Immunization Update

1

• Immunization Update

Andrew Kroger, MD, MPH National Center for
Immunization and Respiratory Diseases
Allegheny County PA Immunization Coaliton
(ACIC) Monroeville, PA October 4, 2012
2
Disclosures

• Andrew Kroger is a federal government employee
  with no financial interest or conflict with the
  manufacturer of any product named in this
  presentation
• The speaker will discuss the off-label use of
  meningococcal and pneumococcal conjugate and Tdap
  vaccines
• The speaker will not discuss a vaccine not
  currently licensed by the FDA

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General Presentation Objectives

• After the presentation the listener should be
  able to
•  
• Schedule patients for all routinely recommended
  vaccines per the Advisory Committee on
  Immunization Practices recommendations,
• Administer newly recommended vaccines to the
  appropriate priority groups, and
• Predict new vaccines on the horizon

4
Overview

• Updates to the 2012 Harmonized Child/Adolescent
  Schedule
• Updates to the 2012 Adult Schedule
• New infant meningococcal vaccine recommendations
• 2012-2013 influenza vaccine recommendations
• New Tdap recommendations
• Adults older than 65 years
• New highest-risk Pneumococcal PCV13
  Recommendations
• Human Papillomavirus Vaccine (HPV)
  Recommendations
• Females and males
• Strategies to increase coverage
• New vaccines, new recommendations

5
2012 Childhood Schedules

• Basic layout of the schedules is unchanged
• Three schedules
• 0 through 6 years
• 7 through 18 years
• Catch-up
• 4 months through 6 years
• 7 through 18 years
• Each schedule has separate footnotes

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(No Transcript)
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Proposed Changes to Figure 2. Recommended
Immunization Schedule for Persons Aged 7 Through
18 Years
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Changes to the 2012 Catch-up Schedule
9
Proposed Changes to the 2012 Catch-up Schedule
10
2012 ACIP Adult Immunization Schedule, Age-Based
Recommendations
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2012 ACIP Adult Immunization Schedule, Medical,
Occupational and Behavior-Based Recommendations
12
Changes to the Meningococcal Recommendations

• New Child/Adolescent schedule footnote heading
• Meningococcal conjugate vaccines, quadrivalent
  (MCV4). Minimum age 9 months for Menactra
  (MCV4-D), 2 years for Menveo (MCV4-CRM).

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MCV4 Recommendations

• New footnotes
• For children ages 9 through 23 months
• With persistent complement component deficiency,
• Who are residents of or travelers to countries
  with hyperendemic or epidemic disease and
• Who are present during outbreaks caused by a
  vaccine serogroup,
• administer 2 primary doses of MCV4-D ideally at 9
  months and 12 months old or at least 8 weeks
  apart.

14
New MCV4 Recommendations

• New Child/Adolescent schedule footnotes
• For children 24 months and older with
• persistent complement component deficiency who
  have not been previously vaccinated or
• anatomic/functional asplenia,
• administer 2 primary doses of either MCV4 at
  least 8 weeks apart, and 1 dose every 5 years
  thereafter.

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Meningococcal Vaccination of Children with
Asplenia

• Data suggest a reduction in response to PCV13 if
  given at the same visit as Menactra brand MCV4
• Asplenic persons are at very high risk of
  invasive pneumococcal disease
• The minimum age for meningococcal vaccination of
  children with asplenia (including those with
  sickle cell disease) remains 2 years
• Separate PCV13 and Menactra by at least 4 weeks

MMWR 201160(No.40)1391-2
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New Spacing Recommendation MCV4-D and PCV13

• For children with anatomic/functional asplenia,
  if MCV4-D (Menactra) is used, administer MCV4-D
  (Menactra) at a minimum age of 2 years old and at
  least 4 weeks after completion of all PCV doses.
• See MMWR 201160(03)72-76 and VFC Resolution
  No.6/11-1 and MMWR 2011 60(40)1391-1392 for
  further guidance, including revaccination
  guidelines.

