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2011 NORTH CAROLINA IMMUNIZATION CONFERENCE “MAKING A BETTER TOMORROW” August 12, 2011 Greensboro, NC

2011 NORTH CAROLINA IMMUNIZATION CONFERENCE “MAKING A BETTER TOMORROW” August 12, 2011 Greensboro, NC. Cocooning Our Infants Enhancing Tdap and Flu Vaccinations Among Parents and Contacts of Newborns. COI - Disclaimers. Definition of Cocoon.

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2011 NORTH CAROLINA IMMUNIZATION CONFERENCE “MAKING A BETTER TOMORROW” August 12, 2011 Greensboro, NC

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  1. 2011 NORTH CAROLINA IMMUNIZATION CONFERENCE“MAKING A BETTER TOMORROW”August 12, 2011Greensboro, NC Cocooning Our Infants Enhancing Tdap and Flu Vaccinations Among Parents and Contacts of Newborns

  2. COI - Disclaimers

  3. Definition of Cocoon • 1 a: an envelope often largely of silk which an insect larva forms about itself and in which it passes the pupa stage • 1 b: any of various other protective coverings produced by animals • 2 a: something suggesting a cocoon especially in providing protection or in producing isolation http://www.merriam-webster.com/dictionary/cocoon. Accessed July 26, 2011

  4. Cocooning Immunization Strategy • Aims to protect newborn infants from becoming infected by vaccinating those in closest contact with them. Vaccination protects those who are immunized from getting infection and subsequently passing it on to the young infant • Household Contacts • Parents • Siblings • Grandparents • Child Care Contacts • Health Care Contacts

  5. Cocooning • Potential advantages • New mothers are easy to access • High motivation to protect newborns and infants • Less expensive than universal strategies • Targets high risk groups • Potential disadvantages • Difficulty accessing fathers and other close contacts • Diffusion of responsibility for vaccination • Tracking vaccination information

  6. Cocooning: Pertussis and Flu • Common Themes • Respiratory Pathogens • Readily Spread • Young Children Vulnerable to Infection • High Morbidity In Young Children • Universal Vaccination Strategy Not Fully Implemented

  7. Pertussis Disease Manifestations • Incubation period - 7-10 days (range 4 – 21 days) • Stages • Catarrhal: runny nose, sneezing, low-grade fever, mild cough (1-2 weeks) • Paroxysmal: severe spasms of cough, thick mucus, whoops, cyanosis, vomiting, exhaustion (1-6 weeks) • Convalescent: gradual recovery with less frequent & less severe coughing (weeks to months) Photograph courtesy of the WHO

  8. Cocooning Rationale: Pertussis • Recent increases in pertussis incidence • Infants have the highest ages-specific incidence, hospitalization rates, and mortality • Unvaccinated and under-vaccinated newborns and infants are most vulnerable • Most young children acquire infection from a parent or family member

  9. Reported pertussis-related deaths by age-groups, U.S., 1980-2009 http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-feb11/02-2-pertus-surveil.pdf. Accessed July 26, 2011 1. VitekCR et al. PediatrInfect DisJ 2003; 22(7):628-34. 2 National Notifiable Diseases Surveillance System, CDC, 2009 * One case unknown age

  10. Source of Infant Pertussis 1. Bisgard et al. Pediatr Infect Dis J. 2004;23:985-989; 2 Wendelboe et al. Pediatr Infect Dis J. 2007;26:293-299; 3. Kowalzik et al. Pediatr Infect Dis J. 2007;26:238-242 4. de Greff SC. Clinical Infectious Diseases 2010;50:1339-1345.

