The following recommendations for the use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) (ADACEL®) are intended for adults aged 19 to 64 years who have not already received a dose of Tdap. Tdap is licensed for a single use only; prelicensure studies on the safety or efficacy of subsequent doses were not conducted. After receipt of a single dose of Tdap, subsequent doses of tetanus and diphtheria toxoid-containing vaccines should follow guidance from previously published recommendations for the use of tetanus and diphtheria toxoids vaccine (Td) and tetanus toxoid vaccine (TT) ("Diphtheria, tetanus, and pertussis," 1991). Adults should receive a decennial booster with Td beginning 10 years after receipt of Tdap ("Diphtheria, tetanus, and pertussis," 1991). Recommendations for the use of Tdap (ADACEL® and BOOSTRIX®) among adolescents are described elsewhere (Broder et al., 2006). BOOSTRIX® is not licensed for use in adults.

1. Routine Tdap Vaccination

   1-A. Recommendations for Use

   1. Routine use: Adults aged 19 to 64 years should receive a single dose of Tdap to replace a single dose of tetanus and diphtheria toxoids vaccine (Td) for active booster vaccination against tetanus, diphtheria, and pertussis if they received their last dose of Td >10 years earlier. Replacing 1 dose of Td with Tdap will reduce the morbidity associated with pertussis in adults and might reduce the risk for transmitting pertussis to persons at increased risk for pertussis and its complications.
   2. Short interval between Td and Tdap: 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 (see "Safety Considerations for Adult Vaccination with Tdap" in the original guideline document). For adults who require tetanus toxoid-containing vaccine as part of wound management, a single dose of Tdap is preferred to Td if they have not previously received Tdap (see "Tetanus Prophylaxis in Wound Management" below).
   3. Prevention of pertussis among infants aged <12 months by vaccinating their adult contacts: Adults who have or who anticipate having close contact with an infant aged <12 months (e.g., parents, grandparents aged <65 years, child-care providers, and health-care personnel [HCP]) should receive a single dose of Tdap at intervals <10 years since the last Td to protect against pertussis if they have not previously received Tdap. Ideally, these adults should receive Tdap at least 2 weeks before beginning close contact with the infant. An interval as short as 2 years from the last dose of Td is suggested to reduce the risk for local and systemic reactions after vaccination; shorter intervals may be used.

      Infants aged <12 months are at highest risk for pertussis-related complications and hospitalizations compared with older age groups. Young infants have the highest risk for death. Vaccinating adult contacts might reduce the risk for transmitting pertussis to these infants (see "Infant Pertussis and Transmission to Infants" in the original guideline document). Infants should be vaccinated on-time with pediatric diphtheria and tetanus toxoids, acellular pertussis antigens (DTaP) ("Pertussis vaccination," 1997; CDC, "Recommended childhood and adolescent immunization schedule," 2006).

      When possible, women should receive Tdap before becoming pregnant. Approximately half of all pregnancies in the United States are unplanned (Henshaw, 1998). Any woman of childbearing age who might become pregnant is encouraged to receive a single dose of Tdap if she has not previously received Tdap (see "Vaccination During Pregnancy" below).

      Women, including those who are breastfeeding, should receive a dose of Tdap in the immediate postpartum period if they have not previously received Tdap. The postpartum Tdap should be administered before discharge from the hospital or birthing center. If Tdap cannot be administered before discharge, it should be administered as soon as feasible.

   4. Health-Care Personnel*: 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.

      * Recommendations for use of Tdap among HCP wee reviewed and are supported by the members of the Healthcare Infection Control Practices Advisory Committee (HICPAC).

      ** Hospitals, as defined by the Joint Commission on Accreditation of Healthcare Organizations, do not include long-term–care facilities such as nursing homes, skilled-nursing facilities, or rehabilitation and convalescent care facilities. Ambulatory-care settings include all outpatient and walk-in facilities.

      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.

      Vaccinating HCP with Tdap will protect them against pertussis and is expected to reduce transmission to patients, other HCP, household members, and persons in the community. Priority should be given to vaccination of HCP who have direct contact with infants aged <12 months (see "Prevention of pertussis among infants aged <12 months by vaccinating their adult contacts" above).

      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) (see Implementing a Hospital Tdap Program in the section of the guideline summary entitled "Description of the Implementation Strategy"). Tdap is not licensed for multiple administrations. After receipt of Tdap, HCP should receive Td or tetanus toxoid vaccine (TT) for booster immunization against tetanus and diphtheria according to previously published guidelines ("Diphtheria, tetanus, and pertussis," 1991).

   1-B. Dosage and Administration

   The dose of Tdap is 0.5 mL, administered intramuscularly (IM), preferably into the deltoid muscle.

