Tdap Vaccination in Patients with Polysorbate Allergy

Current Tdap Vaccine Formulations

• The Advisory Committee on Immunization Practices (ACIP) notes that all currently available Tdap vaccines contain polysorbate, including Boostrix (GlaxoSmithKline) and Adacel (Sanofi Pasteur), which both contain polysorbate 80 1, 2, 3
• There is no polysorbate-free Tdap vaccine currently available in the United States, as stated by the ACIP 3

ACIP Guideline Recommendations for Component Allergies

• The ACIP recommends that Tdap is contraindicated in persons with a history of serious allergic reaction (anaphylaxis) to any vaccine component, emphasizing the importance of tetanus vaccination 1, 2, 4
• Because of the critical importance of tetanus vaccination, patients with anaphylaxis to vaccine components should be referred to an allergist to determine if they have specific allergy to tetanus toxoid and whether they can be safely desensitized, as recommended by the ACIP 1, 2, 5, 6

Clinical Management Algorithm

• The ACIP emphasizes the importance of documenting the specific reaction to polysorbate, including timing, severity, and symptoms, to guide clinical decision-making 1
• Patients with confirmed polysorbate allergy may require alternative vaccination strategies, such as Td vaccine (tetanus-diphtheria without pertussis) or tetanus toxoid (TT) alone, as recommended by the ACIP 1, 2, 4, 6

Important Clinical Considerations

• The ACIP emphasizes that tetanus protection cannot be deferred due to the life-threatening nature of the disease and the lack of alternative prevention methods, highlighting the importance of vaccination 1
• If polysorbate allergy prevents Tdap administration, the patient loses pertussis protection, and consideration of epidemiologic risk is necessary to determine the best course of action, as recommended by the ACIP 1, 2, 4

Common Pitfalls to Avoid

• The ACIP recommends not assuming all reported "allergies" are true contraindications, as many may not be anaphylaxis and may not preclude vaccination, emphasizing the importance of proper evaluation 1, 4
• The ACIP also recommends not delaying allergist referral, given the importance of tetanus protection, and not confusing polysorbate with PEG allergy, as these are distinct allergens requiring separate evaluation 1, 2