Download ACIP Updates February 2017

3/1/2017
Updates from February 2017
ACIP Meeting
Wednesday, March 1, 2017
12:00 PM ET
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Agenda
Agenda
Welcome and Introductions
William Schaffner, MD, NFID Medical Director and Professor of Preventive Medicine and Infectious
Diseases, Vanderbilt University School of Medicine
Advisory Committee on Immunization Practices (ACIP) Overview
Patricia (Patsy) A. Stinchfield, MS, RN, CPNP, CIC, Senior Director of Infection Prevention &
Control, Children’s Minnesota and NFID Secretary
Updates from February 2017 ACIP Meeting
William Schaffner, MD, NFID Medical Director and Professor of Preventive Medicine and
Infectious Diseases, Vanderbilt University School of Medicine
Questions and Answers
This webinar is supported by an unrestricted educational grant from Merck & Co., Inc.
NFID policies restrict funders from controlling program content.
General Information
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evaluation
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 The National Foundation for Infectious Diseases (NFID) is accredited by the
Accreditation Council for Continuing Medical Education to provide continuing
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Disclosures



Marla Dalton (NFID staff, content reviewer) owns stock, stock options, or bonds
from Merck & Co., Inc.
William Schaffner (NFID medical director, presenter) served as an advisor or
consultant for Dynavax, Merck & Co., Inc., Novavax, Inc., Pfizer Inc., and Sanofi
Pasteur; and served as a speaker for Genentech.
All other activity planners/reviewers and staff for this activity have no relevant
financial relationships to disclose
Learning Objectives
At the conclusion of this webinar, participants will be able to:
 Describe most recent ACIP recommendations for adult and
childhood/adolescent immunization
 Explain how recent changes to vaccine recommendations will
impact vaccination programs
 Discuss information on new and/or future vaccines for potential
use in practice
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About NFID
Non-profit 501(c)(3) organization dedicated to educating the public and
healthcare professionals about causes, treatment, and prevention of
infectious diseases across the lifespan

Reaches consumers, health
professionals, and media through:
 Coalition-building activities
 Public and professional educational
program
 Scientific meetings, research, and
training

Longstanding partnerships to
facilitate rapid program initiation
and increase programming impact

