1. OEREP Journal Club: December 12, 2012 Safety and Effectiveness of Childhood Vaccinations Rebecca Trocki, MSHAI and Edwin Lomotan, MD

2. OEREP Journal Club: December 12, 2012 Vaccines are medicine’s bright and shining star. Before, parents in the United States could expect each year Vaccines are medicine’s bright and shining star. Before, parents in the United States could expect each year Polio to paralyze 10,000 children Polio to paralyze 10,000 children Rubella (German Measles) to cause birth defects and mental retardation in 20,000 newborns Rubella (German Measles) to cause birth defects and mental retardation in 20,000 newborns Measles to infect 4 million children and kill 3000 Measles to infect 4 million children and kill 3000 Diptheria to be one of the common causes of death in school children Diptheria to be one of the common causes of death in school children Pertussis (Whooping Cough) to kill 8000 children Pertussis (Whooping Cough) to kill 8000 children

3. How are Vaccines Made  Vaccines are made by taking viruses or bacteria and weakening them so they cannot replicate themselves  When children are exposed to the vaccine, they develop an immunity but not enough to make them sick

4. Ways that viruses and bacteria can be weakened to create a vaccine  Change the blueprint or genetics of the virus so it replicated poorly  Destroy the blueprint of the virus  Utilize part of the virus  Remove the toxin or poison in the bacteria so it cannot do any harm

5. Vaccine Preventable Diseases Diphtheria Diphtheria Diphtheria Haemophilus influenzae type b (Hib) Haemophilus influenzae type b (Hib) Haemophilus influenzae type b Haemophilus influenzae type b Hepatitis A Hepatitis A Hepatitis A Hepatitis A Hepatitis B Hepatitis B Hepatitis B Hepatitis B Influenza Influenza Influenza Measles Measles Measles Meningococcal Meningococcal Meningococcal Mumps Mumps Mumps Pertussis (whooping cough) Pertussis (whooping cough) Pertussis Pneumococcal disease Pneumococcal disease Pneumococcal disease Pneumococcal disease Polio Polio Polio Rotavirus (severe diarrhea) Rotavirus (severe diarrhea) Rotavirus Rubella (German measles) Rubella (German measles) Rubella Tetanus (lockjaw) Tetanus (lockjaw) Tetanus Varicella (chickenpox) Varicella (chickenpox) Varicella For print-friendly fact sheets, flyers, and posters about vaccines and the diseases they prevent in preteens and teens, consult the Print Materials for Preteens and Teens page. For print-friendly fact sheets, flyers, and posters about vaccines and the diseases they prevent in preteens and teens, consult the Print Materials for Preteens and Teens page.Print Materials for Preteens and Teens pagePrint Materials for Preteens and Teens page

6. Selected Childhood Vaccine Statistics 2009 Disease20 th Century2009%Decrease Diphtheria 21,0530100% Measles530,2176399.9% Mumps162,3442,61298% Pertussis200,75227,53886%

7. Laws and Regulations for Vaccinations State Mandatory Vaccination Laws School Vaccination Requirements Every state and the District of Columbia has a law requiring children entering school to provide documentation that they have met the state immunization requirements. 15 In 1827, Boston was the first city to require vaccination against smallpox for public school students. 16 Other cities and states adopted the policy, and state statutes were amended as new vaccines were introduced. 17 Many modern school vaccination laws are the result of measles outbreaks in the 1960s and 1970s. 18

8. Exemption Definitions * All estimates of percentages of children with exemptions are weighted to the number of enrolled children unless otherwise noted. Number of exemptions are unweighted counts. * All estimates of percentages of children with exemptions are weighted to the number of enrolled children unless otherwise noted. Number of exemptions are unweighted counts. † Medical and nonmedical exemptions might not be mutually exclusive. Some children might have both medical and nonmedical exemptions. † Medical and nonmedical exemptions might not be mutually exclusive. Some children might have both medical and nonmedical exemptions. § Exemptions because of philosophic reasons are not allowed. § Exemptions because of philosophic reasons are not allowed. ¶ Exemptions because of religious reasons are not allowed. ¶ Exemptions because of religious reasons are not allowed. ** Rate differences between 2009–10 school year and 2010–11 school year are greater than 1.5 percentage points. ** Rate differences between 2009–10 school year and 2010–11 school year are greater than 1.5 percentage points. †† Exemptions because of medical reasons are allowed but are not reported separately from other exemptions. †† Exemptions because of medical reasons are allowed but are not reported separately from other exemptions. §§ Exemptions because of religious reasons are allowed but are not reported separately from other exemptions. §§ Exemptions because of religious reasons are allowed but are not reported separately from other exemptions. ¶¶ Exemption because of philosophic reasons are allowed but are not reported separately from other exemptions. ¶¶ Exemption because of philosophic reasons are allowed but are not reported separately from other exemptions. *** Did not report exemptions to CDC. *** Did not report exemptions to CDC. ††† Estimates are based on total children surveyed because total children enrolled is unknown. ††† Estimates are based on total children surveyed because total children enrolled is unknown. §§§ The median is based on estimates for 49 states and District of Columbia. §§§ The median is based on estimates for 49 states and District of Columbia. ¶¶¶ Exemptions are allowed but not tracked. ¶¶¶ Exemptions are allowed but not tracked.

