1 / 50

TODAYS SPEAKER HAS NO DISCLOSURE TO MAKE

AS MANDATED BY ACCME SPEAKERS ARE ASKED TO DISCLOSE ANY REAL OR APPARENT CONFLICT RELATED TO THE CONTENT OF THEIR PRESENTATION. TODAYS SPEAKER HAS NO DISCLOSURE TO MAKE. Sandor Feldman, MD Professor Emeritus, Pediatrics Chief of Pediatric Infectious Diseases (ret.)

summer
Download Presentation

TODAYS SPEAKER HAS NO DISCLOSURE TO MAKE

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. AS MANDATED BY ACCME SPEAKERS ARE ASKED TO DISCLOSE ANY REAL OR APPARENT CONFLICT RELATED TO THE CONTENT OF THEIR PRESENTATION • TODAYS SPEAKER HAS NO DISCLOSURE TO MAKE

  2. Sandor Feldman, MD Professor Emeritus, Pediatrics Chief of Pediatric Infectious Diseases (ret.) Billy S. Guyton Distinguished Professor University of Mississippi Medical Center Immunization and Epidemiology Consultant, Mississippi State Dept. of Health Jackson, MS

  3. NIS Q3/’08-Q2/’09; Children, 19-35 mos of age RANK 4+DTP 84.9% 85.5% 20 3+Polio 93.6% 94.2%25 1+MMR 91.5% 91.2% 24 1°Hib 92.9% 96.5%6 1° + Booster Hib 56.9% 70.5% 3 3+HepB 93.3% 96.0%8 1+HepB birth- 3d 58.4% 68.43% 17 1+Var 90.6% 93.2% 9 4+PCV 80.6% 80.4% 23 2+HepA 44.1% 32.5% 47 4:3:1:3:3 75.0% 77.0% 13 4:3:1::3:1 78.7% 81.3% 11 4:3:1::3:1:4 70.9.7% 72.5% 11 FLU (6 -23m)≥ 1 40.7% 22.1% 49 fully 23.4% 7.1% 50

  4. Children Complete (3:3:0) at 12 moby Provider- ’04 vs ’10 MSDH Survey ’10-% Served MSDH-16% Pvt Prov.-50% Rural Health-11% Combo-23% ’04-% Served MSDH-23% Pvt Prov.-38% Rural Health-9% Combo-30%

  5. Children Complete (3:3:0) at age 1 y F/U @ 27 m(4:3:1::3:1) by Provider ’04 vs ’10 Children NOT Complete (3:3:0) at age 1 y F/U @ 27 m(4:3:1::3:1) by Provider ’04 vs ’10 *HIB Shortage-4:3:1::3:1

  6. 2010 MS Survey: Age @27 m 4:3:1::3:1:4 4:3:1::3:1 II 80.3% II 81.3% I 78.6% I 80.4% IV 86% IV 89.5% III 90% III 90% VI 77.4% V 81.2% V 82.2% VI 77.4% VIII 84.8% VII 82.1% VIII 85.8% VII 83.2% IX 78.8% IX 80.2% Statewide 82.9% Statewide 81.7%

  7. Procedure for Exemption • Physician writes a letter to District Health Officer of the county of residence of child, requesting a medical exemption. Letter should include name, DOB, and the rationale or reason(s) for the medical exemption. The specific vaccines to be exempted should be elucidated. It will be helpful to request or provide information for the duration of the exemption, as some conditions are self-limiting, while others are prolonged .

