Medication Monitor



Generic Name (Trade Name—Company)
Notes
January 24, 2019

Tdap vaccine adsorbed

(Adacel—Sanofi)
FDA approves expanded use of Tdap vaccine for repeat vaccination

Sanofi announced FDA approval of the expanded use of Tdap vaccine adsorbed (Adacel) to include repeat vaccination to help protect against tetanus, diphtheria, and pertussis. It is now the first and only Tdap vaccine in the United States approved for a repeat dose 8 years or more after the first vaccination in people aged 10 through 64 years. Adacel is also the only Tdap vaccine available in a syringe made without natural rubber latex, which may help reduce risk to patients with an allergy.

Approval was based on clinical data from a study of the safety and effectiveness of repeat Adacel vaccination in adults. In the study of more than 1,300 adults (aged 18 through 64 years), participants received either Adacel vaccine or a Td vaccine 8 to 12 years after a previous dose of Adacel vaccine. The results of the study published in the Journal of the Pediatric Infectious Diseases Society showed a second dose of Adacel vaccine in adults administered 8 to 12 years after a previous dose found no significant differences in adverse events between vaccine groups. A total of 87.7% of Tdap vaccine recipients (n = 999) and 88% of Td vaccine recipients (n = 328) reported at least 1 injection-site reaction.

Sanofi Pasteur has provided the results of the study to CDC's Advisory Committee on Immunization Practices for their consideration in future recommendations.

Adacel vaccine should not be given to anyone who has had a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine. Some signs of severe allergic reactions are hives, swelling of the throat, low blood pressure, shock, and difficulty breathing. Patients who begin to experience any of these signs should seek treatment right away. These reactions are rare and usually occur before leaving the doctor's office.

Patients should tell their doctor if they have ever experienced a severe brain disorder, such as encephalopathy, Guillain‐Barré syndrome, brachial neuritis, or an Arthus‐type reaction (severe, exaggerated swelling involving an injection site) after a previous dose of a tetanus toxoid– or pertussis antigen–containing vaccine.

Fainting can occur shortly after injecting vaccines, including Adacel.

After the first and second dose of Adacel, the most frequently reported adverse effects were pain, swelling, and redness at the injection site; headache, body ache or muscle weakness, tiredness, muscle aches, and general discomfort.