MMWR. 2009;58(RR02):1-25.

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1 Immunizations 2009 Chris Feddock, MD, MS, FAAP, FACP

2 Objectives Outline the new ACIP vaccine recommendations Identify the new combination vaccines which are now available Recognize i the current vaccine shortages Describe the current court cases regarding vaccines and behavioral disorders

3 New Recommendations

4 Rotavirus Vaccines RV5 (RotaTeq RotaTeq ) RV1 (Rotarix Rotarix ) Pentavalent G1, G2, G3, G4 and P1A[8] 3 Doses 2 ml each 2 months 4 months 6 months Efficacy Any rotavirus GE = 73% Rotavirus admission = 100% Monovalent G1 only 2 doses 1 ml each 2 months 4 months Efficacy Any rotavirus GE = 87% Rotavirus admission = 96% Pediatr Infect Dis J. 2007;26: Lancet. 2007;370:

5 U.S. Rotavirus Strains MMWR. 2009;58(RR02):1-25.

6 Rotavirus Surveillance MMWR. 2009;58(RR02):1-25.

7 Rotavirus Dosing Dosing First dose minimum age 6 weeks First dose maximum age 14 weeks and 6 days (Previous maximum of 12 weeks) Interval between doses > 4 weeks (Previous i set a maximum of 10 weeks) Final Dose by 8 months and 0 days (Previous set at 32 weeks) Interchanging Vaccines (RV1 & RV5) If any dose RV5 3 doses necessary MMWR. 2009;58(RR02):1-25.

8 Pneumococcal Polysaccharide (PPSV23) Now recommended for adults years Asthma Cigarette Smoking Clarification For aged >2 years with Immunocompromised conditions Sickle cell disease Functional or anatomic asplenia 2nd dose of PPSV23 5 years after the first

9 Influenza Season All children aged 6 months through 18 years Antiviral Medications during Most H1N1 viruses resistant t to oseltamivir i Most H3N2 viruses resistant to amantadine and rimantadine Recommendations for antiviral medications Will be reviewed in June 2009 Publication prior to season

10 Combination Vaccines

11 Pentacel (DTaP-Hib Hib-IPV) Sanofi Pasteur combination vaccine Vaccinate at 2, 4, 6 & 15 months Similar immunogenicity to separate vaccines No difference to individual components No change in co-administered vaccines Pneumococcal (PCV-4) Hepatitis B Vaccine reactions Lower incidence of redness & tenderness Lowerratesoffeverafterdoses1&2 rates of fever after Pediatrics. 2009;123;

12 Kinrix (DTaP-IPV) GlaxoSmithKline combination Vaccine Only for the 4 th -5 th dose at 4-6 years of age Good immunogenecity Response in 92.2% to DTaP (92.6% if separate) Response in 96.6% to IPV (92.8% if separate) Adverse reactions Higher rate of any pain (57% vs. 53%) All other reactions were comparable Pediatr Infect Dis J. 2008;27:341-6

13 Vaccine Shortages

14 Hib Shortage Merck PedvaxHIB & Comvax Projected restoration late-2008 Now delayed until mid mid to late late Current options: Pentacel (DTaP-Hib-IPV) & ACTHib Sufficient supplies through mid-2009 Children should receive the primary series 2 2 months, 4 months & 6 months Delay the month dose

15 Hib Vaccine Coverage MMWR. 2009;58:58-60.

16 Invasive Invasive Haemophilus influenza Disease MMWR. 2009;58:58-60.

17 Philadelphia Health Department Hib infections since October 2008 in Pennsylvania Five cases of Hib invasive disease Two deaths All cases were e in unvaccinated ated or under- vaccinated children One children - unvaccinated 4-year-old child Religious community that eschews medical care Died of bacterial meningitis in March 2009

18 Current CDC Recommendations Child months no Hib doses Schedule two doses 8 weeks apart Child months incomplete 1 series Schedule 1 additional dose 8 weeks aparte High-risk Children Asplenia, sickle cell disease, HIV, malignant neoplasms, certain immunodeficiencies, Amerian Indian/Alaskan Native Should receive e 1 series mos. Child > 5 years old Hib vaccine is not necessary

19 Hepatitis B Shortage Backorders for pediatric Hepatitis t B vaccine Both Merck and GSK had difficulty in February 2009 CDC released doses from its stockpiles to each manufacturer Merck - Recombivax HB Supplies expected to be limited for 2009 Anticipates return to a full supply in 2010 GSK Pediatric Engerix-B Supplies sufficient through May Working with CDC -? additional vaccine for 2009

20 New Vaccines

21 Boostrix (Tdap Tdap) Originally approved for ages years Supplement submitted to FDA for Adults 12/8/08 approved Now indicated for ages years

