Slowly but surely over the last two decades, GSK has worked to give more people access to its tetanus, diptheria and whooping cough vaccine Boostrix.
First in 2005, it was adolescents who were cleared to receive the shot. Then within the next six years, adults and the elderly gained access.
Now expecting mothers can pass a measure of protection to their soon-to-be-born babies. On Friday, the FDA expanded use of Boostrix (Dtap) to mothers in their third trimester of pregnancy to safeguard against pertussis (whooping cough), in infants younger than two months old.
People of all ages can catch the highly contagious respiratory condition, but because their immune systems are still developing, infants are particularly vulnerable to serious health consequences, including hospitalization and death from whooping cough.
“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,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a release. “This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy.”
When Boostrix is given during pregnancy, it provides a surge of antibodies in the mother, which are transferred to the baby, the FDA said. Of the total cases of whooping cough reported in the United States in 2021, 4.2% were infants younger than 6 months of age and 31% of those required hospitalization, the CDC said.
Re-analysis of data from an observational case-control study showed that the Dtap vaccine was 78% effective in preventing whooping cough.
Boostrix generated £521 million ($576 million) worldwide for GSK last year, a 14% increase from 2020 at constant exchange rates. Higher demand and market share in the U.S. contributed to the rise.