Sanofi plant problems result in vaccine shortage

Another manufacturing problem is at the heart of yet another shortage, but this time it affects mostly children in Australia.

Sanofi-Aventis Australia has recalled four batches of tuberculosis vaccine and suspended production at a plant in Canada after Australian regulators found problems with sterility. The result will be a shortage as other supplies are sought, according to a statement posted by Australia's Therapeutic Goods Administration on its website.

The vaccine is also being recalled in Canada and New Zealand as well, Patricia Waghorn, Sanofi's head of communications for Australia and New Zealand, tells Bloomberg. She says the company stopped production at a plant in Toronto while improvements are made to address regulators' concerns. Sanofi-Aventis, a division of Sanofi ($SNY), is the largest company in the world devoted exclusively to human vaccines.

"Our monitoring found that the level of sterility was not at an acceptable level," Waghorn says in a statement. "There is currently no stock available in Australia and a return to supply is not expected in the short term."

The vaccine is not given as part of Australia's routine vaccinations, Bloomberg says, but is generally given to newborns in areas where tuberculosis is prevalent, or children under 5 years of age who will be in those areas for more than three months.

It is the second piece of significant vaccine news coming out of Australia in a week. Vaccinemaker CSL last week reported that a two-year study found excessive viral components in its 2010 Fluvax, which had triggered convulsions in some children. It said, however, that an investigation of all of its manufacturing processes had not determined why and that it will continue to investigate until regulators are satisfied that its "manufacturing process can consistently produce a safe and effective influenza vaccine for children." The company has been restricted from selling the vaccine for children under age 5 since the events in 2010.

- read the Bloomberg story
- here's the statement