22 Pending Approval HPV (Cervarix ) HPV type 16 Pending FDA licensure MCV4 (Menveo ) Pending FDA licensure

23 Pertussis

24 Pertussis Hospitalizations Pediatrics 2008;121;

25 Pertussis vs. Vaccination Pediatrics. 2008;121;

26 Rates of Pertussis Infection Timing i of DTaP Immunization Pediatrics. 2008;122;

27 Accelerated DTaP Immunization < < 6 months of age 20,510 pertussis cases 14,631 hospitalizations 121 deaths Accelerated Vaccination Doses at 6 weeks, 3 ½ months & 5 ½ months Prevent eet pertussis s cases (11%) Prevent 1418 hospitalizations (10%) Prevent 9 deaths (7%) Pediatrics. 2008;122;

28 Incidence of Pertussis with State Immunization Exemptions JAMA. 2006;296:

29 Prevention of Pertussis Administer Tdap to all women < age 65 years Tdap during pregnancy Not recommended due to lack of safety data Td is recommended but could be deferred Age < 31 with complete childhood series + 1 Td Age 31 with complete childhood series + 2 Td Immediate postpartum p Tdap Reduces risk of pertussis in newborns Minimum interval of 2 years from last Td MMWR. 2008; 57(04);1-47,51.

30 Immunization Rates

31 2007 National Immunization Survey Children > 36 months of age 4 DTaP, 3 IPV, 1 MMR, 3 Hib, 3 HepB, 1 Varicella 77% were fully vaccinated with all vaccines Kentucky 78.2% High 91.3% in Maryland Low 63.1% in Nevada < 1% had received no vaccines

32 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 4+DTaP 3+Polio 1+MMR 3+Hib 3+HepB 1+Var 3+PCV 4+PCV US National Kentucky

33 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 4:3:1:3 4:3:1:3:3 4:3:1:3:3:1 4:3:1:3:3:1:3 4:3:1:3:3:1:4 National Kentucky

34 2007 National Immunization Survey Adolescents - Healthy People 2010 goals 3 doses of hepatitis B vaccine 2 doses of MMR 1 dose of either Td or Tdap 1 dose of varicella (no prior chickenpox) Newer Vaccines 87.6% 88.9% 72.3% 75.7% Meningococcal MCV4 32.4% Pertussis Tdap 30.1% Human Papilloma Virus HPV4 25.1% MMWR. 2008;57(40):

35 Immunization Refusals

36 Dr. Bob Doctors, myself included, learn a lot about diseases in medical school, but we learn very little about vaccines....we don t review the research ourselves. We never learn what goes into making vaccines or how their safety is studied.... So, when patients want a little more information about shots, all we can really say as doctors is that t the diseases are bad and the shots are good.

37 ACIP vs. Dr. Bob A Closer Look at Vaccines. U.S. News & World Report. February 1, 2009.

38 No vaccines until age 2 years No vaccines containing thimerosal (mercury) No live vaccines Except smallpox (if needed) Vaccines should be given one at a time every 6 months Pertussis (acellular) Diphtheria Tetanus Polio (Salk)

39 Althen vs. DHHS Tetanus caused optic neuritis Did she need scientific proof (studies)? Three factors: Biologically plausible medical theory Logical sequence of cause and effect Scientific studies Expert medical testimony Proximate scientific temporal relationship

40 Vaccines Autism Court Cases Bailey Banks 7/20/07 Received MMR vaccine at 15 months Vaccination caused ADEM which resulted in PDD Hannah Poling 4/11/08 Received DTaP, Hib, MMR, IPV, Varicella at 19 months Vaccines exacerbated mitochondrial i disorder d Resulted in an encephalopathy

41 Omnibus Autism Proceeding Thimerosal-containing vaccines + MMR cause autism No support for a relationship between vaccines or MMR Michelle Cedillo 2/12/09 William Hazlehurst 2/12/09 2/09 Colten Snyder 2/12/09 Would have to believe six impossible (or, at least, highly improbable) things Thimerosal-containing vaccines cause autism Ruling expected mid-2009 MMR vaccine causes autism Deferred as evidence presented in first set of arguments

42 12 children with developmental regression, diarrhea, abdominal pain Diagnosed as autism in 9 children Preceded by MMR in 8 children All were normal prior to vaccination All had intestinal abnormalities Lymphoid nodular hyperplasia (7/12) Chronic inflammation (11/12)

43 Wakefield Fixed Data 12 cases of behavioral problems Children s ailments misrepresented Only one case did symptoms occur after MMR Most had medical concerns before vaccination Inflammatory t bowel disease All pathology cases showed the gut was normal Sunday Times of London. February 8, 2009.

44 Every Child By Two Immunization Education Program paiep AAP Childhood Immunization Support Program

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