Updated Boostrix and Boostrix Polio label to benefit pregnant women approved for GSK

UK pharma major GlaxoSmithKline (LSE: GSK) today announced that it has received approval from the German regulatory authority, Paul-Ehrlich-Institut, acting as the reference authority in Europe, for the update of the Boostrix and Boostrix Polio vaccine labels with additional safety data in pregnant women.

Boostrix is indicated for booster vaccination against diphtheria, tetanus, pertussis (Tdap) and Boostrix Polio for poliomyelitis. The safety data now included in the labels describes that these two vaccines may be considered for use in pregnant women during the third trimester.

“Whooping cough, also called pertussis, is a serious disease that can cause significant complications and death in very young, vulnerable infants across the globe. Studies have shown that vaccinating mothers in the final trimester of pregnancy helps to reduce whooping cough-related severe disease and deaths in infants too young to be vaccinated. This approach is referred to as maternal vaccination. In an effort to reduce severe disease burden in young infants, an increasing number of health authorities including US and European authorities recommend pregnant women to be vaccinated,” commented Dr Thomas Breuer, chief medical officer at GSK Vaccines.