Diphtheria, Tetanus, and Pertussis Vaccines
Number: 0653
Table Of Contents
PolicyApplicable CPT / HCPCS / ICD-10 Codes
Background
References
Policy
Scope of Policy
This Clinical Policy Bulletin addresses diphtheria, tetanus, and pertussis vaccines.
-
Medical Necessity
-
Aetna considers U.S. Food and Drug Administration (FDA)-approved tetanus toxoid-containing immunization (e.g., DTaP [diphtheria, tetanus, acellular pertussis], Tdap (tetanus, diphtheria, acellular pertussis), or Td (tetanus, diphtheria) medically necessary as a preventative service according to the recommendations of the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) for the following indications:
- DTaP vaccination (e.g., Daptacel or Infanrix) for infants and children younger than 7 years old (administered as a 5-dose series);
- Tdap vaccination for:
- Persons 7 years of age or older who are not fully immunized against pertussis, tetanus, or diphtheria as part of a catch-up vaccination series according to CDC recommendations. Catch-up vaccination may include up to 3 doses of tetanus- and diphtheria-containing vaccine, with at least 1 dose administered as Tdap;
- Persons 11 to 18 years of age as a single dose, preferably at 11 through 12 years of age;
- Persons 19 years of age or older as a single dose regardless of the interval since their last tetanus or diphtheria toxoid–containing vaccine and have never received Tdap;
- Pregnant women during every pregnancy (preferably during the early part of the third trimester) irrespective of their history of receiving the vaccine, or in women immediately postpartum if not administered during pregnancy;
- Booster dose:
- Td or Tdap every 10 years for adults following completion of the primary vaccination series; or
- Td or Tdap for tetanus prophylaxis in wound management when at least 5 years have elapsed since the previous receipt of any tetanus toxoid-containing vaccine (Note: If an individual has active tetanus infection, a tetanus toxoid-containing vaccine may be administered in conjunction with other medically necessary therapies; however, it is not used to treat or cure the infection.).
- An FDA-approved combination vaccine may be used as an alternative to the standalone vaccine when administered according to FDA labeling and CDC/ACIP recommendations, including:
- Pediarix (DTaP-HepB-IPV) as part of the primary immunization series in infants and children;
- Pentacel (DTaP-IPV/Hib) as part of the primary immunization series in infants and children;
- Vaxelis (DTaP-IPV-Hib-HepB) as part of the primary immunization series in infants and children;
- Kinrix (DTaP-IPV) as the fifth dose in the DTaP series in children 4 through 6 years of age;
- Quadracel (DTaP-IPV) as the fifth dose in the DTaP series in children 4 through 6 years of age.
- Acceptable vaccine alternatives include:
- Boostrix (Tdap) or Adacel (Tdap) when Tdap vaccination is indicated;
- Tenivac (Td), a preservative-tree vaccine, as an acceptable alternative Td vaccine product when Td vaccination is indicated.
-
Background
Diphtheria, tetanus, and pertussis are serious vaccine-preventable diseases caused by bacterial pathogens and their associated toxins. Diphtheria is an acute respiratory illness caused by Corynebacterium diphtheriae that can result in airway obstruction, myocarditis, neuropathy, and death. Tetanus is caused by the neurotoxin produced by Clostridium tetani and is characterized by painful muscle rigidity and spasms that can be life-threatening. Pertussis, also known as whooping cough, is a highly contagious respiratory infection caused by Bordetella pertussis and is associated with significant morbidity, particularly in infants and young children.