  8. Reported H1N1 Pediatric 279 Mean age-8.8y 4

  9. Cumulative rate of hospitalizations during three influenza seasons, by age group

  10. H1NI Oct’09-Jan’10 Median 6m-17yrs 36.8% 28.2% ≥18yrs 20.1% 8.7% Initial target gr 33.2% 19.4% 25-64 yrs risk 25.2% 10.4% 25-64 yrs NOT Risk 14.5% 6.5% ≥ 65 yrs 22% 12.7% ≥ 6 m 23.9% 12.9%

  11. A/California/7/2009 (H1N1)–like virus, A/Perth/16/2009 (H3N2)–like virus, B/Brisbane/60/2008–like virus.

  12. FLU Vax Efficacy:~±60-70% Adults: TIV > LAIV Children: LAIV >TIV MY OPINION Cost? Efficacy diff- “no great shakes” Ease of admin screening line’im up and shoot

  13. Safety Of Flu Vaccine Administration in Egg-Allergic Patients (Ped ’10;125:e1024) Graded Dose 1/10 then 9/10 No Skin test No Localized or systemic-79% No Systemic- 97% Skin test No Localized or systemic-79% No Systemic- 95%

  14. HD SD Ratio GMT A/H1N1 A/H3N2 B Seroconversion A/H1N1 A/H3N2 B Seroprotection(≥40) A/H1N1 A/H3N2 B HAI 116 609 69 % 49 69 42 90 99 79 HAI 67 333 52 % 23 51 30 77 97 67 1.7 1.8 1.3 % difference 26 18 12 13 2 12 AGE≥ 65YrsHigh dose TIV 60µ HA vs 15 µg standard Comparison HD vs SD (JID’09;200:172) ’

  15. Frequency of Solicited Injection-site and Systemic Reactions, 0-7 Days Post-vaccination1,2 High-dose Standard-dose Injection-site reactions Systemic reactions % of Subjects % of Subjects Local injection-site reactions and systemic complaints occurred more frequently in recipients of high-dose vaccine than in recipients of standard-dose vaccine References: 1. Fluzone vaccine [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.; 2010. 2. Falsey A, et al. J Infect Dis. 2009;200(2):172-180.

  16. TIV Vaccine in Infants-Age 6-12 wks (PIDS 2/2010) TIV N=915 Placebo N=460 ≥1:40 . Percentage of participants with fever or local reactions (tenderness, redness, or swelling) following first and second doses of TIV/Placebo. No significant differences were noted between TIV and placebo groups at either dose 1 or dose 2 for fever or any local reaction.

  17. Influenza Immunization in Pregnancy-Ab Responses in Mothers and InfantsNEJM’10;362:1644 Proportions of Immunized Mothers and Their Infants with Hemagglutination-Inhibition (HAI) Titer of 1:40 or Greater

  18. Vaccine Preventable Diseases ‘09 ’10 YTD ‘08 Tetanus-0 Diphtheria-0 Mumps-1 Measles-0 Rubella-0 HfluB-0 Meningococcus-12 Adol/young ads-3 Pertussis-105 <1yr-50% 1-5yrs-6% 6-9yrs-7% 10-18yrs-13% adults-24% Tetanus-0 Diphtheria-0 Mumps-1 Measles-0 Rubella-0 HfluB-0 Meningococcus-4 Adol/young ads-0 Pertussis-80 <1yr-53% 1-5yrs<1% 6-9yrs-11% 10-18yrs-11% adults-23% Tetanus-0 Diphtheria-0 Mumps-0 Measles-0 Rubella-0 HfluB-0 Meningococcus-3 Adol/young ads-0 Pertussis-44 <1yr-48%(all <6m) 1-5yrs-7% 6-9yrs-14% 10-18yrs-9% adults-23% TypeB }32% }34% }37%

  19. MSDH Preferred Immunization Schedule for Persons 0 – 6 Years Age 2010 Range of Recommended Vaccines Certain high-risk groups Age with specific vaccine indicates the preferred age for vaccine administration (to be used in MSDH clinics) HepB HepB RV5 RV5 RV5 DTaP DTaP DTaP DTaP DTaP Hib Hib Hib Hib IPV IPV IPV IPV IPV PCV PPSV PCV PCV PCV Influenza (yearly) MMR MMR Varicella Varicella HepA #1 HepA #2 HepA Series MCV • *HEPATITIS A VACCINES ARE INTERCHANGEABLE AS ARE HEPATITIS B VACCINES • #First dose of RV5 can be administered age 6 thru 14 wks (max. age is 14 wks, 6 days). Initiation of RV should not be after age 15 wks 0 days. The final dose should not be administered after age 8 mos 0 days. • MSDH CLINICS : PENTACEL @ 2,4,6 & 12 mos –DTaP/Hib/IPV;RotaTeq(RV5) @2,4,6 m for RV5 and . Hep B vaccine is Engerix; Hep A vaccine is Havrix. Children will be required to have last dose of IPV (4th or 5th ) at 4-6 yrs of age. Kinrix, (DTaP/IPV) will be used as 5th dose of DTaP & last dose of IPV (4th or 5th dose).