9. State Snapshots of Exemptions 2010 StateMedical # % Religious # Philosophical # Non-medical (R+P) (%) Total # % Maryland1610.3293-§0.64540.8 Virginia150.3—¶610.8760.9 DC911.353-§0.81441.1 California8710.2—¶12,6652.413,5362.2 Washington3760.51702,9264.23,0966.2 Oregon800.22,648-§5.82,7285.4 Illinois1,74 5 1.17,270 —§ 4.59,0154.3 Michigan7670.69525,2134.96,9324.4 Pennsylvania5980.42,08301.42,6811.5 Oklahoma740.21353391.04741.5 North Dakota00051.050.8 West Virginia440—¶-§1.3440.8 Colorado & Wyoming No information available

10. Exemption Analysis Rates for exemptions vary widely (more than a factor of 10) Rates for exemptions vary widely (more than a factor of 10) Rates for exemptions may reflect different rules for what is allowable… Rates for exemptions may reflect different rules for what is allowable… – Medical exemptions only – Medical and religious exemptions only – Medical, religious, and philosophical exemptions..but not entirely..but not entirely – The highest rate of exemptions appear in states that allow for medical, religious, and philosophical exemptions – Some states with all three allowable types of exemptions still have low rates of exemptions

11. Pertussis Epidemic in Washington State Published every Tuesday afternoon. Data through 11/10/2012 Pertussis cases in Washington, 2012 Pertussis cases reported in 20124,501 Cases reported for the same period in 2011642 New cases reported November 4-10, 201238 Age groups with highest rate Children under age 1 Children ages 10 to 13 Cases in babies under age one in 2012339 County with highest rateSkagit Counties with reported pertussis cases38 Counties with no reported pertussis cases1

12. Pertussis Epidemic in the United States 2012 STATES WITH INCIDENCE OF PERTUSSIS THE SAME OR HIGHER THAN THE NATIONAL INCIDENCE (AS OF SEPTEMBER 20, 2012), WHICH IS 9.3/100,000 PERSONS STATES WITH INCIDENCE OF PERTUSSIS THE SAME OR HIGHER THAN THE NATIONAL INCIDENCE (AS OF SEPTEMBER 20, 2012), WHICH IS 9.3/100,000 PERSONS WISCONSIN 87.6 ALASKA 23.5 WISCONSIN 87.6 ALASKA 23.5 UTAH 33.6 PENNSYLVANIA 11.7 UTAH 33.6 PENNSYLVANIA 11.7 ARIZONA 12.2 VERMONT 51.9 ARIZONA 12.2 VERMONT 51.9 MINNESOTA 72.6* OREGON 21.9 MINNESOTA 72.6* OREGON 21.9 MISSOURI 11.6MONTANA 44.7 MISSOURI 11.6MONTANA 44.7 NEW MEXICO 27.0 KANSAS 17.2 NEW MEXICO 27.0 KANSAS 17.2 IDAHO 12.0COLORADO 11.0 IDAHO 12.0COLORADO 11.0 WASHINGTON 62.3 MAINE 42.6 WASHINGTON 62.3 MAINE 42.6 NEW HAMPSHIRE 14.9 KENTUCKY 10.7 NEW HAMPSHIRE 14.9 KENTUCKY 10.7 IOWA 42.1 NEW YORK 13.8 IOWA 42.1 NEW YORK 13.8 WYOMING 10.3 NORTH DAKOTA 41.9 WYOMING 10.3 NORTH DAKOTA 41.9 ILLINOIS 12.3 NEBRASKA 8.8 ILLINOIS 12.3 NEBRASKA 8.8

