EMBARGO LIFTED AT 8 am AEDT, Thursday March 29, 2012

Two studies to publish in PLoS One suggest that a sudden increase in narcolepsy in Finnish children at the beginning of 2010 was likely to be related to the Pandemrix vaccine used in response to the H1N1 (swine flu) pandemic in 2009. As mentioned below by an expert in the field, this vaccine has never been used in Australia.

Feel free to use these quotes in your stories. If you would like to speak to an expert, please don’t hesitate to contact us on (08) 7120 8666 or by email.

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Dr Alan Hampson is Chairman of the Influenza Specialist Group in Melbourne

“These papers are interesting but simply give detail and substance to reports that were reviewed by the World Health Organisation twelve months ago (and which resulted in the report at: http://www.who.int/vaccine_safety/topics/influenza/pandemic/h1n1_safety_assessing/narcolepsy_statement/en/)

It is important to stress that the vaccine was NEVER used in Australia. It is interesting that paediatric narcolepsy associated with this vaccine appears to be only a Scandinavian experience as it wasn’t seen in other countries using the same vaccine.”

Dr Hampson is available for interviews

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Professor Nikolai Petrovsky is an Adelaide based clinician and Research Director at Vaxine Pty Ltd

“Two scientific papers have just been published establishing a link between administration in 2009 of a particular swine flu vaccine

(Pandemrix) manufactured by GSK and a large rise in cases of narcolepsy in Finnish children. The flu vaccine used in Finland was different to the swine flu vaccine used in Australia and had not been previously satisfactorily tested in children, raising concerns about the adequacy of the regulatory processes around the release of this particular vaccine for use in European children. Pandemrix is different to most other swine flu vaccines in that it also included squalene oil.

Use of squalene oil in vaccines has a troubled history with a published study claiming a link between squalene induced antibodies and chronic fatique symptoms in Gulf War veterans (the Gulf War syndrome). Although the conclusions of this single study were subsequently disputed, the recent demonstration that a vaccine containing squalene causes narcolepsy is likely toreopen debate regarding vaccine safety . What is needed is funding of independent research into vaccines to try and explain why these problems might be occurring. Unfortunately at present almost all such research is largely left to the companies producing and selling vaccines.

Although the Pandemrix vaccine was fortunately not given to any Australian children, Australia has had its own share of problems with childhood influenza vaccine programs. In 2010 CSL’s Fluvax influenza vaccine was indefinitely removed from use in young children after it caused an unacceptable rate of side effects. The message from these adverse events is not that we should stop using vaccines, given their overwhelming benefits in preventing serious infectious diseases, but rather that governments including the Australian government need to invest much more into research into how to develop safer and more effective next generation vaccines.”

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*AS03 Adjuvanted AH1N1 Vaccine Associated with an Abrupt Increase in the Incidence of Childhood Narcolepsy in Finland, Nohynek et al., PLoS ONE, Volume 7, Issue 3, e33536, 2012

and

Increased Incidence and Clinical Picture of Childhood Narcolepsy following the 2009 H1N1 Pandemic Vaccination Campaign in Finland, Partinen et al., PLoS ONE, Volume 7, Issue 3, e33723, 2012

For the full release go to: www.fao.org/news/story/en/item/87196/icode/

Below, influenza and related experts respond.

Feel free to use these quotes in your stories. Any further comments will be posted here. If you would like to speak to an expert, please don’t hesitate to contact us on (08) 7120 8666 or by email.

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Professor Robert Booy is an infectious diseases and immunisation expert at the Centre for Immunisation Research and Surveillance, University of Sydney and The Children’s Hospital at Westmead.

“Although H5N1 bird flu has a very high mortality rate it remains very difficult to transmit between humans.

Children are perhaps at more risk because they sometimes sleep with chickens – prolonged close contact is required to catch the infection. The occasional outbreak in genetically related household members suggests some innate predisposition.

