Upload
jonathan-weaver
View
217
Download
0
Tags:
Embed Size (px)
Citation preview
7th AnnualDell 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
14
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
Meningococcal VaccineRecommendations
Vaccine FDA Routine High Risk
MenACWY-D(Menactra)
9 mo.-55 yr.
11-21 yr. 9 mo.-55 yr.
MenACWY-CRM (Menveo)
2 mo.-55 yr.
11-21 yr. 2 mo.-55 yr.
HibMenCY-TT (MenHibrix)
*not for travelers
6 wk.-18 mo.
Hib 6 wk.-18 mo.*
MMWR 2014; 63:148-54
MMWR 2014; 63:148-54
56%
61%
43%
40% 34%
Influenza Deaths by Age Group122 Cities Mortality Reporting System,
Number of Influenza Deaths by Age Group and Year
*
**Data as of week 6, 2014
**
*Data from week 15, 2009 – week 39, 2010
MMWR 2013; 62:997
Flu vaccination during 2012-13 season
resulted in 79,260 fewer hospitalizations
and 6.6 million fewer cases of influenza
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 vaccineHPV: human papillomavirus vaccine
Strength of HPV Vaccine Recommendation for Female Patients, Pediatricians and
Family Physicians (N=609)
Allison et al. https://cdc.confex.com/cdc/nic2011/webprogram/Paper25181.html
IID-9: Children 19-35 Months Who Received No Vaccinations, 2008-2012, U.S.
Source: National Immunization Survey
Tracking Measure- Program goal to sustain percentage of <1%
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
Safe for mother and infant
Recommended to protect pregnant women and theirinfants
Optimal timing is important Influenza (any trimester) Pertussis (every pregnancy from week 27-36) Only potential strategy to prevent young infant deaths and hospitalizations
Maternal Immunization: Benefits
Clin Obstet Gynecol. 2012;55:474-86
33
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
Human Papillomavirus:Types and Disease Association
Skin warts (hands and feet)
Mucosal/genital(~40 types)
High-risk: types16, 18, 31, 45(and others)
Low-risk:types 6, 11
(and others)
Low-grade cervical abnormalitiesCancer precursorsAnogenital cancers
Low-grade cervical abnormalitiesGenital wartsLaryngeal papillomas
Non-mucosal/cutaneous(~60 types)
Muñoz N et al. N Engl J Med 2003;348:518-527.
Type Attribution by Cancer Site
Cervical In Situ Cervical Vulvar Vaginal Anal Penile Oropharyngeal0
10
20
30
40
50
60
70
80
90
100
66
60
49
55
79
48
60
15
21
1418
8 96
10
18
62 3
64
9
1
31
25
9
37
30
HPV 16/18
HPV 31/33/45/52/58
Other HPV
HPV Negative
Cancer Site
Perc
ent
Saraiya et al, presented at AACR Health Disparities in Cancer, 2013
Revised Estimated Percentages of Cancers Attributed to HPV in the
U.S. Cancer HPV attributabl
e% (95% CI)
HPV 16/18attributable% (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)
Oropharynx
Average Number of New HPV-Associated Cancers by Sex, in the United States, 2005-2009
n=3039 n=2317
n=3084
n=11279n=9312
n=1687
n=1003
Jemal A et al. J Natl Cancer Inst 2013;105:175-201
n=694
HPV VaccinesQuadrivalent
(Gardasil)Bivalent
(Cervarix)
Manufacturer Merck GlaxoSmithKline
VLP types 6, 11, 16, 18 16, 18
Producer cells Saccharomyces cerevisiae (yeast)
Baculovirus infected Trichoplusia in insect cell
line
Schedule (IM) 3 dose series 3 dose series
Estimated to Protect (%)
Genital Warts 90% --
Cervical and other cancers
70% 70%
VLP – virus like particle; IM - Intramuscular
Evolution of recommendations for HPV vaccination in the United States
40
Quadrivalent Routine, females 11 or 12 yrs*and 13-26 yrs not previously vaccinated
Quadrivalent or Bivalent Routine, females 11 or 12 yrs*and 13-26 yrs not previously vaccinated
Quadrivalent May be given, males 9-26 yrs*
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
June October
Quadrivalent Routine, males 11 or 12 yrs* and 13-21 yrs not previously vaccinated
May be given, 22-26 yrs**
October
Disease Associations with Most Frequent Types of HPV
Diseases HPV type
Cutaneous warts 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 HPV-negative 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)
44
Comparison of 9vHPV Vaccine and qHPV VaccineComparison of 9vHPV Vaccine and qHPV Vaccine
AAHS225μg
AAHS500μg
620μg
1140μg
ADJUVANTqHPV vaccine
9vHPV vaccine
1640μg
1820μg
630μg
1140μg
1660μg
1840μg
3120μg
3320μg
4520μg
5220μg
5820μg
AAHS =Amorphous aluminum hydroxyphosphate sulfate
Why Parents Say “No” to HPV Vaccine
* 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
Parents who do not intend to vaccinate daughter in next 12 months, NIS-Teen 2008-2009
Actual and Achievable Vaccination Coverage if Missed Opportunities Were Eliminated: Adolescents 13-17 Years, NIS-Teen 2012
54
93
0
20
40
60
80
100
HPV-1 (girls)
Per
cen
t V
acci
nat
ed
Vaccine
Actual
Achievable
Missed opportunity: Healthcare encounter when some, but not all ACIP-recommended vaccines are given.HPV-1: Receipt of at least one dose of HPV.
Among girls unvaccinated for HPV, 84% had a
missed opportunity
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
• 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
Accelerating HPV Vaccine Uptake in the United States: Goals
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 ratesNumber of coincident events
since a vaccine doseBaseline 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 person-years (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 person-years 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
Disease20th 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%
Haemophilus influenzae 20,000 18* > 99%
† 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
3 infants with CRS born in the U.S. All mothers
exposed to rubella in Africa. All infants
had severe defects.
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 evidence-based 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