On April 30, Professor Jim Bishop, the Australian Government’s Chief Medical Officer, announced that the suspension of seasonal influenza vaccination for children aged five and under would be continued, pending further investigations into an apparent spike in febrile convulsions associated with the jab.
He said that more time was needed to complete epidemiological and scientific investigations. When I interviewed him for this BMJ news story, he said he had asked for the investigations to be completed within two weeks.
When I checked back with his media offsider Kay McNiece tonight, she said “Jim will not be reporting back to the public for two weeks”. So it looks like we won’t be getting any definitive answers for a while yet, and presumably the suspension is going to remain in place.
The BMJ story canvassed a range of views about possible explanations, including whether there were problems with a specific vaccine batch or product or whether the issue was the inclusion of the pandemic vaccine in a trivalent vaccine. Other possibilities being investigated are whether febrile illness has increased more broadly this winter or whether the Western Australian programme has uncovered an increased risk among young children in particular.
Peter Collignon, an infectious diseases specialist in Canberra and two international experts on influenza vaccination, Peter Doshi and Tom Jefferson, responded with a letter to the BMJeditor raising concerns about the reporting of vaccine trials, amongst other things.
Meanwhile, the NZ Government is taking quite a different tack, suggesting that the problem of febrile convulsions needs to be kept “in perspective”.
And here are some other flu-related snippets from around the traps:
• While many influenza experts have been downplaying concerns about the use of multi-use vials in vaccination, a US jury has reportedly decided a company must pay $US500 million damages in a case involving a hepatitis C outbreak in Las Vegas. It was alleged that the re-use of vials of the anesthetic propofol infected patients with the disease. (Update made on May 19: A survey in Sydney general practices suggests high rates of vaccine wastage resulted from the use of multi dose vials. The authors wrote: “These results provide evidence that multidose vials (discarded within 24 hours of first use) are an inefficient method of presenting pandemic influenza vaccines for general practice use. Wastage was substantial. This study is limited to the program’s first month, so initial results may not reflect results over the whole program. However, if similar wastage occurred nationally, over 7.5 million of the 19 million doses available to Australians could be wasted. Nevertheless, the low unit cost and rapid production advantages of multidose vials may justify their use when faced with an urgent threat, and if used in mass vaccination clinics.”
• Our own Stephen Duckett (formerly a National Health and Hospitals Reform Commissioner, now a health executive in Canada) gets a mention in this US public health blog re pandemic management. The same blog also has some interesting reflections on the CDC’s surveillance efforts. And another prominent US public health blog analyses the recent Canadian study showing a possible association between vaccination for seasonal influenza the previous flu season and risk of having a medically diagnosed infection with pandemic influenza.
• This BBC report from last month says the National Health Service in Britain has more than 34 million unused doses of swine flu vaccine despite agreeing deals to break its contracts. Wonder how many we have in Australia?
• This report details how Michigan’s Department of Community Health refused a Freedom of Information request for details of its pandemic spending on the grounds it would “violate terrorism laws”. It subsequently backed down and released the documents. The Association of Health Care Journalists in the US has been concerned about the withholding of information about H1N1, and said there was wide variation in what local and state health officials have been disclosing.
Meanwhile, Croakey has just caught up with the NSW Public Health Bulletin series on what it calls NSW Health’s “most intensive public health surveillance, investigation and containment effort in living memory”. (I’m not sure whether I somehow missed this when it was released, as the cover says January-February issue but the website suggests it is the most recent edition).
Here are some of the snippets that leapt out on a first, quick read (though it’s worth having a look at the articles in full).
This article from the NSW Department of Health Pandemic (H1N1) Influenza Vaccine Team noted:
“Decisions regarding the supply of the pandemic vaccine were made early in the pandemic, one month after the World Health Organization declared an emergency and well before the disease was established in Australia. It was correctly anticipated that worldwide demand for the pandemic vaccine would outstrip the production capacity of the vaccine manufacturer. This was despite the pandemic being characterised as moderate and the World Health Organization stating that the overwhelming majority of cases recover with no treatment. By August 2009 it became clear that a vaccine would likely be available only after the first wave of the pandemic had subsided and the rate of admissions for critical care and deaths had decreased.
