Tetanus Diphtheria and Pertussis Vaccine Tdap for Adolescents

Tetanus, Diphtheria and Pertussis Vaccine (Tdap) for Adolescents and Adults Trudy V. Murphy, MD March 8, 2006 National Immunization Program Centers for Disease Control and Prevention

Tdap for Adolescents and Adults • Background rationale • Recommendations • Challenges 03 -08 -06

Reported Pertussis Cases U. S. , 1922 -2004 30, 000 300, 000 25, 000 > 18 yrs 20, 000 Number of cases 250, 000 15, 000 11 -18 yrs DTP 10, 000 200, 000 5, 000 < 11 yrs 0 1990 150, 000 1995 2000 100, 000 50, 000 0 1922 1930 03 -08 -06 1940 1950 1960 Year 1970 1980 1990 2000

Adolescent and Adult Pertussis Estimated Annual Number of Cases Age Population Incidence/100, 000 (years) (Millions)* 100 350 11 -18 ~30, 000 ~105, 000 cases 19 -64 ~170, 000 ~600, 000 cases *2000 census Incidence from MA, WI DOH: unpublished data, 03 -08 -06 Ward 2005, Strebel 2001, Nennig 1996

30 10000 20 DTP 10 5000 0 1980 1990 2000 03 -08 -06 Year 20 00 19 90 19 80 19 70 19 60 19 50 19 40 0 19 30 Number of Deaths Reported Pertussis Deaths U. S. , 1922— 2004

Relationship of Reported Source to 494* Infants <4 Months of Age with Pertussis, 1999 -2002 Relationship of source to infant Unknown Mother Father Grandparent Sibling Other Number %* 282 75 29 17 57% 15% 6% 3% 38 53 8% 11% Adapted from Bisgard K et al. Pediatr Infect Dis J 2004 24%

Health-Care Workers with Pertussis Adult-Care Settings Author (year) Location Boulay (2006) Ward, 2005 Zivna (2005)* Bagget (2005)* 03 -08 -06 Index Case 20 Cases Close Contacts Hem-Oncology Care HCW Unit 10 117 General Hospital (France) PACU* HCW 17 74 HCW 3 191 Obstetric Clinic HCW 7 737

Pertussis or “Whooping Cough” Adolescents and Adults • Paroxysmal cough 80% -100% – Lasting median 6 -9 weeks • • Post-tussive vomiting ~50% Whoop ~30% - 60% Disturbed sleep 3/4 Weight loss 1/3 ACIP June & October 2005 03 -08 -06

Morbidity from Pertussis Reported Cases among Adolescents and Adults • • • 03 -08 -06 Incontinence, 28% >18 years Rib fracture, 1%-4% Syncope 3%-6% Pneumonia 2%-5% Hospitalization 1% -3% Lee G. et al CID 2004; 39: 1572 ACIP June & October 2005

Impact of Pertussis among Adolescents and Adults • Medical costs • Missed school (mean 5. 5 days) or work (mean 10 days) • Public health and infection control responses: time, testing, treatment, prophylaxis 03 -08 -06 Lee G. et al CID 2004; 39: 1572 ACIP June & October 2005

Rationale for a Tdap Vaccination Program for Adolescents and Adults • To protect the Tdap recipient from pertussis • To decrease spread of B. pertussis to persons at risk of severe pertussis (e. g. , infants aged <12 months, adults with co-morbid conditions) • To reduce cost and disruption of pertussis in institutional settings • To reduce the reservoir B. pertussis 03 -08 -06

Tetanus Toxoid, Reduced Diphtheria Toxoid and Pertussis Antigens (Tdap) • BOOSTRIX® (GSK) May 3, 2005 – Licensed use: 10 -18 years of age • ADACEL™ (sanofi pasteur) June 10, 2005 – Licensed use: 11 -64 years of age • Single Dose 03 -08 -06

Tdap Background • Safe and immunogenic • Efficacy against pertussis ~85% – Inferred from non-inferiority with responses among infants protected after 3 -doses DTa. P • Protection 5 -10 years; boosters likely to maintain protection • Cost ~ $20 per dose more than Td 03 -08 -06

ACIP Recommends Tdap for Adolescents, June 2005 • http: //www. cdc. gov/mmwr/PDF/rr/rr 5 5 e 223. pdf • Routine: 11 -12 years of age instead of Td • Catch-up for pertussis protection 03 -08 -06 – 11 -18 years of age if >5 years since last Td, DTa. P (DTP, DT) – Interval shorter than 5 years can be used in settings with increased risk for pertussis or its complications

Safety of Short Interval Tdap after Td (or DTP/DTa. P) 3 Canadian Studies • Largest: province-wide, schoolbased, non-randomized, open label, >7000 students – Tdap ~ 2 years (18 -23 months) vs >10 years after last Td – No increase in adverse events 03 -08 -06 Halperin SA. Pediatr Infect Dis J 2006 (in press)

ACIP Recommends* Tdap for Adults October 2005 -February 2006 • Routine: Adults 19 -64 years of age to replace next dose of Td • Short interval since last Td – To protect infants (“Cocoon”) – To protect health-care workers 03 -08 -06 *Provisional until published by MMWR

ACIP Recommends* Tdap for Adults October 2005 • To protect infants (“Cocoon”) – Adults <65 years of age who have or who anticipate having contact with an infant <12 months of age – Women in the immediate postpartum period (if no previous Tdap) – An interval of 2 years or more since last Td is suggested 03 -08 -06 *Provisional until published by MMWR

ACIP Recommends* Tdap for Adults February 2006 • To protect health-care workers – Direct patient contact in hospitals and ambulatory care settings – Interval of 2 years or more since last Td is recommended – Priority Tdap for workers in contact with infants <12 months of age – Facilities should provide the Tdap and maximize uptake 03 -08 -06 *Provisional until published by MMWR

Tdap for Adolescents and Adults Challenges • Educate: physicians, public – Morbidity, mortality from pertussis – Improve coverage among adults • 19 - 64 years of age, Td 55%67% (NHIS 1999) • Laboratory diagnostics • Potential benefits of Tdap for pregnant women and their infant 03 -08 -06

Tdap for Adolescents and Adults Challenges • Post-exposure prophylaxis among exposed, vaccinated persons? • Effectiveness of Tdap strategies over time; monitor post-licensing safety • Burden of pertussis, and high risk groups among older adults 03 -08 -06

Reported Cases of Vaccine. Preventable Diseases, United States Disease Smallpox Diphtheria Pertussis Tetanus Polio (paralytic) Measles Mumps Rubella Congenital Rubella Hib (invasive <5 years) 03 -08 -06 Average Annual No. Cases Pre-vaccine 2004 29, 005 0 21, 053 0 192, 752 580 16, 316 4, 000 162, 344 47, 745 152 20, 000 25, 827 34 0 37 258 10 0 17

Acknowledgements ACIP Pertussis Working Group, John Moran, CDC/NIP/BVPD & the DTP-Hib Team • Katrina • Karen Broder Kretsinger • Kristin Brown • Christina Mijalski • Amanda Cohn • Manisha Patel • Margaret Cortese • Pam Srivastava • Kashif Iqbal • Barbara Slade • Patricia Joyce • Tej Tiwari 03 -08 -06

THANK YOU 03 -08 -06