Flexible and nimble organization
Updates from
February 2017 ACIP Meeting
Wednesday, October 5, 2016
12:00 PM ET
Patricia (Patsy) A. Stinchfield, MS, RN, CPNP, CIC
NFID Secretary
Senior Director of Infection Prevention & Control
Children’s Minnesota
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Advisory Committee on
Immunization Practices (ACIP)
 15 members
 3 meetings/year
 36 liaison representatives from professional/academic
societies
 8 ex-officio members from federal agencies
 Media may be present
 Public comment at each meeting
 Meeting agenda, transcripts, slides available at:
www.cdc.gov/vaccines/acip
February 22-23, 2017 ACIP Agenda
One Vote:
 Hepatitis B vaccine in infants born to hepatitis Binfected mothers, updated recommendations
and Vaccines for Children (VFC) vote
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February 22-23, 2017 ACIP Agenda
DISCUSSION ONLY TOPICS:
 Influenza
 Adult Immunization
 Herpes Zoster Vaccines
 Meningococcal Vaccines
 Global Immunization Update
 Polio eradication
 Dengue, Zika, Yellow Fever
 Vaccination Errors
 Mumps Disease and Vaccine
Hepatitis B Vaccine: Revaccination for Infants
Born to HBV-Infected Moms (HBsAg+)
Current guidance:
 After birth, HBIG and 3 dose hepatitis B vaccine series
 Lab test 1-2 months after vaccine series is done
 Hepatitis B surface antigen (HBsAg)—should be
negative
 Hepatitis B antibody (Anti-HBs)—protection
 Positive and protected if >10mlU/ml
 Negative and not protected if <10mlU/ml—need revaccination.
Previous practice has been to repeat 3 doses, but workgroup
question was is 1 dose sufficient?
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Hepatitis B Revaccination Strategies
Noele Nelson, MD, PhD, MPH
Hepatitis B Antibody Response to Single Dose
Revaccination vs. 3 Dose Revaccination
 Initial non-responder follow up study with 2 groups:
 Group A with HBIG and 3 additional doses 96% seroconverted
at 12 months, 100% after a 4th dose
 Group B with 3 additional doses of vaccine, (no HBIG) 95.2%
seroconversion at 12 months and 95.2% at 13 months after 4th
dose
 94.8% AB+ of initial non-responders who complete a second
3 dose series
 14/15 (93.3%) had anti-HBs > 10mlU/ml after single dose
revaccination (N=15)
1Assateerawatt et al, Asian Pacific journal of allergy and immunology; 1991; 11(1)85-91
2Ko et al. Vaccine 2014: 32(18) 2127-33
3Perinatal Hep B Prevention Program 2012-2016 Georgia, Michigan, New York City
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VOTE: Hepatitis B Revaccination for Infants
Born to HBV+ Mothers
 Language will allow lab testing after initial 3 dose series and
if seropositive, no further vaccination
 If seronegative, may do one additional dose and retest after
1-2 months
 Language remains that allows for choosing to just repeat
the 3 dose series without lab testing after the first dose
followed by lab testing after the 6th dose
 If Anti-HBs is > 10 is protected, no further vaccination or
testing
 If Anti-HBs is < 10 is a non-responder, no further vaccination
or testing
Influenza Current Season Surveillance
 Most circulating strains are A strains and
predominantly H3N2; influenza B may just be starting
 Contents of injectable vaccine are a good match for the
low levels of virus circulating in US
 Moderate season so far; vaccine efficacy is 48%
 We have not peaked with influenza yet except possibly
in the Northwest
 29 pediatric deaths to date
 Vaccine virus selection for 2017-2018 will be made in
early March by WHO

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Influenza Vaccine Updates
 Afluria® by Seqirus evaluation of 2010 increase in adverse events of
fever and febrile seizures in children <5 years in Southern Hemisphere
CSL TIV
 Excellent presentation of safety review and analysis of all systems
 Root cause was TIV stimulated release of cytokines and chemokines
more robustly than previously; manufacturing process may have not
fully split the B virus adequately yielding a greater immune response
 Problem studied, resolved, similar fever rates in TIV and QIV and the
vaccine will be offered in US during 2017-2018 season
 Fluzone® Sanofi Pasteur HD vs. SD showed HD in nursing home
residents reduces lab confirmed flu, is cost effective at 81 residents at
$30/vaccine ($2,430) or less than the average cost of hospitalization
LAIV Influenza Vaccine Updates

FluMist® by MedImmune presented review of 2015-2016 vaccine effectiveness
data of LAIV against influenza hospitalization in 6 studies; CDC VE network
showed no effectiveness compared to consolidated other sites in England,
Finland, Canada, etc. at 54.5%

Two potential hypotheses:
 Reduced replication of H1N1 component in human cells
 Vaccine virus interference by quadrivalent formulation

Will be using A/Slovenia H1N1 for 2017-2018 vaccine studying in cells and ferrets

Committee had multiple questions before considering using LAIV:
 More human studies, bigger power, would like to fully understand original US
vaccine failure better, non-manufacturer studies to consider