13. Current Pertussis Epidemic

14. AHRQ Innovation Snapshot Snapshot Summary Summary The El Rio Health Center developed a comprehensive program to increase pediatric immunization rates consisting of the following key elements: ongoing immunization training for pediatricians and nurses, a computerized data system to track immunizations, reminders for both patients and providers, and nurse-run immunization clinics offered at the center and in the community. The program has more than tripled immunization rates since its inception, achieving levels that exceed Federal standards for childhood immunizations. Evidence Rating (What is this?) The El Rio Health Center developed a comprehensive program to increase pediatric immunization rates consisting of the following key elements: ongoing immunization training for pediatricians and nurses, a computerized data system to track immunizations, reminders for both patients and providers, and nurse-run immunization clinics offered at the center and in the community. The program has more than tripled immunization rates since its inception, achieving levels that exceed Federal standards for childhood immunizations. Evidence Rating (What is this?)What is this?What is this? Moderate: The evidence consists of pre- and post-implementation comparisons of immunization rates, along with informal feedback from providers and parents.begin do Developing Organizations Moderate: The evidence consists of pre- and post-implementation comparisons of immunization rates, along with informal feedback from providers and parents.begin do Developing Organizations El Rio Health Center, Tucson AZ end do Date First Implemented El Rio Health Center, Tucson AZ end do Date First Implemented 1992 begin pp Patient Population 1992 begin pp Patient Population Age > Adolescent (13-18 years); Child (6-12 years); Vulnerable Populations > Children; Age > Infant (1-23 months); Insurance Status > Medicaid; Vulnerable Populations > Medically uninsured; Age > Preschooler (2-5 years); Vulnerable Populations > Urban populationsend pp Age > Adolescent (13-18 years); Child (6-12 years); Vulnerable Populations > Children; Age > Infant (1-23 months); Insurance Status > Medicaid; Vulnerable Populations > Medically uninsured; Age > Preschooler (2-5 years); Vulnerable Populations > Urban populationsend pp

15. AHRQ Innovation Results Results Pre- and post-implementation comparisons show that the program has more than tripled immunization rates since its inception, achieving levels that exceed Federal standards for childhood immunizations. Anecdotal reports from providers and parents suggest that the program has improved the quality of care. Tripling of immunization rates: During the first 3 to 5 years of the program, immunization rates for 2-year-old children increased from approximately 30 to 94 percent. By 2006, rates reached 97 percent. The program has maintained these high rates each year that adequate supplies of vaccines are available. As of 2012, all El Rio Pediatric Clinics have achieved immunization rates of 90 percent for the combo-3 vaccines for two-year-old patients who remain in the clinic's care. Pre- and post-implementation comparisons show that the program has more than tripled immunization rates since its inception, achieving levels that exceed Federal standards for childhood immunizations. Anecdotal reports from providers and parents suggest that the program has improved the quality of care. Tripling of immunization rates: During the first 3 to 5 years of the program, immunization rates for 2-year-old children increased from approximately 30 to 94 percent. By 2006, rates reached 97 percent. The program has maintained these high rates each year that adequate supplies of vaccines are available. As of 2012, all El Rio Pediatric Clinics have achieved immunization rates of 90 percent for the combo-3 vaccines for two-year-old patients who remain in the clinic's care. Exceeding standards: The program won the Daniel T. Cloud Outstanding Practice Award from The Arizona Partnership for Immunization for exceeding Federal standards and achieving immunization rates of 90 percent or more for children turning 2 years old. Exceeding standards: The program won the Daniel T. Cloud Outstanding Practice Award from The Arizona Partnership for Immunization for exceeding Federal standards and achieving immunization rates of 90 percent or more for children turning 2 years old. Anecdotal reports of better quality: Anecdotal reports from providers suggest that the training sessions have allowed for a more collaborative approach to monitoring whether immunizations are up-to-date and administered correctly. Parents view the immunization clinics as an added benefit, and providers have not noticed changes in compliance with well-child visits. Anecdotal reports of better quality: Anecdotal reports from providers suggest that the training sessions have allowed for a more collaborative approach to monitoring whether immunizations are up-to-date and administered correctly. Parents view the immunization clinics as an added benefit, and providers have not noticed changes in compliance with well-child visits. Evidence Rating (What is this?) Evidence Rating (What is this?)What is this?What is this? Moderate: The evidence consists of pre- and post-implementation comparisons of immunization rates, along with informal feedback from providers and parents. Moderate: The evidence consists of pre- and post-implementation comparisons of immunization rates, along with informal feedback from providers and parents.

16. Some Vaccine Myths  Vaccines do not work  Vaccines are not necessary  Vaccines are not safe  Infants are too young to get vaccinated  Better to have natural immunity than vaccination  Vaccines use up the immune system

17. For discussion Why are there outbreaks Why are there outbreaks – Vaccination rates are decreasing – Vaccine effectiveness is decreasing? Why do parents refuse vaccines? Why do parents refuse vaccines? – Autism controversy – Vaccine myths (from previous slide) Are there appropriate research questions for AHRQ? Are there appropriate research questions for AHRQ?