Transcript Immunization Update, 2013

7th Annual
Dell Children’s Medical Center
Pediatric Conference
Current and Future Vaccine
Recommendations from the ACIP
Larry K. Pickering, MD, FAAP
April 11, 2014
Austin, TX
Faculty Disclosure Information:
In the past 12 months, I have had no relevant
financial relationships with the manufacturer(s)
of any commercial product(s) and/or provider(s)
of commercial services discussed in this CME
activity.
I do not intend to discuss an
unapproved/investigative use of a commercial
product/device in my presentation.
OBJECTIVES
• Describe recent changes to the pediatric
and adult immunization schedules
• Lessons learned from vaccine
surveillance systems
• Highlight major vaccine issues and
updates
• Discuss future directions

1994 schedule from Red Book paper
The Fine Print
Vaccines Recommended
Number of ACIP Vaccine
Recommendations, by Year, Since 1995*
* This chart takes into account General Recommendations on Immunization, recommendations for health care professionals, the annual
recommended routine childhood immunization schedule (1995-present), the annual recommended routine adult immunization schedule, and
recommendations pertaining to vaccines such as those for rabies, yellow fever, smallpox, and Japanese encephalitis that are not part of any
routine immunization schedule in the United States.
Changes to the 2014 Immunization Schedules
• Infant meningococcal vaccination (January 2013)
• Tdap in pregnant women (February 2013)
• Meningococcal disease: Prevention and Control: RR (March
2013)
• Interim influenza recommendations (May 2013)
• MMR and congenital rubella syndrome: RR
(June 2013)
• PCV13 and PPSV23 vaccines for 6-18 year olds with
immunocompromising conditions (July 2013)
• Update on use of VariZIG (July 2013)
• Influenza vaccines (2013/14 season): RR (September 2013)
• Japanese encephalitis vaccine for children: (November 2013)
• Haemophilus influenzae RR: (February 2014)
http://www.cdc.gov/vaccines/hcp/acip-recs/recs-by-date.html
Incidence Declines in All Age Groups
ABCs cases from 1993-2011 estimated to the U.S. population with 18% correction for under reporting
*In 2010, estimated case counts from ABCs were lower than cases reported to NNDSS and may not
be representative
Incidence in All Serogroups, United States,
1993-2012*
*Source: ABCs cases from 1993-2012 estimated to the U.S. population with 18% correction for under reporting
14
Meningococcal Vaccine
Recommendations
Vaccine
FDA
Routine
High Risk
MenACWY-D
(Menactra)
9 mo.55 yr.
11-21 yr.
9 mo.55 yr.
MenACWYCRM (Menveo)
2 mo.55 yr.
11-21 yr.
2 mo.55 yr.
HibMenCY-TT
(MenHibrix)
6 wk.18 mo.
Hib
6 wk.18 mo.*
*not for travelers
MMWR 2014; 63:148-54
MMWR 2014; 63:148-54
56%
61%
43%
40%
34%
Influenza Deaths by Age Group
122 Cities Mortality Reporting System,
Number of Influenza Deaths by Age Group and Year
*
**
*Data from week 15, 2009 – week 39, 2010
**Data as of week 6, 2014
MMWR 2013; 62:997
National Estimated Vaccination Coverage
Levels among Adolescents 13-17 Years,
National Immunization Survey-Teen, 2006-2012
Tdap: tetanus, diphtheria, acellular pertussis vaccine.
MCV4: meningococcal conjugate vaccine
HPV: human papillomavirus vaccine
Strength of HPV Vaccine Recommendation
for Female Patients, Pediatricians and
Family Physicians (N=609)
IID-9: Children 19-35 Months Who Received
No Vaccinations, 2008-2012, U.S.
Tracking Measure- Program goal to sustain percentage of <1%
Source: National Immunization Survey
MMWR 2013; 62(30): 607-612
Vaccination coverage among children in kindergarten- US, 2012-2013. MMWR 2013;62:607.
“I’m pregnant. I was told that
vaccines are now
recommended for pregnant
women but I don’t know ...”
