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.
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Precision Epigenomics partners with TruDiagnostic
Illumina's GRAIL divestment plan receives EC approval
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Ondine Biomedical's Steriwave approved for use by HCA UK
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial
Syros receives Fast Track Designation from FDA for tamibarotene in AML