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Meningococcal Conjugate (MCV4) Revaccination

• In its 2005 recommendations for MCV, ACIP made no
  recommendation about revaccination pending the
  availability of additional data
• Serologic data are now available from the
  manufacturer that show significant decline in
  antibody 3-5 years after vaccination although few
  breakthrough cases have been reported

MMWR 200958(No. 37)1042-3
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Rates of Meningococcal Disease (C and Y) by Age,
1999-2008
Option 2 Single dose at 16 yrs
Option 1 Dose at 11-12 yrs and booster at 16 yrs
Active Bacterial Core surveillance (ABCs),
1998-2008
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Routine Adolescent MCV4 Recommendation

• 3.Meningococcal conjugate vaccines, quadrivalent
  (MCV4) .
• Administer MCV4 at age 11 through 12 years with a
  booster dose at age 16 years.
• Administer MCV4 at age 13 through 18 years if not
  previously vaccinated.

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Adolescent MCV4 Minimum Intervals and Number of
Doses

• If the first dose is administered at age 13
  through 15 years, a booster dose should be
  administered at age 16 through 18 years with a
  minimum interval of at least 8 weeks from the
  preceding dose.
• If the first dose is administered at 16 years or
  older, a booster dose is not needed.

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New MCV4 Adolescent Vaccination Recommendations

• The minimum interval between doses is 8 weeks
• A booster dose is not recommended for healthy
  persons if the first dose is administered at
  16-21 years of age
• A booster dose is not recommended for healthy
  persons 22 years or older even if the first dose
  is administered at 11-15 years of age
• The booster dose should always be MCV4 (not
  MPSV4)

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MCV Revaccination Recommendations

• Other high-risk persons recommended for
  revaccination
• microbiologists with prolonged exposure to
  Neisseria meningitidis
• frequent travelers to or persons living in areas
  with high rates of meningococcal disease
• Revaccinate every 5 years as long as the person
  remains at increased risk
• MCV for persons 2 through 55 years of age
• MPSV for persons 56 years and older

off-label recommendation. MMWR 200958(No.
37)1042-3
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Influenza Introduction

• Influenza viruses cause yearly epidemics and
  sporadic pandemics
• Influenza illnesses occur in all age groups
• Highest illness rates in young children
• Severe illness, hospitalizations and deaths
  disproportionately affect very young, elderly,
  pregnant women and persons with certain medical
  conditions
• E.g. asthma, diabetes, heart disease, neurologic
  conditions, chronic renal and liver disease,
  immune compromised conditions
• Average of 226,000 hospitalizations per year
• About 60 among people 65 years and older
• From 3,000 49,000 influenza-related deaths per
  year
• About 90 among people 64 years and older

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Influenza Vaccine Recommendation

• Everyone six months of age older should be
  vaccinated as soon as the 2012-2013 vaccine is
  available, even if they got vaccinated last
  season
• protection declines over the course of a year
  after vaccination
• a flu shot last year may not protect this season

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Persons at Increased Risk of Complications of
Influenza

• Children 6 months through 4 years of age
• Persons 50 years of age and older
• Persons 6 months of age and older with underlying
  medical conditions, particularly cardiovascular,
  pulmonary, and metabolic conditions
• Immunosuppressed

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Persons at Increased Risk of Complications of
Influenza

• Children 6 months through 18 years receiving
  long-term aspirin therapy
• Residents of long-term care facilities
• American Indians/Alaska Natives
• Morbidly obese (BMI 40 or higher)

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Proposed 2012-2013 Algorithm for Children 6 Mos.
Through 8 yrs.