The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) recommends routine vaccination against diphtheria, tetanus, and pertussis throughout the lifespan using diphtheria, tetanus, and acellular pertussis (DTaP) vaccines for children younger than 7 years of age and tetanus, diphtheria, and acellular pertussis (Tdap) or tetanus and diphtheria (Td) vaccines for older children, adolescents, and adults. Routine immunization, catch-up vaccination, vaccination during each pregnancy, and periodic booster doses are recommended to maintain protection against these potentially severe infections. In addition, combination vaccines are available that provide protection against diphtheria, tetanus, and pertussis while also immunizing against other vaccine-preventable diseases, including hepatitis B, poliomyelitis, and Haemophilus influenzae type b infection. These combination products may reduce the number of injections required and simplify adherence to recommended immunization schedules while providing protection equivalent to the individual vaccine components. Note that the abbreviations used to denote diphtheria, tetanus and pertussis include upper-case letters which means the vaccine has full-strength doses of that part of the vaccine. The lower-case "d" and "p" in Td and Tdap means these vaccines use smaller (reduced) doses of diphtheria and pertussis. The "a" in DTaP and Tdap stands for "acellular," meaning that the pertussis component contains only parts of the bacteria instead of the whole bacteria (CDC, 2020a).
DTP was a vaccine that consisted of diphtheria, tetanus, and whole-cell pertussis (whooping cough). DTP was replaced with acellular pertussis toxin (DTaP) (CDC, 2020a). Fewer side effects have been reported with the DTaP vaccines than with DTP; thus, DTaP vaccines are recommended by ACIP.
The routine diphtheria, tetanus, and pertussis vaccination schedule for children aged less than 7 years comprises five doses of vaccine containing diphtheria, tetanus, and pertussis antigens. Three (primary) doses should be administered during the first year of life, generally at ages 2, 4, and 6 months. To maintain adequate immunity during preschool years, U.S. Advisory Committee on Immunization Practices (ACIP) recommends the fourth (first booster) dose for children aged 15 to 18 months. ACIP recommends the fifth (second booster) dose for children aged 4-6 years to confer continued protection against disease during the early years of schooling.
In 2019, ACIP concluded that in light of the higher cost of Tdap relative to Td and uncertainty about the impact that receipt of multiple Tdap doses would have on pertussis control and transmission, there was insufficient evidence to preferentially recommend that Tdap replace Td. However, given the reassuring safety profile and evidence of widespread use of Tdap in place of Td, to allow providers more flexibility, either Tdap or Td was recommended for use in situations when previously only Td was recommended. For 2020, ACIP recommends that either Td or Tdap be used for the decennial Td booster, tetanus prophylaxis for wound management, and for additional required doses in the catch-up immunization schedule if a person has received at least 1 Tdap dose (Havers et al., 2020).
If persons aged 7-18 years have never been vaccinated against pertussis, tetanus, or diphtheria, these persons should receive a series of three tetanus and diphtheria toxoid-containing vaccines, which includes at least 1 Tdap dose. The preferred schedule is 1 dose of Tdap, followed by 1 dose of either Td or Tdap ≥4 weeks afterward, and 1 dose of either Td or Tdap 6 - 12 months later. Persons aged 7-18 years who are not fully immunized against tetanus and diphtheria should receive 1 dose of Tdap, preferably as the first dose in the catch-up series; if additional tetanus toxoid-containing doses are required, either Td or Tdap may be used. The vaccination series does not need to be restarted for those with incomplete DTaP history, regardless of the time that has elapsed between doses (Havers et al., 2020).
For persons aged 7 to 9 years who receive a dose of Tdap as part of the catch-up series, an adolescent Tdap dose should be administered at age 11 to 12 years. If a Tdap dose is administered at age ≥10 years, the Tdap dose may count as the adolescent Tdap dose (Havers et al., 2020).
If persons aged ≥19 years have never been vaccinated against pertussis, tetanus, or diphtheria, these persons should receive a series of three tetanus and diphtheria toxoid-containing vaccines, which includes at least 1 Tdap dose. The preferred schedule is 1 dose of Tdap, followed by 1 dose of either Td or Tdap at least 4 weeks afterward, and 1 dose of either Td or Tdap 6 - 12 months later. Persons aged ≥19 years who are not fully immunized against tetanus and diphtheria should receive 1 dose of Tdap, preferably as the first dose in the catch-up series; if additional tetanus toxoid–containing doses are required, either Td or Tdap may be used (Havers et al., 2020).
In January, 2020 ACIP published general recommendations which include the following (Havers et al., 2020):
- Persons aged 11 to 18 years should receive a single dose of Tdap, preferably at a preventive care visit at age 11 to 12 years. To ensure continued protection against tetanus and diphtheria, 1 booster dose of either Td or Tdap should be administered every 10 years throughout life.
