No increased IS risk from rotavirus vaccines
The reassuring US data comes from a prospective post-licensure safety monitoring study involving nearly 800,000 doses, including around 309,000 first doses, given to children aged 4–34 weeks.
It follows ongoing concern that the vaccines may cause IS, and signals from Australian and other overseas research of an increased risk of IS in the week following the first dose of either RotaTeq (CSL, Merck) or Rotarix (GSK).
Last year the TGA investigated 274 cases of IS from three states, finding a fourfold increased risk of IS in the seven days after the initial dose.
The TGA ordered an update of PI but concluded