Swine flu vaccine is still a long way off

A SWINE flu vaccine may still be many months away, despite the continuing rise in cases, Australia’s first fatalities and the growing threat to vulnerable Indigenous communities.

The Therapeutic Goods Administration (TGA) is not commenting on whether the vaccine will be fast-tracked, with the manufacturer’s scheduled trial program due to take six months to complete.

While batches of the vaccine could be ready for use in August, little trial data will be available to the TGA by then, CSL spokeswoman Dr Rachel David said.

“Given that currently the mortality from the H1N1 [flu] is not high, you would expect that at least interim data would be required prior to vaccine distribution, mainly to ensure that people are not inadvertently under-dosed,” she said.

A Federal Health Department spokeswoman said the TGA could not answer any of Medical Observer’s questions about the likely timing of the rollout of the vaccine, or whether the Government would purchase the vaccine from other companies if it was available earlier.

Dr David said CSL was seeking 240 adults aged 18-64 years for a trial in Adelaide over the next six months.

“Scale-up for vaccine manufacture commences in parallel with the trials... with endpoints which determine the ideal dose of vaccine antigen in adults and children,” she said.

Leading virologist Professor John Mackenzie, an adviser on H1N1 to the World Health Organization, said candidates for early vaccination would likely be people with underlying vulnerabilities, such as diabetes, and Indigenous people.

Meanwhile, concern is growing about the swine flu threat to Indigenous communities, with half of the Northern Territory’s 100-plus cases being among Indigenous people.

Commonwealth chief medical officer Professor Jim Bishop said an appendix to the national pandemic influenza plan was in development.

But Dr Sophie Couzos, public health officer with the National Aboriginal Community Controlled Health Organisation in Townsville, Queensland, said the organisation had been calling for a dedicated Indigenous pandemic plan for four years.

It was concerning that there had been no dialogue between the Government and Aboriginal medical services about how the pandemic vaccine would be delivered, she said.