  20. On-time Vaccine Receipt in the 1st Year Does Not Adversely Affect Neuropsychological Outcomes Ped ’10;125:1134 • N=1047-total study population; b ’93-’97; 7-10 yr f/u • Timely-vaccines received within 30 d of recommended age • N=491 • Untimely-did not meet above definition • N=556 • Secondary analysis • Most timely (10 vaccines in 1st 7m of life vs Least timely (  6 vaccines in 1st 7 mos of life) • 42 specific neuropsychological tests • Timely children significantly better 12/42 where as untimely was similar but in no instance better • Most vs least timely showed again “most” was either better or same but not worse

  21. Odds and Ends • Administration of expired vaccine-invalid dose and requires repeat • Merck- Ø produces separate M, M & R vaccines • In USA, a Ø vax 35x develop measles, 22x develop pertussis & 9-16x develop “pops than vax • MMRV will not be available in MSDH clinics, but is available to VFC/pvt providers • 5-12 days, post vaccination, ages 12-23 m, 1st dose (hi risk period for febrile seizures  47m) • 7.0/104 MMRV vs 3.2/104 MMR+V • Rotateq efficacy against ER/Hosp after #1, #2 doses was 69%, 81%, respPed 2/10 • ~55 k hospitalizations prevented in ’08 or elimination of 1 in every 20 hospitalizations among US child.,<5yrs JID’10;201:1617

  22. Odds and Ends • Ped’10;126:e493 Adverse reaction profile, similar PCV13/PCV7. Ab responses (several measures) PCV13/PCV7 similar and not inferior to PCV7. Excellent boosting in toddlers • Vaccine’10;28:4169. 1991-2000; 37k children;158k vaccinations. Rate of medically attended fever (380C) visits within 7d, 6.4x103-other than during use of Rotoshield, no change as new and more vacines added • Dtap->400,000 child.- Ø  risk for early childhood seizures Ped’10;16:e263 • MMWR .10;59:657 Ø  GBS after H1N1 • Acquistion costs have  >$900 ♂ & >$1200 ♀; 6x since ’95

  23. JID 202(5):667-674. One dose efficacy ~60+% Two dose efficacy~80% Fig.1 Seropositivity for IgG antibody to mumps virus, by birth cohort and the race/ethnicity/birthplace National Health and Nutrition Examination Survey, 1999–2004.

  24. Age MSDH Recommended Immunization Schedule for Persons Aged 7 thru 18 yrs 2010 Range of recommended ages Catch-up Vaccination Certain high-risk groups Tdap* Tdap* See footnote1 HPV (3 doses) HPV Series See footnote 2 MCV MCV MCV Influenza (Yearly) PPSV HepA Series HepB Series IPV Series MMR Series Varicella Series MSDH Clinics - Adolescent Tdap-BOOSTRIX (Adults [>19yrs] will receive Adacel) HPV-GARDASIL MCV-Menactra

  25. Estimated vaccination coverage adolescents, Aged, 13-17 years- NIS -Teen, 2009 RANK ≥2MMR 89.1% 93.1% 14 ≥ 3HepB 89.9% 78.6%48 ≥ 1Var 87.0% 47.2% 51 ≥ 2 Var 48.6% 12.2% 51 ≥ 1Td or Tdap 76.2% 29.1% 51 ≥ 1Tdap 55.6% 22.6% 51 ≥ 1MenACWY 53.6% 19.3% 51 ≥ 1HPV4 44.3% 22.9% 51

  26. US Population (Millions) WANING IMMUNITY Projected Pertussis Epidemiology in the United States Through the Year 2020 10 yrs?? Bass JW, Stephenson SR. Pediatr Infect Dis J. 1987;6:141-144.

