Update on recent policy changes by ACIP recommendations on the use of Tdap for adolescents and adults in the United Stat

1. Update on recent policy changes by ACIP recommendations on the use of Tdap for adolescents and adults in the United States Jennifer L. Liang, DVM, MPVM National Center for Immunization and Respiratory Diseases Current Issues in Immunization NetConference April 21, 2011 

2. Objectives Present recent changes to ACIP Tdap recommendations Discuss rationale for changes to recommendations

4. Tdap coverage among adolescents 13-17 years, 2006-2009

5. Reasons for changes to 2005 Tdap recommendations New data on Tdap Facilitate the uptake of Tdap across age groups by removing identified barriers and programmatic challenges

6. TIMING OF TDAP FOLLOWING TD

7. 2005 ACIP recommendation for interval between Td and Tdap Adolescent An interval of at least 5 years between Td and Tdap is encouraged to reduce the risk for local and systemic reactions after Tdap vaccination. However, an interval less than 5 years between Td and Tdap can be used. Adult Intervals <10 years since the last Td may be used to protect against pertussis. Particularly in settings with increased risk for pertussis or its complications, the benefit of using a single dose of Tdap at an interval <10 years to protect against pertussis generally outweighs the risk for local and systemic reactions after vaccination. The safety of an interval as short as approximately 2 years between Td and Tdap is supported by a Canadian* study; shorter intervals may be used.

8. 2005 language creates barrier Survey of primary care physicians on use of Tdap in adolescents 48% - shortest acceptable interval before providing Tdap – 5 years 44% - would wait at least 2 years 27% of health care workers did not plan to receive Tdap because they had received Td within the last two years 74% Obstetricians/Gynecologists reported the major barrier postpartum and/or pregnant women vaccination was not knowing date of Td booster Most parents with infants in the NICU could not recall their last tetanus booster

9. Updated ACIP Recommendation Tdap should be administered regardless of interval since the last tetanus or diphtheria toxoid-containing vaccine While longer intervals between Td and Tdap vaccination could decrease the occurrence of local reactions, the benefits of protection against pertussis from shorter intervals outweigh the potential risk for adverse events.

10. ADULTS AGED 65 YEARS AND OLDER

11. Source of pertussis transmission 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%)

12. 2005 Tdap recommendations Adults aged =65 years Tdap is not licensed for use among adults aged >65 years. The safety and immunogenicity of Tdap among adults aged =65 years were not studied during U.S. pre-licensure trials. Adults aged =65 years should receive a dose of Td every 10 years for protection against tetanus and diphtheria and as indicated for wound management. Research on the immunogenicity and safety of Tdap among adults aged =65 years is needed. Recommendations for use of Tdap in adults aged =65 years will be updated as new data become available.

13. Updated ACIP recommendation Adults aged 65 years and older Those who have or anticipate having close contact with an infant aged less than 12 months should receive a single dose of Tdap. Other adults ages 65 years and older may be given a single dose of Tdap.

14. UNDERVACCINATED CHILDREN AGED 7 THROUGH 10 YEARS

15. Pertussis immunization in the U.S. Infants (1997) DTaP at 2, 4, 6 months Toddler (1992) DTaP at 15-18 months Pre-school (1992) DTaP at 4-6 years Adolescent/adult (2005) Single Tdap, preferred at 11-12 years

16. 2005 ACIP Tdap recommendation for children ages 7-10 years Incomplete Pediatric DTP/DTaP Vaccination History Neither Tdap vaccine is licensed for use in children aged <10 years. Children aged 7–10 years who never received a pediatric DTP/DTaP/DT dose or a Td dose generally should receive 3 doses of Td. When these children become adolescents (aged 11–18 years), they should receive Tdap according to the routine recommendations and interval guidance used for adolescents who completed the childhood DTP/DTaP series.

17. Updated ACIP recommendation: Under-vaccinated children ages 7 through10 years Those not fully vaccinated against pertussis* and for whom no contraindication to pertussis vaccine exists should receive a single dose of Tdap. Those never vaccinated against tetanus, diphtheria, or pertussis or who have unknown vaccination status should receive a series of three vaccinations containing tetanus and diphtheria toxoids. The first of these three doses should be Tdap.