  11. Tdap Vaccines • Adacel (sanofipasteur) • Approved for persons 11-64 years of age • Boostrix (GlaxoSmithKline) • Approved for persons 10 years of age and older

  12. ACIP Tdap Recommendations • 2006 • Adolescents aged 11-18 years should receive a single dose of Tdap instead of Td • Adolescents 11-18 years who received Td, but not Tdap, are encouraged to receive a single dose of Tdap • Encouraged 5 year interval • Permissive of interval < 5 years • Adults aged 19-64 years should receive a single dose of Tdap to replace Td if they received their last dose of Td > 10 years earlier and have not previously received Tdap • Permissive of interval < 10 years MMWR 2006:55(No.RR0-3):1-34, MMWR 2006 55(No. RR-17): 1-44

  13. ACIP Tdap Cocooning Recommendations • 2006 • Adults who expect to have close contact with an infant aged <12 months (parents , grandparents<65 years, child-care providers, and health care personnel) should receive Tdap • Permissive of interval as short at 2 years from last Td; shorter intervals can be used • Women should receive Tdap before becoming pregnant • Women who have not previously received Tdap should receive a dose of Tdap in the immediate post-partum period , MMWR 2006 55(No. RR-17): 1-44

  14. ACIP Tdap Cocooning Recommendations • 2008 • Pregnant women not vaccinated previously with Tdap should be receive Tdap in the immediate postpartum period before discharge from hospital or birthing center • Permissive of interval as short as 2 years since most recent Td • If Tdap cannot be administered at or before discharge, the dose should be administered as soon as feasible thereafter. MMWR 2008:57(No.RR-4):1-51

  15. National Tdap Coverage http://www.cdc.gov/vaccines/stats-surv/nisteen/figures/09-maps/09-1-tdap.pdf Accessed on 7/28/2011

  16. National Tdap Coverage http://www.cdc.gov/vaccines/stats-surv/nhis/2009-nhis.htm#08. Accessed July 31, 2011

  17. TIP Study - Tdap Immunization for Parents • Specific Aims • Determine Tdap coverage rates among new mothers and fathers offered Tdap in pediatric clinic setting (TIP 1) • Determine Tdap coverage rates among new mothers offered Tdap in the postpartum setting (TIP 2) • Examine potential determinants of Tdap vaccination coverage and reasons for vaccine refusal • Primary Outcome – Tdap coverage Walter, CDC:3U01-IP000074-02S1

  18. TIP 1 - Methods • Pediatric providers/nurses introduced Tdap study to parents of 100 consecutive newborns • Location - DCPC Pickett Rd. Clinic • June 11, 2007 – Nov. 5, 2007 • Tdap provided free of charge • Study coordinator • Reviewed clinic schedules to determine potential study subjects • Reviewed Tdap indications and contraindications with potential subjects • Obtained written informed consent • Tdap • Survey about reasons for vaccine refusal • Reviewed medical records to obtain demographic information • Race, ethnicity, insurance status, number of siblings, mother’s age • Clinic nurse • Administered Tdap vaccine

  19. TIP 1 – Methods (Tdap Exclusions) • Prior receipt of Tdap • Receipt of Td in previous two years • History of a bleeding disorder • History of Guillain-Barré Syndrome • Ongoing neurologic disorder • Fever in the preceding 24 hours • Any of the following reactions to a diphtheria, tetanus, or pertussis containing vaccine: • A life threatening allergic reaction • Severe local limb pain or swelling following • A prolonged seizure or coma within 7 days

  20. TIP 1 – Results (Cocooning: Postnatal PeriodPediatric Office – Tdap Vaccine) Table 1: Tdap Exclusions and Tdap Coverage Among New Parents Walter EB et al. Acad Pediatr. 2009;9:344-347 .

  21. TIP 1 – Results: Tdap Coverage ifBoth Parents Eligible n =70

  22. TIP 1 Results: Factors Associated With Higher Tdap Coverage Rates • For vaccine eligible fathers • Tdap coverage was higher if father present at the first visit (61.0% vs. 4.2%) • Tdap coverage was higher if newborn was privately insured versus having Medicaid (52.9% vs. 7.1%)