For future pandemics, it will be important to consider:
- how best to build confidence around pandemic vaccines so that health professionals are comfortable delivering the vaccination
- how best to communicate to both the health community and the general public the challenges of advancing vaccination program planning with limited available information
- how best to work with the Australian Government and other partners to balance the resources required to plan and manage a pandemic vaccination campaign with those needed by other existing, high-priority health programs and responses.
Future pandemics may be more severe than that caused by the current H1N1 virus, resulting in a completely different approach to a national vaccination program. This possibility emphasises the importance of building a degree of flexibility into any pandemic response plan.”
• This article by Robert Booy and Dominic Dwyer from The Children’s Hospital at Westmead and Westmead Hospital, said that given the current era of mass travel, and knowledge about how influenza is transmitted, traditional border control measures (such as airport screening, on-site sample collection and laboratory testing) are not a beneficial use of scarce resources.
They noted that concerns about multi-dose vials had affected confidence in the vaccination program and said: “In retrospect, given that the vaccine was not, and almost certainly could not, be available until the first wave of the pandemic was over, and also that there was likely to be some months before the second wave of cases occurred, there was perhaps more time than anticipated to both prepare the medical and general community. There may have therefore been time to produce large quantities of vaccine in single, as well as multi-dose vials. The time and cost required to produce the vaccine in the single-dose presentation may have been offset by improved professional support, public confidence and vaccine uptake. Now that a safe and effective vaccine is widely available, the herd immunity required to prevent the next wave of infections can be effective only if vaccines become vaccinations.”
• A theme running through many of the articles was the evolving use of online technologies, including Wikis to assist surveillance and reporting. This article said:
“After years of planning for an influenza pandemic, the lessons learned from this response will be important to incorporate when these plans are revised. These <included>:
- Effective network communication is a critical element of emergency response. Clear communication channels are important. Use of several mechanisms (email, wiki and teleconference) increases reliability but can result in redundancy and information overload. The network should develop familiarity with using wikis as communication tools and contribute to the evolution of a more robust version.
• On a similar theme, communication challenges were mentioned repeatedly. This article by area health service and NSW Health staffers noted that:
“High-level decision makers typically require only high-level summary information, except when dealing with specific issues, when they tend to need highly detailed information about specific issues. Conversely, those responsible for managing smaller regions or more specific aspects of the public health response require summary information at much higher levels of granularity, while those implementing public health interventions tend to need highly-detailed operational ‘line listing’ reports, rather than aggregated information. Distribution of such low-level, disaggregated information also carries privacy concerns, and it is necessary to ensure that only those staff with a need to know have access to such information.
No single form of situation report can simultaneously satisfy all these requirements, and thus communication of surveillance information must be able to be tailored to each recipient’s needs. Currently available web technologies, many of them originally developed to facilitate social networking, could be adapted for such purposes. However, implicit in such an approach is the need to automate surveillance reporting as far as possible. This remains a challenge, with the majority of public health emergency situation reports still being assembled by hand. Automatic reporting takes time and very high-level skills to establish, and may not be able to adapt to rapidly changing requirements with sufficient speed. The solution is to develop mechanisms and tools which make the setting up and modification of automated reporting and analysis of surveillance data much faster and easier than it is at present, and to ensure that a skilled cadre of staff familiar with these tools is always available.”
The article also described a surveillance system that was quickly established in about 30 GP practices, which revealed that at its peak in the third week of July, approximately 10% of all presentations to participating GPs were for influenza-like illnesses, and nearly one-third of the swabs taken from these patients confirmed infection with pandemic (H1N1) 2009 influenza. In the final week of July and the first week of August, the GP sentinel surveillance system data showed a dramatic drop in influenza presentations, which was mirrored by a slower but nevertheless pronounced drop in presentations to emergency departments and flu clinics.
As the dust settles, the lessons emerge….