- Persons aged ≥19 years, regardless of the interval since their last tetanus or diphtheria toxoid-containing vaccine, who have never received a dose of Tdap should receive 1 dose of Tdap. To ensure continued protection against tetanus and diphtheria, booster doses of either Td or Tdap should be administered every 10 years throughout life.
- For pregnant women, no change was made to the recommendations for routine Tdap immunization during pregnancy. Pregnant women should receive 1 dose of Tdap during each pregnancy, irrespective of their history of receiving the vaccine. Tdap should be administered at 27 to 36 weeks’ gestation, preferably during the earlier part of this period, although it may be administered at any time during pregnancy.
A tetanus toxoid-containing vaccine is indicated for wound management when greater than 5 years have passed since the last tetanus toxoid-containing vaccine dose. If a tetanus toxoid-containing vaccine is indicated for persons aged greater than or equal to 11 years, Tdap is preferred for persons who have not previously received Tdap or whose Tdap history is unknown. If a tetanus toxoid-containing vaccine is indicated for a pregnant woman, Tdap should be used. For nonpregnant persons with documentation of previous Tdap vaccination, either Td or Tdap may be used if a tetanus toxoid-containing vaccine is indicated (Havers et al., 2020).
Wound management for tetanus prevention includes assessing the type of wound and provide appropriate wound care, evaluate immunization status, and assess the need for administering human tetanus immune globulin (TIG) for prophylaxis. TIG provides temporary immunity by directly providing antitoxin. TIG can help remove unbound tetanus toxin but cannot neutralize toxin that is already bound to nerve endings. Persons who have contaminated and dirty wounds and are either unvaccinated or have not received a primary series of tetanus toxoid-containing vaccines should receive TIG for prophylaxis. The dose of TIG for prophylaxis is 250 IU administered intramuscularly. Persons with HIV infection or severe immunodeficiency who have contaminated wounds (including minor wounds) should also receive TIG, regardless of their history of tetanus immunizations (CDC, 2020b; Liang, 2018).
U.S. Food and Drug Administration (FDA)-approved diphtheria, tetanus, and pertussis vaccines include:
- Routine DTaP vaccines (children younger than 7 years of age) -
- Daptacel (Sanofi Pasteur)
- Infanrix (GlaxoSmithKline)
- Combination DTaP-containing vaccines -
- Pediarix (DTaP-HepB-IPV) (GlaxoSmithKline)
- Pentacel (DTaP-IPV/Hib) (Sanofi Pasteur)
- Vaxelis (DTaP-IPV-Hib-HepB) (MCM Vaccine Company LLC; marketed by Sanofi Pasteur and Merck)
- Kinrix (DTaP-IPV) (GlaxoSmithKline)
- Quadracel (DTaP-IPV) (Sanofi Pasteur)
- Tdap vaccines (adolescents, adults, and pregnancy) -
- Adacel (Sanofi Pasteur)
- Boostrix (GlaxoSmithKline)
- Td vaccines (booster and wound management when indicated) -
- Tenivac (Sanofi Pasteur).
FDA-approved diphtheria, tetanus, and pertussis vaccines, including DTaP, Tdap, Td, and combination vaccine products, are generally contraindicated in individuals with a history of severe allergic reaction (e.g., anaphylaxis) to a previous dose of a diphtheria-, tetanus-, or pertussis-containing vaccine or any vaccine component. Important precautions include encephalopathy occurring within 7 days of receipt of a prior pertussis-containing vaccine, progressive or unstable neurologic disorders, a history of Guillain-Barré syndrome following a tetanus toxoid-containing vaccine, and certain severe reactions following prior pertussis-containing vaccines, such as high fever, hypotonic-hyporesponsive episodes, persistent inconsolable crying, or seizures. The most frequently reported adverse reactions include injection-site pain, redness, or swelling, as well as fever, irritability, headache, fatigue, malaise, and gastrointestinal symptoms. Serious adverse reactions are uncommon but may include severe allergic reactions and neurologic events. Product-specific warnings, precautions, contraindications, and adverse reactions are described in the individual prescribing information.
