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Exciting Update on Adacel® Vaccine Usage

Posted 01/23/19

Previously, all Tdap vaccines were licensed as a single dose. We are excited to inform you that as of January 11, 2019, Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed) is the first and ONLY Tdap vaccine approved for repeat vaccination.1

Additional important information is provided below:

· Adacel vaccine is now approved for repeat vaccination 8 years or more after the initial dose1

· Immunity acquired from vaccination can wane; giving a second dose can help to maintain pertussis protection2

· Adacel vaccine is the first and ONLY Tdap vaccine in a prefilled syringe manufactured without natural rubber latex

After the first and second dose of Adacel, the most frequently reported solicited reactions were pain, swelling, and erythema at the injection site; headache, body ache or muscle weakness, tiredness, myalgia, and malaise1

Please see full Important Safety Information below.

The NDC number for Adacel vaccine in both the prefilled syringe presentation made without natural rubber latex and the unit-dose vial presentation made without natural rubber latex:

Under your Main Street Vaccines contract, the price will not change.

INDICATION FOR ADACEL VACCINE

Adacel vaccine is indicated for active booster immunization against tetanus, diphtheria, and pertussis. Adacel is approved for use in individuals 10 through 64 years of age.

IMPORTANT SAFETY INFORMATION FOR ADACEL VACCINE

Adacel vaccine is contraindicated in persons who have had a severe allergic reaction (eg, anaphylaxis) to any other tetanus toxoid‐, diphtheria toxoid‐, or pertussis antigen‐containing vaccine, or to any component of Adacel; or encephalopathy within 7 days after a previous dose of a pertussis antigen‐containing vaccine with no other identifiable cause.

For one presentation of Adacel, the tip caps of the prefilled syringes may contain natural rubber latex, which may cause allergic reactions in latex‐sensitive individuals. The vial stopper is not made with natural rubber latex.

If Guillain‐Barré syndrome or brachial neuritis has occurred within 6 weeks following previous vaccination with a tetanus toxoid‐containing vaccine, if progressive or unstable neurologic disorders exist, or if adverse events have occurred in temporal relation to receipt of pertussis antigen‐containing vaccine, the decision to give Adacel should be based on careful consideration of the potential benefits and risks.

Persons who experienced an Arthus‐type hypersensitivity reaction following a prior dose of tetanus toxoid‐containing vaccine should not receive Adacel unless at least 10 years have elapsed since the last dose of tetanus toxoid‐containing vaccine.

Syncope (fainting) can occur in association with administration of injectable vaccines, including Adacel. Procedures should be in place to prevent falling injury and manage syncopal reactions.

After the first and second dose of Adacel, the most frequently reported solicited reactions were pain, swelling, and erythema at the injection site; headache, body ache or muscle weakness, tiredness, myalgia, and malaise.

Other adverse reactions may occur. Vaccination with Adacel may not protect all individuals.

Please see the full Prescribing Information.

Please reach out to Sanofi Pasteur at 1-800-VACCINE for any product questions.



References: 1. Adacel vaccine [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur

Inc. 2. Centers for Disease Control and Prevention. Prevention of Pertussis, Tetanus,

and Diphtheria with Vaccines in the United States: Recommendations of the Advisory

Committee on Immunization Practices (ACIP). MMWR. 2018;67(2):1-46.

SAUS.ADAC.18.12.6981 1/19


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