GSK’s Boostrix approved by FDA for use during pregnancy to prevent whooping cough in infants
GSK’s Boostrix (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed [Tdap]) has been approved by the US Food and Drug Administration (FDA) for immunisation during the third trimester of pregnancy to help prevent pertussis (whooping cough) in infants less than two months of age, the company announced.
Pertussis is a highly contagious respiratory infection caused by the bacterium Bordetella pertussis. Severity of the disease varies, but infants are at a high risk of complications because their immune systems are still developing.
According to the Centers for Disease Control and Prevention, 4.2% of the total cases of pertussis reported in the US in 2021 were in infants younger than six months of age and approximately 31% required hospitalisation.
“While vaccination is the best method for providing protection, infants younger than two months of age are too young to be protected by the childhood pertussis vaccine series. This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy,” explained Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
Read more: https://www.pmlive.com/pharma_news/gsks_boostrix_approved_by_fda_for_use_during_pregnancy_to_prevent_whooping_cough_in_infants_1456660
Pertussis is a highly contagious respiratory infection caused by the bacterium Bordetella pertussis. Severity of the disease varies, but infants are at a high risk of complications because their immune systems are still developing.
According to the Centers for Disease Control and Prevention, 4.2% of the total cases of pertussis reported in the US in 2021 were in infants younger than six months of age and approximately 31% required hospitalisation.
“While vaccination is the best method for providing protection, infants younger than two months of age are too young to be protected by the childhood pertussis vaccine series. This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy,” explained Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
Read more: https://www.pmlive.com/pharma_news/gsks_boostrix_approved_by_fda_for_use_during_pregnancy_to_prevent_whooping_cough_in_infants_1456660
