TB vaccine shortage fear amid test hold-up

HEALTH authorities across Europe are facing a potential shortage of the vaccine that protects against TB because of difficulties getting the product independently assessed.

Yesterday its Danish manufacturers, the Statens Serum Institut (SSI), blamed “technical difficulties” at the Norwegian laboratory where the BCG is independently verified for the hold-up in its release.

Biaditte Knudsen, head of quality assurance at the Copenhagen-based institute, said: “The situation is acute. All of the vaccines for Europe are in storage, but we can only produce it and are unable to sell it.” SSI is the only company that supplies the vaccine to the European market.

Ms Knudsen denied the delay in releasing the vaccine was a quality issue.

“There is nothing wrong with the product. It is normal for the authorities to retest the product independently before it is released, but in this case the lab in Norway has been unable to perform the test, which is very difficult and takes up to six weeks. Nobody knows what is causing the difficulty, but the matter is under investigation,” she said.

Ms Knudsen said release of the vaccine had been held up for the past two months, and was leading to a shortfall in France and Ireland.

Health authorities in Europe, including the Irish Medicines Board, require that vaccines are independently assessed — a process known as the double-test — before release for sale. Once verified, they are given what is known as European batch release, currently withheld from the BCG.

The Norwegian lab at the centre of the controversy is contracted by the Danish Medicines Agency to carry out the test. Ms Knudsen said the agency had used the same lab for years but a problem had only arisen recently. She said the delay in validating the vaccine had caused frustration at the SSI as well as “respect” issues in terms of the institute’s reputation.

A statement from the HSE warned there may be a shortage of the vaccine over the coming weeks. It said it anticipates receiving fresh stocks by January. There are enough vaccines in stock to last for the next three to four weeks.

Dr Kevin Kelleher, HSE assistant national director for population health, said there had been “a dramatic decline in TB over the past 40 years in this country” and the vaccine shortage was not a cause for alarm because the risk of contracting TB was low. However, statistics from the Health Protection Surveillance Centre show the number of people with TB rose year on year over a five-year period from 2001-2005, from 381 to 461 cases.

Earlier this year, an outbreak of TB at two Cork creches left 21 people infected. Cork is the only county where the BCG is not routinely given to newborns, a situation due to be addressed this month, but on hold because of the HSE embargo on recruitment.