Is there a Tdap (tetanus, diphtheria, and pertussis) vaccine available for patients allergic to polysorbates?

Tdap Vaccination in Patients with Polysorbate Allergy

Patients with polysorbate allergy should be referred to an allergist for evaluation and potential desensitization, as all currently available Tdap vaccines contain polysorbate, but tetanus protection is critically important and alternative strategies exist. 1

Current Tdap Vaccine Formulations

Both FDA-approved Tdap vaccines contain polysorbate as an excipient:

• Boostrix (GlaxoSmithKline): Contains polysorbate 80 1
• Adacel (Sanofi Pasteur): Contains polysorbate 80 1

There is no polysorbate-free Tdap vaccine currently available in the United States. 1

ACIP Guideline Recommendations for Component Allergies

The Advisory Committee on Immunization Practices (ACIP) provides clear guidance for patients with allergies to vaccine components:

• Tdap is contraindicated in persons with a history of serious allergic reaction (anaphylaxis) to any vaccine component 1
• 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 1

Clinical Management Algorithm

Step 1: Confirm the Allergy History

• Document the specific reaction to polysorbate (timing, severity, symptoms) 1
• Identify which polysorbate-containing product caused the reaction 2
• Determine if the reaction meets criteria for true anaphylaxis 1

Step 2: Refer to Allergist

Mandatory referral to an allergist/immunologist for:

• Skin testing to polysorbate 2
• Evaluation for cross-reactivity with polyethylene glycol (PEG) 2
• Assessment of whether the patient can safely receive tetanus toxoid through alternative formulations 1

Step 3: Consider Alternative Vaccination Strategies

If Tdap is contraindicated due to confirmed polysorbate allergy:

Option A: Td Vaccine (Tetanus-Diphtheria without Pertussis)

• Check if available Td formulations contain polysorbate (formulation-dependent)
• Provides protection against tetanus and diphtheria but not pertussis 1
• This is the recommended alternative when pertussis component is contraindicated 1

Option B: Tetanus Toxoid (TT) Alone

• May be available in polysorbate-free formulation depending on manufacturer
• Provides tetanus protection only 1
• Allergist can determine if patient can safely receive TT after desensitization 1

Option C: Desensitization Protocol

• Allergist may perform desensitization to allow administration of tetanus-containing vaccine 1
• This approach prioritizes the critical importance of tetanus protection 1

Important Clinical Considerations

Why Tetanus Protection Cannot Be Deferred

• Tetanus is a life-threatening disease with high mortality 1
• No alternative to vaccination exists for tetanus prevention 1
• ACIP emphasizes that tetanus vaccination importance outweighs most contraindications 1

Pertussis Component Trade-off

• If polysorbate allergy prevents Tdap administration, the patient loses pertussis protection 1
• Consider epidemiologic risk: healthcare workers, those with infant contact, and pregnant women have higher priority for pertussis protection 1, 3
• In outbreak settings or high-risk situations, more aggressive allergy evaluation and desensitization may be warranted 1

Common Pitfalls to Avoid

Do not assume all "allergies" are true contraindications: Many reported allergies are not anaphylaxis and may not preclude vaccination 1. History of non-anaphylactic reactions, family history of allergies, or allergies to unrelated substances are not contraindications to Tdap 1.

Do not delay allergist referral: Given the importance of tetanus protection, referral should be urgent rather than deferring all tetanus vaccination indefinitely 1.

Do not confuse polysorbate with PEG allergy: While structurally related, these are distinct allergens requiring separate evaluation 2. Recent COVID-19 vaccine data shows that reported PEG/polysorbate allergies often do not result in vaccine reactions upon formal testing 4.

Do not use pediatric DTaP formulations: These contain the same excipients as Tdap but have higher antigen content and cause more severe local reactions in adults 5. If inadvertently given, count it as the Tdap dose but do not intentionally use as an alternative 5.

Evidence Quality Note

The ACIP guidelines consistently emphasize across multiple publications (2006,2008,2018) that allergist referral is the standard of care for patients with vaccine component allergies when tetanus protection is needed 1. This represents the highest quality guideline evidence available and should direct clinical decision-making.