  27. 2005 ~adolescents/adults, cough >2wks Post-tussive vomiting THINK PERTUSSIS! Tdap ‘05 25616 Pertussis-’10,>9,000

  28. Adol+young adults 40% 17% 28% • Outbreak of pertussis in Calif (primarily hispanic population)-over 2700 cases YTD • 7 ,all underage 3 mos • Nationally, yearly average 17

  29. FOOD FOR THOUGHT-Tdap/Flu Overcoming obstacles-Ob-Gyn; peds, NICU, IM, -cooperation Hosp Admin Legal Reimbursement

  30. Tdap • Routine 11- 18yrs • 5 yr interval between prior Td and Tdap • However if circumstances warrant Tdap, an interval as short as 2 yrs has been shown safe • Pregnancy-AAP recommends during pregnancy whereas ACIP recommends postpartum • Recent- 6/10 Bill Atkinson, CDC-if necessary interval between Td and Tdap-none-can give same day

  31. Clinically Significant N meningitidis Serogroups • A-Leading cause of epidemic meningitis, worldwide • Africa/ China; rare in Europe/Americas • B-Major cause epidemic disease, Americas/Europe • No US vaccine (Cuba/Australia??) • C-Major cause of endemic disease in Europe/NA • Outbreaks in schools/community • Y-Associated with pneumonia •  in US, all ages • W-135-small percent worldwide • Hajj pilgrims Each ~33% in adolescents

  32. 1000-3000 cases per year in the US1 More than 95% of cases are sporadic; fewer than5% are related to outbreaks1 Case fatality rate of 9%-12%1,2 Up to 40% for meningococcemia1,2 Significant sequelae in 11%-19% of survivors2 Amputation, hearing loss, neurologic or cognitive deficits Meningococcal Disease: Significant Morbidity and Mortality References: 1. CDC. Meningococcal disease. In: Epidemiology and Prevention of Vaccine-preventable Diseases. (The Pink Book). Atkinson W, Wolfe S, Hamborsky J, McIntyre L, eds. 11th edition. Washington DC: Public Health Foundation, 2009:177-188. 2. Rosenstein N, et al. N Engl J Med. 2001;344(18):1378-1388.

  33. Severity of Meningococcal Disease in Adolescents1 Adolescents 15 years of age or older are more likely than infants and children to have: Meningococcemia without meningitis (40% vs. 20%) Shock at presentation (69% vs. 27%) Fatal outcome (22.5% vs. 4.6%) ~2/3-3/4 of cases of meningococcal disease in adolescents 11-18 years of age are caused by serogroups A, C, Y, or W-135 and thus are potentially vaccine-preventable Reference: 1. American Academy of Pediatrics Committee on Infectious Diseases. Pediatrics. 2005;116(2):496-505.

  34. Annual Cases of Meningococcal Disease—United States, 1970-20081,2 All Ages MCV4 Impact ’08-’09 ‘05 MCV4 Number of cases (’09-~900) Adol’09- ~50+% vax Year References: 1. CDC. MMWR. 2007;56(53):1-94. (Published July 9, 2009 for 2007). 2.CDC. MMWR. 2009;58(31):856-869.

  35. Incidence Rates of Meningococcal Disease, By Age—United States, 1998-20071 Rate 1.4: 18-23 yrs 2.3: dorm residents 5.1: freshmen living dorms Reference: 1. Cohn AC, et al. Clin Infect Dis. 2010;50(2):184-191.

