1st Tdap Vaccine Approved for a 2nd Dose
Sanofi Adacel vaccine now FDA approved to prevent tetanus, diphtheria, and pertussis (whooping cough) when administered 8-12 years after a previous dose
The U.S. Food and Drug Administration (FDA) has approved the expanded use of Adacel to include a repeat vaccination.
Adacel is now the 1st and only Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis (Tdap) Vaccine Adsorbed approved in the USA for a repeat dose in people 10 through 64 years of age, 8 years or more after the first vaccination, to help protect against tetanus, diphtheria, and pertussis.
As of December 17, 2018, the FDA had licensed 11 combination vaccines for use in the USA to help protect against diphtheria and tetanus. Eight of these vaccines also help protect against whooping cough.
Some of these vaccines include protection against other diseases, such as polio, Haemophilus influenzae type b disease, and hepatitis B.
"A single Tdap immunization does not offer lifetime protection against pertussis due to waning immunity," said David P. Greenberg, M.D., Regional Medical Head North America at Sanofi Pasteur.
The FDA licensure was based on clinical data from a study published in the Journal of the Pediatric Infectious Diseases Society that showed the 2nd dose of Adacel vaccine in adults administered 8-12 years after a previous dose, found no significant differences in adverse events between vaccine groups.
A total of 87.7 percent of Tdap vaccine recipients (n=999) and 88 percent of Td vaccine recipients (n=328) reported at least 1 injection-site reaction.
The U.S. Centers for Disease Control and Prevention (CDC) currently recommends a single dose of Tdap vaccine for adolescents and adults, and for pregnant women during every pregnancy.
The Tdap vaccine helps protect adolescents and adults and may prevent the spread of the infection to babies and young children who are still building immunity.
Adacel vaccine is given to people 10 through 64 years of age to help prevent tetanus (lockjaw), diphtheria, and pertussis (whooping cough).
And, 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.
The most frequently reported side effects of Adacel were pain, swelling, and redness at the injection site; a headache, body ache or muscle weakness, tiredness, muscle aches, and general discomfort.
For more information about the Sanofi Adacel vaccine, please visit Sanofi.