Has the child ever received influenza vaccine?
No/Dont know
2 doses
Yes
Did the child receive a total of 2 or more doses
of seasonal influenza vaccine since July 1, 2010?
No/Dont know
2 doses

• Doses should be administered at least 4 weeks
  apart.
• For simplicity, this algorithm takes into
  consideration only doses of seasonal influenza
  vaccine received since July 1, 2010. As an
  alternative approach in settings where
  vaccination history from prior to July 1, 2010 is
  available, children 6 months through 8 years of
  age need only 1 dose of vaccine in 2013-2013 if
  they have received any of the following
• 2 or more doses of seasonal influenza vaccine
  since July 1, 2010 or
• 2 or more doses of seasonal influenza vaccine
  before July 1, 1010 and 1 or more doses of
  monovalent 2009 H1N1 vaccine or
• 1 or more doses of seasonal influenza vaccine
  before July 1, 2010 and 1 or more doses of
  seasonal influenza vaccine since July 1, 2010
• Children for whom one of these conditions is not
  met require 2 doses in 2012-2013.
•  

Yes
1 dose
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Seasonal Influenza Vaccination Coverage by
Race/Ethnicity 2008-09 -- 2010-11 Seasons,
BRFSS and NIS
Group 2008-09 () 1 2009-10 () 2 2010-11 () 2
Race/ethnicity (adults)
White, non-Hispanic 39.7 43.8 43.3
Black, non-Hispanic 26.8 31.3 34.9
Hispanic 25.6 30.6 32.4
Race/ethnicity (children)
White, non-Hispanic 24.9 42.5 46.3
Black, non-Hispanic 20.0 35.5 47.9
Hispanic 18.4 43.9 55.3
1. BRFSS estimates, (19 states for children 43
states plus DC for adults) online at
http//www.cdc.gov/mmwr/PDF/wk/mm5839.pdf and
CDC, unpublished 2. BRFSS and NHFS estimates,
2009-10 BRFSS and NIS estimates, 2010-11, both
years for 50 states plus DC for children, 43
states plus DC for adults. In press, MMWR, June
10, 2011
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H3N2v Swine to Human Transmission of Variant
influenza A Virus

• Transmission of influenza viruses between humans
  and pigs known to occur
• Since July 2012, increase reporting and
  identification of human infections with H3N2v
• Children most susceptible to this virus
• Virus is combination of 2009 H1N1 and
  swine-origin H3N2 strain
• Nearly all cases associated with exposure to live
  pigs at state or county fairs
• No risk of influenza in eating pork or pork
  products
• Pigs, like people, have illness that ranges from
  no symptoms to cough, fever, and runny nose
• Seasonal influenza vaccine unlikely to provide
  protection
• Situation being closely monitored

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Human Cases of H3N2v comparison of 2011 and
2012, as of September 7, 2012Updated weekly at
www.cdc.gov/flu
States Reporting H3N2v Cases Cases in2011 Cases in2012
Hawaii   1
Illinois   4
Indiana 2 138
Iowa 3  
Maine 2  
Maryland   12
Michigan   5
Minnesota   2
Ohio   102
Pennsylvania 3 11
Utah   1
West Virginia 2 3
Wisconsin   18
Total 12 297
16 hospitalizations, 1 death reported
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Pertussis - United States, 1940-2010
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• Pertussis - United States, 1980-2010

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• Reported Pertussis Incidence by Age Group -
  1990-2010

SOURCE CDC, National Notifiable Diseases
Surveillance System and Supplemental Pertussis
Surveillance System. 2010 data are provisional
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Reported Pertussis-related Deaths by Age Groups,
U.S., 1980-2010
Age-Group 1980-19891 1990-19991 2000-20102
0-3 month 49 84 198
4-5 month 5 5 2
6-11 month 7 4 1
1-4 years 13 2 3
5-10 years 1 6 3
11-18 years 0 0 3
gt18 years 1 2 11
Total 77 103 221
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Tdap

• Reduces the risk of pertussis by 60 - 80
• Both products currently approved for one lifetime
  dose
• Tdap approved ages
• 10 years and older for Boostrix
• 11 through 64 years for Adacel
• Neither brand of Tdap is approved by the FDA for
  children 7 years through 9 years and Adacel is
  not approved for adults 65 years or older

Wei SC et al. Clin Infect Dis 201051315-21
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New Tdap Recommendations for Adolescents