LAIV not recommended in the coming season
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Updates from
February 2017 ACIP Meeting
Wednesday, October 5, 2016
12:00 PM ET
William Schaffner, MD
NFID Medical Director
Professor of Preventive Medicine and Infectious Diseases
Vanderbilt University School of Medicine
Herpes Zoster Vaccines
 Zostavax® (Merck); live, attenuated vaccine, 1 dose
 2008 - ACIP recommended for immunocompetent ≥
60 years
 Efficacy: 51% vs zoster; 67% vs PHN
 Reduced in older recipients
 Duration of protection vs zoster
 Year 4 45%
 Year 9 7%
 31% adults ≥ 60 years in US have been vaccinated
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Anticipated Herpes Zoster Vaccine
(Unlicensed)
 (GSK) subunit vaccine (zoster/su), 2 doses
 Surface glycoprotein E + ASO1B adjuvant
 Efficacy: 97% vs zoster in persons ≥ 50 years
 91% vs zoster in persons ≥ 70 years
 Duration of protection vs zoster
 Year 4- 85% in persons ≥ 70 years
 More local reactions than with Zostavax®
Herpes Zoster Work Group Deliberations
Gaps:
 HZ/su Protection beyond 4 years?
 Efficacy in immunocompromised patients?
Considerations:
 Recommend HZ/su routine age 50 vs. 60 years?
 Recommended for Previous Zostavax® recipients?
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Adult Immunization
Standards for Adult Immunization Practice (2014)
 ACCESS vaccination status at every encounter
 Strongly RECOMMEND needed vaccines
 ADMINISTER vaccines or REFER to a vaccine
provider
 DOCUMENT vaccines received in a state
registry
Adult Immunization
Online survey of adults and healthcare professionals
(2016)
 Adult patients reported low levels of care that
reflected the Standards
 Vaccination assessment 9%-53%
 Providers reported high levels of Standards
implementation
 Vaccination assessment 67%-97%
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Meningococcal Vaccines
 Sanofi Pasteur discontinuing production and supply of
 Menomune (polysaccharide vaccine)
 Last lots will expire June–September 2017
 Thus, a licensed meningococcal vaccine for persons
≥56 years will not be available
 ACIP: Such persons should receive MenACWY
conjugate vaccine
Meningococcal Disease Incidence –
United States, 1996-2015
1.3 cases/100,000 population
1.4
Incidence per 100,000
1.2
1
0.8
MenACWY vaccine
0.6
0.12 cases/100,000
population
0.4
MenB vaccine
0.2
0
1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015
Year
•Abbreviations: MenACWY = quadrivalent conjugate meningococcal vaccine against serogroups A, C, W, Y; MenB vaccines = serogroup B meningococcal vaccines
•Source: 1996-2015 NNDSS Data
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Trends in Meningococcal Disease Incidence
by Serogroup – United States, 2006-2015
B
0.12
C
Y
W
Other
Incidence per 100,000
0.1
0.08
0.06
0.04
0.02
0
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
Year
National Notifiable Diseases Surveillance System (NNDSS) data with additional serogroup data from Active Bacterial Core
surveillance (ABCs) and state health departments
Average Annual Incidence by Age-Group and
Serogroup―United States, 2006-2015
2.5
B
CWY
Oth/Unk
Incidence per 100,000
2
1.5
1
0.5
0
<1 year
1 year
2-4 years
5-10 years
11-15 years 16-20 years 21-25 years 26-44 years 45-64 years 65-84 years ≥ 85 years
Age Group
National Notifiable Diseases Surveillance System (NNDSS) data with additional serogroup data from Active Bacterial Core surveillance
(ABCs) and state health departments
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Two MenB Vaccines For Persons Aged 10–25
Years in the United States
 MenB-FHbp (Trumenba®, Pfizer)
 Components: fHbp subfamily A/v2,3; subfamily B/v1
 Licensed in the US on October 29, 2014
 3-dose series, administered at 0, 1–2, and 6 months
 For persons at increased risk for serogroup B meningococcal disease
 2-dose series, administered at 0 and 6 months
 For healthy adolescents who are not at increased risk for
meningococcal disease
 MenB-4C (Bexsero®, GlaxoSmithKline)



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Components: fHbp subfamily B/v1; NhbA; NadA; Por A1.4
Licensed in the US on January 23, 2015
2 dose series, administered at 0 and ≥1 month
Licensed in >35 countries for persons ≥2 months of age
Current ACIP Serogroup B Meningococcal
(MenB) Vaccine Recommendations
 February 2015
 Certain persons aged ≥10 years who are at increased risk for meningococcal
disease should receive MenB vaccine (Category A)1. These include:




