The TGA has been closely monitoring reports of adverse events following immunisation 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 1 March 2014 to 17 December 2015 there have been 44 reports of fever in patients of all ages following immunisation with Bexsero. During the same time period, there have been two reports of febrile seizures. Other adverse events reported included generalised allergic reaction (18), injection site reaction (48), pain in the vaccinated limb (23) and Kawasaki disease (1).
All of these adverse events were identified in association with immunisation with Bexsero in the pre-market evaluation and the numbers of reports were within expectations. Information about these potential adverse events can be found in the Bexsero Product Information and Consumer Medicine Information documents.
Health professionals are reminded that the Australian Technical Advisory Group on Immunisation has recommended the prophylactic use of paracetamol with every dose of Bexsero administered to children less than two years old, as described in the monitoring communication below.
The TGA will continue routine monitoring of the safety and risk profile of Bexsero and encourages consumers and health professionals to report any suspected adverse events involving this product.
Monitoring communication
2 April 2014
Consumers and health professionals are advised that the TGA is undertaking intensive monitoring of the safety and risk profile of Bexsero meningococcal B vaccine following its introduction to the Australian market.
Bexsero is the first vaccine in Australia intended to prevent invasive meningococcal disease. It targets disease caused by strains of Neisseria meningitidis serogroup B (Men B).
While fever occurs after administration of many vaccines, during pre-market evaluation of the vaccine, the TGA identified that Bexsero commonly induced fever in infants and children, including high fever, a potential risk factor for the development of a seizure.
The Australian Technical Advisory Group on Immunisation has recommended the prophylactic use of paracetamol with every dose of Bexsero administered to children less than two years old, to reduce the probability and severity of fever that may develop. However, the control of fever alone may not necessarily prevent development of a seizure.
To help with our monitoring, the TGA encourages the reporting of any seizures associated with the use of Bexsero including:
- both febrile and afebrile seizures
- whether Bexsero was administered singly or in combination with other vaccines
- whether an accompanying anti-fever medicine such as paracetamol was used or not.
The TGA will regularly review any adverse event reports and the benefit-risk profile of Bexsero.
For further information regarding Bexsero, see the Consumer Medicine Information. Health professionals are encouraged to read the Product Information.
For clinical advice about the use of Bexsero, visit the Immunise Australia website.
Reporting problems
While the TGA is urging consumers and health professionals to submit adverse event reports regarding the above issue, we also encourage reporting problems with any medicine or vaccine. Your reports contribute to the TGA's monitoring of these products.
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medicine or vaccine.