• Children 7 through 10 years of age who are not
  fully immunized against pertussis (including
  those never vaccinated or with unknown pertussis
  vaccination status) should receive a single dose
  of Tdap
• Either brand may be used
• If Tdap is given at this age a second dose at
  11-12 years is not needed

off-label recommendation. MMWR 2011 60 (No.
1)13-5
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New Tdap Recommendations for Adolescents

• Not fully immunized
• fewer than 4 doses of DTaP, or
• 4 doses of DTaP and last dose was prior to age 4
  years

MMWR 2011 60 (No. 1)13-5
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New Tdap Recommendations for Adults

• Adults 65 years of age and older who have or who
  anticipate having close contact with an infant
  younger than 12 months of age and who have not
  previously received Tdap should receive a single
  dose of either brand of Tdap
• Other adults 65 years of age and older may
  receive a dose of either brand of Tdap

Off-label recommendation. MMWR 2011 60 (No.
1)13-5
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Tdap and Pregnancy
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Tdap and Pregnancy

• Infants are most likely to be hospitalized or die
  from pertussis
• If a woman receives Tdap before or during
  pregnancy, her passive immunity might help
  protect the newborn from pertussis
• There are few safety data for pregnant women
  given Tdap
• There are concerns by some experts that the
  passive pertussis antibody could interfere with
  the infants response to DTaP

MMWR 201160(No. 41)1424-6 (October 21)
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Tdap Recommendations for Pregnant Women

• Any woman who might become pregnant is encouraged
  to receive a single dose of Tdap
• Tdap should be administered to pregnant women who
  have not received a dose
• Vaccinate during third trimester or late in
  second trimester (after 20 weeks gestation)
• Alternatively, administer Tdap immediately
  postpartum

MMWR 201160(41)1424-6 (October 21)
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1 Question about Td and Tdap since 2005
What is the interval between Td and Tdap?
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Td to Tdap Interval
Adolescent 2006
Adult 2006
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Td-Tdap Interval Recommendation

• Tdap can be administered regardless of the
  interval since the last tetanus and diphtheria
  containing vaccine
• ACIP concluded that while longer intervals
  between Td and Tdap vaccination could decrease
  the occurrence of local reactions, the benefits
  of protection against pertussis outweigh the
  potential risk for adverse events

Off-label recommendation. MMWR 2011 60 (No.
1)13-5
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Pneumococcal Vaccine(ppsv23 and PCV13)
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Pneumococcal Polysaccharide Vaccine (PPSV23)
Recommendations (1)

• Previously unvaccinated adults 65 years and older
• Persons 65 years or older who received PPSV23 for
  any reason prior to age 65 years
• Persons 19 years and older with
• cigarette smoking
• asthma

at least 5 years after previous dose
MMWR 201059(No.34)1102-5
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Pneumococcal Polysaccharide Vaccine (PPSV23)
Recommendations (2)

• Persons 19 years and older with normal immune
  systems who have chronic illness
• Chronic heart disease (excluding HTN)
• Chronic lung disease
• diabetes
• alcoholism
• CSF leak
• Chronic liver disease, including cirrhosis
• cochlear implant
• Persons with functional or anatomic asplenia

MMWR 201059(No.34)1102-5
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Pneumococcal Polysaccharide Vaccine (PPSV23)
Recommendations (3)

• Persons 19 years and older who are
  immunocompromised
• Congenital or acquired immunodeficiencies
• HIV infection
• Chronic renal failure
• Nephrotic syndrome
• Leukemias
• Lymphomas
• Hodgkin disease
• Generalized malignancy
• Solid organ transplantation
• Multiple myeloma
• Diseases requiring treatment with
  immunosuppressive drugs, including long-term
  systemic corticosteroids or radiation therapy

MMWR 201059(No.34)1102-5
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MMWR 201059(No.34)1102-5
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Pneumococcal Polysaccharide Vaccine Revaccination

• For most persons for whom PPSV23 is indicated,
  ACIP does not recommend routine revaccination.
• Revaccination recommended for persons 19 through
  64 years of age who are at highest risk of
  serious pneumococcal infection