   1-C. Simultaneous Vaccination with Tdap and Other Vaccines

   If two or more vaccines are indicated, they should be administered during the same visit (i.e., simultaneous vaccination). Each vaccine should be administered using a separate syringe at a different anatomic site. Certain experts recommend administering no more than two injections per muscle, separated by at least 1 inch. Administering all indicated vaccines during a single visit increases the likelihood that adults will receive recommended vaccinations (Kroger et al., 2006).

   1-D. Preventing Adverse Events

   The potential for administration errors involving tetanus toxoid-containing vaccines and other vaccines is well documented (Graham et al., 1981; Institute for Safe Medication Practices, 2003; CDC, 2004). Pediatric DTaP vaccine formulations should not be administered to adults. Attention to proper vaccination technique, including use of an appropriate needle length and standard routes of administration (i.e., IM for Tdap) might minimize the risk for adverse events (Kroger et al., 2006).

   1-E. Record Keeping

   Health-care providers who administer vaccines are required to keep permanent vaccination records of vaccines covered under the National Childhood Vaccine Injury Compensation Act; the Advisory Committee on Immunization Practices (ACIP) has recommended that this practice include all vaccines (Kroger et al., 2006). Encouraging adults to maintain a personal vaccination record is important to minimize administration of unnecessary vaccinations. Vaccine providers can record the type of the vaccine, manufacturer, anatomic site, route, and date of administration and name of the administering facility on the personal record.

2. Contraindications and Precautions for Use of Tdap

   2-A. Contraindications

   • Tdap is contraindicated for persons with a history of serious allergic reaction (i.e., anaphylaxis) to any component of the vaccine. Because of the importance of tetanus vaccination, persons with a history of anaphylaxis to components included in any Tdap or Td vaccines should be referred to an allergist to determine whether they have a specific allergy to tetanus toxoid and can safely receive TT vaccinations.
   • Tdap is contraindicated for adults with a history of encephalopathy (e.g., coma or prolonged seizures) not attributable to an identifiable cause within 7 days of administration of a vaccine with pertussis components. This contraindication is for the pertussis components, and these persons should receive Td instead of Tdap.

   2-B. Precautions and Reasons to Defer Tdap

   A precaution is a condition in a vaccine recipient that might increase the risk for a serious adverse reaction (Kroger et al., 2006). The following are precautions for Tdap administration. In these situations, vaccine providers should evaluate the risks for and benefits of administering Tdap.

   • Guillain-Barré syndrome <6 weeks after previous dose of a tetanus toxoid-containing vaccine. If a decision is made to continue vaccination with tetanus toxoid, Tdap is preferred to Td if otherwise indicated.

   Tdap vaccination should generally be deferred during the following situations:

   • Moderate or severe acute illness with or without fever. Defer Tdap vaccination until the acute illness resolves.
   • Unstable neurologic condition (e.g., cerebrovascular events and acute encephalopathic conditions) (see "Safety Considerations for Adult Vaccination with Tdap" in the original guideline document for a discussion of neurological conditions).*

     * For adolescents, any progressive neurologic disorder (including progressive encephalopathy) is considered a precaution for receipt of Tdap. For adults, progressive neurologic disorders are considered precautions only if the condition is unstable (Broder et al., 2006).

   • History of an Arthus reaction following a previous dose of a tetanus toxoid-containing and/or diphtheria toxoid-containing vaccine, including meningococcal conjugate vaccine (MCV4) (see "Safety Considerations for Adult Vaccination with Tdap" in the original guideline document for description of Arthus reaction). Vaccine providers should review the patient's medical history to verify the diagnosis of Arthus reaction and can consult with an allergist or immunologist. If an Arthus reaction was likely, vaccine providers should consider deferring Tdap vaccination until at least 10 years have elapsed since the last tetanus toxoid-containing and/or diphtheria toxoid-containing vaccine was received. If the Arthus reaction was associated with a vaccine that contained diphtheria toxoid without tetanus toxoid (e.g., MCV4), deferring Tdap or Td might leave the adult inadequately protected against tetanus. In this situation, if the last tetanus toxoid-containing vaccine was administered >10 years earlier, vaccine providers can obtain a serum tetanus antitoxin level to evaluate the need for tetanus vaccination (tetanus antitoxin levels >0.1 IU/ mL are considered protective) or administer TT.

   2-C. Not Contraindications or Precautions for Tdap

   The following conditions are not contraindications or precautions for Tdap, and adults with these conditions may receive a dose of Tdap if otherwise indicated. The conditions in italics are precautions for pediatric DTP/DTaP but are not contraindications or precautions for Tdap vaccination in adults ("Pertussis vaccination," 1997).

