Diphtheria vaccine

Caitlin Soto, PharmD, BCIDP, Edina Avdic, Pharm.D.
Pediatric Dosing Author: Lisa Hutchins, Pharm.D.

VACCINE TYPE

Types/abbreviations:
- DT (tetanus + diphtheria toxoids)
- Td (tetanus toxoid + reduced-dose diphtheria toxoid)
- DTaP (DT + acellular pertussis)
- Tdap (Td + reduced-dose acellular pertussis)
Usual administrations:
- DT: pediatric diphtheria and tetanus toxoids; no longer available in the U.S.
  DTaP is routinely used in children younger than 7 years.
  - Tdap and Td are used beginning at age 7 years.
  - For a child younger than 7 years with the specific contraindication to pertussis-containing vaccine, Td may be used off-label for remaining doses.
- Tdap and Td are given to older children and adults.
- For other combinations, see formulations.

INDICATIONS

ACIP RECOMMENDATIONS

Routine childhood and adolescent vaccination:
- All children should receive 5 doses of DTaP
  - 1 dose at each of the following ages: 2, 4, 6, and 15-18 months and 4-6 years
- All adolescents between the ages of 11 and 12 should receive a single dose of Tdap.
- Pregnant adolescents should get a Tdap during each pregnancy (preferably between the 27th and 36th week).
Catch-up immunization:
- Children < 7 years, utilizing DTaP:
  - Doses 1-3 should be given 4 weeks apart
  - Dose 4 should be administered at least 6 months after dose 3 and at age 12 months or older; the routinely recommended age is 15–18 months.
  - Dose 5 should be given at least 6 months after dose 4 and between the ages of 4 and 6 years.
    - Dose 5 is unnecessary if dose 4 was administered at age 4 years or older and at least 6 months after dose 3.
  - For more information, see the ACIP immunization schedule.
- Children and adolescents aged 7–18 years who are not fully vaccinated:
  - Should receive Tdap, preferably as the first catch-up dose; use Td or Tdap for additional needed doses.
  - A child who receives Tdap at age 7–9 years should still receive the routine adolescent Tdap dose at age 11–12 years.
  - Tdap given at age 10 years counts as the adolescent dose; see ACIP immunization schedule
- Inadvertent doses of DTaP vaccine, see ACIP immunization schedule
Adults (≥19 yrs):
- Complete a 3-dose primary series if not received during childhood:
  - Tdap first, Td or Tdap at least 4 weeks later, and Td or Tdap 6–12 months after the second dose.
- Td or Tdap every 10 years after completion of the primary series.
- Adults who completed a primary series but have never received Tdap at age 10 years or older should receive 1 dose of Tdap, regardless of the interval since the last tetanus- or diphtheria-toxoid-containing vaccine.
  - Thereafter, administer Td or Tdap every 10 years.
- Pregnancy:
  - Administer Tdap during every pregnancy, preferably during the early part of gestational weeks 27–36, regardless of prior Tdap history.
- All health-care workers who have not previously received Tdap should receive Tdap independent of their previous Td dose

OTHER INFORMATION

Travelers:
- Ensure that travelers are current with routine diphtheria vaccination.
- For travel to an active outbreak area, administer an age-appropriate diphtheria-toxoid-containing vaccine if the traveler is not fully vaccinated or has not received a booster within the previous 5 years.
Wound management (see tetanus and tetanus toxoid vaccine modules)
- For persons who have received at least 3 tetanus-toxoid-containing vaccine doses: for a clean minor wound, administer Td or Tdap if more than 10 years have elapsed since the last dose; for other wounds, administer Td or Tdap if more than 5 years have elapsed. Tdap is preferred when previous Tdap receipt is absent or unknown. For persons with fewer than 3 doses or an unknown history, see the tetanus and tetanus-toxoid vaccine modules for vaccination and TIG recommendations.

FORMS

Definitions:

D = full pediatric quantity of diphtheria toxoid
d = reduced quantity of diphtheria toxoid
aP = pediatric acellular pertussis antigens
ap = reduced quantities of acellular pertussis antigens