Safety and Effectiveness of Acellular Pertussis Vaccination During Pregnancy
Vygen-Bonnet and colleagues (2020) noted that infants less than 3 months of age are at the highest risk for developing severe complications after pertussis. The majority of pregnant women have low concentrations of pertussis-specific antibodies, and therefore, newborns are insufficiently protected by maternally transferred antibodies. Acellular pertussis vaccination during pregnancy was recently implemented in various countries. These researchers examined the evidence for the safety and effectiveness of pertussis vaccination during pregnancy. They searched Medline, Embase, and ClinicalTrials.gov from January 1, 2010, to January 10, 2019. The investigators assessed the risk of bias (ROB) using the Cochrane ROB tool and ROBINS-I, and they evaluated the quality of evidence using the GRADE approach. They identified 1,273 articles and included 22 studies (14 for safety; 8 for effectiveness), comprising 1.4 million pregnant women in safety studies and 855,546 mother-infant pairs in effectiveness studies. No significant differences between vaccinated and unvaccinated women and their infants were observed for safety outcomes, with the exception of fever and chorioamnionitis. Compared to no vaccination, three studies showed a significantly increased relative risk (RR) for the presence of the ICD-9 code for chorioamnionitis in electronic patient data after pertussis vaccination. However, no study reported an increased risk for clinical sequelae of chorioamnionitis after vaccination during pregnancy, such as preterm birth or neonatal intensive care unit (ICU) admission. Vaccine effectiveness against pertussis in infants of immunized mothers ranged from 69% to 91% for pertussis prevention, from 91% to 94% for prevention of hospitalization, and was 95% for prevention of death due to pertussis. The risk of bias was serious to critical for safety outcomes and moderate to serious for effectiveness outcomes. GRADE evidence quality was moderate to very low, depending on the outcome. The authors concluded that although an increased risk for a diagnosis of fever and chorioamnionitis was detected in pregnant women after pertussis vaccination, there was no association with a higher frequency of clinically relevant sequelae. Vaccine effectiveness for the prevention of infant pertussis, hospitalization, and death was high. These investigators stated that pertussis vaccination during pregnancy had an overall positive benefit-risk ratio. In view of the overall quality of available evidence, ongoing surveillance of chorioamnionitis and its potential sequelae is recommended when pertussis vaccination in pregnancy is implemented.
Nasser and associates (2020) stated that pregnant travelers and their offspring are vulnerable to severe outcomes following a wide range of infections. Vaccine-preventable diseases can have a particularly severe course in pregnant women, but little is known about the safety of travel vaccines in this population. These researchers performed a systematic review of all published literature concerning the safety of vaccines frequently given to travelers, such as yellow fever, MMR (mumps, measles, and rubella), influenza, Tdap (tetanus, diphtheria, and pertussis), meningococcus, hepatitis A and B, rabies, polio, typhoid fever, tick-borne encephalitis, and Japanese encephalitis vaccines. They included case series studies, cohort studies, and randomized controlled trials (RCTs). For the meta-analysis, these investigators included only RCTs that compared the administration of a vaccine to placebo or to no vaccine. Outcome measures included severe systemic adverse events (AEs), maternal outcomes related to the course of pregnancy, neonatal outcomes, and local AEs. They calculated the RR and its 95% confidence interval (CI) as the summary measure. The safety of the influenza vaccine was supported by high-quality evidence. For the Tdap vaccine, no evidence of any harm was found in the meta-analysis of RCTs. A slight increase in the chorioamnionitis rate was reported in 3 out of 12 observational studies. However, this small possible risk was far outweighed by a much larger benefit in terms of infant morbidity and mortality.
