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 03-08-06

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

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

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~30 ~30,000 cases ~105,000cases 19-64 ~170 ~170,000 ~600,000 *2000 census Incidence from MA, WI DOH: unpublished data, Ward 2005, Strebel 2001, Nennig 1996 03-08-06

Reported Pertussis Deaths 10 20 30 1980 1990 2000 5000 10000 1930 1940 1950 1960 1970 1980 1990 2000 Year Number of Deaths Reported DTP 03-08-06

Relationship of Reported Source to 494 Relationship of Reported Source to 494* Infants <4 Months of Age with Pertussis, 1999-2002 Relationship of source to infant Number %* Unknown 282 57% Mother 75 15% Father 29 6% Grandparent 17 3% Sibling 38 8% Other 53 11% 24% Adapted from Bisgard K et al. Pediatr Infect Dis J 2004 03-08-06

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

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 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 03-08-06

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 Lee G. et al CID 2004;39:1572 ACIP June & October 2005 03-08-06

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

ADACEL™ (sanofi pasteur) June 10, 2005 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

Efficacy against pertussis ~85% Tdap Background Safe and immunogenic Efficacy against pertussis ~85% Inferred from non-inferiority with responses among infants protected after 3-doses DTaP 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/rr55e223.pdf Routine: 11-12 years of age instead of Td Catch-up for pertussis protection 11-18 years of age if >5 years since last Td, DTaP (DTP, DT) Interval shorter than 5 years can be used in settings with increased risk for pertussis or its complications 03-08-06

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

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 *Provisional until published by MMWR 03-08-06

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 post-partum period (if no previous Tdap) An interval of 2 years or more since last Td is suggested *Provisional until published by MMWR 03-08-06

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

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

THANK YOU 03-08-06