FDA Approves Sanofi’s Supplemental BLA for Adacel

The FDA has approved Sanofi Pasteur’s supplemental biologics license application (sBLA) for  its Adacel vaccine to provide immunization during the third trimester of pregnancy to prevent pertussis — whooping cough — in infants less than two months old.

The approval was supported by results from two observational studies.

Adacel is also used as an active booster against tetanus, diphtheria and pertussis in individuals 10 through 64 years old. The vaccine was first approved in the U.S. in 2005.