Departmental

Australian health authorities give green light to Australian vaccines

Australia's Chief Medical Officer, Professor Richard Smallwood, announces that vaccines sourced from UK cattle were safe and would stay on the market.

1 November 2000

Australian health authorities give green light to Australian vaccines

Australia's Chief Medical Officer, Professor Richard Smallwood, announced today that an expert committee which has undertaken a review of vaccines in Australia that were "grown" in calf serum originally sourced from UK cattle, were considered to be safe and would stay on the market.

Professor Smallwood said although some vaccines have been produced using master and working seed banks using 1987-88 bovine material, no country has recalled any of the vaccines, except for the recent UK recall of a polio vaccine brand which is not used in Australia.

The findings follow a similar verdict from the American Food and Drug Administration (FDA) which recently declared that the risk of contamination from calf serum, used to prepare master and working seed banks for some vaccines, to be negligible and the benefit of immunising children outweighed the remote theoretical risk of Variant Creutzfeldt-Jakob Disease (the human equivalent of so-called mad cow disease).

It went on to advise that vaccines should not be withdrawn from the market.

"Because of the theoretical risk, I convened an independent committee of experts to audit the information on vaccine manufacture in Australia," he said.

"The Committee has already reviewed documentary evidence from the Therapeutics Goods Administration, the American Food and Drug Administration and the Medical Control Agency in the UK as well as evidence from the published scientific literature.

"After meeting on October 31, the Committee forwarded its initial finding to the Minister for Health today (November 1) and I am pleased to say that the Expert Committee has given a green light to all vaccines distributed in Australia."

Professor Smallwood said even though calf serum is sometimes used in the early stages of viral growth, the manufacture process literally washes away the bovine material to the extent that the final vaccine could only potentially contain a minute trace of the calf serum, if at all.

"Australia has been in forefront of action to respond to the BSE/vCJD issue, removing a small number of food items from sale that were derived from British beef in 1996 and more recently placing a temporary ban on blood donations from people who had lived in the UK for six months or more during 1980-96, as a precautionary measure against vCJD from infected beef," he said.

"For this reason we have conducted a full review of all vaccines, but the risk of exposure to vCJD through vaccines is considered negligible and substantially less than the theoretical risk of transmission through blood."

Professor Smallwood said the expert committee comprised Professor Colin Masters, who heads Australia's CJD Register; Dr Alison Kakakios from the New Children's Hospital in Sydney; Professor Yvonne Cossart, Department of Virology at the University of Sydney and Professor John Mathews, Head of the Australian National Centre for Disease Control.

"As a follow on from the work of this committee, I will be convening an expanded working party comprising medical and scientific experts, vaccination networks, state and territory health authorities and consumers to conduct ongoing monitoring of this issue," Professor Smallwood said.

Media contact:
Kay McNiece, Public Health Media Unit,
Commonwealth Department of Health and Aged Care 02 6289 9264 or 0412 132 585