Australian regulator finds no new or unexpected safety issues with Bexsero

Australian regulator the Therapeutics Goods Administration (TGA) has been closely monitoring reports of adverse events following immunization with Bexsero meningococcal B vaccine, specifically those relating to fever in infants and children.

Fever is a potential risk factor for the development of a seizure. These monitoring activities have found no new or unexpected safety issues.

From March 1, 2014 to December 17, 2015 there have been 44 reports of fever in patients of all ages following immunization with Bexsero. During the same time period, there have been two reports of febrile seizures. Other adverse events reported included generalized allergic reaction (18), injection site reaction (48), pain in the vaccinated limb (23) and Kawasaki disease (1).