1. ARKANSAS DEPARTMENT OF HEALTH Immunizations: Overview and Changes to the Rules & Regs Jennifer Dillaha, MD Medical Director, Immunizations Medical Advisor, Health Literacy and Communications Arkansas Department of Health School-based Health Alliance of Arkansas School Health Spring Symposium Camp Aldersgate, Little Rock, AR April 22, 2015

2. ARKANSAS DEPARTMENT OF HEALTH Objectives 1.Review the ACIP recommendations for Immunizations and the current Arkansas Rules & Regulations Pertaining to Immunization Requirements for school attendance 2.Describe the major risks associated vaccine administration 3.Identify the major myths associated with childhood immunizations

3. ARKANSAS DEPARTMENT OF HEALTH Arkansas Has the Lowest Immunization Rates in U.S. 2013 National Immunization Survey for children aged 19-25 months AR ranked 51 st in combine vaccine series (57.1% vs 70.4% US) Additional information about the 2013 NIS data is available on the CDC website at http://www.cdc.gov/vaccines/imz- managers/coverage/nis/child/index.html http://www.cdc.gov/vaccines/imz- managers/coverage/nis/child/index.html

4. ARKANSAS DEPARTMENT OF HEALTH Arkansas Kindergartners CDC reported for 2013-2014 school year, AR had 3rd lowest rates for –2 doses of MMR (86.5% vs 94.7%) –4 doses of DTaP (83.3% vs 95.0%) –2 doses of Varicella (85.4% vs 93.3%) A full report on vaccination rates among children in kindergarten in the U.S. during the 2013–14 School Year can be found at http://www.cdc.gov/mmwr/preview/mmwrhtml/m m6341a1.htm http://www.cdc.gov/mmwr/preview/mmwrhtml/m m6341a1.htm

5. ARKANSAS DEPARTMENT OF HEALTH 2013 NIS-Teen Survey For adolescents ages 13-17 years For routinely recommended vaccinations: –1 dose of Tdap (77.7% vs 86.0%) (45 th ) –1 dose of MCV4 (40.4% vs 77.8%) (51 st ) –1 dose of HPV for females (44.3% vs 57.3%) (tied for 50 th ) –1 does of HPV for males (17.7% vs 34.6%) (48 th ) For “catch up” vaccinations: –2 doses of MMR (89.5% vs 91.8%) (41 st ) –2 doses of varicella (59.6% vs 78.5%) (45 th ) More information about the 2013 NIS-Teen data is available on the CDC website at http://www.cdc.gov/vaccines/imz- managers/coverage/nis/teen/index.htmlhttp://www.cdc.gov/vaccines/imz- managers/coverage/nis/teen/index.html

6. ARKANSAS DEPARTMENT OF HEALTH Arkansas Immunization Registry Web IZ Operated by the Arkansas Dept. of Health Mandatory reporting of all vaccine doses given to children under the age of 22 Optional reporting of vaccine doses given to adults age 22 and older

7. ARKANSAS DEPARTMENT OF HEALTH ACIP Recommended Vaccines for Children Advisory Committee for Immunization Practices Advisory to the Centers for Disease Control and Prevention (CDC) Birth-18 Years & “Catch-up” Immunization Schedules: http://www.cdc.gov/vaccines/schedules/hcp/imz/child- adolescent.html http://www.cdc.gov/vaccines/schedules/hcp/imz/child- adolescent.html Easy-to-Read Schedules for All Ages: http://www.cdc.gov/vaccines/schedules/ http://www.cdc.gov/vaccines/schedules/

8. ARKANSAS DEPARTMENT OF HEALTH Changes to the Arkansas Rules & Regulations Effective September 1, 2014 Students immunized according to the ACIP recommended schedule will meet the school requirements http://www.healthy.arkansas.gov/aboutADH/Rule sRegs/ImmunizationRequirements.pdfhttp://www.healthy.arkansas.gov/aboutADH/Rule sRegs/ImmunizationRequirements.pdf

9. ARKANSAS DEPARTMENT OF HEALTH Preschool/Childcare Requirements Age appropriate Diphtheria, tetanus, acellular pertussis (DTaP) Polio (IPV) Haemophilus influenzae Type B (Hib) Hepatitis B Measles, mumps, rubella (MMR) Varicella Pneumococcal (PCV13) Hepatitis A

10. ARKANSAS DEPARTMENT OF HEALTH Preschool/Childcare Requirements 1 or 2 doses of Hepatitis A vaccine, depending on their age 1 to 4 doses of Polio vaccine with at least 6 months between the third and fourth doses Children age 13 months and older are to have 1 dose of varicella vaccine –Medical history of varicella disease will be accepted

