Sanofi (SAN) voluntarily recalled four batches of Bacillus Calmette-Guerin tuberculosis vaccine because the product’s sterility can’t be assured, Australia’s drugs regulator said.
The supply interruption may cause a shortage of the vaccine in Australia while alternatives are sought, the Therapeutic Goods Administration in Canberra said in a June 20 statement on its website. The recall was classified “class II,” meaning the defects may cause illness or mistreatment.
The vaccine is also being voluntarily recalled in Canada and New Zealand, while manufacturing at a plant in Toronto is being suspended for renovation and to improve environmental quality management within the building, said Patricia Waghorn, Sanofi’s head of communications for Australia and New Zealand.
“Our monitoring found that the level of sterility was not at an acceptable level,” Waghorn said in an e-mail today. “There is currently no stock available in Australia and a return to supply is not expected in the short term.”
Isolated from a cow with tuberculosis by scientists at the Pasteur Institute in Paris, BCG was first used in 1921 and is the only vaccine available to protect against tuberculosis. It is most effective in protecting children from the disease, the World Health Organization said on its website.
The vaccine, which contains live, weakened bacteria, isn’t part of Australia’s routine vaccination schedule, and is typically given to newborns living in areas of higher TB incidence, children under 5 years living in high-prevalence countries for more than three months, and people handling dead bodies.
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