MMWR 201059(No.34)1102-5
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PPSV23 Recommendations for Adults at Highest Risk
of Invasive Pneumococcal Disease (IPD)

• Adults ages 19 through 64 years with the
  following conditions should receive two doses of
  PPSV23 separated by at least 5 years
• functional or anatomic asplenia
• Immunocompromised persons, including those
  immunocompromised secondary to disease and/or
  immunosuppressive drugs or therapy

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PPSV23 Revaccination

• Persons who received one or two doses of PPSV23
  before age 65 years for any indication should
  receive another dose at age 65 or older if at
  least 5 years have passed since previous dose
• Those who receive their first dose of PPSV23 at
  or after age 65 do not need any additional doses

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Pcv13 use in adults
54
PCV13 Licensure

• PCV13 is approved by the Food and Drug
  Administration for
• children 6 weeks through 71 months of age
• adults 50 years of age and older
• ACIP recommended use of PCV13 for
  immunocompromised persons 19 years and older
  (June 20, 2012)

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Pneumococcal Conjugate Vaccine (PCV13) for Adults

• On December 30, 2011, PCV13 (Prevnar13, Pfizer)
  was approved for use among adults 50 years of age
  and older
• FDA approved expanded age indication through the
  Accelerated Approval Pathway

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Pneumococcal Conjugate Vaccine (PCV13) for Adults

• Immunogenicity of PCV13 was found to be
  non-inferior to PPSV23
• Indication for use of PCV13
• prevention of pneumococcal disease, including
  pneumonia and invasive disease caused by the 13
  Streptococcus pneumoniae serotypes in PCV13

57
Summary of Feb 2012 ACIP Deliberations PCV13
for Adults

• ACIP deferred universal recommendation for all
  adults pending the further collection of data
• Efficacy of PCV13 against pneumonia (CAPITA
  trial, results in 2013)
• Indirect (herd) effects of PCV13 use in
  children

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PCV13 use for Some Adults

• Voted on at June 2012 ACIP meeting
• For adults with
• immunocompromising conditions
• Functional or anatomical asplenia
• Cochlear implants
• CSF leaks
• (Official Publication Pending)

59
ACIP Recommendations June 2012 PCV13 for
Immunocompromised Adults

• Extremely high burden of disease among
  immunocompromised adults
• Benefits outweigh any risks for use of PCV13 in
  some adults
• Indirect effects of PCV13 use in children not
  likely to eliminate IPD due to PCV13 serotypes in
  adults
• PCV13 use alone may not provide adequate coverage
  of serotypes causing disease in adults
• Combined use of PCV13 and PPSV23 more effective
  than either vaccine alone
• (Official Publication Pending)

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Incidence of IPD in adults aged 18--64 years with
selected underlying conditions, United States,
2009
20 fold increased risk
3-7 fold increased risk
Active Bacterial Core Surveillance, 2009.
Unpublished data
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PCV13 Use in Some Adults

• ?PCV13 dose is recommended to be given before
  PPSV23, whenever possible
• ?Recommendations for those persons needing a 2nd
  dose of PPSV and a dose at age 65 years or older
  remain unchanged from earlier (2010)
  recommendations

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Recommendations for use of PCV13 and PPSV23 in
Pneumococcal Vaccine-Naïve Adults

• Adults 19 through 64 years of age with
  immunocompromising conditions, functional or
  anatomic asplenia, CSF leak, or a cochlear
  implant who are vaccine naïve, should receive a
  single dose of PCV13 followed by a dose of PPSV23
  at least 8 weeks later
• Recommendations for 2nd dose of PPSV23 and a dose
  at age 65 years or older remain unchanged from
  earlier (2010) recommendations
• For those that require additional doses of PPSV,
  a second dose of PPSV23 is recommended 5 years
  after the first dose of PPSV23

(Official Publication Pending)
63
Recommendations for use of PCV13 in Adults
Previously Vaccinated with PPSV23

