Meningococcal B vaccine under scrutiny
The vaccine was approved in August last year and is available on private prescription.
The TGA said that during pre-market evaluation of the vaccine it was commonly associated with fever in infants and children, including high fever, a potential risk factor for seizure.
The Australian Technical Advisory Group on Immunisation (ATAGI) has recommended the prophylactic use of paracetamol with every dose of Bexsero administered to children under the age of two to reduce the probability and severity of fever. However, it warned that the control of fever alone may not prevent development of afebrile seizure.
The head of medical affairs at Novartis Vaccines Australia, Dr Victor Carey, said the company supports the routine monitoring of Bexsero but maintained the announcement, which is in line with the vaccine’s product information, was not a safety alert.
“The department of health issued the advice from ATAGI which