Tuberculosis Bacillus Calmette-Guérin (BCG) vaccine recall fact sheet

Sanofi-Aventis Pty Ltd trading as Sanofi Pasteur is voluntarily recalling all unused batches of BCG vaccine in Australia after consultation with the Therapeutic Goods Administration (TGA).

In this section:

Sanofi-Aventis Australia Pty Ltd trading as Sanofi Pasteur is voluntarily recalling all unused batches of BCG vaccine in Australia after consultation with the Therapeutic Goods Administration (TGA). The BCG vaccine that is being recalled is manufactured by Sanofi Pasteur in its Canadian manufacturing plant. The recall notice can be found on the TGA website.

What is the BCG vaccine?

The BCG vaccine is a live vaccine which can provide partial protection against tuberculosis (TB). BCG vaccination does not prevent infection with TB but can limit the spread of the infection through the body. The vaccine is most effective in children and there is limited evidence of effectiveness in adults.

Who receives the BCG vaccine in Australia?

The prevention and control of TB relies primarily on early detection and treatment of cases to limit any transmission to the community. In countries where the prevalence of TB is low, such as Australia, the role for BCG vaccination is very limited. Following very successful TB control programs in Australia, general use of the BCG vaccine was discontinued in the mid-1980s in favour of targeted vaccination programs due to the low level of TB in Australia.

Currently, BCG vaccination is recommended for use in selected high risk groups only, including:

Aboriginal and Torres Strait Islander newborns in communities of high incidence of TB;
Newborns and children 5 years and under who will be travelling or living in countries or areas with a high prevalence of TB for extended periods;
Newborns born to parents with leprosy or a family history of leprosy.

BCG vaccination may be considered in other at-risk groups, in consultation with state and territory TB control programs.

The National Tuberculosis Advisory Committee has developed nationally agreed recommendations for the use of the BCG vaccine, however some vaccination practices vary at the local level.

Why has the BCG vaccine been recalled?

The BCG vaccine is being recalled because sterility cannot be assured due to an environmental monitoring excursion identified during the manufacturing process. All product in Australia is from the affected batch.

Have any adverse effects been reported?

The TGA reports that the numbers of adverse events associated with BCG vaccine administration have not increased. Health Canada has reported there have been 3 adverse reactions potentially linked to the recalled vaccine lots, and all were the kind of mild reactions normally associated with this vaccine.

What are the implications for those people who have recently received the vaccine?

For those who have recently received the vaccine, the symptoms of a reaction if any, would likely to be mild reactions normally associated with this vaccine and would occur within a few days of receiving the vaccine. They would include injection site soreness and mild irritation. People concerned are encouraged to consult with their healthcare practitioner.

What are the implications for the at risk population?

Children who would require vaccination under the current guidelines will not be able to be vaccinated until the matter is resolved and supply resumes, and this will slightly increase their risk of TB. However, state and territory TB control programs will continue to provide strong services that ensure measures are in place to protect children at risk of exposure to TB. Antibiotic treatments are available on the Australian market to treat tuberculosis, even in very young patients.

Will this result in more TB in Australia?

Australia has ongoing low rates of TB in the general population. The control of TB in Australia primarily relies on early detection and treatment of infectious cases to minimise transmission to the community. This is supported by the secondary strategy of targeting those most at risk from latent TB infection for preventative therapy. BCG vaccination has a very limited role in the control and prevention of TB in a low prevalence setting like Australia.

How are other countries responding?

Sanofi Pasteur is voluntarily recalling the BCG vaccine in Canada and New Zealand.

Are there alternatives to the BCG vaccine?

TGA is working with Sanofi Pasteur to identify possible alternative products.

Further information

Concerned consumers should contact their state or territory health department.

For more information on the recall go to TGA website.
BCG factsheet_supply issues 2012 v5 Jun 20, 20121:18:01 PM