Does the Tdap (tetanus, diphtheria, and pertussis) vaccine contain PEG 22 dodecyl glycol?

Does Tdap Vaccine Contain PEG 22 Dodecyl Glycol?

No, the Tdap (tetanus, diphtheria, and pertussis) vaccines licensed in the United States do not contain PEG 22 dodecyl glycol based on the available FDA-approved product information.

Composition of Available Tdap Vaccines

According to the Advisory Committee on Immunization Practices (ACIP) guidelines, there are two Tdap products licensed for use in the United States:

1. Boostrix (GlaxoSmithKline)

• Licensed for persons aged ≥10 years 1
• Contains:
  • Tetanus toxoid (5 Lf)
  • Diphtheria toxoid (2.5 Lf)
  • Pertussis antigens (8 μg)
  • Aluminum phosphate as adjuvant
  • No thimerosal or other preservative 1
  • The tip and rubber plunger of the Boostrix needleless syringe contain latex (relevant for those with severe latex allergies) 1

2. Adacel (Sanofi Pasteur)

• Licensed for persons aged 10-64 years 1
• Contains:
  • Tetanus toxoid (5 Lf)
  • Diphtheria toxoid (2 Lf)
  • Pertussis antigens (2.5 μg)
  • Aluminum phosphate (0.33 mg aluminum) as adjuvant
  • <5 μg residual formaldehyde
  • <50 ng residual glutaraldehyde
  • 3.3 mg 2-phenoxyethanol (not as a preservative)
  • No thimerosal 1

Excipients and Manufacturing Process

The ACIP guidelines specifically detail the components of both Tdap vaccines and do not list PEG 22 dodecyl glycol as an ingredient in either formulation 1. The guidelines are comprehensive in listing the active components, adjuvants, and other ingredients in these vaccines.

Clinical Implications

For patients concerned about PEG allergies:

• Neither Tdap vaccine (Boostrix or Adacel) is documented to contain PEG 22 dodecyl glycol
• The main precautions for Tdap relate to:
  • Previous severe allergic reactions to vaccine components
  • History of Guillain-Barré syndrome
  • Progressive neurologic disorders
  • Latex allergy (specifically for the Boostrix needleless syringe) 1

Important Considerations for Special Populations

For patients with allergies:

• Latex allergy: The Boostrix single-dose vial and all Adacel preparations do not contain latex 1
• Milk allergy: Recent evidence suggests that despite theoretical concerns, Tdap vaccines are tolerated by those with milk allergies 1

It's worth noting that vaccine formulations can change over time, so healthcare providers should always check the most current package inserts for the most up-to-date information on vaccine ingredients for patients with specific allergy concerns.