Persons with persistent complement component deficiencies
Persons with anatomic or functional asplenia
Microbiologists routinely exposed to isolates of Neisseria meningitidis
Persons identified as at increased risk because of a serogroup B meningococcal
disease outbreak
 June 2015
 Adolescents and young adults aged 16–23 years may receive MenB vaccine
to provide short-term protection against most strains of serogroup B
meningococcal disease (Category B)2
 No guidance for booster doses
1. Folaranmi T., et al. Use of Serogroup B Meningococcal Vaccines in Persons Aged ≥10 Years at Increased Risk for Serogroup B
Meningococcal Disease: Recommendations of the Advisory Committee on Immunization Practices, 2015. MMWR; June 12, 2015;
Vol. 64, No. 22, p 608-612.
2. MacNeil JR, et al. Use of Serogroup B Meningococcal Vaccines in Adolescents and Young Adults: Recommendations of the
Advisory Committee on Immunization Practices, 2014. MMWR; October 23, 2015, Vol. 64, No. 41, p 1171-1176.
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Statement of Problem

Certain persons at increased risk for meningococcal disease likely remain at
increased risk throughout their lifetime
 Persons with persistent complement component deficiencies or taking eculizumab
 Persons with anatomic or functional asplenia
 Microbiologists routinely exposed to isolates of Neisseria meningitidis

Data suggest waning of protection after vaccination with serogroup B
meningococcal (MenB) vaccines

Limited data on:

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

Duration of protection of MenB vaccines among persons at increased risk
Efficacy of MenB booster doses among persons at increased risk
Immunogenicity to primary series among immunocompromised subjects
Unlikely more data will be available
Need to optimize protection for persons at increased risk for meningococcal
disease
MenB-4C (Bexsero®) - Antibody persistence (hSBA ≥1:4) at 24–36
months post primary series and hSBA responses to a booster dose at
24–36 months post primary series in children aged 4–7 and 8–12 years
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Summary: MenB Vaccine Antibody Persistence and
Booster Response Among Healthy
Children and Adolescents
 Decay of antibody levels against all strains for both
MenB vaccines
 Infants, children, adolescents
 As early as 12 months
 Different waning rates observed for antibodies to each
antigen
 Increase in antibody levels among previously
vaccinated subjects in response to a booster dose
Policy Options
 Booster doses of MenB vaccine should be administered
every ? years throughout life to persons aged ≥10 years in
each of the following groups:
 Persons with persistent complement component deficiencies
including persons taking eculizumab
 Persons with anatomic or functional asplenia
 Microbiologists routinely exposed to isolates of Neisseria
meningitidis (as long as exposure continues)
 Booster doses of MenB vaccine should be administered to
persons identified as at ongoing increased risk because of a
serogroup B meningococcal disease outbreak based on a
minimum interval since their last MenB dose (interval to be
further discussed)
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Global Immunization Update
 Polio
 Advancing toward eradication
 Last strongholds: Afghanistan, Pakistan, Nigeria
 Strategy: Surveillance, virus detection
 Oral Polio Vaccine (OPV) change to Inactivated Polio
Vaccine (IPV)
 Research laboratory survey
 Measles
 79% reduction in cases, 2000-2015 (Target: 95%)
 Rubella
 Only 46% of the world’s children are vaccinated against rubella
Global Immunization Update
 Dengue vaccine
 Recombinant tetravalent live attenuated vaccine
(Dengvaxia®, Sanofi Pasteur)
 Safe, partial protection when given to children living in
endemic areas with high background of previous dengue
infection
 Zika vaccines
 Several Zika vaccine candidates are entering Phase I clinical
trials
 Yellow Fever vaccine
 The shortage of Yellow Fever vaccine is being resolved
 Product ordering restrictions will continue through mid-2017
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Updates from
February 2017 ACIP Meeting
Wednesday, October 5, 2016
12:00 PM ET
Patricia (Patsy) A. Stinchfield, MS, RN, CPNP, CIC
NFID Secretary
Senior Director of Infection Prevention & Control
Children’s Minnesota
Vaccination Errors
Vaccine Safety Office Tom Shimabukuro, MD, Beth Hibbs, RN
 Vaccine Adverse Event Reporting System (VAERS) in 2000-2013 311,185
reports, 7% are error reports (21,843)
 Main errors are inappropriate schedule (27%), storage and dispensing
(23%) and wrong vaccine (15%) - 2/3rds of errors
 Top 3 vaccines with errors often sound alike





