Diphtheria vaccine

Edina Avdic, Pharm.D.
Pediatric Dosing Author: Alice Jenh Hsu, PharmD, BCPS, AQ-ID

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:
    • DTaP and DT: are given to children < 7 y/o
    • Tdap and Td: are given to older children and adults
    • For other combinations, see formulations

INDICATIONS

ACIP RECOMMENDATIONS

  • Children (birth to 18 y/o):
    • All children should receive 5 doses of DTaP as a primary series
      • 1 dose at each of the following ages: 2, 4, 6, and 15-18 months and 4-6 years.
    • All adolescent between the ages of 11 and 12 should receive a single dose of Tdap.
      • This can be administered regardless of the timing of the last TD-containing vaccine administration.
    • Pregnant adolescents: Tdap during each pregnancy (preferably between the 27th and 36th week).
    • Catch-up immunizations:
      • Children (>7 y/o) should receive 5 doses of DTaP during the catch-up months.
        • Doses 1-3 doses should be given 4 weeks apart, dose 4 should be given 6 months after dose 3, followed by dose 5, 6 months later.
        • For more information see ACIP immunization schedule
      • Children (7-10 y/o) who are not fully vaccinated with DTaP should receive a single dose of Tdap (preferably the first dose in the catch-up series).
        • An additional dose of Tdap should NOT be administered at age 11-12.
        • Td should be administered instead 10 years after the Tdap dose.
      • Adolescent (11-18 y/o): if never having received Tdap vaccine, should receive a single dose of Tdap, followed by Td booster doses every 10 years thereafter.
      • Inadvertent doses of DTaP vaccine, see ACIP immunization schedule.
  • Adults (≥19 y/o):
    • Unvaccinated individuals: complete primary Td series (3 doses) with Td.
    • Boosters:
      • All adults, to receive single dose of Tdap.
        • This can be administered regardless of the timing of the last Td administration.
      • Td booster every 10 years
    • Pregnant women: all to get a Tdap during EACH pregnancy (preferably between the 27th and 36th week).
    • All health-care workers should receive Tdap independent of their previous Td dose.

OTHER INFORMATION

  • Travelers: give booster (Td or Tdap, depending) if diphtheria acquisition risk high.

FORMS

brand name

preparation

manufacturer

route

form

dosage^

cost*

ADACELTetanus toxoid

Tetanus toxoid, reduced Diphtheria toxoid, and acellular Pertussis vaccine adsorbed (Tdap)

Sanofi Pasteur

IM

vial, syringe

2-5-2.5/0.5 mL

$51.65

BOOSTRIX

Tetanus toxoid, reduced Diphtheria toxoid, and acellular Pertussis vaccine adsorbed (Tdap)

GlaxoSmithKline

IM

vial, syringe

2.5-5-8/0.5 mL

$45.88

DAPTACEL

Diphtheria and tetanus toxoids, and acellular Pertussis vaccine adsorbed (DTaP)

Sanofi Pasteur

IM

vial

15-5-10/0.5 mL

$67.29

Td (generic)

Diphtheria and Tetanus toxoids (Td)

Grifols USA LLC

IM

vial

2-2 LF/0.5 mL

$26.34

DT

Diphtheria and tetanus toxoids (DT)

Sanofi Pasteur

IM

vial

5-25/0.5 mL

$113

INFARIX

Diphtheria and tetanus toxoids and acellular Pertussis vaccine adsorbed (DTaP)

GlaxoSmithKline

IM

vial, syringe

25-10-25/0.5 mL

$26

KINRIX

Diphtheria and tetanus toxoids, and acellular Pertussis adsorbed and inactivated Poliovirus vaccine (DTaP-IPV)

GlaxoSmithKline

IM

vial, syringe

25-10-25/0.5 mL

$58.62

PEDIARIX

Diphtheria and Tetanus toxoids and acellular Pertussis adsorbed, Hepatitis B (recombinant) and inactivated Poliovirus vaccine (DTaP-HBV-IPV)

GlaxoSmithKline

IM

syringe

25-10-25/0.5 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

KIT

15-20-5-10

$105

TENIVAC

Tetanus and diphtheria toxoids adsorbed (Td)

Sanofi Pasteur

IM

vial, syringe

2-5/0.5 mL

$70.8

QUADRACEL

Diphtheria and tetanus toxoids, and acellular Pertussis adsorbed and inactivated Poliovirus vaccine (DTaP-IPV)

Sanofi Pasteur

IM

vial

15-25-20/0.5 mL

N/A

*Prices represent cost per unit specified, are representative of "Average Wholesale Price" (AWP).
^Dosage is indicated in mg unless otherwise noted.