Estimated Influenza Vaccination
(trivalent) Coverage, Pregnant Women*
* Behavioral Risk Factor Surveillance (BRFSS) data from December-February interviews only, for women 18-44 years pregnant or not pregnant
when interviewed; sample sizes for pregnant women per season ranged from 400-800. Differences in influenza vaccination coverage between
pregnant and not pregnant women were statistically significant (p<0.05) for 2005-06 and 2008-09 through 2012-13 seasons (age adjusted),
p<0.05). Other estimates for pregnant women from PRAMS (MMWR February 24, 2012 / 61(07);113-118); NHFS (Ding et al. Am. J. Obstetrics &
Gynecology, June 2011 Supplement); and internet panel survey (MMWR August 19, 2011 / 60(32);1078-1082, MMWR September 28, 2012 /
61(38 ):758 – 763, MMWR September 27, 2013 / 62(38): 787-792)
Vaccination coverage by provider
recommendation and/or offer
*Women who didn't visit a provider since August 2012 (n=27) or women who didn't know whether they received
provider recommendation or offer (n=55) were excluded from this analysis.
AAP 2013 Tdap Recommendations
 Tdap vaccine is recommended for every
pregnancy administered from week 27 to 36 of
gestation
 “Cocooning“ is still important since Tdap
effectiveness is only 65-81% and ineffective in
small premature infants
 Tdap-induced pertussis antibodies transferred
to newborn in high concentrations and persist
for 2 months
Maternal Immunization: Benefits
•
•
•
Safe for mother and infant
Recommended to protect
pregnant women and their
infants
Optimal timing is important

Influenza (any trimester)
 Pertussis (every pregnancy from week 27-36)
 Only potential strategy to prevent young infant
deaths and hospitalizations
Clin Obstet Gynecol. 2012;55:474-86
Conclusions
 No new unexpected vaccine safety concerns
noted among pregnant women who received
Tdap (or their infants)
 Limited number of pregnancy reports with repeat
Tdap doses received by VAERS
 CDC will continue to monitor the safety of Tdap
vaccine during pregnancy, with special emphasis
on repeated doses of Tdap

ACIP meeting: February 26-27, 2014
33
Human Papillomavirus:
Types and Disease Association
Non-mucosal/cutaneous
(~60 types)
Mucosal/genital
(~40 types)
High-risk: types
16, 18, 31, 45
(and others)
Low-risk:
types 6, 11
(and others)
Skin warts
(hands and feet)
Low-grade cervical
abnormalities
Cancer precursors
Anogenital cancers
Low-grade cervical abnormalities
Genital warts
Laryngeal papillomas
Muñoz N et al. N Engl J Med 2003;348:518-527.
Type Attribution by Cancer Site
100
HPV 16/18
HPV 31/33/45/52/58
90
Other HPV
79
80
70
HPV Negative
66
60
60
60
Percent
55
49
50
48
40
37
31
30
30
25
21
20
10
18
18
15
14
10 9
2
1
9
8
6
3
9
6
6
4
0
Cervical
In Situ Cervical
Vulvar
Vaginal
Cancer Site
Saraiya et al, presented at AACR Health Disparities in Cancer, 2013
Anal
Penile
Oropharyngeal
Revised Estimated Percentages of
Cancers Attributed to HPV in the U.S.
