7/28/2016
Where We Are Now and
How We Can Do Better
Advisory Committee on Immunization Practices (ACIP)
The recommendations to be discussed are primarily those of the ACIP
• comprised of 15 experts in clinical medicine and public health who are not government employees
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Immunization Action Coalition
• provides guidance on the use of vaccines and other biologic products to the Department of Health and Human Resources, CDC, and the U.S. Public Health Service
J U LY 2016 / S8005
www.cdc.gov/vaccines/acip
ACIP Recommendation Categories
Category A recommendations
• made for all persons in an age‐ or risk‐factor‐based group
• EXAMPLE: MenACWY vaccine is recommended for all adolescents at 11 or 12 years of age
Category B recommendations
Category B recommendations
• do not apply to everyone, but in the context of a clinician‐patient
interaction, vaccination may be found to be appropriate for a person
• EXAMPLE: MenB vaccine series may be administered to adolescents
and young adults age 16–23 years
www.cdc.gov/vaccines/acip/recs/GRADE/downloads/handbook.pdf
Adolescent Vaccination Recommendations 2016
Category A
• MenACWY – 2 doses at 11–12 years and 16 years
(1 dose 2005, booster dose 2010)
• Tdap – single dose at 11–12 years (2006)
• HPV – 3 doses over 6 months at 11–12 years (female 2007, male 2011)
) annual (2008)
(
)
• Influenza ((IIV or LAIV*) –
* LAIV not recommended for 2016–2017 season
• MenB – persons at increased risk (2015)
Category B
• MenB – 2 or 3 doses at 16–18 years (2015)
Vaccination Coverage Among Adolescents
National Immunization Survey – Teen
• established in 2006 to provide an on‐going, consistent data set for analyzing vaccination levels among adolescents in the U.S.
• random‐digit‐dialing locates households with adolescents aged 13 to 17 years
13 to 17 years
• nationally representative sample provides estimates of coverage that are weighted to represent the entire population
• coverage estimates are based on provider‐reported vaccination histories
High‐risk (pneumococcal, Hib)
Catch‐up (MMR, varicella, hepatitis A, hepatitis B, IPV)
www.cdc.gov/vaccines/imz‐managers/coverage/nis/teen/index.html
www.cdc.gov/vaccines/schedules/hcp/child‐adolescent.html
Immunization Action Coalition • (651) 647‐9009 • www.immunize.org • www.immunize.org/catg.d/S8005.pdf • Item #S8005 (7/16)
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Vaccination Coverage Among 13–17 Year‐Olds, United States, 2006–2014
% VACCINA
ATED
1+HPV female
1+HPV female
1+HPV male
2+MenACWY
3+HPV female
MMWR 2015;64(29):784‐792
3+HPV male
SURVEY YEAR
Influenza Vaccines by FDA‐Approved Age Group, 2016–2017
Age Group
Vaccines Approved for This Age Group
0 through 5 months None
6 months and older
Fluzone IIV4 (not ID or HD)
3 years and older
Fluarix IIV4, FluLaval IIV4
4
4 years and older
d ld
Fl i i IIV3 Fl l
Fluvirin IIV3, Flucelvax
IIV4
5 years and older
Afluria IIV3*
18 years and older
Flublok RIV3
18 through 64 years Fluzone IIV4 intradermal
65 years and older
Fluzone IIV3 high dose, FLUAD IIV3
* Afluria IIV3 is approved by FDA for persons 5 years and older but recommended by ACIP for persons 9 years and older. Afluria is approved for persons 18 through 64 years when given by Stratis jet injector.
