The Australian Infection Control Association (AICA) has warned the Federal Government against proceeding with the planned swine flu vaccination program, warning that the use of multidose vials poses an unacceptable risk.

The Association, which represents health professionals — mainly nurses — working in infection control, says the use of multidose vials in the current context is “unacceptable practice from an infection prevention risk management perspective”.

Using multidose vials would breach national Infection Control Guidelines, which state:  “The Australian Drug Evaluation Committee (ADEC) has advised that injectable products packaged in multidose vials should not be used except where products such as insulin are intended solely for the exclusive use of an individual patient.”

AICA president Claire Boardman told Crikey by email that healthcare facilities are required to comply with these guidelines, and said the use of multidose vials would pose a “significant potential risk to patient safety”, and that numerous adverse events related to their use had been well documented.

“We advise strongly against the use of multidose vials and do not support this mechanism for dissemination of the vaccine,” she said.

Her statements follow similar concerns raised recently by the Australasian Society of Infectious Diseases, but contrast with CSL’s insistence that the multidose vials are safe.

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

She warned that the “high risk of failure” of the pandemic vaccination campaign had the potential to compromise future vaccination campaigns.

There is also the risk that there may be poor uptake of seasonal influenza vaccination next year, if this campaign goes ahead when there is not a public health emergency, she says.

If the vaccine was to be used, the informed consent process should ensure recipients were made aware that the vaccine had not been approved by the Therapeutic Goods Administration, she added.

One reason the AICA comments are significant is that the association has been prepared to make them in public. Many similar concerns are being raised behind closed doors.

In wide circulation are 1970 Medical Journal of Australia articles, describing the deaths of two men in Geelong in 1969 as a result of infection related to multidose syringes in a mass influenza vaccination program.

As well, these are some of the media clips doing the rounds:

  • The New York Times: Growing Focus on Reused Medicine Vials (here and here)
  • Newsday: Health Commissioner Wants Ban on Multidose Vials (here and here)
  • USA Today: CDC Warns of Safety Problems at Clinic (here and here)
  • BBC News: Hepatitis C warning for US clinic  (here and here)

But many experts are wary of speaking out publicly, because of the political repercussions and also because they fear fanning the campaigns of anti-vaccinationists more broadly.

However, if a report in the latest British Medical Journal (here and here) is anything to go by, it seems that health professionals and the general public may vote with their feet — in choosing not to take up vaccination if it is offered. The report cites surveys conducted in several countries of health care workers and the general public, showing scepticism about the merits of pandemic influenza vaccination.

One issue highlighted by the unfolding debate is that Minister Roxon has repeatedly framed the availability of a vaccine as the answer to the pandemic.

You can understand that she might have wanted to reassure the public for reasons of politics and public health. But the simplicity of the message doesn’t do justice to the complexities involved in weighing up the potential costs and benefits of vaccination in the current context.

It also has the effect of painting the Government into a corner and encouraging a line of media questioning — “when will the vaccination start?”, rather than “what are the pros and cons of starting the vaccination now?”

The Australian Government’s Chief Medical Officer, Professor Jim Bishop, responded to the AICA concerns with this statement:

The use of multi-dose vials was always envisaged during the pandemic planning phase. Their use means that a large vaccination program can be rolled out more quickly, and they are more efficient than single dose vials when used in large vaccination clinics.

Single use syringes and single use needles will be used to draw up and administer the vaccine, so there are no concerns with cross contamination between patients. Training will be delivered to vaccination providers on use of multi-dose vials to maximise infection control and minimise wastage.

MDV will only be used for adults and children from five years of age, and single use syringes will be produced for pandemic influenza vaccine use in children 0-5 years of age.

It is important to note that the expert advisory committees and the chief health officers around the country agreed on the use of multidose vials in agreeing to the pandemic plan.

Other countries such as the USA intend to use multidose vials for the pandemic influenza vaccine rollout.