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2012 Immunization Update

2012 Immunization Update

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2012 Immunization Update

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  1. 2012 Immunization Update Compiled by Richard K Zimmerman MD MPH University of Pittsburgh School of Medicine

  2. Influenza Antiviral 2012 • Oseltamivir (Tamiflu®) and zanamivir (Relenza®). • Shorten the duration of fever & symptoms by about 1 day • Reduce the risk of complications and shorten the duration of hospitalization. • Recommended as early as possible for confirmed or suspected influenza patient who • is hospitalized ; • has severe, complicated, or progressive illness; or • is at higher risk for influenza complications. • <48 hours of symptom onset. • Might still work for severe or progressive illness and in hospitalized patients after 48 hours. • Considered for healthy, symptomatic outpatient not at high risk with confirmed or suspected influenza if <48 hours of onset.

  3. 2012 Recommended Immunization Schedule for Children 7-18 Years, US

  4. Anal transformation zone similarity to cervical transformation zone • Morphologically analogous to cervical transformation zone • Susceptible to HPV

  5. Prevalence of anal HPV among MSM

  6. Estimated US HPV Burden of Cancers in Males

  7. Background on Clinical Trial of HPV4 (Gardasil) in Males: Protocol 20 • Randomized double-blind, placebo-controlled trial • Multiple continents/countries • Vaccine/placebo administered at Day 1, Months 2 and 6 • Subjects: • 3463 Heterosexual Men (HM) 16-23 years • 602 Men who have sex with men (MSM) 16-26 years • Exclusion criteria: history of genital warts, genital lesions possibly HPV related, >5 or <1 lifetime sexual partner • All men: Condyloma • MSM: Condyloma, AIN, AIN 2/3 • Per protocol analysis: Males who were naïve to the respective vaccine-type infection (by DNA and by serologic assessment)

  8. Benefits: HPV vaccine for males Intent to Treat Analysis Reference: Package insert, Table 16 for outcomes of Condyloma, AIN1/2/3, and AIN2/3

  9. Benefits: HPV vaccine for males per protocol Efficacy in All Males Reference: Package Insert, page 504 Table 12: Analysis of Efficacy of GARDASIL in the PPE Population of 16- through 26 year old Boys and Men for Vaccine.

  10. Benefits: HPV vaccine for males Per protocol EfficacyMen who have sex with men (MSM) Reference: Package Insert, page 504 Table 13: Analysis of Efficacy of GARDASIL for Anal Disease in the PPE Population of 16- through 26- year old boys and men in the MSM Sub-Study for Vaccine HPV types, *unpublished data from manufacturer

  11. Benefits: HPV vaccine General Population Males Estimates calculated using HPV model of a single birth cohort of males vaccinated at age 12 years, assuming 90% vaccine efficacy for prevention of condyloma and 75% for anal cancer. The number needed to vaccinate reflects the number of 12-year-old males needed to vaccinate to prevent a single case of the given outcome (genital warts, anal cancer) over the lifetime of the birth cohort of males. This application of the model does not include indirect effects (herd immunity). If including indirect effects, the number needed to vaccinate could be notably higher if female coverage is high. See Chesson et al (Vaccine 2011) for model details.

  12. Harm: Summary data RCTs Males

  13. Quadrivalent HPV vaccine for Males to Prevent infection/disease/cancer in Females • Lacking • Observational data available on vaccine for females to prevent disease in males (GW data from Australia) • Observational data available on vaccine to females to prevent infection in partners (McGill cohort) • No RCT/other direct data on vaccine efficacy

  14. Limitations in female HPV vaccine coverage • National female coverage for 1 HPV dose among 13-17 year olds is 44%

  15. Cost-effectiveness of male vaccinationby female vaccination coverage (30% vs 50%) Cost per QALY gained by vaccinating 12-year-old boys • Includes transmission effects to females • “Indicated” outcomes include cervical outcomes, vaginal, vulvar, anal cancers, and genital warts. All outcomes include indicated outcomes plus oropharyngeal cancer, penile cancer, and recurrent respiratory papillomatosis. Lower coverage scenario: 30% 3-dose coverage at age 12 and 50% 3-dose coverage by age 26. Higher coverage scenario: 50% 3-dose coverage at age 12 and 70% 3-dose coverage by age 26. • Chesson et al.