Intra-Nasal Live Attenuated Pertussis Vaccine
Keech et al. (2023) noted that Bordetella pertussis epidemics persist as transmission remains unabated despite high acellular pertussis vaccination rates. BPZE1, a live attenuated intra-nasal pertussis vaccine, was designed to prevent B pertussis infection and disease. In a double-blind, multi-center phase-IIb clinical trial, these researchers examined the immunogenicity and safety of BPZE1 compared with Tdap. This trial was carried out at 3 research centers in the U.S.; healthy adults aged 18 to 50 years were randomly assigned (2:2:1:1) via a permuted block randomization schedule to receive BPZE1 vaccination followed by BPZE1 attenuated challenge, BPZE1 vaccination followed by placebo challenge, Tdap followed by BPZE1 attenuated challenge, or Tdap followed by placebo challenge. On day 1, lyophilized BPZE1 was reconstituted with sterile water and given intra-nasally (0.4 ml delivered to each nostril), whereas Tdap was given intra-muscularly. To maintain masking, subjects in the BPZE1 groups received an intra-muscular saline injection, and those in the Tdap groups received intra-nasal lyophilized placebo buffer. The attenuated challenge took place on day 85. The primary immunogenicity endpoint was the proportion of subjects achieving nasal secretory IgA sero-conversion against at least 1 B pertussis antigen on day 29 or day 113. Reactogenicity was assessed up to 7 days after vaccination and challenge, and AEs were recorded for 28 days after vaccination and challenge. Serious AEs were monitored throughout the study. Between June 17 and October 3, 2019, a total of 458 subjects were screened and 280 were randomly assigned to the main cohort: 92 to the BPZE1-BPZE1 group, 92 to the BPZE1-placebo group, 46 to the Tdap-BPZE1 group, and 50 to the Tdap-placebo group. Sero-conversion of at least 1 B pertussis-specific nasal secretory IgA was recorded in 79 (94% [95% CI: 87% to 98%]) of 84 subjects in the BPZE1-BPZE1 group, 89 (95% [88% to 98%]) of 94 in the BPZE1-placebo group, 38 (90% [77% to 97%]) of 42 in the Tdap-BPZE1 group, and 42 (93% [82% to 99%]) of 45 in the Tdap-placebo group. BPZE1 induced broad and consistent B pertussis-specific mucosal secretory IgA responses, whereas Tdap did not induce consistent mucosal secretory IgA responses. Both vaccines were well-tolerated, with mild reactogenicity and no serious AEs related to study vaccination. The authors concluded that BPZE1 induced nasal mucosal immunity and produced functional serum responses. These researchers stated that BPZE1 has the potential to avert B pertussis infections, which ultimately could result in reduced transmission and diminished epidemic cycles. Moreover, these investigators stated that these findings should be confirmed in large phase-III clinical trials.
DTaP-IPV and DTaP Vaccination Among Adult Allogeneic Hematopoietic Stem Cell Transplant Recipients
Kobayashi et al. (2025) state that hematopoietic stem cell transplantation (HSCT) can potentially cure hematological malignancies; however, post-transplant patients have a high risk of infection owing to their immunocompromised status. Vaccination against pathogens, such as diphtheria, tetanus, pertussis, and polio, is essential post-transplantation; however, neither the long-term effectiveness of vaccines nor the optimal vaccination schedule has been fully established. In a prospective, observational study, these researchers examined the short- and long-term immunogenicity of 3 doses of the diphtheria, tetanus, acellular pertussis, and inactivated poliovirus (DTaP-IPV) vaccines, or DTaP vaccines in 29 adult allogeneic HSCT (allo-HSCT) recipients, with antibody levels measured at baseline, 1 to 3 months post-vaccination, and 1-year after vaccine completion. At baseline, a substantial portion of patients lacked protective antibody levels for the targeted pathogens. However, within 1 to 3 months post-vaccination, sero-positivity rates significantly increased, reaching 78% to 100% for diphtheria, tetanus, pertussis, and poliovirus. Despite this, antibody levels significantly declined 1-year post-vaccination, especially for pertussis, with only 58% to 65% of patients maintaining protective levels. In contrast, 85% to 96% of patients retained protective levels for diphtheria, tetanus, and poliovirus, although antibody values also decreased. Compared to human leukocyte antigen (HLA)-mismatched cases, HLA-matched cases showed significantly higher antibody levels for diphtheria, pertussis, and poliovirus types 1 and 3. The authors concluded that the findings of this study showed the short-term effectiveness of DTaP-IPV and DTaP vaccines in adult allo-HSCT patients; but emphasized the challenge of maintaining long-term immunity. These investigators stated that given the difficulties in sustaining long-term vaccine effectiveness in allo-HSCT recipients, especially in HLA-mismatched cases, re-evaluating the current vaccination schedule may be necessary to maintain protection.
