increase site reactions
Manufacturer Merck & Co., Inc. GlaxoSmithKline Inc.
Professional Resource, Shingles Vaccine: FAQs. Pharmacist’s Letter/Prescriber’s Letter. Dec 2016. | CDC. Update on Recommendation for Use of Herpes Zoster Vaccine: Recommendations of the ACIP. MMWR 2014; 63(33): 729-731 .Lal H, et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. NEJM 2015;372:2087-96 | Cunningham AL, et al. Efficacy of the herpes zoster subunit vaccine in adults ≥70 years of age. NEJM 2016;375:1019-1032
HZ = Herpes zoster; PHN = Post herpetic neuralgia; YOA = Years of age;
Slide courtesy of Kathy Povlius, Pharm D, BCACP
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Zoster CandidateHZ/su
Submitted to FDA for approval
ACIP recommendation planned for October 2017
• Age 50 and above
• Good efficacy and safety when given 5 years after Zostavax
• Refrigerate, not frozen
• Not a live vaccine – may recommend giving to immunocompromised
• Preferential recommendation?
Summary
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Yellow Fever Vaccine
Access limited during manufacturing plant reconstruction
YF-VAX ® (Sanofi) unavailable until mid-2018
To find sites providing Stamaril® (Sanofi) under IND Protocol:
https://wwwnc.cdc.gov/travel/page/search-for-stamaril-clinics
Utah: Davis County HD, Passport Health-Midvale, SLCounty HD, University of Utah Travel Clinic,Utah County HD, BYU)
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Intermountain Healthcare Immunization Resources
Located on the Medical Group’s Clinical Resources Webpage:
Type: IMG in the URL line
Also located in the Primary Care Clinical Program Webpage in the topics on the left sidebar
Not at Intermountain? Go to www.immunize.org or www.cdc.gov/vaccines (hcp page)
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Intermountain Healthcare Immunization Resources
Located on the Medical Group’s Clinical Resources Webpage:
Type: IMG in the URL line
Go to Clinical Resources, then Immunizations
• Policies, Procedures
• Vaccine Protocols
• Links to immunization programs/resources
• Tools
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Questions?
Tamara Sheffield, MD, MPA, MPH
Medical Director, Community Health and Prevention
Intermountain Healthcare
36 S State Street, 21st Floor
Salt Lake City, UT 84111
(801) 442-3946