ADOLESCENTS VAC
CCINATED (%)
Tdap
1+MenACWY
Disparity Between the First and Second Doses of MenACWY – 2014
100
90
80
70
60
79.3%
50
40
30
20
28.5%
10
0
≥1 dose
Second dose
(by 13−17 years of age)
(by 17 years of age)
MMWR 2015;64(29):784‐792
Tdap Vaccines
• Boostrix (GlaxoSmithKline) – approved for persons age 10 years and older
• Adacel (Sanofi Pasteur) – approved for persons ages 10 through 64 years
• Neither approved by FDA for persons 7 through 9 years of age
• Neither approved by FDA for persons 7 through 9 years of age
• ACIP recommends both may be used in persons age 65 years
and older*
• Both approved for a single dose
*off‐label recommendation for Adacel
MMWR 2015;64:818‐25
Adolescent Tdap Recommendations
Tdap in Pregnancy • Single dose recommended at 11 or 12 years of age
• Administer a dose of Tdap vaccine during each pregnancy
regardless of the woman’s prior history of receiving Tdap* • Catch up 13 through 18 years who have not been vaccinated
with Tdap
• Children 7 through 10 years who are not “fully vaccinated
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y
against pertussis”*
“fully vaccinated against pertussis” is
• 5 doses of DTaP, or
• 4 doses of DTaP if the fourth dose was administered on or after the fourth birthday
• To maximize passive transfer of antibody to the fetus optimal
timing of Tdap is between 27 and 36 weeks gestation
• Tdap may be administered earlier in pregnancy if necessary
(e.g., wound management)
*off‐label recommendation
*off‐label recommendation
MMWR 2011; 60 (No. 1):13‐15
MMWR 2013:62(No.7):131‐135
Immunization Action Coalition • (651) 647‐9009 • www.immunize.org • www.immunize.org/catg.d/S8005.pdf • Item #S8005 (7/16)
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Tdap Vaccine Effectiveness Original Tdap licensure was based on immunologic bridging to DTaP recipients rather than clinical trials of vaccine effectiveness
Subsequent studies have demonstrated that Tdap vaccine effectiveness decreases with increased time ff
d
h
d
since vaccination
• 70%–75% within 1 year
• 30%–35% within 2–4 years
J Infect Dis 2014;210(6):942‐53, Pediatrics 2015;135(6):981‐9
Tdap Revaccination
Revaccination with Tdap applies ONLY to pregnant women
Revaccination is not recommended for family members, other contacts or healthcare providers
ACIP’ss recommendation is to focus on the current Tdap ACIP
recommendation is to focus on the current Tdap
program
• improve adolescent and adult Tdap coverage, including HCP (42% in 2014)
• vaccination of pregnant women
MMWR 2013:62(No.7):131‐135
Tdap Revaccination
A routine booster dose of tetanus and diphtheria toxoid is recommended every 10 years throughout life.
It is acceptable to use Tdap for the decennial booster dose if Td is not available.
MMWR 2013:62(No.7):131‐135
Meningococcal Disease
The Expanding Universe of Meningococcal Vaccine
MenACWY Vaccines
Meningococcal polysaccharide vaccine (MPSV4)
Menactra
• first licensed in 1974
• limited indications
Meningococcal conjugate vaccines (MenACWY) • first licensed in 2005
• recommended routinely for adolescents and high‐risk groups (category A)
• Approved for persons 9 months through 55 years*
• Approved for revaccination of persons 15 through 55 years
Menveo
• Approved for persons 2 months through 55 years*
Meningococcal B vaccines (MenB)
• first licensed in 2014
• recommended routinely only for high‐risk people (asplenia,
complement component deficiency, microbiologists)
• category B recommendation for non‐high‐risk adolescents
and young adults
*may be used off‐label in persons 56 years and older. MMWR 2013;62(RR‐2):15
Immunization Action Coalition • (651) 647‐9009 • www.immunize.org • www.immunize.org/catg.d/S8005.pdf • Item #S8005 (7/16)
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MenACWY Routine Recommendations
Age at first dose
Booster dose
11–12 years
16 years*
13 15 years
13–15
16 18
16–18 years*
*
16–18 years
No
*off‐label recommendation for Menveo
MMWR 2013;62(RR‐2):1‐28
MenACWY Recommendations
Not routinely recommended for person age 19 years or older who are not at increased risk Recommended for persons age 19 through 21 who are first‐year college students AND living in a residence hall
• 1 dose if previously unvaccinated
• booster dose if previous dose given at age younger than 16 years
Why Boost MenACWY at 16 Years of Age?
• Antibody persistence studies indicate that protective levels
of circulating antibody decline 3 to 5 years after a single MenACWY dose
• Vaccine effectiveness case‐control study suggests that many
adolescents are not protected 5 years after vaccination
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• A single dose of meningococcal conjugate vaccine
administered at age 11 or 12 years is unlikely to protect most adolescents through the period of increased risk at ages 16 through 21 years
MMWR 2013;62(RR‐2):1‐28, MMWR 2011;60(3):72‐76
Persons at Highest Risk of Meningococcal Disease or Suboptimal Vaccine Response
Complement deficiency
• very high antibody titer required to compensate for complement
deficiency Asplenia
• evidence of suboptimal response
HIV infection
Single dose primary series may not be sufficient to confer protection for persons with these high‐risk conditions
MMWR 2013;62(RR‐2):1‐28
MMWR 2013;62(RR‐2):18
MenACWY Recommendations for High‐Risk Groups
Administer 2 doses* of MenACWY at least 8 weeks apart to persons with persistent complement component deficiency and anatomic or functional asplenia, and 1 dose every 5 years* thereafter
every 5 years
www.immunize.org
*off‐label recommendations
MMWR 2013;62(RR‐2):1‐28
Immunization Action Coalition • (651) 647‐9009 • www.immunize.org • www.immunize.org/catg.d/S8005.pdf • Item #S8005 (7/16)
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Second Dose MenACWY Coverage Is Suboptimal
MenACWY Second Dose
• First dose coverage at 79% among adolescents
13–17 years of age
• Only 29% for booster dose among 17‐year‐olds
who received a first dose before age 16
• Opportunities to vaccinate are often missed
Resources to help improve second dose
second dose MenACWY coverage available at
www.give2mcv4.org
(a collaborative project between IAC and Sanofi Pasteur)
MMWR 2015;64(29):784‐792
Groups at Increased Risk for Meningococcal B Disease
High‐risk medical conditions: Meningococcal Serogroup B Vaccines
rLP2086 (Trumenba, Pfizer)
• Licensed by FDA on October 29, 2014
• persistent complement component deficiencies
• 2 components
• functional or anatomic asplenia • Approved for 10 through 25 years of age
Certain microbiologists
Populations at risk during an outbreak
NOT at increased risk: international travelers, first‐year college students
• 2‐
2 or 3‐dose series (0, 6 months or 0, 2, 6 months)
3d
i (0 6
th
0 2 6
th )
4CMenB (Bexsero, GlaxoSmithKline)
• Licensed by FDA on January 23, 2015
• 4 components
• Approved for 10 through 25 years of age
• 2‐dose series (0, 1 month)
CDC unpublished data
Pfizer and GSK product information. CBER website.