• Adults with immunocompromising conditions,
  functional or anatomic asplenia, CSF leak, or a
  cochlear implant previously vaccinated with
  PPSV23 should receive PCV13 one or more years
  after the last PPSV23 dose
• For those that require additional doses of
  PPSV23, the first dose should be administered no
  sooner than 8 weeks after PCV13 and at least 5
  years after the most recent dose of PPSV23

(Official Publication Pending)
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HPV Vaccine Recommendations

• ACIP recommends routine vaccination of
  adolescents at 11 or 12 years of age
• HPV4 for males
• HPV4 or HPV2 for females
• May be administered as young as 9 years of age

• MMWR 201059(No. 20)626-9

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HPV Vaccine Recommendations

• Females
• Administer to females ages 13 through 26 years if
  not previously vaccinated
• Males
• Administer 13 through 21 years of age if not
  previously vaccinated
• HPV4 may be administered to males 22 through 26
  years of age

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HPV Vaccine- Ensuring Protection
67
Human Papillomavirus (HPV)

• Most common sexually transmitted pathogen in
  males and females in U.S.
• Approximately 20 million people currently
  infected1
• Another 6 million new infections annually1
• At least 50 of sexually active males and females
  will contract an HPV infection at some time in
  their lives1
• Highest prevalence in sexually active adolescents
  and young adults
• First infection occurs soon after onset of sexual
  activity2

1CDC http//www.cdc.gov/std/hpv/stdfact-hpv.htm 2W
iner RL, et al. AmJ Epidemiol. 2003 157218-226
2Partridge JM. J Infect Dis. 20071961128-1136
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ACIP HPV Recommendations

• 2 vaccines HPV2 (Cervarix) and HPV4 (Gardasil)
• Both vaccines are a 3-dose series
• Schedule
• Administer 2nd dose 1-2 months after dose 1
• Administer 3rd dose 6 months (24 weeks) after
  dose 1 and at least 12 weeks after dose 2

• Females
• Routine 11 or 12 years
• Catch-up 13 through 26 years
• Administer HPV4 or HPV2

• Males
• Routine 11 or 12 years
• Catch-up 13 through 21 years, 21 through 26
  years who have sex with men or are
  immunocompromised
• Healthy men 22 through 26 years may be vaccinated
  
• Administer HPV4 only

69
Tdap, MenACWY, and HPV vaccination estimates
among adolescents, 13-17 years, NIS-Teen, United
States, 2007-2011

• Tetanus toxoid, diphtheria toxoid, acellular
  pertussis vaccine since age 10
• Meningococcal conjugate vaccine
• Among Females
• Among Males

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HPV Vaccination Coverage

• Low teenage uptake compared to meningococcal and
  Tdap vaccines
• HPV vaccine uptake has stalled
• 53 of teen girls began HPV vaccine series
• Almost 30 who receive first dose do not complete
  vaccine series
• Only 35 of all girls 13 through 17 years
  complete the 3-dose series

National Immunization Survey (Teen) MMWR 2012
61671-7
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Strategies for Increasing HPV Vaccination Rates
in Clinical Practices

• Recommend HPV vaccine!
• Include HPV vaccine when discussing other needed
  vaccines
• Integrate standard procedures
• Assess for needed vaccines at every clinical
  encounter
• Immunize at every opportunity
• Standing orders
• Reminder and recall
• AFIX assessment, feedback, incentive, and
  eXchange
• NEW! HEDIS measure (Jan 2012)
• Proportion of 13 year old girls who have not
  received 3 doses
• Tools for improving HPV vaccine uptake at
  www.cdc.gov/vaccines/teens

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Predictions are difficult, particularly when they
involve the future.
- Yogi Berra
74
New Vaccines, New Recommendations

• Additional combination vaccines
• Meningococcal vaccination of infants
• More than 1 dose of Tdap
• PCV13 vaccination of adults

75
CDC Vaccines and ImmunizationContact Information

• Telephone 800.CDC.INFO
• (for patients and parents)
• Email nipinfo_at_cdc.gov
• (for providers)
• Website www.cdc.gov/vaccines/
• Vaccine Safety www.cdc.gov/vaccinesafety/