brand name	preparation	manufacturer	route	form	dosage	cost*
ADACEL	Tetanus toxoid, reduced Diphtheria toxoid, and acellular pertussis vaccine adsorbed (Tdap)	Sanofi Pasteur	IM	vial, syringe	0.5 mL	$48.19
BOOSTRIX	Tetanus toxoid, reduced Diphtheria toxoid, and acellular pertussis vaccine adsorbed (Tdap)	GlaxoSmithKline	IM	vial, syringe	0.5 mL	$48.71
DAPTACEL	Diphtheria and tetanus toxoids, and acellular pertussis vaccine adsorbed (DTaP)	Sanofi Pasteur	IM	vial	0.5 mL	$28.17
Tenivac TdVax	Diphtheria and Tetanus toxoids (Td)	Sanofi Pasteur MassBiologics	IM	vial	0.5 mL	$26.34
DT	Diphtheria and tetanus toxoids (DT, no longer available in the U.S.)	Sanofi Pasteur	IM	vial	0.5 mL	$113
INFANRIX	Diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DTaP)	GlaxoSmithKline	IM	vial, syringe	0.5 mL	$29.83
KINRIX	Diphtheria and tetanus toxoids, and acellular Pertussis adsorbed and inactivated Poliovirus vaccine (DTaP-IPV)	GlaxoSmithKline	IM	vial, syringe	0.5 mL	$63.34
PEDIARIX	Diphtheria and Tetanus toxoids and acellular Pertussis adsorbed, Hepatitis B (recombinant) and inactivated Poliovirus vaccine (DTaP-HBV-IPV)	GlaxoSmithKline	IM	syringe	0.5 mL	$68.47
PENTACEL	Diphtheria and tetanus toxoids, and acellular Pertussis adsorbed, and inactivated Poliovirus vaccine, and Haemophilus b conjugate vaccine (DTaP-IPV-Hib)	Sanofi Pasteur	IM	0.5 mL KIT		$115
TENIVAC	Tetanus and diphtheria toxoids adsorbed (Td)	Sanofi Pasteur	IM	vial, syringe	0.5 mL	$40.91
QUADRACEL	Diphtheria and tetanus toxoids, and acellular Pertussis adsorbed and inactivated Poliovirus vaccine (DTaP-IPV)	Sanofi Pasteur	IM	vial	0.5 mL	$59.68
VAXELIS	Diphtheria and Tetanus Toxoids, Acellular Pertussis, Hepatitis B (Recombinant), Poliovirus (Inactivated), and Haemophilus influenzae B Conjugate (Adsorbed) Vaccine (hexavalent DTaP-IPV-Hib-HepB)	Sanofi Pasteur	IM	syringe	0.5 mL	$146.36

FDA-approved ages and product-specific usages:

Daptacel/Infanrix: 6 weeks through 6 years.
Kinrix/Quadracel: 4–6 years; used for the final DTaP/IPV doses.
Pediarix: 6 weeks through 6 years; used for the 3-dose infant primary series, not booster doses.
Pentacel: 6 weeks through 4 years; used for doses at 2, 4, 6, and 15–18 months.
Vaxelis: 6 weeks through 4 years; 3-dose primary series, not a booster.
Boostrix: FDA-approved at age 10 years and older.
Adacel: persons 10–64 years; also indicated during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months.

*Prices represent cost per unit specified and are representative of "Average Wholesale Price" (AWP).

PATHOGEN DIRECTED PROTECTION

Protection against toxin-mediated diphtheria caused by toxigenic Corynebacterium diphtheriae.

DOSE/ADMINISTRATION

Adult PRIMARY SERIES

Adults with an incomplete or unknown primary series should receive 3 doses:
- Tdap initially, Td or Tdap at least 4 weeks later, and Td or Tdap 6–12 months after dose 2.
  - Tdap is preferred for the first dose but may substitute for any Td dose.

Adult BOOSTER

0.5 mL Td or Tdap every 10 years.
Pregnancy: give Tdap with every pregnancy (to help avoid pertussis in the infant).

Pediatric PRIMARY SERIES

DTaP is used routinely in children younger than 7 years. Tdap and Td are used beginning at age 7 years;
- Td may also be used off-label in a child younger than 7 years when pertussis-containing vaccine is contraindicated.
INFANRIX or DAPTACEL (DTaP): 0.5 mL IM dose at each of the following ages: 2, 4, 6, and 15-18 months and 4-6 years for 5 total doses
DT (no longer available in the US; has been used when pertussis vaccine contraindicated): starting at 6 weeks, administer three doses of 0.5 mL IM 4 to 8 weeks apart, followed by 2 booster doses, administered at 15 to 18 months of age and at 4 to 6 years of age
- For a child younger than 7 years with a contraindication specifically to the pertussis component, current CDC guidance permits Td for the remaining doses.

Other combination vaccines exist that include DTaP/DT and may be substituted for DTaP or DT as appropriate.

Pediatric BOOSTER

INFANRIX or DAPTACEL (DTaP): 0.5 mL IM given according to ACIP primary schedule or catch-up schedule, see ACIP immunization schedule
DT (no longer available in the US; has been used when pertussis vaccine is contraindicated): 0.5 mL IM given according to manufacturer instructions.
Tdap (ADACEL or BOOSTRIX): single 0.5 mL IM at age 11-12 years. May be administered to children 7 years and older according to ACIP catch-up schedule, see ACIP immunization schedule

Other combination vaccines exist that include DTaP/DT/Tdap/Td and may be substituted for DTaP, DT, Tdap, or Td as appropriate

ADVERSE DRUG REACTIONS

GENERAL

Generally well tolerated.

COMMON

Injection-site pain, redness, and swelling (DTaP 20-40%, more frequent after doses 4 and 5; Td or Tdap 25-75% depending on product)
Headache
Fatigue
Gastrointestinal symptoms

OCCASIONAL

Fever
- Temperature ≥101°F occurs in approximately 3%–5% after DTaP.
- Temperature ≥100.4°F occurs in approximately 1%–5% after Tdap or Td.

