Transcript Document

Immunization Update
Andrew Kroger, MD, MPH
National Center for Immunization and
Respiratory Diseases
Allegheny County PA Immunization Coaliton
(ACIC)
Monroeville, PA
October 4, 2012
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
2
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
3
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
4
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
5
6
Proposed Changes to Figure 2. Recommended
Immunization Schedule for Persons Aged 7
Through 18 Years
7
Changes to the 2012 “Catch-up” Schedule
8
Proposed Changes to the 2012
“Catch-up” Schedule
9
2012 ACIP Adult Immunization Schedule,
Age-Based Recommendations
10
2012 ACIP Adult Immunization Schedule, Medical,
Occupational and Behavior-Based
Recommendations
11
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).
12
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.
13
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.
14
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 2011;60(No.40):1391-2
15
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 2011;60(03);72-76 and VFC
Resolution No.6/11-1 and MMWR 2011;
60(40);1391-1392 for further guidance, including
revaccination guidelines.
16
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 2009;58(No. 37):1042-3
17
Rates of Meningococcal Disease
(C and Y) by Age, 1999-2008
1.4
Rate per 100,000
1.2
1
Option 1
Dose at 11-12 yrs
and booster at 16 yrs
0.8
Option 2
Single dose at 16 yrs
0.6
0.4
0.2
0
1
3
5
7
9
11 13 15
Age (year)
17
19
21
23
25
Active Bacterial Core surveillance (ABCs), 1998-2008
18
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.
19
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.
20
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)
21
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 2009;58(No. 37):1042-3
22
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
23
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
24
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
25
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)
26
Proposed 2012-2013 Algorithm for Children 6 Mos. Through 8 yrs.
Has the child ever
received influenza
vaccine?
No/Don’t know
2 doses*
No/Don’t know
2 doses*†
Yes
Did the child receive a
total of 2 or more
doses of seasonal
influenza vaccine
since July 1, 2010?
Yes
1 dose
*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.
27
Seasonal Influenza Vaccination Coverage by
Race/Ethnicity: 2008-09 -- 2010-11 Seasons,
BRFSS and NIS
2008-09 (%) 1
2009-10 (%) 2
2010-11 (%) 2
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
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
Group
Race/ethnicity (adults)
Race/ethnicity (children)
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
28
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
29
Human Cases of H3N2v – comparison of 2011 and
2012, as of September 7, 2012
Updated weekly at www.cdc.gov/flu*
States Reporting
H3N2v Cases
Cases in
2011
Cases in
2012
Hawaii
1
Illinois
4
Indiana
2
Iowa
3
Maine
2
138
Maryland
12
Michigan
5
Minnesota
2
Ohio
Pennsylvania
102
3
Utah
West Virginia
1*
2
Wisconsin
Total
*16 hospitalizations, 1 death reported
11
3
18
12
297
30
Pertussis - United States,
1940-2010
31
Pertussis - United States, 1980-2010
32
Reported Pertussis Incidence by
Age Group - 1990-2010*
SOURCE: CDC, National Notifiable Diseases Surveillance System and Supplemental Pertussis Surveillance System.
*2010 data are provisional
33
Reported Pertussis-related Deaths by Age
Groups, U.S., 1980-2010*
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
>18 years
1
2
11
77±
103
221
Age-Group
Total
±
Includes one case with unknown age
1 Vitek
CR et al. Pediatr Infect Dis J 2003; 22(7):628-34.
2 National
Notifiable Diseases Surveillance System, CDC, *Provisional 2010 data
34
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 2010;51:315-21
35
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
36
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
37
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
38
Tdap and
Pregnancy
39
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 infant’s
response to DTaP
MMWR 2011;60(No. 41):1424-6 (October 21)
40
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 2011;60(41):1424-6 (October 21)
41
#1 Question about Td and
Tdap since 2005:
What is the interval
between Td and Tdap?
42
Td to Tdap Interval
Adolescent 2006
Adult 2006
43
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
44
PNEUMOCOCCAL VACCINE
(PPSV23 AND PCV13)
45
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 2010;59(No.34):1102-5
46
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 2010;59(No.34):1102-5
47
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 2010;59(No.34):1102-5
48
MMWR 2010;59(No.34):1102-5
49
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 2010;59(No.34):1102-5
50
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
51
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
52
PCV13 USE IN ADULTS
53
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)
54
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
55
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
56
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
57
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)
58
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)
59
Incidence of IPD in adults aged 18--64 years with
selected underlying conditions, United States, 2009
200
186
180
Cases per 100,000 persons
160
140
120
100
80
60
20 fold
increased
risk
3-7 fold
increased
risk
52
173
59
41
40
20
26
28
CVD
DIABETES
32
8
0
HEALTHY
PULMONARY
Active Bacterial Core Surveillance, 2009. Unpublished data
KIDNEY
LIVER
ALCOHOL
HIV/AIDS HEMATOLGICAL
CANCER
60
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
61
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)
62
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)
63
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 2010;59(No. 20):626-9
64
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
65
HPV VaccineEnsuring Protection
66
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
RL, et al. AmJ Epidemiol. 2003; 157:218-226
2Partridge JM. J Infect Dis. 2007:196:1128-1136
2Winer
67
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
•
•
•
•
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
•
•
•
Females
Routine: 11 or 12 years
Catch-up: 13 through 26
years
Administer HPV4 or HPV2
68
Tdap, MenACWY, and HPV vaccination estimates among
adolescents, 13-17 years, NIS-Teen, United States,
2007-2011
100
90
80
70
Tdap*
60
MenACWY†
Percent Vaccinated 50
1 HPV§
40
3 HPV§
1HPV**
30
3 HPV**
20
10
0
2006
2007
2008
2009
2010
2011
Survey Year
* Tetanus toxoid, diphtheria toxoid, acellular pertussis vaccine since age 10
† Meningococcal conjugate vaccine
§ Among Females
**Among Males
69
70
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; 61:671-7
71
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
72
Predictions are difficult,
particularly when they
involve the future.
- Yogi Berra
73
New Vaccines, New
Recommendations
• Additional combination vaccines
• Meningococcal vaccination of infants
• More than 1 dose of Tdap
• PCV13 vaccination of adults
74
CDC Vaccines and Immunization
Contact Information
• Telephone
800.CDC.INFO
(for patients and parents)
• Email
[email protected]
(for providers)
• Website
www.cdc.gov/vaccines/
• Vaccine Safety
www.cdc.gov/vaccinesafety/
75