Cancer
HPV
attributable
% (95% CI)
HPV 16/18
attributable
% (95% CI)
HPV 31/33/45/52/58
attributable
% (95% CI)
Cervical
91 (88-92)
66 (63-69)
15 (12-17)
Vaginal
75 (63-84)
55 (43-67)
18 (11-30)
Vulvar
69 (62-75)
49 (41-56)
14 (10-20)
Anal
Male
Female
89 (77-95)
92 (85-96)
79 (66-88)
80 (70-87)
4 (1-13)
11 (6-19)
Penile
63 (52-73)
48 (37-59)
9 (4-17)
Oropharyngeal
Male
Female
72 (68-76)
63 (55-71)
63 (59-68)
51 (43-59)
4 (3-7)
9 (6-15)
Average Number of New HPV-Associated
Cancers by Sex, in the United States, 2005-2009
n=694
n=3039
n=1003
n=2317
n=1687
n=3084
Oropharynx
n=9312
n=11279
Jemal A et al. J Natl Cancer Inst 2013;105:175-201
HPV Vaccines
Quadrivalent
(Gardasil)
Bivalent
(Cervarix)
Manufacturer
VLP types
Merck
6, 11, 16, 18
GlaxoSmithKline
16, 18
Producer cells
Saccharomyces
cerevisiae (yeast)
Baculovirus infected
Trichoplusia in insect cell
line
Schedule (IM)
3 dose series
3 dose series
Genital Warts
Cervical and
other cancers
VLP – virus like particle; IM - Intramuscular
Estimated to Protect (%)
90%
-70%
70%
Evolution of recommendations for
HPV vaccination in the United States
Quadrivalent
Quadrivalent or Bivalent
Routine, females 11 or 12 yrs*
and 13-26 yrs not previously vaccinated
Routine, females 11 or 12 yrs*
and 13-26 yrs not previously vaccinated
Quadrivalent
Quadrivalent
May be given,
males 9-26 yrs*
Routine, males 11 or 12 yrs*
and 13-21 yrs not previously vaccinated
May be given, 22-26 yrs**
June
October
October
Quadrivalent (HPV 6,11,16,18) vaccine; Bivalent (HPV 16,18) vaccine
* Can be given starting at 9 years of age; ** For MSM and immunocompromised males, quadrivalent HPV vaccine through 26 years of age
40
Disease Associations with Most
Frequent Types of HPV
Diseases
Cutaneous warts
HPV type
1, 2, 3, 4, 10, others
Cancer (cervical, anal,
penile, oropharyngeal)
16, 18, 31, 33, 45,
52, 58
Condyloma acuminata
(anogenital warts)
6, 11
Recurrent respiratory
papillomatosis
6, 11
Burd. Clin Microbiol Rev 2003; 16:1-17
Oropharyngeal Cancer
• HPV 16 causes head and neck cancers
• Molecular, epidemiologic, and clinical evidence
•
suggest these tumors are distinct from HPVnegative oropharyngeal cancers
Risk factors for HPV-positive and HPV-negative
oropharyngeal cancers differ:
 HPV-positive cancers: tobacco, sexual
behaviors
(typically younger victims)
 HPV-negative cancers: tobacco, alcohol
(typically older victims)
Comparison of 9vHPV Vaccine and qHPV Vaccine
ADJUVANT
AAHS
225μg
qHPV vaccine
6
11
16
18
20μg
40μg
40μg
20μg
AAHS
500μg
9vHPV vaccine
6
11
16
18
31
33
45
52
58
30μg
40μg
60μg
40μg
20μg
20μg
20μg
20μg
20μg
AAHS =Amorphous aluminum hydroxyphosphate sulfate
44
Why Parents Say “No” to
HPV Vaccine
Parents who do not intend to vaccinate daughter in next
12 months, NIS-Teen 2008-2009
* Not mutually exclusive.
** Did not know much about HPV or HPV vaccine.
2011 NIS-Teen available at http://www.cdc.gov/vaccines/stats-surv/nis/nis-2011-released.htm#nisteen
Actual and Achievable Vaccination Coverage if Missed Opportunities
Were Eliminated: Adolescents 13-17 Years, NIS-Teen 2012
Percent Vaccinated
100
Among girls
unvaccinated for
HPV, 84% had a
missed opportunity
80
60
93
40
54
20
0
HPV-1 (girls)
Vaccine
Missed opportunity: Healthcare encounter when some, but not all ACIP-recommended vaccines are given.
HPV-1: Receipt of at least one dose of HPV.