11. ARKANSAS DEPARTMENT OF HEALTH Kindergarten 4 doses of DTaP 3 or 4 doses of IPV with one dose after 4 th birthday and minimum of 6 month between next to last and last dose 2 doses of MMR with one dose after 1 st birthday and at least 28 days between doses 3 doses Hep B 2 doses of Varicella or a history by a medical professional 1 dose Hep A after 1 st birthday

12. ARKANSAS DEPARTMENT OF HEALTH Grades 1-12 Grade 1 only: 1 dose of Hep A 4 doses TDaP and 1 dose of Tdap for age 11 as of September 1 each year 3 doses of IPV 2 doses of MMR 2 or 3 doses of Hep B 1 dose of MCV4 in 7 th grade and second dose at age 16 as of September 1 each year 2 doses of varicella

13. ARKANSAS DEPARTMENT OF HEALTH College/University Requirements For freshmen and foreign-born students who are full-time students or part-time students living on campus: –2 doses of MMR with 1 dose on or after the 1 st birthday and 28 days between the 2 doses For all other full-time students and part-time students living on campus: –1 dose of MMR on or after the 1 st birthday No recent changes for the college/university immunization requirements

14. ARKANSAS DEPARTMENT OF HEALTH Tdap Vaccine One dose of tetanus, diphtheria, and acellular pertussis (Tdap) vaccine required for children aged 11 years or older on or before September 1 of each school year Previously, the requirement was for students entering Grade 7 Students entering Grades 1-12 must have had 4 doses of DTaP vaccine (or 3 doses if none were given before age 7 years).

16. ARKANSAS DEPARTMENT OF HEALTH Meningococcal Vaccine MCV4 Students entering Grade 7 need 1 dose of the meningococcal (MCV4) vaccine regardless of age. Students turning age 16 years on or before September 1 –If a student has had 1 dose of MCV4, a second dose is required, if it has been 8 weeks since the first dose. –If no previous dose was received and is student 16 by September 1, the student needs 1 dose and no second dose is required.

17. ARKANSAS DEPARTMENT OF HEALTH Meningococcal Vaccine To meet thes requirement for 16-year olds, a student must receive a MCV4 dose on or after their 16th birthday. A dose given at age 15 years will not meet this requirement.

18. ARKANSAS DEPARTMENT OF HEALTH Polio Vaccine Students entering K-12: a series of at least 3 doses of polio vaccine. The new requirement is that one of the doses must be given on or after the child’s 4 th birthday and there must be a minimum of 6 months between the second and third dose Students who receive 4 doses of the polio vaccine with one dose on or after their 4 th birthday and a minimum interval of 6 months between the third and fourth doses will meet the requirement

19. ARKANSAS DEPARTMENT OF HEALTH Hepatitis A Vaccine For Kindergarten and Grade 1 Students need 1 dose Hepatitis A vaccine given on or after their first birthday ACIP recommends 2 doses, although only 1 is required

20. ARKANSAS DEPARTMENT OF HEALTH Varicella Vaccine Kindergarten through Grade 12 2 doses of varicella vaccine are required History of disease meets this requirement if reported by a medical professional –Medical doctor –Doctor of osteopathy –Advanced practice nurse –Physician assistant Parental history of disease is no longer accepted

21. ARKANSAS DEPARTMENT OF HEALTH MMR and Hep B Vaccines Measles, Mumps, and Rubella (MMR) vaccine requirements are 2 doses –1 dose on or after the first birthday –28 days between the 2 doses Hepatitis B vaccine –Kindergarten: 3 doses required –Grades 1-12: 2 or 3 depending on whether or not a 2- dose schedule was used

22. ARKANSAS DEPARTMENT OF HEALTH Contraindications & Precautions Contraindication: a condition in a recipient that increases the chance of a serious adverse reaction Precaution: a condition in a recipient that might: –Increase the chance or severity of an adverse reaction, or –Compromise the ability of the vaccine to produce immunity

23. ARKANSAS DEPARTMENT OF HEALTH Invalid Contraindications to Vaccination Minor illness Mild/moderate local reaction or fever following a prior dose Antimicrobial therapy Disease exposure or convalescence Pregnancy or immunosuppression in the household Premature birth Breastfeeding Allergies to products not in vaccine Family history (unrelated to immunosuppression)

24. ARKANSAS DEPARTMENT OF HEALTH Possible Side-effects from Vaccines Side effects vary with vaccine type Generally mild, including: –Pain, redness, tenderness or swelling at injection site –Fatigue –Headache –Itching at injection site –Nausea –Mild rash –Fever –Dizziness or fainting (most common in adolescents) List for each specific vaccine: http://www.cdc.gov/vaccines/vac-gen/side-effects.htm http://www.cdc.gov/vaccines/vac-gen/side-effects.htm