  16. 2012 Recommended Immunization Schedule for Adults, US

  17. 2012 Recommended Immunization Schedule for Adults based on Medical Indications, US

  18. New Table to US Adult Immunization Schedule - contraindication

  19. US Hospitalizations and Deaths as Percentage of Total Cases, 2001-2009: Implications for maternal vaccination

  20. Source of Pertussis Transmitted to Infants • Household members responsible for 75%–83%: • Parents and siblings were common sources Parents (55%) • Siblings (16%-20%) • Aunts/uncles (10%) • Friends/cousins/others (10%-24%) • Grandparents (6%) • Caretakers (2%) • WendelboeAM, et al. Transmission of Bordetellapertussis to Young Infants. PediatrInfectDisJ 2007;26: 293–299. • Bisgard KM, et al. Infant pertussis: who was the source? PediatrInfectDisJ 2004; 23(11):985-989.

  21. Effectiveness of post-partum Tdap & Cocooning in pertussis transmission • In CA, pertussis incidence in infants born at hospitals with a postpartum Tdap policy was lower compared to hospitals without a postpartum Tdappolicy, suggesting that vaccinating new mothers may reduce transmission. • Winter K, et al. Effectiveness of postpartum Tdap vaccination in California hospitals. CSTE, Portland Oregon. Presented June 2010. • Cocooning not working at national level • Very limited success of vaccinating fathers or other family members • Poor uptake of Tdap when made available at birthing hospitals • No demonstration of program sustainability or scale-up • ACIP Working Group Conclusion: Cocooning is an insufficient national strategy to prevent pertussis morbidity and mortality in newborn infants

  22. Tdap during pregnancy • Cord blood from newborn infants whose mothers received Tdap during pregnancy or before pregnancy had higher concentrations of pertussis antibodies when compared with cord blood from newborn infants of unvaccinated mothers (7,11). • Pediatr Infect Dis J 2011;30:608—10 • Am J ObstetGynecol 2011;204:334.e1--5. • Half-life of transferred maternal pertussis antibodies is about 6 weeks. • J Infect Dis 1990;161:487—92 • Therefore vaccinate later in pregnancy (e.g., 3rd trimester)

  23. Tdap Safety • VAERS does not show any signals of concern for mother or fetus • Review of manufacturer’s pregnancy registry did not reveal signals of concerns • Td and TT used extensively in pregnant women • Data and expert opinion support that Tdap is acceptably safe to both a pregnant woman and unborn fetus

  24. Limited concern about blunting of infant immune response to primary DTaPwhen maternal Tdap • Transplacental antibodies may interfere with infant’s active antibody production following primary DTaP • maternal pertussis antibodies can inhibit active pertussis-specific antibody production after administration of DTaPto infants • J Infect Dis 1990;161:487—92, Pediatrics 1995;96(3 Pt 2):580--4 • correlates of protection are not fully understood • Degree of interference to infant’s immune response not yet known but short lived because maternal antibodies decline rapidly • Might result in a decrease in infant cases early, due to maternal antibody, offset by in increase in cases later, due to blunted infant vaccine response • Clinical importance not clear • Given timing of disease burden, benefits of protection outweigh risk of less protection later in infancy due to smaller airway size

  25. Cost effectiveness of Tdap Cocooning

  26. Summary of Tdap in Pregnancy Policy Decisions • Postpartum vaccination is a suboptimal national strategy • Vaccinating pregnant women during the late 2nd or 3rd trimester is • acceptably safe for both mother and fetus • may prevent infant pertussis • Postpartum more cost-effective • Concerns about blunting of an infant’s immune response to primary DTaP series do not outweigh the benefits. • Policy: If a Td booster is indicated during pregnancy for a woman who has previously not received Tdap (i.e., >10 years since previous Td), then Tdap should be administered during pregnancy, preferably during the 3rd or late 2nd trimester (after 20 weeks).

  27. Tdap recommendations >65 years • ACIP recommends that adults >65 years who previously have not received Tdap should receive a single dose of Tdap to protect against pertussis and reduce the likelihood of transmission. • Tdap can be administered regardless of interval since the last tetanus- or diphtheria-toxoid containing vaccine.