References
The above policy is based on the following references:
- America Academy of Pediatrics Committee on Infectious Diseases. Prevention of pertussis among adolescents: Recommendations for use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine. Pediatrics. 2006;117(3):965-978.
- American Academy of Pediatrics (AAP). Red Book Online Special Alert. Recommended changes for Tdap vaccine use. Elk Grove Village, IL: AAP; January 11, 2011.
- American College of Obstetricians and Gynecologists (ACOG). 2026 maternal immunization schedule [website]. 2026. Available at: https://www.acog.org/clinical-information/maternal-immunization-schedule. Accessed July 6, 2026.
- American College of Obstetricians and Gynecologists (ACOG). ACOG committee opinion No. 718: Update on Immunization and Pregnancy: Tetanus, Diphtheria, and Pertussis Vaccination. Obstet Gynecol. 2017;130(3):e153-e157.
- American College of Obstetricians and Gynecologists (ACOG). The Tdap vaccine and pregnancy [website]. Reviewed April 2026. Available at: https://www.acog.org/womens-health/faqs/the-tdap-vaccine-and-pregnancy. Accessed July 6, 2026.
- Andersen AR, Kolmos SK, Flanagan KL, Benn CS. Systematic review and meta-analysis of the effect of pertussis vaccine in pregnancy on the risk of chorioamnionitis, non-pertussis infectious diseases and other adverse pregnancy outcomes. Vaccine. 2022;40(11):1572-1582.
- Centers for Disease Control and Prevention (CDC). Pregnancy and vaccination: Guidelines for vaccinating pregnant women [website]. August 22, 2025. Available at: https://www.cdc.gov/vaccines-pregnancy/hcp/vaccination-guidelines/index.html. Accessed July 6, 2026.
- Centers for Disease Control and Prevention (CDC). Tetanus: For clinicians. Atlanta, GA: CDC; January 23, 2020b. Available at: https://www.cdc.gov/tetanus/clinicians.html. Accessed July 29, 2020.
- Centers for Disease Control and Prevention (CDC). Tdap (tetanus, diphtheria, pertussis) vaccine VIS: for health care providers [website]. February 28, 2025. Available at: https://www.cdc.gov/vaccines/hcp/current-vis/tdap.html. Accessed July 6, 2026.
- Centers for Disease Control and Prevention (CDC). Vaccines and preventable diseases: Diphtheria, tetanus, and whooping cough vaccination: What everyone should know. Atlanta, GA: CDC; January 22, 2020a. Available at: https://www.cdc.gov/vaccines/vpd/dtap-tdap-
td/public/index.html#:~:text=However%2C%20the%20latest%20studies%20suggest,effective
%20despite%20recent%20genetic%20changes.&text=Compared%20to%20the%20vaccine
%20the,whooping%20cough%20for%20as%20long. Accessed July 29, 2020. - Committee on Obstetric Practice, Immunization and Emerging Infections Expert Work Group. Committee Opinion No. 718: Update on immunization and pregnancy: Tetanus, diphtheria, and pertussis vaccination. Obstet Gynecol. 2017;130(3):e153-e157.
- Demicheli V, Barale A, Rivetti A. Vaccines for women for preventing neonatal tetanus. Cochrane Database Syst Rev. 2015;7:CD002959.
- Demicheli V, Barale A, Rivetti A. Vaccines for women to prevent neonatal tetanus. Cochrane Database Syst Rev. 2005;(4):CD002959.
- Dhillon S, Keam SJ. DTaP-IPV/Hib vaccine (Pentacel). Paediatr Drugs. 2008;10(6):405-416.
- Dire DJ. Tetanus. Emergency Medicine Topic 574. Omaha, NE: eMedicine; July 17, 2002.
