FDA nod for Tdap vaccine for use in late pregnancy to prevent pertussis in infants

On Friday, the US Food and Drug Administration approved Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed [Tdap]) for immunization during the third trimester of pregnancy to prevent pertussis, commonly known as whooping cough, in infants younger than two months of age.

The FDA granted the approval to GlaxoSmithKline Biologicals, a unit of UK pharma major GSK (LSE: GSK), whose shares edged up 1.7% to 1,345 pence. The vaccine generated first-half 2022 global sales of £284 million ($321 million) for the company.

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. Subsequently, the FDA also approved Boostrix to include use in individuals 19 years of age and older and to include use of an additional dose nine years or more after the initial dose of a Tdap vaccine. The FDA’s approval of Boostrix has always included its use during pregnancy to protect the vaccinated individual. Today’s approval is specific to use in pregnancy to prevent pertussis in infants younger than two months of age.