FDA Approves Boostrix for Whooping Cough Prevention
The FDA has approved GlaxoSmithKline’s Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis) vaccine for immunization during the third trimester of pregnancy to prevent pertussis, or whooping cough, in infants younger than two months of age.
Given during pregnancy, the vaccine boosts antibodies in the mother which are then transferred to the developing baby. Babies are at highest risk for getting pertussis and having serious complications.
The approval was supported by study data indicating that the vaccine has 78 percent efficacy in preventing pertussis among infants younger than two months of age when administered during the third trimester of pregnancy.
Boostrix was initially approved by the FDA in 2005 as a single dose for booster immunization against tetanus, diphtheria and pertussis in individuals 10 through 18 years of age. It was later approved for individuals 19 years of age and older and to include an additional dose nine years or more after the first dose.