Human Papillomavirus Vaccine HPV by mikeholy


									Adolescent Vaccination

       April 6, 2010
    Robert Brayden, MD
   Professor of Pediatrics
   University of Colorado
I have no financial interest in any vaccine
or vaccine delivery device
Pharmaceutical companies do not pay my
salary directly or indirectly
Trade names do not imply endorsement
No photograph of any patient in this talk is
of the stated patient
– the prevalence and seriousness of HPV
– HPV vaccines and their recommended use
– review use of the new meningococcal vaccine
– review use of the Tdap vaccine
– discuss the schedule and school regulations
    Adolescent vaccination
Between 2005 and 2006, vaccines
recommended for adolescents included:
– Meningococcal
– Tdap
Human Papillomavirus (HPV)
               Types of HPV
About 100 types
– 60 types – Cutaneous   warts
– 40 types – Mucosal
Mucosal HPV are the most common
sexually transmitted disease in the US
– 4.6 million cases of HPV
– 1.9 million cases of trichomonas
– 1.5 million cases of Chlamydia
– 431,000 cases of gonorrhea
– 8,200 cases of syphilis
Age-specific Prevalence of Genital HPV
Usually, but not always, a woman clears
HPV infection from the cervix
– 70% cleared within one year
– 91% cleared within two years
– 630 million cervical infections
– 10 million high-grade CIN
– 500,000 cervical cancers
– 233,000 cervical cancers deaths annually
     HPV cervical infection
Type 16 – 57%
Type 18 – 17%
Types 45, 31,33,52,58 and 35 – 22%
8 additional types – about 4% total
Is HPV infection necessary to get
        cervical cancer?
Yes, chronic HPV infection is a necessary
 – More than 99% of those with cervical cancer
   will demonstrate evidence of HPV infection
HPV vaccines are not therapeutic
Some pre-cancerous vulvar lesions have
improved with a research vaccine (NEJM,
2009; 361: 1838.)
                Sexual debut
9th grade
– 40% males
– 30% female
12th grade
– 55% for both genders
Source: Grunbaum JA et al. MMWR Surveill Summ 2004; 53(2):1-

2 years after sexual debut 60% of males
are colonized with the HPV – Source -
              HPV vaccine
Both HPV vaccines cover types 16 and 18
– 95% effective in preventing cervical pre-cancer
  caused by these types.
3 dose series (0, 2, 6 months)
– 24 week minimum interval doses 1 - 3
Ages 11 – 12 years
FDA approved ages 9 to 26 years
Sub-unit vaccine
– Cannot cause HPV infection
HPV4 (Gardasil) also covers HPV types 6, 11
– Non-carcinogenic, causal of genital warts
   Adverse Events Reports
Affecting the arm
– Pain (84%)
– Swelling, redness (25%)
   Adverse Events Reports
Affecting the entire body
– Guillain-Barre Syndrome 1 – 2/ 100,000
    No indication - greater than the population risk
– Venous thromboembolism (VTE)
    Most cases (n = 31) have rival explanations, e.g.
    BCPs, family hx, obesity, smoking, immobility
    Caution interpreting a passive reporting system
    No signal in Vaccine Safety Datalink
    Close monitoring of VTE in the future
   Adverse Events Reports
– Deaths
    32 as of 12/31/08
    20 with medical records available
   No common pattern
   In the majority with autopsy, death certificate and
   medical records, cause of death was explained by
   factors other than the vaccine
Conclusions of Safety Review
JAMA . 2009; 302: 750-757
– “The post-licensure safety profile presented
  here is broadly consistent with safety data
  from pre-licensure trials.
HPV vaccines continue to be
Behavioral impact of vaccination
 Vaccinating those with high risk of HPV
 infection would miss 80% of those that
 would eventually be infected
 Many advise universal vaccination
Other methods of prevention
– Best method for the prevention of HPV
– Reduce but do not eliminate passage of HPV
      Regular pap smears
Help to identify chronic cervical infection in
its early stages when it is more treatable
compared to later detection
Meningococcal disease
New meningococcal vaccine
Novartis – Menveo
Induces immunity to types A, C, Y, W-135
FDA approved for 11 – 55 years of age
– Routine for 11 – 18 year olds
– High risk for 18 – 55 year olds
– High risk 2 – 10 year olds should receive
Routine meningococcal vaccination
 11 – 12 years of age
   Meningococcal outbreak
Involve local health department
Outbreak definition
– ≥ 3 cases in ≤ 3 months
              Tetanus incidence, US 1947 - 2003

per million


              2                           Incidence


                  1947   1960   1970   1980      1990   2000
         Diphtheria - United States, 1940-2001*

            1940   1950   1960   1970   1980   1990   2000
   Could diphtheria return?
Yes, without vaccination
1990s, former Soviet Union
– Massive epidemic associated with under-
– 140,000 cases