  28. Tdap Brands • 2 Tdap vaccines are available in the United States: • Adacel (Sanofi Pasteur) is licensed for use in persons aged 11 through 64 years. • Boostrix (GlaxoSmithKline Biologicals) is licensed for use in persons aged ≥10 years

  29. Pneumococcal disease Osler (public domain) • > 25,000 U.S. deaths per year • ~ 500,000 severe pneumococcal disease cases per year • Invasive pneumococcal disease • Nonbacteremic pneumococcal pneumonia • Risk of illness and death increase with age • “Captain of the men of death” • “Old man’s friend”

  30. Nonbacteremic pneumococcal pneumonia 5-10% risk in the remaining lifetime of 50 year olds (300,000-400,000 cases/yr) Not clear if PPSV prevents this

  31. Efficacy against nonbacteremic pneumococcal pneumonia 1Moberley et al. Cochrane Database Syst Rev. 2008 2Huss et al. CMAJ. 2009 Cochrane review1: “The meta-analysis does not provide compelling evidence to support the routine use of [the current adult vaccine] to prevent all-cause pneumonia” Another meta-analysis2: “Pneumococcal vaccination does not appear to be effective in preventing pneumonia, even in populations for whom the vaccine is currently recommended.”

  32. So why use it? 1Maruyama et al. BMJ. 2010 • It does prevent invasive pneumococcal disease • At modest levels, may prevent nonbacteremic pneumonia • Various smaller studies in special populations, e.g. Japanese nursing home patients1 • However, magnitude of effect (if any) is unclear • It covers more pneumococcal serotypes (23 vs 13)

  33. Invasive pneumococcal disease rates PCV7 = 7-valent pneumococcal conjugate vaccine Pilishvili et al. JID 2010

  34. Serotypes causing invasive disease(age ≥ 65) – 19 A in PCV13 Pilishvili et al. JID 2010

  35. FDA approved for adults aged 50 and older, condition data on proof it prevents pneumonia Safety studies favorable Insurance coverage depends on whether the CDC recommends it http://www.businessweek.com/news/2011-12-30/pfizer-s-prevnar-13-shot-wins-u-s-approval-for-older-adults.html

  36. Methods – Cost Effectiveness PCV • Markov decision model • Cost effectiveness of PCV13 vs. PPSV23 (the current vaccine) in US 50-year-olds • Lifetime time horizon • Societal perspective, 2006 US$, 3% per year discount rate • JAMA 2012;307(8):804-812

  37. Strategies examined • No vaccination • Present recommendation • PPSV23 at age 65 • If a comorbidity exists, PPSV23 when diagnosed, then a 2nd at age 65 or five years after the 1st (whichever comes last) • Present recommendation, substituting PCV13 for PPSV23 • PCV13 at age 50, PPSV23 at age 65 • PCV13 at ages 50 and 65 • PCV13 at ages 50 and 65, PPSV23 at age 75

  38. Public health results* IPD = invasive pneumococcal disease NPP = nonbacteremic pneumococcal pneumonia HR = high risk (in current recommendation strategies) * In 50 year olds over their lifetimes

  39. Cost-effectiveness analysis results*

  40. Sensitivity analysis • If both PCV13 and PPSV23 effectiveness are set at low range estimates: • Current PPSV23 recommendations cost $60,200 per QALY gained • PCV13 substituted into current recommendations cost $93,000/QALY • If PCV13 vaccination costs > $237 (base case estimate = $128), PCV13 in current recommendations cost >$100,000/QALY • Not sensitive to individual variation of other parameters

  41. Next steps • What will the Advisory Committee on Immunization Practices (ACIP) do? • Pfizer is seeking a recommendation for use in adults aged 50 and older • PCV13 is covered by Medicare Part B • If the ACIP does not recommend PCV13 for adults, then many insurers will not cover it

  42. ACIP considerations • Dutch study of adult PCV13 against pneumonia will likely have results in 2013 • Ongoing monitoring of invasive pneumococcal disease cases via the CDC Active Bacterial Core Surveillance (ABCs) system • Case frequency • Serotype distribution

  43. 2012 Recommended Immunization Schedule for Adults based on Medical Indications, US

  44. Misuse of Diabetes Equipment: Recent Patient Notifications Recommendation for bloodborne pathogen testing to potentially exposed