The TGA ( Therapeutic Goods Administration ) has been undertaking enhanced monitoring of the meningococcal B vaccine, Bexsero.
Bexsero is the first vaccine in Australia intended to prevent invasive meningococcal disease caused by strains of Neisseria meningitidis serogroup B ( meningococcal B ).
Bexsero is indicated for immunisation of patients aged two months and older. For infants aged under six months, three primary doses of Bexsero, plus a booster at 12 months of age, are recommended. Fewer doses are required for older age groups.
According to the National Notifiable Diseases Surveillance System, the majority of invasive meningococcal disease in Australia is caused by group B ( 84% in 2011-12 ). The highest incidence of group B disease occurs in children aged under five years, particularly infants aged under 12 months. A lower, secondary peak in incidence has been observed in late adolescence and early adulthood.
As with many other vaccines, patients may experience a rise in temperature following vaccination with Bexsero.
During pre-market evaluation of Bexsero, the TGA identified that use of the vaccine commonly induced fever in infants and children, including high fever, which is a risk factor for inducing a seizure.
When fever occurred, it generally followed a predictable pattern starting within six hours after vaccination. In the majority of cases, the fever had ceased by the next day.
Information for health professionals
The Australian Technical Advisory Group on Immunisation has recommended the prophylactic use of Paracetamol for children aged under two years to reduce the probability and severity of fever.
It is recommended that the first dose of Paracetamol ( 15 mg/kg per dose ) be given within the 30-minute period before vaccination or as soon as practicable afterwards. This can be followed by two more doses given six hours apart.
Control of fever alone may not necessarily prevent the development of a seizure. ( Xagena )
Source: TGA ( Therapeutic Goods Administration ), 2014