The WA review, which was established in May to investigate the response by health authorities to adverse events in children following seasonal influenza vaccination, was released today (although dated July), and is available here.
At a quick glance, it directs some rather stern criticism towards not only WA health authorities but also the Commonwealth.
It recommends that the public and health professionals be given much more detailed and accurate information about seasonal influenza vaccination, including the risk of side effects. It also calls for better surveillance and reporting systems for adverse events.
“It is disturbing that neither this State nor the Commonwealth put in place the measures recommended by the World Health Organisation (WHO) in August 2009 regarding the surveillance and reporting of adverse events following the
introduction of pandemic vaccination programs. This Review did not assess the processes in other States.”
“The current dual mechanism of reporting adverse events to either the Therapeutic Good Administration Branch (TGA) of the Commonwealth Department of Health and Ageing (DoHA) or to the Public Health Division of the State Department of Health (DoH) is confusing and does not allow for a timely and comprehensive collection of data on these events. This combined with the lack of knowledge at any given time of the number of vaccinations already given so that the rate of adverse events could be quickly calculated added further to reporting difficulties.”
“This Review has revealed an adverse event reporting system that is not robust or timely and which does not conform to WHO recommendations concerning mass immunisation programs. In addition, there is evidence that the Communicable Disease Control Directorate (CDCD) of the WA DoH was informed of a significant rise in AEFIs (adverse events following immunisation) by e-mail in early April 2010, but did not take any further action whilst they gathered data to carefully analyse the situation.”
“In summary, it is clear to the Reviewer that there was a slow response both by this State and the Commonwealth to apparent emerging adverse events arising from the 2010 vaccination program. While no one cause for the slow
response can be elucidated, it is clear that governance and the current reporting system needs correction and a timely process put in place.”
The review’s recommendations include:
• Detailed product information must provide information about the content, testing and safety of vaccines being supplied to the public; to enable informed decisions about the vaccine before administration.
• Product information must be written in a way that is clear to all sections and groups in the community.
• The process for reporting an adverse event by parents or consumers is established in WA and outlined on parent advice brochures.
• A web-based mechanism to record the number of vaccinations, including batch number and product name, to provide real time data such as the denominator.
• A surveillance system to provide ongoing monitoring of vaccination programs.
• Intensive surveillance is required to follow up with one in ten recipients (randomised) of the seasonal influenza vaccine to ensure adverse events are identified, recorded appropriately and case managed
• A web-based user friendly reporting system which can be used by all, including consumers, is established which simultaneously transmits AEFI information to both the State and Commonwealth.
• This reporting system will provide immediate feedback and efficient follow up to AEFI reports.
• WA DoH implements active data linkage processes to make the best use of health intelligence across the system.
Other snippets from the report:
“The consumer information that accompanies the vaccine product says little about product testing. In this instance, the Reviewer found no information concerning the side effects of vomiting and diarrhoea, which had been recorded in field testing CSL’s Fluvax. These side effects had not apparently been observed in previous years’ vaccines. This information was in the professional information material, but was not conveyed to parents.”
“It was unacceptable that when it appeared there were an increasing number of AEFIs that vaccination providers, especially family practitioners, were not informed to particularly report issues and indeed inform parents of possible complications in an appropriate manner. The only information distributed was sent about a week before the program was ceased to Public Health Units and some of these reported that they did not consider this to be an alert.”
“Two doctors reported adverse events in their own children after vaccination but even this professional input did not spark a response in a timely fashion.”
“It is therefore recommended that more information is provided about the content, testing and safety of vaccines being supplied to the public, especially when a new vaccine is introduced. This can be done sensitively to give consumers and vaccine providers’ support and advice.”
The report runs to more than 100 pages; the quotes above are only brief extracts. It looks like the report is well worth reading in some depth. Perhaps some Croakey contributors or readers could help out with a more thorough reading and report on the review?