Whooping baby.lnk
Pertussis – Why the Increase?
Pertussis has been underdiagnosed
– By how much is uncertain
Diagnostic bias – PCR, a more sensitive
test for the bacterium
Surveillance bias – education, we are
looking more carefully for it
Is the acellular vaccine as effective as the
whole cell vaccine?
Could tetanus return?
– Yes, soil based organism
Circle of protection around an infant
School regulation requirement
– 2010 - 2011 – all 6th graders and older
If Tdap inadvertantly used in <7 year old it
– should be counted if 4th or 5th DTaP were
– should not be counted if 1st,2nd or 3rd DTaP
 were intended
Tdap and DTaP are not equivalent
– Small “p” = generally smaller amounts of
  pertussis antigens
Universal influenza vaccination
Recommended for all over 6 months of
2010-2011 vaccine
– A/California/7/2009 (H1N1)-like
– A/Perth/16/2009 (H3N2)-like
– B/Brisbane/60/2008-like
  Vaccinations and syncope
After 2005, the rate of syncope reported to
VAERS rose rapidly
463 cases 1/1/05 to 7/1/07
26 cases ruled associated, serious
– 70% within 15 minutes of vaccination
– 9 head injuries, 1 MVA
– One death (head injury)
Vaccines and syncope
    Vaccines and syncope
“Strongly consider observing patients for
15 minutes after they are vaccinated.”
Presyncopal symptoms
– Weakness, dizziness
– Usually a rapid onset after vaccination
Colorado Immunization Law
 Adolescent Requirements
   2010-11 School Year

      Jamie D’Amico, RN, MSN, CNS
   Schools & Community Immunizations
  Colorado Immunization Program- CDPHE
Rules of the Colorado Board of Health
         Presentation Outline

*   Immunization Laws in Colorado
*   Board of Health Process
*   Recommended vs Required vaccines
*   Minimum Requirements for adolescents
 Immunization Laws in Colorado

• The Colorado School Entry Immunization
  laws were approved by the state legislators
  on May 21, 1963.
       Colorado School
      Immunization Law

The purpose of the Immunization
Law is to protect Colorado’s children
against vaccine-preventable diseases
         Guiding Documents
• Colorado Revised Statutes: School Entry
  Immunizations (The Law)

• Rules Pertaining to the Infant Immunization
  Program, Vaccines for Children Program &
  Immunization of Students Attending School
                (The BOH Rules)
  The Process of Requiring School

1st Board of Health Workgroup Convenes
2nd Colorado Board of Health Reviews and
Board of Health Workgroup
   Board of Health Workgroup
• Stakeholders:
 - School nurses
 - Childcare nurse consultants
 - Physicians
 - Public health representatives
 - IZ Coalition
 - Colorado Immunization Program
 - Communicable Disease partners
    Board of Health Workgroup
• Discussion Items:
  - Epidemiology of VPD
  - Specific vaccine issues
  - Clarification of existing rules
     Colorado Board of Health
• Immunization proposals from the BOH
  Workgroup are then presented to the BOH

• Hearing is scheduled, proposals posted for
  the public to review and meeting is
  convened to discuss proposals
              Legislative Action
• There are rare occasions when a legislative action
  will be initiated by an outside entity without
  consultation form the Colorado Board of Health

  College requirement for Meningococcal vaccine
  HPV (failed)
- SB 10-056 (Require notification of parents/guardians of
  students in Colorado schools to inform of both, required
  and recommended immunizations)
Recommended vs Required
      Recommended Vaccines
• ACIP Recommendations – This is the
  standard for optimum vaccine protection
  against disease
         Required Vaccines
• Vaccines required for Colorado school
  entry and attendance as determined by
  the Colorado BOH
 Required Adolescent Vaccines
• 3 Hep B
 Prior to 7/1/09, students who have received 3 Hep
 B vaccines, regardless of minimum intervals, are
 considered compliant for school entry

 Students who have not received 3 Hep B vaccine
 doses by the 7/1/09 SY will be required to follow
 the ACIP guidelines as described in the BOH rules
   Required Adolescent Vaccines
• Tetanus/diphtheria/pertussis
(3 appropriately spaced tetanus/diphtheria containing vaccines)

   - Tdap – required 6th – 12th grades
     * 2 year interval between Td & Tdap
     * 5 year interval between DTaP & Tdap

There is no “absolute minimum” between Td and Tdap
    (MMWR December 15, 2006/55(RR17) 1-33)
  Required Adolescent Vaccines
• Polio
 - 4 doses of vaccine required unless 3rd dose given
   at 4 years of age. 4 doses are a complete series
   regardless of age at completion

 Proposal to the BOH will suggest following the ACIP
 recommendations: “The final dose in the series to be
 administered on or after the fourth birthday and at least 6
 months following the previous dose”
 Required Adolescent Vaccines
 - All students are required to have 2 appropriately
   spaced MMR vaccines

 Issue: Some students present an immunization record that
 shows the 1st MMR was administered more than 4 days
 before the 1st birthday (this is not a valid dose and must be
  Required Adolescent Vaccines
• Varicella
 Students 6th through 10th grades are required to
 have 1 dose of varicella or documentation of
 chickenpox disease by a health care provider
 (physician, PA, school nurse, public health nurse)

  Varicella vaccination is implemented on an “integrated”
  schedule, so by the 2019-20 school year, ALL grades will
  be required to receive 2 doses of varicella
       Success of Vaccines