   • Temperature >105 degrees F (>40.5 degrees C) within 48 hours after pediatric DTP/DTaP not attributable to another cause
   • Collapse or shock-like state (hypotonic hyporesponsive episode) within 48 hours after pediatric DTP/DTaP
   • Persistent crying lasting >3 hours, occurring within 48 hours after pediatric DTP/DTaP
   • Convulsions with or without fever, occurring within 3 days after pediatric DTP/DTaP
   • Stable neurologic disorder, including well-controlled seizures, a history of seizure disorder that has resolved, and cerebral palsy (See section, "Safety Considerations for Adult Vaccination with Tdap" in the original guideline document)
   • Brachial neuritis
   • Immunosuppression, including persons with human immunodeficiency virus (HIV). The immunogenicity of Tdap in persons with immunosuppression has not been studied and could be suboptimal.
   • Breastfeeding
   • Intercurrent minor illness
   • Use of antimicrobials
   • History of an extensive limb swelling (ELS) reaction following pediatric DTP/DTaP or Td that was not an Arthus hypersensitivity reaction (see "Safety Considerations for Adult Vaccination with Td" section in the original guideline document for descriptions of ELS and Arthus reactions).

3. Special Situations for Tdap Use

   3-A. Pertussis Outbreaks and Other Settings with Increased Risk for Pertussis or its Complications

   During periods of increased community pertussis activity or during pertussis outbreaks, vaccine providers might consider administering Tdap to adults at an interval <10 years since the last Td or TT if Tdap was not previously received (see "Spacing and Sequencing of Vaccines Containing Tetanus Toxoid, Diphtheria Toxoid, and Pertussis Antigens" in the original guideline document). Postexposure chemoprophylaxis and other pertussis control guidelines, including guidelines for HCP, are described elsewhere (see "Management of Exposed Persons in Settings with Nosocomial Pertussis" in the original guideline document) (Schrag et al., 2003; "Immunization of health-care workers," 1997; American Academy of Pediatrics [AAP], 2006). The benefit of using a short interval also might be increased for adults with comorbid medical conditions (see "Clinical Features and Morbidity Among Adults with Pertussis" in the original guideline document).

   3-B. History of Pertussis

   Adults who have a history of pertussis generally should receive Tdap according to the routine recommendation. This practice is preferred because the duration of protection induced by pertussis is unknown (waning might begin as early as 7 years after infection [Wendelboe et al., 2005]) and because the diagnosis of pertussis can be difficult to confirm, particularly with tests other than culture for Bordetella pertussis. Administering pertussis vaccine to persons with a history of pertussis presents no theoretical safety concern.

   3-C. Tetanus Prophylaxis in Wound Management

   ACIP has recommended administering tetanus toxoid-containing vaccine and tetanus immune globulin (TIG) as part of standard wound management to prevent tetanus (see Table below) ("Diphtheria, tetanus, and pertussis," 1991). Tdap is preferred to Td for adults vaccinated >5 years earlier who require a tetanus toxoid-containing vaccine as part of wound management and who have not previously received Tdap. For adults previously vaccinated with Tdap, Td should be used if a tetanus toxoid-containing vaccine is indicated for wound care. Adults who have completed the 3-dose primary tetanus vaccination series and have received a tetanus toxoid-containing vaccine <5 years earlier are protected against tetanus and do not require a tetanus toxoid-containing vaccine as part of wound management.

   An attempt must be made to determine whether a patient has completed the 3-dose primary tetanus vaccination series. Persons with unknown or uncertain previous tetanus vaccination histories should be considered to have had no previous tetanus toxoid-containing vaccine. Persons who have not completed the primary series might require tetanus toxoid and passive vaccination with TIG at the time of wound management (see Table below). When both TIG and a tetanus toxoid-containing vaccine are indicated, each product should be administered using a separate syringe at different anatomic sites. Adults with a history of Arthus reaction following a previous dose of a tetanus toxoid-containing vaccine should not receive a tetanus toxoid-containing vaccine until >10 years after the most recent dose, even if they have a wound that is neither clean nor minor. If the Arthus reaction was associated with a vaccine that contained diphtheria toxoid without tetanus toxoid (e.g., MCV4), deferring Tdap or Td might leave the adult inadequately protected against tetanus, and TT should be administered (see precautions for management options above). In all circumstances, the decision to administer TIG is based on the primary vaccination history for tetanus (see Table below).

   Table. Guide to Tetanus Prophylaxis in Routine Wound Management Among Adults Aged 19 to 64 Years

   Characteristic	Clean, minor wound		All other wounds*
   History of adsorbed tetanus toxoid (doses)	Tdap or Td**	TIG	Tdap or Td**	TIG
   Unknown or <3	Yes	No	Yes	Yes
   >3	No***	No	No#	No
   * Such as, but not limited to, wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; avulsions; and wounds resulting from missiles, crushing, burns, and frostbite. ** Tdap is preferred to Td for adults who have never received Tdap. Td is preferred to TT for adults who received Tdap previously or when Tdap is not available. If TT and TIG are both used, Tetanus Toxoid Adsorbed rather than tetanus toxoid for booster use only (fluid vaccine) should be used. ***Yes, if >10 years since the last tetanus toxoid-containing vaccine dose. # Yes, if >5 years since the last tetanus toxoid-containing vaccine dose.

