The TGA advises health professionals and consumers that some batches of Typhim Vi Vaccine (Salmonella typhi Vi polysaccharide typhoid vaccine, AUST R 45073) have been recalled by the sponsor, Sanofi-Aventis Pty Ltd (trading as Sanofi Pasteur), because they may have lower than expected antigen content, which may result in reduced efficacy.
This is a precautionary recall and there are no safety concerns for individuals who have received a dose from a recalled batch.
The affected batches are listed in the following table.
Information for consumers
While some individuals may have received less than the intended amount of antigen, Sanofi Pasteur is not recommending revaccination earlier than otherwise indicated for individuals who have received an affected dose.
The TGA advises individuals who are planning to travel to regions where typhoid is endemic - where food hygiene may be suboptimal and drinking water may not be adequately treated - to discuss their individual situation with a health professional or travel doctor.
Travellers are encouraged to to visit the Australian Department of Health and Ageing website's travel health and quarantine web page for general information and advice or the Smartraveller website.
Information for health professionals
Please review the batch numbers of all Typhim Vi Vaccine you have in stock. Return only the affected batches.
While Sanofi Pasteur does not have clinical trial data on the immunogenicity and efficacy of the vaccine with below-specification antigen content, the company does not recommend revaccination earlier than otherwise indicated.
Other batches of Typhim Vi Vaccine are not affected and can still be used.
Sanofi Pasteur is looking to source unaffected batches of Typhim Vi Vaccine as quickly as possible. However, there may be a shortage until normal supply resumes in early 2013. Three alternative products have been identified that may be used:
- Typherix (GSK)
- Vivotif (CSL)
- Vivaxim (Sanofi) - a product which also contains hepatitis A
Sanofi Pasteur has written to wholesalers, general practitioners, travel clinics and community pharmacies in Australia about this recall.
The cause of the lower than expected antigen in some doses in the affected batches has been identified as a problem with the filling process at one of their manufacturing facilities. The sponsor is continuing to investigate the problem.
Typhoid vaccines are not included in the National Immunisation Program - they are 'optional' protection for travellers to endemic areas.
Reporting problems to the TGA
Consumers and health professionals are encouraged to report problems with medicines. Your report will contribute to our monitoring of medicines.
The TGA cannot give personal 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 medical device.