FDA approves BOOSTRIX for immunisation during pregnancy for the prevention of whooping cough in newborn infants

GSK plc announced that the US Food and Drug Administration (FDA) has approved BOOSTRIX (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed; Tdap) for immunisation during the third trimester of pregnancy to help prevent pertussis (whooping cough) in infants younger than two months of age.

Since 2010, the Centers for Disease Control and Prevention (CDC) has reported 15,000 to 48,000 pertussis cases among people of all ages in the United States each year. Infants are at high risk of complications from whooping cough because their immune systems are still developing.

According to the CDC, the Tdap vaccination given during pregnancy provides the best protection to infants against whooping cough in the first months of life. When pregnant women are vaccinated, protective antibodies are passed from mother to child.

Roger Connor, President, Vaccines and Global Health, GSK, said: “We’re immensely proud to have the first-ever Tdap vaccine approved by the FDA specifically for this use during pregnancy. We believe this approval may help protect more infants from the potentially life-threatening implications of whooping cough.”

BOOSTRIX is currently approved in over 80 countries worldwide, including the US, most European Union countries, Canada, Australia and New Zealand for immunisation against tetanus, diphtheria and pertussis.