18. VACCINATING HEALTH-CARE PERSONNEL

19. Pertussis in health-care personnel 12-14 million HCP in the United States Protecting HCP from acquiring and transmitting infectious diseases is a public health goal

20. 2005 ACIP language: HCP§§ HCP in hospitals or ambulatory care settings who have direct patient contact should receive a single dose of Tdap as soon as feasible if they have not previously received Tdap. Although Td booster doses are routinely recommended at an interval of 10 years, an interval as short as 2 years from the last dose of Td is recommended for the Tdap dose among these HCP. These HCP include but are not limited to physicians, other primary care providers, nurses, aides, respiratory therapists, radiology technicians, students (e.g., medical, nursing, and other), dentists, social workers, chaplains, volunteers, and dietary and clerical workers. Other HCP (i.e., not in hospitals or ambulatory care settings or without direct patient contact) should receive a single dose of Tdap to replace the next scheduled Td according to the routine recommendation at an interval no greater than 10 years since the last Td. They are encouraged to receive the Tdap dose at an interval as short as 2 years following the last Td.

21. HCP Tdap coverage rates Hospital-based coverage rates 60% all employees1 72% healthcare personnel2 15.9% among health-care personnel3

22. Approved ACIP language:Use of Tdap in HCP Health-care personnel (HCP), regardless of age, should receive a single dose of Tdap as soon as feasible if they have not previously received Tdap and regardless of the time since last Td dose. Tdap is not currently licensed for multiple administrations. After receipt of Tdap, HCP should receive routine booster immunization against tetanus and diphtheria according to previously published guidelines. Hospitals¶¶ and ambulatory-care facilities should provide Tdap for HCP and use approaches that maximize vaccination rates (e.g., education about the benefits of vaccination, convenient access, and the provision of Tdap at no charge).

23. HEALTH-CARE PERSONNEL & POST-EXPOSURE PROPHYLAXIS

24. Is PEP necessary?Vanderbilt pertussis exposure study Objective Is symptom monitoring without PEP following pertussis exposure non-inferior to antibiotic PEP among Tdap-vaccinated HCP? Results 116 exposures occurred among 94 different HCP Pertussis infection did not occur in 40/44 (90.9%) exposed persons without PEP 41/42 (97.6%) exposed persons with PEP Pre-defined non-inferiority criteria were not met ACIP interpretation There may be a benefit to PEP in vaccinated HCP Low risk of pertussis suggests both strategies acceptable

25. ACIP considerations for reducing risk of transmission of pertussis in healthcare facilities Sub-optimal Tdap coverage Adjunct to other pertussis prevention measures Droplet precautions Postexposure prophylaxis Cautious interpretation of data Language needs to allow flexibility in implementation

26. Approved ACIP language: Recommendation for PEP in HCP Health-care facilities should maximize efforts to prevent transmission of Bordetella pertussis. Respiratory precautions should be taken to prevent unprotected exposure to pertussis. Data on the need for postexposure antimicrobial prophylaxis in Tdap-vaccinated HCP are inconclusive. Some vaccinated HCP are still at risk for B. pertussis. Tdap may not preclude the need for postexposure antimicrobial prophylaxis. Postexposure antimicrobial prophylaxis is recommend for all HCP who have unprotected exposure to pertussis and are likely to expose a patient at risk for severe pertussis (e.g., hospitalized neonates and pregnant women). Other HCP should either receive postexposure antimicrobial prophylaxis or be monitored daily for 21 days after pertussis exposure and treated at the onset of signs and symptoms of pertussis.

27. Updated guidelines Published CDC. Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine from the Advisory Committee on Immunization Practices, 2010. MMWR 2011; 60:13-15. Provisional Recommendations for HCP on use of Tetanus Tdap and use of PEP http://www.cdc.gov/vaccines/recs/provisional/default.htm#acip

28. Future considerations for Tdap recommendations Pregnant women Cocooning strategies Revaccination with Tdap Tdap licensure for ages 65 years and older

29. Thank you For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA, 30333 Telephone, 1-800-CDC-INFO (232-4636)/TTY: 1888-232-6348 E-mail: cdcinfo@cdc.gov Web: www.cdc.gov The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.