Epidemiologic surveillance demonstrates
that the implementation of immunization
programs has decreased, and in some cases,
eliminated the incidence of Vaccine
Preventable Disease
Colorado Immunization Program

The Website provides immunization
information for Schools/Childcares, Health
Care Providers, Parents, and others
interested in keeping Colorado citizens free
from vaccine preventable disease

Jamie D’Amico, RN, MSN, CNS
              Rosemary Spence, RN MA
Adolescent Immunization Coordinator/CO Immunization
National Immunization Survey-Teen, 2008
Barriers to Adolescent Immunizations
Overcoming These Barriers
Frequently Asked Questions (FAQs)
Collects vaccination information on
adolescents 13-17 years in the 50 states and
selected local areas
Uses a random-digit-dialed sample of
household telephone numbers
Guardians identify adolescents’ vaccination
Surveys mailed to vaccination providers to
obtain vaccination histories
Measures coverage for MCV, Tdap, HPV and
additional vaccines
Included adolescents born during January 1990-February
Substantial differences observed in coverage estimates
among states and local areas
Variability in coverage observed among racial/ethnic groups
and by poverty status
Additional information available at:
CO coverage:
◦   >   1   Tdap: 63.0%
◦   >   1   Td or Tdap: 77.4%
◦   >   1   MCV4: 32.4%
◦   >   1   HPV4: 33.5%
◦   >   3   HPV4: 19.0%
US national coverage:
◦   >   1   Tdap: 40.8%
◦   >   1   Td or Tdap: 72.2%
◦   >   1   MCV4: 41.8%
◦   >   1   HPV4: 37.2%
◦   >   3   HPV4: 17.9%
Cited by physicians:
◦ Lack of adequate reimbursement for vaccines
◦ Not seeing adolescent patients more than once or
  twice a year
◦ Lack of time during patient visit to address
◦ Difficulty in assessing and verifying past
◦ Lack of confidence/self-efficacy in addressing
  adolescent immunizations
◦ Lack of school entry mandates
◦ Lack of reminder/recall systems
Cited by adolescents and parents:
◦ Lack of knowledge regarding VPDs and associated
◦ Limited awareness of adolescent vaccination
  recommendations or requirements
◦ No medical home for ongoing medical care
◦ Time constraints
◦ Cost concerns
◦ Lack of transportation to doctor’s office
Vaccines for Children (VFC) Program
◦   Medicaid eligible < 18 years
◦   Uninsured < 18 years
◦   American Indian or Alaska Native < 18 years
◦   Underinsured < 18 years (FQHCs and RHCs only)
◦   Contact or to enroll
CO Infant Immunization Program (IIP)
◦ Automatically enrolled if VFC provider
◦ Can use CDPHE-supplied vaccines on 19 and 20-
  year-olds enrolled in Medicaid
Local health departments and nursing services
receive additional CDPHE-supplied vaccines
◦ Tdap for anyone 10-64 years of age
◦ Vaccines for under and fully insured < 18 years
◦ Contact your local public health agency for more
11-12 year preventive care visit:
 ◦ Endorsed by the American Academy of Pediatrics
   (AAP), the Centers for Disease Control and
   Prevention (CDC), and the Society for Adolescent
   Medicine (SAM)
 ◦ Objectives:
     Preventive care check up
     Catch-up preteens on any missed childhood
     Introduce the new preteen vaccines
CO Immunization Information System (CIIS)
◦ Confidential, population-based, computerized
  information system
◦ Collects and disseminates consolidated
  immunization information for Coloradoans of all
◦ Operated by CDPHE
◦ Contact information:
   303/692/2437 or 1/888/611/9918
◦ Provider and parent resources:
   CO Immunization Program (CIP):
   CIP: Regional public health nurse consultants: 303.692.2650
   or go to CIP website (VFC Program: VFC/AFIX site visit
   CO Children’s Immunization Coalition:
   Immunization Action Coalition:
   The Children’s Hospital of Philadelphia Vaccine Education
   Center (CHOP):
   Local public health agency
Provider and parent resources
◦ National Meningitis Association:
◦ Association of Women’s Health, Obstetric and
  Neonatal Nurses (AWONN) “Be Confident” campaign:
Adolescent resources:
◦ CDC’s “kid-friendly” sites:
◦ Parents of Kids with Infectious Diseases (PKIDS)
  Vaccine Initiative: GetVaxed:
Action                      Affirmative      Permissive
                            recommendation   recommendation
Expected to offer vaccine   Yes              No
Expected to vaccinate       Yes              Yes, if provider stocks
child on request                             vaccine, else refer
May offer vaccine           Yes              Yes
Immunization programs       Yes              No
expected to promote
Uptake is measure of        Yes              No
When will the new HPV Vaccine Information
Statement (VIS) become available? Currently
available at:
I work in a university student health center.
We are seeing college freshmen (living in
dormitories) that received MCV4 when they
were 11-12 years of age. Do we have to
routinely revaccinate? No.
Rosemary Spence: 303/692/2798 or

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