ACIP Recommendations for Meningococcal B Vaccine of High‐Risk Persons
ACIP Recommendations for Meningococcal B Vaccine
Certain persons 10 years of age or older* who are at increased risk for meningococcal disease should receive MenB vaccine
Approximately 15 to 29 cases and two to five deaths could be prevented annually with a routine adolescent MenB vaccination program administered at age 11, 16, or 18 years
• persistent complement component deficiency
• anatomic or functional asplenia
• anatomic or functional asplenia • risk in a serogroup B meningococcal disease outbreak
• certain microbiologists
MenB vaccines are included in VFC
A recommendation to vaccinate only college students is estimated to prevent approximately nine cases and one death annually
Not routinely recommended for college students or international travelers
*off‐label for persons 26 years and older
MMWR 2015;64(No. 41):1171‐76
MMWR 2015;64:608‐12
Immunization Action Coalition • (651) 647‐9009 • www.immunize.org • www.immunize.org/catg.d/S8005.pdf • Item #S8005 (7/16)
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Meningococcal Incidence in Adolescents and Young Adults by Serogroup, 2009–2013
ACIP Recommendations for Meningococcal B Vaccine
The preferred age for MenB vaccination is 16 through 18 years (Category B recommendation)
• vaccines with a Category B recommendation are included in the VFC program and ACA insurance programs
0.3
INCIDENCE P ER 100,000
A MenB vaccine series may be administered to healthy adolescents and young adults age 16 through 23 years to provide protection against most strains of serogroup B meningococcal disease
meningococcal disease
Serogroup B
Serogroup C and Y
0.2
0.1
0.0
11
MMWR 2015;64(No. 41):1171‐76
ACIP Recommendations for Meningococcal B Vaccine
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Minimum intervals between doses have not been defined –
• Minimum intervals between doses have not been defined use routine schedule only
• Need for booster dose(s) unknown – not recommended at this time
• MenB vaccines can be given at the same time as other vaccines including MenACWY
14
15
16
17
18
19
20
21
22
23
24
4vHPV
(Gardasil, Merck)
9vHPV
(Gardasil 9, Merck)
16, 18
6, 11, 16, 18
6, 11, 16, 18, 31, 33, 45, 52, 59
Yes
Yes
Yes
Licensure
Females 9–25 yrs
Females 9–26 yrs
Males 9–26 yrs
Females 9–26 yrs
Males 9–26 yrs
Prevents
Cervical cancer and precancerous lesions
Cervical, vulvar, vaginal, and anal cancer and precancerous lesions, genital warts
Cervical, vulvar, vaginal, and anal cancer and precancerous lesions, genital warts
Virus types
Adjuvant
www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093833.htm
HPV Vaccines
HPV Vaccine Recommendations
Virus types
6, 11, 16, 18, 31, 33, 45, 52, 59
Adjuvant
Yes
Licensure
Females 9–26 yrs
Males 9–26 yrs
Prevents
Cervical, vulvar, vaginal, and anal cancer and precancerous lesions, genital warts
www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093833.htm
26
2vHPV
(Cervarix, GSK)
MMWR 2015;64(No.41):1171‐76
9vHPV
(Gardasil 9, Merck)
25
AGE (years)
HPV Vaccines
• The two MenB vaccines are NOT interchangeable
• The same vaccine must be used for all doses
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Source: NNDSS data supplemented with additional serogroup data from ABCs and state health departments
Routine vaccination at 11 or 12 years of age
Catch‐up vaccination
• female 9 through 26 (any HPV vaccine)
• male 9 through 21, permissive through 26 (4vHPV or 9vHPV only)
Any vaccine can be used to finish an incomplete series
ACIP does not state a preference for one HPV vaccine over another
MMWR 2015;64(No.11):300‐4
Immunization Action Coalition • (651) 647‐9009 • www.immunize.org • www.immunize.org/catg.d/S8005.pdf • Item #S8005 (7/16)
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9vHPV ACIP Recommendations
ACIP has made no recommendation regarding revaccination with 9vHPV for persons who already completed a series of 2vHPV or 4vHPV
What You Can Do to Help Protect Adolescents
