Fonte: FirstWord Pharma
(Texto original, publicado em inglês)
FDA clears GSK’s Boostrix for use during pregnancy to prevent pertussis in newborns
The FDA on Friday said it is allowing GlaxoSmithKline’s Boostrix (Tdap) vaccine to be given during the third trimester of pregnancy to prevent whooping cough in infants younger than two months old. Boostrix was already indicated for active booster immunisation against tetanus, diphtheria and pertussis in individuals aged 10 years and up, but the agency says the latest nod makes it the first approved specifically for use during pregnancy to prevent a disease in young infants whose mothers are vaccinated while pregnant.
The decision was based on a re-analysis of Boostrix-relevant data from an observational case-control study of Tdap vaccine effectiveness. Data were derived from 108 cases of pertussis in infants younger than two months old, and 183 control infants who did not have pertussis. The groups included four cases and 18 cases, respectively, whose mothers had received Boostrix during the third trimester.
The FDA said the re-analysis yielded a preliminary estimate of Boostrix being 78% effective at preventing pertussis in these infants. Updated statistical analyses using data from published observational studies also provided estimates of effectiveness that were “consistent” with the preliminary 78% estimate, the agency added.
Meanwhile, it said safety of the vaccine used in this way was assessed in a randomised, placebo-controlled study involving a non-US formulation of Boostrix that contains the same components as the US version, but more aluminum per dose. The study included 680 pregnant women who received either Boostrix or placebo. After childbirth, placebo recipients were then vaccinated with Boostrix. Results showed comparable rates of side effects, whether the vaccine was given during pregnancy or after childbirth. The study did not identify any vaccine-related adverse effects on pregnancy or on the foetus/newborn, the FDA said.
