The US Food and Drug Administration (FDA) has approved GlaxoSmithKline’s (GSK) Boostrix (tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine adsorbed [Tdap]) for pregnant women during their third trimester to prevent pertussis (whooping cough) in newborn infants.
Boostrix has been approved for preventing whooping cough in infants aged up to two months.
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Administered during pregnancy, the vaccine boosts antibodies in women, which will be transferred to the growing baby.
The Centers for Disease Control and Prevention (CDC) estimates that 4.2% of total pertussis cases reported in the US last year were in infants younger than six months, with nearly 31% of them requiring hospitalisation.
FDA Center for Biologics Evaluation and Research director Peter Marks said: “Pertussis disease is a highly contagious respiratory illness affecting all age groups. However, babies are at the highest risk of getting pertussis and having serious complications from it.
“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.
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By GlobalData“This is the first vaccine approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated during pregnancy.”
In 2005, Boostrix was approved by the FDA as a single dose to boost immunisation against pertussis, tetanus, and diphtheria in individuals aged 10 years to 18 years.
Later, the vaccine was also approved for use in individuals aged 19 years and above, as well as for use as an additional dose for individuals aged nine years or above following the first Tdap vaccine dose.
The CDC has also recommended the Tdap vaccines’ use during the third trimester of each pregnancy since 2012.
Boostrix’s effectiveness was determined based on its re-analysis from an observational case-control study of Tdap vaccine effectiveness.