Clinicians are free to revaccinate with 9vHPV, but VFC will not cover additional doses and insurance plans may not pay for these doses
The 16‐Year‐Old Vaccination Visit
Strongly Recommend Adolescent Vaccines
Critical to assure that the adolescent is up to date with all recommended vaccines
A healthcare provider’s recommendation to vaccinate is a powerful motivator for patients to get immunized
• MenACWY 2nd dose
Reinforce your recommendation with an environment that is:
• MenB series if indicated
• enthusiastically pro‐vaccine
• Tdap if not given earlier
Td if t i
li
•• committed to fully vaccinating ALL eligible adolescent patients,
committed to fully vaccinating ALL eligible adolescent patients
regardless of whether they are college bound
• HPV series if not completed earlier
• Other vaccines if indicated by season (influenza), medical conditions,
or incomplete or undocumented “childhood” vaccines
Provide training, promote leadership
• educate staff ‐ keep them up to date on all ACIP vaccine recommendations • make sure they are fully immunized themselves with the vaccinations they need CDC. Epidemiology and Prevention of Vaccine‐Preventable Diseases 2015:33‐46.
Use Every Opportunity to Immunize
Consider every patient encounter an opportunity to vaccinate with all age‐appropriate vaccines
• Well visits • Acute care and follow‐up visits
• Sports and camp physicals
• Sports and camp physicals
• Routine visits for chronic illnesses (such as asthma)
• Visits for influenza vaccines
Administer all indicated vaccines at the same visit Epidemiology and Prevention of Vaccine‐Preventable Diseases 2015:33‐46,
MMWR 2011;60(RR‐2):1‐61, National Vaccine Advisory Committee (NVAC), Pediatrics 2003;112(4):958‐963
Implement Immunization Processes and Procedures
Check immunization status of patients at every visit (“vital sign”)
• Review immunization information system (IIS) record
Establish mechanisms to identify patients due for vaccination
• Electronic medical record (EMR) prompts
• “Immunization due” clip attached to paper chart
J Adolesc Health 2013;53(4):550‐553 Am J Prev Med 2009;36(3):278‐279 Immunization Action Coalition • (651) 647‐9009 • www.immunize.org • www.immunize.org/catg.d/S8005.pdf • Item #S8005 (7/16)
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Other Strategies to Improve Adolescent Vaccination Coverage
Other Strategies to Improve Adolescent Vaccination Coverage
Standing orders
Measure your practice’s vaccination rates at least annually
Patient reminder and recall systems
• Strong evidence of effectiveness in improving adolescent g
p
g
vaccination rates*
www.give2mcv4.org
• Checklists, standing orders, tip sheets, patient handouts, and more
* Community Preventive Services Task Force www.thecommunityguide.org/vaccines/clientreminder.html
• IIS
• EMR system
• chart audit
h
di
• claims data review
• Assessment, Feedback, Incentives, and eXchange (AFIX)
For additional information and helpful contacts:
www.cdc.gov/vaccines/programs/afix/index.html
Pediatrics 2003;112(4):958‐963 Epidemiology and Prevention of Vaccine‐Preventable Diseases 2015:33‐46
Other Strategies to Improve Adolescent Vaccination Coverage
Immunization Action Coalition Resources
Websites
Create a culture that values well care for adolescents
• www.immunize.org (for HCP)
Establish expectations of compliance with vaccination recommendations – among patients, parents, and providers • www.vaccineinformation.org (for the public)
Emphasize the importance of following the ACIP‐recommended immunization schedule for adolescents
• 11−12 years of age
• 16 years of age
• Whenever a patient is behind on immunization
• www.give2mcv4.org (for HCP)
• www.immunizationcoalitions.org
i
i ti
liti
(f
(for coalitions)
liti )
Publications – Needle Tips, Vaccinate Adults, IAC Express
• www.immunize.org/publications
Subscribe
• www.immunize.org/subscribe
Immunization Action Coalition • (651) 647‐9009 • www.immunize.org • www.immunize.org/catg.d/S8005.pdf • Item #S8005 (7/16)
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