  23. TIP 1- Results: Reasons for Tdap Refusal n=7 * Concern about Tdap while breast feeding

  24. TIP 2 - Methods • Study population: Mothers of newborns • Study location: Durham Regional Hospital, Durham, NC • Study dates: January – April 2009 • Intervention: Standing computerized order for staff nurses to offer and administer Tdap to new mothers • Study procedures: • Mother introduced to study coordinator by nurse • Written informed consent obtained • Brief interview conducted by study coordinator (demographic information and reasons for refusal of Tdap vaccination) • Verification of Tdap vaccination using computerized medication records and pharmacy charges

  25. TIP 2 - Results • 615 mothers (622 babies) • 140 (22.8%) received Tdap • 348 approached to interview • 200 (57%) interviewed • 200 mothers interviewed • 154 (77%) Tdap eligible • 90 (45%) offered Tdap • 69 (34%) eligible and offered Tdap • 52 (26%) received Tdap • 25 (12%) awareness of Tdap prior to delivery • 3 (2%) father received Tdap

  26. TIP 2 - Results

  27. TIP 2: Cocooning: Immediate Postpartum PeriodBirthing Hospital – Tdap Vaccine .

  28. TIP 2 - Results

  29. Hospital Based Cocooning Studies for Tdap

  30. Cocooning Effectiveness (Tdap) • Mixed results • One ecological study found no impact of only maternal postpartum Tdap on infant disease • In a California study, pertussis incidence in infants born at hospitals with a postpartum Tdap policy was lower compared to hospitals without a postpartum Tdap policy suggesting that vaccination new mothers may reduce transmission of pertussis from mothers to infants http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-jun11/05-5-pertuss-cocooning.pdf 1. CastagniniL, et al. Impact of maternal post-partum Tdap vaccination on pertussis illness in young infants. IDSA , Vancouver Canada. Presented on October 23, 2010 2. Winter K, et al. Effectiveness of postpartum Tdap vaccination in California hospitals. CSTE, Portland Oregon. Presented June 2010.

  31. Pertussis Outbreak – California 2010 • 9,120 cases in 2010 (23.3 cases/100,000) • Most cases since 1947 (9,394) • Highest incidence since 1958 (26.0/100,000) • 804 hospitalizations • 72% were less than 6 months of age • 76% of hospitalized infants with known race were Hispanic • 10 deaths • 9 were Hispanic infants • 9 were < 2 months of age and had not received any vaccine http://www.cdph.ca.gov/programs/immunize/Documents/PertussisReport2011-07-12.pdf, Accessed July 26, 2011

  32. ACIP - Expanded Tdap Recommendations • Can be administered regardless of interval since last tetanus- or diphtheria- toxoid containing vaccine • Adults age 65 years and Older • Particularly those with close contact to infant < 12 mo. • Children Aged 7 through 10 years • Those not fully vaccinated against pertussis • Those never vaccinated against tetanus, diphtheria, or pertussis or who have unknown vaccination status should receive a series of 3 vaccinations containing tetanus and diphtheria toxoids and the first of these should be Tdap MMWR / Jan 14, 2011 / Vol.60 / No.1 /p13-15

  33. 2011 ACIP Tdap Recommendations: Rationale • Suboptimal results have been obtained through providing Tdap postpartum • Tdap administered during pregnancy will provide protection to the mother and indirectly to the infant through transplacental passage of antibody • Pregnancy is not a contraindication for receiving Tdap • Any potential risks from receiving Tdap during pregnancy are likely to be small • Tdap during pregnancy would reduce infant cases (hospitalizations and deaths) making it more cost-effective • May interfere with infant’s immune response DTaP

  34. 2011 ACIP Tdap Recommendations • Women’s health care providers should implement a maternal Tdap vaccination program for women who have not previously received Tdap. Health care providers should administer Tdap preferably during the third or late second trimester (after 20 weeks gestation). Alternatively, administer Tdap immediately postpartum. • Adolescents and adults who have or anticipate having close contact with an infant aged less than 12 months (e.g., parents, siblings, grandparents, child-care providers and healthcare providers) should receive a single dose of Tdap to protect against pertussis if they have not previously received Tdap. Ideally, these adolescents and adults should receive Tdap at least 2 weeks before beginning close contact with the infant. http://www.cdc.gov/vaccines/recs/acip/downloads/mtg-slides-jun11/05-6-pertuss-tdap-vac.pdf

