Australia’s swine flu vaccination plans come under fire

The Australian government’s impending programme of vaccination against H1N1 flu has been criticised by some professional groups that have raised concerns about potential risks.

The Australian Infection Control Association this week warned the government against proceeding with the programme, saying that the planned use of multidose vials (used to vaccinate several people) posed a “significant potential risk to patient safety.”

The association’s president, Claire Boardman, said that use of multidose vials would contravene national infection control guidelines (www.safetyandquality.gov.au/internet/safety/publishing.nsf/Content/02A94EEE98D72244CA25740F00251B98/$File/NationalInfectionControlGuidelines.pdf) and that numerous adverse events related to their use had been well documented.

Ms Boardman said there was no justification for using multidose vials, as “the occurrence and distribution of H1N1 in 2009 within Australia does not constitute an emergency.”

She added, “We advise strongly against the use of multidose vials and do not support this mechanism for dissemination of the vaccine,” and warned that the “high risk of failure” of the pandemic vaccination campaign could compromise future programmes and also risked causing poor uptake of seasonal flu vaccination next year.

The association’s comments follow similar concerns raised by the Australasian Society of Infectious Diseases in a letter to the government’s chief medical officer, Jim Bishop, widely reported in the media (www.abc.net.au/pm/content/2008/s2662248.htm).

However, some experts involved in trials of an H1N1 vaccine being developed by the vaccine manufacturer CSL Limited believe that any potential risks are minimal and are being blown out of proportion.

Robert Booy, professor of paediatrics and child health at the Children’s Hospital, Westmead, Sydney, and the coauthor of a blog defending the vaccine’s safety (www.aussmc.org/ScienceBlog.php), told the BMJ: “There is considerable and emerging evidence for safety of multidose vials, especially in the hands of trained nurses. Being stalled by this controversy may make us a laughing stock to the rest of the world.”

CSL has repeatedly said that the multidose vials are safe.

But Peter Collignon, an infectious diseases physician and microbiologist at the Australian National University, said it was hard to see why Australia should abandon its usual practice of using mainly single dose, preloaded syringes.

“The only reason to use multidose vials is to save money or else because there is a rapidly evolving emergency with a high death rate,” Professor Collignon said. “Neither of these conditions is currently present in Australia. We passed the peak of this epidemic in most states in Australia in mid-July.”

However, Professor Bishop said that this view overlooked the possibility of another wave of infections before next winter.

“The World Health Organization has said this virus is unpredictable; past pandemics have told us that pandemics don’t run in seasons,” he said.

Professor Bishop said that multidose vials would be used in all H1N1 vaccination programmes that he knew of around the world and that they were also used in the United States for vaccination against seasonal flu. Vaccination providers would be trained in use of multidose vials to maximise infection control and minimise wastage.

“In order to get vaccines out in a reasonable quantity and logistically, the multidose vial has many advantages,” he said.

He said he expected that vaccine supplies would start to become available this week and that the vaccine would initially be given to high risk groups, with the eventual aim of having at least 40% of the population protected.

Julie Leask, a University of Sydney social scientist who researches public acceptance of vaccines, said that the poor image of swine flu vaccination among the public meant that there may be “underwhelming demand” and that “full transparency from the authorities” would be needed to ensure public confidence.

The public would need to know the data the government was using to assess the vaccine and the risks of swine flu in Australia and that systems for reporting adverse events were in place, she said.

Carol Bennett, the head of the Consumers Health Forum of Australia, said it was important that the potential benefits and risks of flu vaccination were openly discussed.

“It’s a complex issue which needs to be thrashed out publicly,” she said. “We’d encourage the key bodies involved to have that debate, to provide that information. Consumers want to know the facts.”