25. ARKANSAS DEPARTMENT OF HEALTH Vaccine Adverse Event Reporting System Severe adverse events after administration of any vaccine are rare Reports may be made online, by fax, or by mail National reporting system administered by CDC and FDA Passive (depends on healthcare providers and others to report) Receives about 28,000 reports per year More information: http://vaers.hhs.govhttp://vaers.hhs.gov

26. ARKANSAS DEPARTMENT OF HEALTH Vaccine Safety Monitoring The Vaccine Adverse Event Reporting System (VAERS) –An early warning public health system where people can report adverse health events following vaccination, that helps CDC and FDA detect possible new, unexpected, or increased trends in reported adverse events The Vaccine Safety Datalink (VSD) –Collaboration between CDC and several healthcare organizations which uses de-identified health records to monitor and evaluate adverse events following vaccination The Clinical Immunization Safety Assessment (CISA) –Collaboration between CDC and several medical research centers in the United States to conduct research to understand how adverse events might be caused by vaccines http://www.cdc.gov/vaccinesafety/vaccines/HPV/Index.html#monitor

27. ARKANSAS DEPARTMENT OF HEALTH References The Pink Book. Epidemiology and Prevention of Vaccine-Preventable Disease, 12 th Edition, May 2012. CDC. http://www.cdc.gov/vaccines/pubs/pinkbook/index.html http://www.cdc.gov/vaccines/pubs/pinkbook/index.html Red Book, 29 th Edition. 2012 Report of the Committee on Infectious Diseases. American Academy of Pediatrics. http://aapredbook.aappublications.org/ http://aapredbook.aappublications.org/

28. ARKANSAS DEPARTMENT OF HEALTH Vaccine Hesitancy Defined “Vaccine-hesitant individuals are a heterogeneous group who hold varying degrees of indecision about specific vaccines or vaccination in general.” Strategic Advisory Group of Experts (SAGE)

29. ARKANSAS DEPARTMENT OF HEALTH Modern Vaccine Hesitancy A Historical Progression 1982 DPT: Vaccine Roulette 15 1982 Barbara Loe Fisher, National Vaccine Information Center 16 1998 Andrew Wakefield published in The Lancet 17 1999 AAP/USPHS recommend Thimerosal removal 18 2003 Arkansas legislation, Act 999, nonmedical exemptions 2007 Jenny McCarthy’s Louder Than Words 20 2012 SAGE Working Group, “Vaccine Hesitancy” 23,2 4 2013 Non-medical Exemptions 97.8% of All Exemptions in AR 19

30. ARKANSAS DEPARTMENT OF HEALTH

31. Vaccines and Autism MMR vaccine Thimerosal Too many vaccines Gerber JS and Offit PA. Vaccines and Autism: A Tale of Shifting Hypotheses. CID 2009: 48, 456-461.

32. ARKANSAS DEPARTMENT OF HEALTH MMR Vaccine Ecological studies Retrospective, observational studies Prospective, observational studies

33. ARKANSAS DEPARTMENT OF HEALTH Thimerosal Ecological studies Cohort studies

34. ARKANSAS DEPARTMENT OF HEALTH Too Many Vaccines Vaccines do not overwhelm the immune system Multiple vaccinations do not weaken the immune system Autism is not an immune-mediated disease No studies have compared the incidence of autism in vaccinated, unvaccinated, or alternatively vaccinated children

35. ARKANSAS DEPARTMENT OF HEALTH Internet Myths/Urban Legends Myth: HPV Vaccine has been proved to have cause the deaths of 32 women. Myth: Dr. Diane Harper (misidentified as the lead researcher in development of Gardasil) gave a talk and admitted that “Gardisil and Cervarix don’t work, are dangerous and weren’t tested”. Snopes.com http://www.snopes.com/medical/drugs/gardasil.asp

36. ARKANSAS DEPARTMENT OF HEALTH What You May Hear from Parents Questions about whether vaccines cause autism Questions about the number of vaccines Questions about vaccine ingredients Questions about known side effects Questions about unknown serious adverse events www.cdc.gov/vaccines/conversations

37. ARKANSAS DEPARTMENT OF HEALTH Communication Strategies Take time to listen. Solicit and welcome questions. Keep the conversation going. Science versus anecdote? Acknowledge benefits and risks. Respect parents’ authority. Reduce the stress of shots.

38. ARKANSAS DEPARTMENT OF HEALTH Jennifer Dillaha, MD Medical Director for Immunizations Medical Advisor for Health Literacy and Communication Arkansas Department of Health 4815 W. Markham Street, Slot 48 Little Rock, AR 72205 Office: 501-661-2864 Email: Jennifer.Dillaha@Arkansas.gov