PATHOGEN DIRECTED PROTECTION

Corynebacterium diphtheriae, Diptheria

DOSE/ADMINISTRATION

Adult PRIMARY SERIES

  • ADACEL, BOOSTRIX (adult Tdap): one dose of 0.5 mL IM.
  • TENIVAC (adult Td): three doses of 0.5 mL IM.
    • Dose 1 and 2 should be separated by 1-2 months.
    • Dose 2 and 3 should be separated by 6-12 months.
    • One-time dose of Tdap can be substituted for one of the doses in the series, preferably the first.

Adult BOOSTER

  • 0.5 mL Td booster every 10 years.
    • Tdap should replace Td for adults without prior Tdap dose.
    • Tdap can be used if Td unavailable for any q 10-year dose.
  • Pregnancy: give Tdap with every pregnancy (to help avoid pertussis in the infant).

Pediatric PRIMARY SERIES

  • Primary vaccine series:
    • Infants/children 6 weeks to < 7 years old:
      • INFANRIX (DTaP) or DAPTACEL (DTaP): 0.5 mL IM per dose x 5 doses, 1st dose at 2 months of age, 2nd dose at 4 months of age, 3rd dose at 6 months of age, 4th dose at 15-18 months of age, 5th dose at 4-6 years of age
  • For infants/children in whom pertussis vaccine is contraindicated:
    • Infants/children 6 weeks to < 7 years old:
      • Pediatric DT: 0.5 mL IM per dose x 5 doses, 1st dose at 2 months of age, 2nd dose at 4 months of age, 3rd dose at 6 months of age, 4th dose at 15-18 months of age, 5th dose at 4-6 years of age

Pediatric BOOSTER

  • Booster vaccine series:
    • Children/adolescents ≥10 years old:
      • BOOSTRIX (Tdap) or ADACEL (Tdap): 0.5 mL IM per dose x 1 dose at age 11-12 years, after primary childhood vaccine series with DTaP completed
        • TENIVAC (Td): 0.5 mL IM per dose booster every 10 years after the Tdap booster at age 11-12 years

ADVERSE DRUG REACTIONS

GENERAL

  • Generally well tolerated.

COMMON

  • Pain and tenderness at the injection site; rate increases with more doses.

RARE

  • Anaphylaxis
  • Encephalopathy
  • Arthralgia
  • Fever
  • Guillain-Barre syndrome
  • Arthus reaction (severe pain, swelling, induration, edema, hemorrhage, and occasional local necrosis)

VACCINE/DRUG INTERACTIONS

  • The simultaneous administration of DT, MMR, OPV, or inactivated poliovirus vaccine (IPV), and Haemophilus b Conjugate Vaccine (HbCV) is acceptable.
  • Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs, and corticosteroids (used in greater than physiologic doses), may reduce the immune response to vaccines.

CONTRAINDICATIONS

  • History of anaphylaxis to vaccine components.
  • Encephalopathy within 7 days of administration of pertussis vaccine should not receive Tdap.
  • Use with caution with history of Guillain-Barre syndrome (within 6 weeks after previous tetanus toxoid-containing vaccine), moderate or acute severe illness, unstable neurological conditions, and Arthus hypersensitivity reaction.

IMMUNE RESPONSE

  • Response usually good, but reduced in the elderly.
  • Anti-diphtheria response: 99.9% had seroprotective anti-diphtheria levels >0.1 IU/mL and booster response was 91-96%.

CLINICAL EFFICACY

  • Clinical efficacy of ~ 97%
  • < 5 diphtheria cases have been reported in the U.S. since 2000, but 7,100 reported to the WHO (2016).

OTHER INFORMATION

  • Td preferred for adults (less local reactions) and during pregnancy
  • DT: Pediatric preparation, contraindicated in persons >7 yrs.

Basis for recommendation

  1. 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.  [PMID:29702631]

    Comment: This report does not contain any new recommendations but rather consolidates all prior recommendations into a comprehensive document.

References

  1. Maple PA, Efstratiou A, George RC, et al. Diphtheria immunity in UK blood donors. Lancet. 1995;345(8955):963-5.  [PMID:7715300]

    Comment: Report suggests that to maintain protective immunity against diphtheria, a booster is needed based on waning protective titers over time.

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Last updated: March 6, 2019