FDA/CDC

FDA approves Adacel for repeat Tdap vaccinations


 

The Food and Drug Administration has approved the expanded use of Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine Adsorbed) to include repeat vaccinations 8 years or more after the first vaccination in people aged 10-64 years.

FDA icon Wikimedia Commons/FitzColinGerald/Creative Commons License

The expanded indication was based on results of a randomized, controlled trial, published in the Journal of the Pediatric Infectious Diseases Society, in which more than 1,300 adults aged 18-64 years received either Adacel or a Td (tetanus-diphtheria) vaccine 8-12 years after receiving a previous dose of Adacel.

Over the course of the study, no significant difference in adverse event incidence was observed between groups. Injection-site reaction was the most common adverse event during the study, occurring in 87.7% of those who received Adacel and 88.0% of those who received the Td vaccine. Other common adverse events associated with Adacel include headache, body ache or muscle weakness, tiredness, muscle aches, and general discomfort.

“While strong vaccination programs are in place for young adolescents, a single Tdap immunization does not offer lifetime protection against pertussis due to waning immunity. The licensure of Adacel as the first Tdap vaccine in the U.S. for repeat vaccination is an important step for eligible patients and offers flexibility for health care providers to help manage their immunization schedules,” said David P. Greenberg, MD, regional medical head North America at Sanofi Pasteur, in the press release.

Find the full press release on the Sanofi website.

Recommended Reading

ACIP votes unanimously in favor of immunization schedule update and redesign
MDedge Pediatrics
Full-dose quadrivalent flu vaccine shows increased efficacy in children
MDedge Pediatrics
Medical exemptions spike after vaccine policy change
MDedge Pediatrics
Discussing immunization with vaccine-hesitant parents requires caring, individualized approach
MDedge Pediatrics
Responding to pseudoscience
MDedge Pediatrics
2018-2019 flu season starts in earnest
MDedge Pediatrics
Aspirin and Omega-3 fatty acids fail
MDedge Pediatrics
Cerebral small vessel and cognitive impairment
MDedge Pediatrics
LAIV4 was less effective for children than IIV against influenza A/H1N1pdm09
MDedge Pediatrics
Incidence of late-onset GBS cases are higher than early-onset disease
MDedge Pediatrics