RARE

Anaphylaxis; Arthus-type local reactions; and rare moderate or severe systemic reactions after DTaP, including fever ≥105°F, persistent crying, febrile seizure, or hypotonic-hyporesponsive episode.
Arthralgia

VACCINE/DRUG INTERACTIONS

DTaP, Tdap, and Td are non-live vaccines and may be administered simultaneously with other indicated vaccines at separate anatomic sites.
Immunosuppressive therapy may reduce the immune response but is not a contraindication to these vaccines.

CONTRAINDICATIONS

Contraindications
- Severe allergic reaction after a previous dose or to a vaccine component.
- For DTaP or Tdap: encephalopathy not attributable to another identifiable cause within 7 days after a previous pertussis-containing vaccine.
Precautions
- Moderate or severe acute illness, with or without fever.
- Progressive or unstable neurologic disorder, uncontrolled seizures, or progressive encephalopathy for DTaP/Tdap; defer until evaluated and stabilized.
- Guillain–Barré syndrome within 6 weeks after a previous tetanus-toxoid-containing vaccine.
- Previous Arthus-type reaction after a diphtheria- or tetanus-toxoid-containing vaccine; defer another tetanus/diphtheria toxoid dose until at least 10 years after the previous dose.

IMMUNE RESPONSE

More than 95% of recipients attain protective diphtheria antitoxin concentrations after a properly spaced primary series.
Protection wanes over time, supporting booster vaccination.

CLINICAL EFFICACY

Diphtheria toxoid-containing vaccine is estimated to be approximately 97% effective against diphtheria after completion of the recommended series.

OTHER INFORMATION

Diphtheria remains uncommon in the U.S. and is often associated with international travel, but substantial global transmission and outbreaks continue.
- WHO recorded 25,146 reported cases globally in 2024, compared with 7,102 in 2016.
- Ensure that travelers are up to date with routine diphtheria vaccination. For travel to an active outbreak area, consult current destination-specific CDC guidance; an earlier Td or Tdap booster may be considered when close contact with cases is likely or access to medical care is limited.
Additional details can also be found in the Corynebacterium diphtheriae module
Adults may receive either Td or Tdap for routine boosters.
- Tdap—not Td—is recommended during every pregnancy, preferably early in weeks 27–36.
DT: no longer available in the U.S., may still be available globally.
HIV-positive patients
- DTaP, Tdap, and Td are inactivated vaccines and should be administered to people with HIV according to the routine age-appropriate schedule at any CD4 count. Immune responses may be attenuated in advanced HIV, but low CD4 count is not a contraindication and is not a reason routinely to defer vaccination.
Vaxelis may be used for the 3-dose infant primary series at ages 2, 4, and 6 months but is not recommended as a booster.
- Administer an age-appropriate DTaP-containing booster at 15–18 months and another at 4–6 years.
- Vaxelis is also not used for the Hib booster dose.
The diphtheria vaccine component induces antitoxin immunity.
- It does not protect against disease caused by nontoxigenic C. diphtheriae, which can cause pharyngitis, cutaneous infection, bacteremia, endocarditis, and other invasive disease independent of diphtheria toxin.

References

Kitamura N, Bahkali K, Chem ED, et al. Waning rate of immunity and duration of protective immunity against diphtheria toxoid as a function of age and number of doses: Systematic review and quantitative data analysis. Hum Vaccin Immunother. 2022;18(6):2099700. [PMID:35862651]
Comment: A systematic review and quantitative analysis of 15 age-stratified serosurveys estimated that mean diphtheria antitoxin concentrations declined to 0.1 IU/mL approximately 2.5, 10.3, and 25.1 years after receipt of 3, 4, and 5 doses, respectively. Findings support the importance of booster doses but are limited by heterogeneous cross-sectional data from countries with differing vaccine schedules and epidemiology.
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. MMWR Morb Mortal Wkly Rep. 2020;69(3):77-83. [PMID:31971933]
Comment: Updated ACIP recommendations to allow either the tetanus and diphtheria toxoids (Td) vaccine or Tdap to 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.
Hammarlund E, Thomas A, Poore EA, et al. Durability of Vaccine-Induced Immunity Against Tetanus and Diphtheria Toxins: A Cross-sectional Analysis. Clin Infect Dis. 2016;62(9):1111-1118. [PMID:27060790]
Comment: Cross-sectional U.S. study estimated a diphtheria-antitoxin half-life of 27 years and predicted maintenance of concentrations ≥0.01 IU/mL in most adults for at least 30 years. The findings suggest durable basic protection after a complete series, although they do not negate current booster recommendations and used a lower seroprotection threshold than many waning-immunity analyses.
CDC. Adult Immunization Schedule Noteshttps://www.cdc.gov/vaccines/hcp/imz-schedules/adult-notes.html(updated 7/2/25, accessed 8/4/26)
Comment: Adult schedule.
Recommended Child and Adolescent Immunization Schedule for Ages 18 Years or Younger—United States, 2025. https://www.cdc.gov/vaccines/hcp/imz-schedules/downloads/child/0-18yrs-chi...
Comment:
Schedule favored by the JH ABX Guide.

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