FDA expands use of Sanofi's Adacel vaccine

French pharma major Sanofi (Euronext: SAN) revealed late yesterday that the US Food and Drug Administration (FDA) has approved its Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) during the third trimester of pregnancy to help protect against pertussis, or whooping cough, in infants younger than two months of age.

This expanded indication of the FDA-approved Tdap vaccine will help protect infants from this highly contagious and potentially life-threatening respiratory infection during this time when their immune systems are still developing, the company noted.

Commenting on the development, Dr Michael Greenberg, North American medical head, vaccines, at Sanofi, said: “We are pleased to receive the FDA’s approval for use of Adacel vaccine specifically during pregnancy to help protect young infants against pertussis, a potentially life-threatening disease. We pursued the label expansion to align fully with the long-standing health agency recommendations to provide Tdap vaccination to every woman in every pregnancy. We hope for higher and higher rates of Tdap vaccination in pregnancy so that fewer and fewer infants are likely to get pertussis.”