Biopharmaceutical company Sanofi reported on Monday the receipt of approval from the US Food and Drug Administration for the expanded use of Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine Adsorbed) to include the repeat vaccination to help protect against tetanus, diphtheria and pertussis.
Sanofi said this US FDA licensure was based on clinical data from a study of the safety and effectiveness of repeat Adacel vaccination in more than 1,300 adults aged 18 to 64 years of age. The participants received either Adacel vaccine or a tetanus-diphtheria (Td) vaccine eight-12 years after a previous dose of Adacel vaccine.
According to the company, the results of the study were published in the Journal of the Pediatric Infectious Diseases Society as well as provided to the CDC's Advisory Committee on Immunization Practices for their consideration in future recommendations.
The company added that Adacel is now the first and only Tdap vaccine in the US approved for a repeat dose in people ten through 64 years of age eight years or more after the first vaccination. it also stated that Adacel is the only Tdap vaccine available in a syringe made without natural rubber latex, which may help reduce risk to patients with an allergy.
Currently, the US Centers for Disease Control and Prevention (CDC) recommends a single dose of Tdap vaccine for adolescents, adults and pregnant women during every pregnancy.
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