- Frydenberg A, Starr M. Pertussis. Presentation, investigation and management. Aust Fam Physician. 2004;33(5):317-319.
- Fulton TR, Phadke VK, Orenstein WA, et al. Protective effect of contemporary pertussis vaccines: A systematic review and meta-analysis. Clin Infect Dis. 2016;62(9):1100-1110.
- Gao H, Lau EHY, Cowling BJ. Waning immunity after receipt of pertussis, diphtheria, tetanus, and polio-related vaccines: A systematic review and meta-analysis. J Infect Dis. 2022;225(4):557-566.
- GlaxoSmithKline Biologicals. Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed). Prescribing Information. BO:LX. Research Triangle Park, NC: GlaxoSmithKline; 2005.
- GlaxoSmithKline. Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed) injectable suspension, for intramuscular use. Prescribing Information. Research Triangle Park, NC: GlaxoSmithKline; revised April 2019.
- GlaxoSmithKline. FDA approves Boostrix, a new vaccine for adolescents against pertussis. Pertussis (whooping cough), a highly contagious disease on the rise in U.S. teens. Press Release. Philadelphia, PA: GlaxoSmithKline; May 3, 2005.
- GlaxoSmithKline. Infanrix (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) suspension for intramuscular injection. Prescribing Information. Research Triangle Park, NC: GlaxoSmithKline; revised May 2026.
- GlaxoSmithKline. Kinrix (diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) suspension fo rintramuscular injection. Prescribing Information. Research Triangle Park, NC: GlaxoSmithKline; revised May 2026.
- GlaxoSmithKline. Pediarix [diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B (recombinant) and inactivated poliovirus vaccine], suspension for intramuscular injection. Prescribing Information. Research Triangle Park, NC: GlaxoSmithKline; revised May 2026.
- Havers FP, Moro PL, Hunter P, et al. Use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines: Updated recommendations of the Advisory Committee on Immunization Practices - United States, 2019. Morbidity and Mortality Weekly Report (MMWR). 2020;69(3):77-83.
- Healy CM, Rench MA, Swaim LS, et al. Association between third-trimester Tdap immunization and neonatal pertussis antibody concentration. JAMA. 2018;320(14):1464-1470.
- Heininger U. Update on pertussis in children. Expert Rev Anti Infect Ther. 2010;8(2):163-173.
- Howdieshell TR, Heffernan D, Dipiro JT; Therapeutic Agents Committee of the Surgical Infection Society. Surgical infection society guidelines for vaccination after traumatic injury. Surg Infect (Larchmt). 2006;7(3):275-303.
- Iannelli V. Discontinued vaccines. Vaxopedia [online]. October 26, 2016. Available at: https://vaxopedia.org/2016/10/26/discontinued-vaccines/. Accessed July 27, 2020.
- Johns TL, Hutter GE. New combination vaccines: DTaP-IPV (Kinrix) and DTaP-IPV/Hib (Pentacel). Ann Pharmacother. 2010;44(3):515-523.
- Kandeil W, van den Ende C, Bunge EM, et al. A systematic review of the burden of pertussis disease in infants and the effectiveness of maternal immunization against pertussis. Expert Rev Vaccines. 2020;19(7):621-638.
- Keech C, Miller VE, Rizzardi B, et al. Immunogenicity and safety of BPZE1, an intranasal live attenuated pertussis vaccine, versus tetanus-diphtheria-acellular pertussis vaccine: A randomised, double-blind, phase 2b trial. Lancet. 2023;401(10379):843-855.
- Kharbanda EO, Vazquez-Benitez G, Lipkind HS, et al. Evaluation of the association of maternal pertussis vaccination with obstetric events and birth outcomes. JAMA. 2014;312(18):1897-1904.
- Kobayashi T, Fujiwara S, Ide A, et al. Impact of DTaP-IPV and DTaP vaccination among adult allogeneic hematopoietic stem cell transplant recipients: A prospective observational study. Vaccines (Basel). 2025;13(3):275.