Varivax®/Zostavax®
DTaP®/TDaP®
IIV age indication issues
Pneumo Conjugate/Pneumo Polysaccharide
Hep A/Hep B
 75% of vaccination errors reports to VAERS did not document adverse
health events (AE)
 Of the 25% error reports that did have AE they were similar to non-error
related reports; 92% are non-serious reports
 Case studies: rotavirus injected, insulin instead of influenza, injecting
diluent
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Strategies for Reducing Vaccination Errors





Education and training on the schedule
Training on administration techniques
Monitor vaccine storage temperatures
Pay attention to expiration dates
Engineer differentiation between sound alike
names/acronyms
 Screening for contraindications standardized
 Engineer interventions
 Bar coding for box and product to match
Mumps Epidemiology
 Mumps vaccine has reduced disease by 99%
 Mumps outbreaks persist 2006, 2010, 2016 (nearly
6,000 cases)
 Most are in fully vaccinated college students
 If vaccine immunity is waning, no older vaccinated
cases
 2-dose schedule may be sufficient for general
population
 3 doses commonly used in outbreaks
 Benefit of 3rd dose in general population needs
assessing
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Mumps Disease and Vaccine
Questions for the Workgroup

Why do we see mumps primarily in a tight age-range of teens and young adults?
(19-23 years median in 16 outbreaks)

When the outbreaks occur, they are largely on college campuses where there are
close living situations, but we don't similarly see mumps outbreaks in military
recruits. Why not?

If we are seeing waning immunity of the vaccine how does that explain specific
geographic outbreaks and no cases in older adults?

Are certain populations at higher risk for mumps disease compared to others?

Are there proper vaccine storage and handling concerns in certain areas?

Has there been a shift in mumps genotypes in the US compared to what is in the
vaccine?

Should a 3rd dose of mumps containing vaccine be used in an outbreak setting
only or is there evidence to support a 3rd dose as a more broad routine
recommendation?
Questions & Answers
Register at: www.nfid.org/cvc
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CME/CNE Credit & Webinar Evaluation
 The National Foundation for Infectious Diseases (NFID) is accredited by the
Accreditation Council for Continuing Medical Education to provide continuing
medical education (CME) for physicians. NFID designates this enduring
material for a maximum of 1.0 AMA PRA Category 1 CreditTM
 This continuing nursing education activity was approved by the Ohio Nurses
Association, an accredited approver by the American Nurses Credentialing
Center’s Commission on Accreditation (OBN-001-91). This education activity
has been approved for a maximum of 1.o contact hour.
 To receive contact hours, you must complete the online evaluation and pass
the post-test with a score of 80% or higher
 Online evaluation and post-test will be available following the webinar at:
bit.ly/ACIP-0301-Webinar
 Certificate will be available for print or download following successful
completion of online evaluation and post-test until March 1, 2018.
CPE Credit & Webinar Evaluation
 Visit: http://nacds.learnercommunity.com/webinars/acip-recommendations2017
 Select course “Advisory Committee on Immunization Practices (ACIP)
Recommendations, 2017–Live” under Claiming Credit
 Select “Add to Cart”
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 Enter Attendance Code, complete Post-Test and Evaluation, and enter NABP
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 Contact [email protected] with any questions
ATTENDANCE CODE:
KRTM7P
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3/1/2017
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