  36. Mortality by Age Group, Meningococcal Disease (All Serogroups) in the US United States, 1997-2006 21% of all Mening

  37. MCV4 • Adolescents ages 11 thru 18 yrs • Unvax college freshmen living in dorms • Age >2 yrs with anatomic or functional asplenia or terminal complement deficiencies • Microbiologists or routine exposure to mening • Travel to hyperendemic areas • Military recruits • Any other person wishing to decrease risk • Previously vax with MCV4 or MPSV4 at age ≥ 7 yrs and remain at hi risk should be revax after 5 yrs • Previously vax with MCV4 or MPSV4 at ages 2-6 yrs and remain at hi risk should be revax after 3 yrs • College students who received prior MPSV4 ≥ 5 YRS REVAX

  38. ACIP 6/10 Update • ACIP 6/10-Mening vaccines not an increased risk for GBS • ~ efficacy 75-85% • case control studies ongoing • Assumption conjugate vaccine would protect ≥ 10 yrs • Recent data suggest memory alone not sufficient to protect against mening • ~ 1/3 of 11-18 yrs have Mening C SBA≥4 at 3 yrs • Duration of Protection • Limited data do not suggest vaccinated 11-12 yr olds will maintain protective ab thru college • RETHINK MENING STRATEGY • Multiple options-cost, logistics, confusion MY OPINION-OFF LABEL, NOT LICENSED , NOT REC ACIP BOOSTER DOSE AT AGE FOR THOSE ENTERING COLLEGE (ALL ADOLESCENTS????)

  39. Estimated Annual Incidence of Select HPV-Related Disease in the United States 9,710 new cases of cervical cancer1 ~3-4x103 deaths/yr Virtually 100% of cases of cervical cancer come from CIN 2/3 & AIS 330,000 new cases of high-grade cervical dysplasia (CIN 2/3)2 1.4 million new cases of low-grade cervical dysplasia (CIN 1)2 Approximately1 million new cases of genital warts3 1. American Cancer Society. Cancer Facts & Figures 2005. Atlanta, Ga: ACS; 2005:1−60. 2. Schiffman M, Solomon D. Arch Pathol Lab Med. 2003;127:946–949. 3. Fleischer AB, Parrish CA, Glenn R, Feldman SR. Sex Transm Dis. 2001;28:643–647.

  40. GARDASIL Placebo GARDASIL: Efficacy Against HPV 16– or 18–Related CINa 2/3 or AISb Per-Protocol Efficacy Population Total 120 112 100 93 98% Efficacy (94, 100) 98% Efficacy (92, 100) 73% 20% 80 6% 60 Related Cases 1.2% 40 100% Efficacy (87, 100) 29 0.1% 20 2c 2c 0 0 HPV 16/18–Related HPV 16–Related HPV 18–Related n=8,493 n=8,464 n=7,402 n=7,205 n=7,382 n=7,316 Please refer to slide 7 for a brief overview of the clinical study design. aCIN = cervical intraepithelial neoplasia. bAIS = adenocarcinoma in situ. cOne case was a coinfection with HPV 52, the other was a coinfection with HPV 51 and 56.

  41. GARDASIL Placebo GARDASIL: Efficacy Against HPV 6/11/16/18–Related External Genital Lesions Per-Protocol Efficacy Population 99% Efficacy (96, 100) 250 200 193 100% Efficacy (56, 100) 100% Efficacy (50, 100) 150 Related Cases 100 50 10 9 0 2 0 0 HPV 6/11/16/18– Related Genital Warts VINa 2/3 VaINb 2/3 n=7,772 n=7,744 n=7,900 n=7,902 n=7,744 n=7,772 aVIN = vulvar intraepithelial neoplasia. bVaIN = vaginal intraepithelial neoplasia.

  42. Genital warts are estimated to be clinically apparent in ~1% of sexually active US adult population2

  43. -POPS VACCINE FOR TEENAGERS WHO RECEIVED ONLY ONE DOSE OF VARICELLA VACCINE but I did have my circ!! MARGARET!-I WILL NOT MARRY YOU UNTIL YOU GET YOUR GARDASIL SHOTS!!!!!!!!!!!. I DON’T WANT WARTS!!!!!!!!!! (Aussie study-incidence of warts in ♂♀ ↓in HPV study- 18th ISSTDR Congress)

More Related