- Kosalaraksa P, Mehlsen J, Vesikari T, et al. An open-label, randomized study of a 9-valent human papillomavirus vaccine given concomitantly with diphtheria, tetanus, pertussis and poliomyelitis vaccines to healthy adolescents 11-15 years of age. Pediatr Infect Dis J. 2015;34(6):627-634.
- Li WC, Wu TZ, Huang YC, Huang LM. Boostrix: A reduced-dose acellular pertussis vaccine for use in adolescents and adults. Expert Rev Vaccines. 2009;8(10):1317-1327.
- Liang JL, Tiwari T, Moro P, et al. Prevention of pertussis, tetanus, and diphtheria with vaccines in the United States: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2018;67(2):1-44.
- Mallet E, Belohradsky BH, Lagos R, et al. A liquid hexavalent combined vaccine against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b and hepatitis B: Review of immunogenicity and safety. Vaccine. 2004;22(11-12):1343-1357.
- Mansour-Ghanaei R, Moradi-Lakeh M, Shakerian S, et al. Acellular pertussis vaccine efficacy: An updated systematic review and meta-analysis. Med J Islam Repub Iran. 2016;30:451.
- McGirr A, Fisman DN. Duration of pertussis immunity after DTaP immunization: A meta-analysis. Pediatrics. 2015;135(2):331-343.
- Morgan JL, Baggari SR, Chung W, et al. Association of a best-practice alert and prenatal administration with tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccination rates. Obstet Gynecol. 2015;126(2):333-337.
- Morgan JL, Baggari SR, McIntire DD, Sheffield JS. Pregnancy outcomes after antepartum tetanus, diphtheria, and acellular pertussis vaccination. Obstet Gynecol. 2015;125(6):1433-1438.
- Nasser R, Rakedzon S, Dickstein Y, et al. Are all vaccines safe for the pregnant traveller? A systematic review and meta-analysis. J Travel Med. 2020;27(2):taz074.
- Nguyen HS, Vo N-P, Chen S-Y, Tam K-W. The optimal strategy for pertussis vaccination: A systematic review and meta-analysis of randomized control trials and real-world data. Am J Obstet Gynecol. 2022;226(1):52-67.
- Sanofi Pasteur Inc. Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed), suspension for intramuscular injection. Prescribing Information. Swiftwater, PA: Sanofi Pasteur; revised August 2023.
- Sanofi Pasteur Inc. Pentacel (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus and haemophilus b conjugate (tetanus toxoid conjugate) vaccine suspension for intramuscular injection. Prescribing Information. Swiftwater, PA: Sanofi Pasteur; revised January 2025.
- Sanofi Pasteur Inc. TENIVAC (tetanus and diphtheria toxoids adsorbed) suspension for intramuscular injection. Prescribing Information. Swiftwater, PA: Sanofi Pasteur; revised April 2026.
- Sanofi Pasteur Inc. Quadracel (diphtheria and tetanus toxoids and acellular pertussis adsorbed and inactivated poliovirus vaccine) suspension for intramuscular injection. Prescribing Information. Swiftwater, PA: Sanofi Pasteur; revised January 2026.
- Sanofi Pasteur Inc. VAXELIS (diphtheria and tetanus toxoids and acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine) suspension for intramuscular injection. Prescribing Information. Swiftwater, PA: Sanofi Pasteur; revised April 2026.
- Sanofi Pasteur, Ltd. DAPTACEL (diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed) suspension for intramuscular injection. Prescribing Information. R5-0308. Swiftwater, PA: Sanofi Pasteur; April 2026.
- Vygen-Bonnet S, Hellenbrand W, Garbe E, et al. Safety and effectiveness of acellular pertussis vaccination during pregnancy: A systematic review. BMC Infect Dis. 2020;20(1):136.
- World Health Organization. Diphtheria vaccine: WHO position paper, August 2017 - Recommendations. Vaccine. 2018;36(2):199-201.
- Xu J, Liu S, Liu Q, et al. The effectiveness and safety of pertussis booster vaccination for adolescents and adults: A systematic review and meta-analysis. Medicine (Baltimore). 2019;98(16):e15281.