  35. Influenza: Clinical Manifestations • Abrupt onset of fever, chills or rigors, headache, malaise, diffuse myalgia, and a non-productive cough • Sore throat, nasal congestion, rhinitis, cough • Conjunctival injection, abdominal pain, nausea, and vomiting • May appear as URI or as febrile illness with few respiratory tract signs • Young infants – sepsis like picture, croup, bronchiolitis or pneumonia • Myositis – presents as calf tenderness and refusal to walk

  36. Cocooning Rationale: Influenza • Newborns and young children experience increased rates of hospitalizations and outpatient visits. • Influenza vaccine is not approved for children younger than 6 months of age • Methods for preventing infection in youngest children • Influenza vaccination of pregnant women • Vaccination of close contacts (cocooning) • Maternal immunization is effective at preventing infection in young children

  37. Influenza Hospitalizations http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/flu.pdf

  38. Influenza-Associated Deaths AmongChildren in the US (2003-2004) Bhat N. N Engl J Med 2005;353:2559-67.

  39. Poehling KA. N Engl J Med 2006;355:31-40

  40. Source of Influenza Infection • Children are vectors for spread of influenza in households and communities1 • Reduction in influenza related illness in households and communities after influenza immunization of children2-4 • Infection rates in young infants vary significantly by the number of older siblings in the family5 • Fox JR et al. Am J Epidemiol 1982;116:212-27 • 2-4. Hurwitz et al. JAMA 2000;284:1677-1682 ,Piedra et al. Vaccine 2005;23:1540-1548, • King et al. N Engl J Med 2006;355:2523-32. • 5. Glezen WP et al. Pediatr Infect Dis J. 1997;16:1065-8.

  41. Influenza immunization TIV Approved for people 6 months of age and older Clinical trials in children 2 mo. of age LAIV Approved for children 2 years of age and older Superior efficacy in children 6-59 mo. Potential for more frequent adverse events in children 6-23 mo. Medically significant wheezing within 42 days (5.9% vs. 3.8%) Hospitalization for any cause within 180 days (4.2% vs. 3.2%) Belshe RB.et al. N Engl J Med 2007;356:685-96.

  42. Englund J A. Vaccine 21 (2003): 3460-3464

  43. Influenza – Role of Maternal Antibody • Infants are protected from symptomatic influenza A infection by transplacentally- acquired antibody • Transplacentally acquired antibody may interfere with immune response of the infant to TIV Englund J A. Vaccine.2003; 21:3460-3464, Piedra PA. Vaccine .1993; 11: 718-724

  44. Added Benefits of Influenza Vaccine During Pregnancy

  45. Evolution of Influenza Vaccination Recommendations *Emphasis on children < 6 months of age

  46. Flu Vaccine Coverage in Pregnancy • Suboptimal rates of vaccine coverage during pregnancy http://www.cdc.gov/flu/professionals/acip/coveragelevels.htm Accessed July 31, 2011 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5947a1.htm. Accessed July 31, 2011

  47. Flu Vaccine Coverage in Health Care Workers • Suboptimal rates of vaccine coverage for HCW http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5912a1.htm. Accessed July 31 2011 http://www.cdc.gov/flu/professionals/acip/coveragelevels.htm Accessed July 31, 2011

  48. Piiitch Study - Prevention of Influenza in Infants by Immunization of Their Contacts in the Household • OBJECTIVE - To develop and assess a hospital-based program for administering influenza vaccine to newborn household contacts during the immediate postpartum period (October 2007 - February 2008) • Assess influenza vaccine coverage among household contacts of newborns delivered at a hospital with postpartum influenza immunization program • Simultaneously assess influenza vaccine coverage among household contacts of newborns delivered at a hospital without a postpartum influenza immunization program Walter, CDC:5U01IP00074-02 ClinicalTrials.gov:NCT00570037

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