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TB vaccine shortage looms

Supplies of a crucial TB vaccine may soon run out after production was halted following a potentially harmful breakdown in the manufacturing process. Sanofi-Aventis Australia Pty Ltd has recalled batches of its Bacillus Calmette-Guerin vaccine amid concerns its sterility cannot be assured because of an “environmental monitoring excursion” during manufacture.

01 Jul 2012

Supplies of a crucial TB vaccine may soon run out after production was halted following a potentially harmful breakdown in the manufacturing process.

Sanofi-Aventis Australia Pty Ltd has recalled batches of its Bacillus Calmette-Guerin vaccine amid concerns its sterility cannot be assured because of an “environmental monitoring excursion” during manufacture.

Though the breakdown was not considered life-threatening, there are concerns tainted vaccine could cause illness.

The Therapeutic Goods Administration said production of the vaccine has been halted and will only resume when it is satisfied that its sterility can be assured.

The TGA said that in the interim it was working with Sanofi-Aventis to secure alternate supplies of the vaccine, but admitted this may not happen quickly enough to prevent a severe depletion of stocks.

“There may be a potential shortage of BCG vaccine in Australia in the interim,” the regulator said.

The batches of BCG 1.5 milligram powder for injection being recalled are:

  • C3787AA (expiry date August 2012);
  • C3787AC (expiry date December 2012);
  • C3787AE (expiry date February 2013); and
  • C3787AG (expiry date February 2013).

In a separate development, two painkiller manufacturers have succeeded in forcing the TGA to reconsider a ban on their products.

Late last month the Administrative Appeals Tribunal directed the TGA to revisit its decision to ban Di-Gesic and Doloxene, along with two other types of painkillers containing dextropropoxyphene, from the Australian Register of Therapeutic Goods.

Late last year the TGA announced its decision to cancel all four drugs from the Register, effective from 1 March this year, a ruling subsequently affirmed by a delegate of the Health Minister in January.

But the manufacturers of Di-Gesic and Doloxene mounted a challenge to the decision in the AAT, which in February granted a stay on the ban pending a full hearing, which was conducted in late May.

The Tribunal decided last month the TGA should reconsider the ban, and it is expected to make a final determination by 15 August.

The regulator has flagged it still remains concerned about the potential for harm from the painkillers.

While it formulates its final decision, the TGA is urging doctors and patients to “carefully consider” product and consumer warnings and contraindications for Di-Gesic and Doloxene before prescribing or taking these medicines.

 

AR


Published: 01 Jul 2012