Actual
Achievable
HPV Vaccine Communications
During the Healthcare Encounter
• HPV vaccine is often presented as ‘optional’
whereas other adolescent vaccines are
recommended
• Some expressed mixed or negative opinions about
the vaccine: ‘new vaccine’; concerns over
safety/efficacy
• When parents expressed reluctance, providers
were hesitant to engage in discussion
• Some providers shared parent’s views that teen
was not at risk for HPV and could delay vaccination
until older
Goff et al. Vaccine (2011). doi:10.1016/i.vaccine.2011.07.082
Hughes et al. BMC Pediatrics. 2011;11:74. www.biomedcentral.com/1471-2431/11/74
HPV Vaccine Safety Summary
• Six years of post-marketing safety
surveillance in females demonstrating
safety of Gardasil
• Syncope has been reported after HPV
vaccine
• Ongoing safety studies for males and
bivalent vaccine
• CDC and FDA are continuing to monitor
HPV vaccine safety
HPV vaccine safety concerns
• Safety questions for any new vaccine
 More due to high visibility of HPV vaccine
• Anecdotes in press due to events
temporally related to vaccination
• Anti-vaccine websites
Accelerating HPV Vaccine Uptake
in the United States: Goals
• Goal 1: Reduce missed clinical opportunities to
recommend and administer HPV vaccines
• Goal 2: Increase parents’, caregivers’, and
adolescents’ acceptance of HPV vaccines
• Goal 3: Maximize access to HPV vaccination
services
• Goal 4: Promote global HPV vaccination uptake
IOM Report - 2011
•
•
•
Evaluated a list of adverse events and their
association with 8 different vaccines covered by
the National Vaccine Injury Compensation
Program (VICP)
Benefits or effectiveness were not assessed
Based on scientific evidence, the committee
developed 158 causality conclusions and
assigned each to one of four categories
MMWR 2013; 62:591-95
Predicted numbers of coincident, temporally associated
events after a single dose of a hypothetical vaccine,
based upon background incidence rates
Number of coincident events
since a vaccine dose
Baseline rate used for
estimate
Within 1
day
Within 7
days
Within
6
weeks
GBS (per 10 million
vaccinated people)
0.51
3.58
21.50
1.87 per 100,000 personyears (all ages: UK Health
Protection Agency data)
Optic neuritis (per 10
million female vaccinees
2.05
14.40
86.30
7.5 per 100,000 personyears in US females
Spontaneous abortions
(per 1 million vaccinated
pregnant women)
397
2780
16,684
Based on date from the UK
(12% of pregnancies)
Sudden death within 1 h
of onset of any symptoms
(per 10 million
vaccinated)
0.14
0.98
5.75
Based upon UK background
rate of 0.5 per 100,000
person-years
Lancet 2009; 374:2115-22
Comparison of 20th Century Annual Morbidity and
Current Morbidity: Vaccine-Preventable Diseases
Disease
20th Century
Annual Morbidity†
2013
Reported Cases † †
Percent
Decrease
Smallpox
29,005
0
100%
Diphtheria
21,053
0
100%
Measles
530,217
184
> 99%
Mumps
162,344
438
> 99%
Pertussis
200,752
24,231
88%
Polio (paralytic)
16,316
0
100%
Rubella
47,745
9
> 99%
Congenital Rubella Syndrome
152
0
100%
Tetanus
580
19
97%
20,000
18*
> 99%
Haemophilus influenzae
†
JAMA. 2007;298(18):2155-2163
CDC. MMWR January 3, 2014;62(52);ND-719-ND-732. (MMWR week 52 provisional data)
* Haemophilus influenzae type b (Hib) < 5 years of age. An additional 13 cases of Hib are estimated to have
occurred among the 212 reports of Hi (< 5 years of age) with unknown serotype.
††
Figure 1. Estimated incidence of invasive Hib infection in <5 year olds, United
States, 1980-2011* Bacterial Core Surveillance (ABCs) data; 2010-2011
**Among those with known vaccination status (n=241/288)
FIGURE 3. Percentage of children aged <5 years with cases of invasive
Haemophilus influenzae type b (Hib) disease,* by vaccine status — United
States 2002–2012
MMWR 2013;62(12): 226-229
MMWR 2013;62(12): 226-229
MMWR 2010; 59:1305-1308
http://www.cdc.gov/vaccines/hcp/patient-ed/conversations/index.html
Conclusions
• Routine immunizations provide a tremendous
benefit to infants, children, adolescents, adults
and to society
• Immunization is a shared public / private
responsibility
• During visits, vaccines and other evidencebased preventive services should be provided
• Continue monitoring adolescent vaccination
coverage among different groups to assess
coverage by race/ethnicity and other
sociodemographic factors to identify barriers
• Every day, 11,000 births occur in the U.S.
Future Considerations
•
•
•
•
•
•
•
•
•
Duration of protection of Tdap
Tdap repeat doses in pregnancy
Use of PCV13 in adults and integration with PPSV13
PCV13 dose reduction in children
Use of zoster vaccine in adults beginning at 50 years of
age, and duration of protection
HPV vaccine: integration of HPV9 and number of doses
Meningococcal B-containing vaccines
Several influenza vaccine preparations
Vaccine hesitancy and pseudoscience