   3-D. Adults with History of Incomplete or Unknown Tetanus, Diphtheria, or Pertussis Vaccination

   Adults who have never been vaccinated against tetanus, diphtheria, or pertussis (no dose of pediatric DTP/DTaP/DT or Td) should receive a series of three vaccinations containing tetanus and diphtheria toxoids. The preferred schedule is a single dose of Tdap, followed by a dose of Td >4 weeks after Tdap and another dose of Td 6 to 12 months later (CDC, "Recommended adult immunization schedule," 2006). However, Tdap can substitute for any one of the doses of Td in the 3-dose primary series. Alternatively, in situations in which the adult probably received vaccination against tetanus and diphtheria but cannot produce a record, vaccine providers may consider serologic testing for antibodies to tetanus and diphtheria toxin to avoid unnecessary vaccination. If tetanus and diphtheria antitoxin levels are each >0.1 IU/mL, previous vaccination with tetanus and diphtheria toxoid vaccine is presumed, and a single dose of Tdap is indicated.

   Adults who received other incomplete vaccination series against tetanus and diphtheria should be vaccinated with Tdap and/or Td to complete a 3-dose primary series of tetanus and diphtheria toxoid-containing vaccines. A single dose of Tdap can be used in the series.

   3-E. Nonsimultaneous Vaccination with Tdap and Other Vaccines, Including MCV4

   Inactivated vaccines may be administered at any time before or after a different inactivated or live vaccine, unless a contraindication exists (Kroger et al., 2006). Simultaneous administration of Tdap (or Td) and MCV4 (which all contain diphtheria toxoid) during the same visit is preferred when both Tdap (or Td) and MCV4 vaccines are indicated (Broder et al., 2006). If simultaneous vaccination is not feasible (e.g., a vaccine is not available), MCV4 and Tdap (or Td) can be administered using any sequence. It is possible that persons who recently received one diphtheria toxoid-containing vaccine might have increased rates for adverse reactions after a subsequent diphtheria-containing vaccine when diphtheria toxoid antibody titers remain elevated from the previous vaccination (see "Safety Considerations for Adult Vaccination with Tdap" in the original guideline document).

   3-F. Inadvertent Administration of Tdap (BOOSTRIX®) or Pediatric DTaP

   Of two licensed Tdap products, only ADACEL® is licensed and recommended for use in adults. BOOSTRIX® is licensed for persons aged 10–18 years and should not be administered to persons aged >19 years. Pediatric DTaP is not indicated for persons aged >7 years. To help prevent inadvertent administration of BOOSTRIX® or pediatric DTaP when ADACEL® is indicated, vaccine providers should review product labels before administering these vaccines; the packaging might appear similar. If BOOSTRIX® or pediatric DTaP is administered to an adult aged >19 years, this dose should count as the Tdap dose and the patient should not receive an additional dose of Tdap (ADACEL®). The patient should be informed of any inadvertent vaccine administration.

   Both Tdap products are licensed for active booster immunization as a single dose; neither are licensed for multiple administrations. After receipt of Tdap, persons should receive Td for booster immunization against tetanus and diphtheria, according to previously published guidelines ("Diphtheria, tetanus, and pertussis," 1991). If a dose of Tdap is administered to a person who has previously received Tdap, this dose should count as the next dose of tetanus toxoid-containing vaccine.

   3-G. Vaccination during Pregnancy

   Recommendations for pregnant women will be published separately (CDC, "Prevention of tetanus," 2006). As with other inactivated vaccines and toxoids, pregnancy is not considered a contraindication for Tdap vaccination (Kroger et al., 2006). Pregnant women who received the last tetanus toxoid-containing vaccine during the preceding 10 years and who have not previously received Tdap generally should receive Tdap after delivery. In situations in which booster protection against tetanus and diphtheria is indicated in pregnant women, the ACIP generally recommends Td. Providers should refer to recommendations for pregnant women for further information (Kroger et al., 2006; CDC, "Prevention of tetanus," 2006).

   Because of lack of data on the use of Tdap in pregnant women, Sanofi Pasteur has established a pregnancy registry. Health-care providers are encouraged to report Tdap (ADACEL®) vaccination during pregnancy, regardless of trimester, to Sanofi Pasteur (telephone: 800-822-2463).

   3-H. 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 ("Diphtheria, tetanus, and pertussis," 1991).

   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.

Reporting of Adverse Events

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