There is no evidence that the newly mutated virus recently found in Vietnam can pass between humans more easily. However, the H5N1 vaccine used for poultry has become less effective due to a viral genetic change increasing its resistance.

If outbreaks in poultry continue to increase in number, exposure to humans will be amplified and more human cases are likely.

There is concern about spread of the new Bird flu virus to Korea, Japan, Malaysia and elsewhere in Asia but Australia is not presently on the high alert list.

Some, but not all, wildfowl can carry the virus innocuously in their guts and excrete it in their faeces for a prolonged time without becoming ill, even though it is deadly to domestic poultry.

These wildfowl may migrate long distances spreading the virus. Outbreaks may be recognised when there are multiple unexpected deaths in wild birds.

The critical surveillance of birds in Asia needs to be in domestic poultry on farms and in markets. Research suggests that implementation of WHO guidelines over the past five years in Asia is patchy at best.

Awareness needs to be raised and prompt outbreak control instituted in key countries across Asia and the Middle East- even Mongolia, Bulgaria and Romania now appear at risk of spread to humans.

Nigh on half a billion livestock have been culled since the problem emerged; millions more may soon need to be sacrificed. Better vaccines need to be fast-tracked.

Australia is quite unlikely to be affected by this new Bird flu mutant. The Asian birds don’t migrate our way. Sentinel poultry flocks and other surveillance in Australia will however continue and our response should any outbreak occur will be rapid and comprehensive.”

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Dr Raina MacIntyre is Professor of Infectious Diseases Epidemiology and Head of the School of Public Health and Community Medicine at the University of NSW. She is an expert in influenza and emerging infectious diseases.

“The endemicity of H5N1 in birds creates circumstances where human and avian strains could mix and reassort genetically to create a human pandemic strain. At this stage, the concern is about re-emergence of H5N1 in birds after a period of apparent decline, resulting from large scale culling of birds between 2006 and 2008.

The concern is the emergence of a variant strain of H5N1 in poultry in China and Vietnam, which could spread through migratory birds to other geographic regions. Because of the upcoming Northern Hemisphere autumn and winter, there is concern that H5N1 activity in birds could flare up. This in turn increases the risk of mixing with human strains to create a pandemic strain. The risk to human health is the emergence of a novel human H5 influenza strain which can spread easily between humans. At this stage, careful surveillance of influenza in both birds and humans and veterinary public health measures (such as culling of infected birds) will enable better control of the situation.”

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Dr Ian Barr is Deputy Director of the WHO Collaborating Centre for Reference and Research on Influenza based in Melbourne.

“The FAO media release today (30 August 2011) on bird flu highlights the continued presence of highly pathogenic avian influenza A(H5N1)) in several countries in South East Asia and Africa. Different varieties of H5N1 viruses have been found in different regions and countries however the vast majority of viruses reported have still been isolated from either wild birds or poultry, with only the occasional human infection. The FAO report describes a new virus strain of H5N1 which they term 2.3.2.1. This virus is similar to other viruses in the 2.3.2 group which have been found previously in wild birds or poultry in Japan, Myanmar, Republic of Korea, Nepal, Hong Kong and Vietnam from 2006-11. The effectiveness of existing H5N1 poultry vaccines currently in use in some countries against this new virus will need to be determined. No human cases have been detected with this new virus to date.”
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Professor Peter Doherty is a Laureate Professor from the Department of Microbiology and Immunology at the University of Melbourne. Professor Doherty won a Nobel Prize for Medicine in 1996.

“The first point to make is that we have not had any H5N1 ‘bird ‘flu’ outbreaks in Australia, though this virus is active in countries to our north and west. We are protected by our quarantine, and by “Wallace’s Line” which determines avian migration patterns. Since the emergence of a high pathogenicity (HP) H5N1 in wild water birds at Qinghai Lake in 2003, the HP H5N1 virus spread extensively to India, the Middle East, Europe and North Africa. Prior to that, it had also gone as far south as Indonesia, possibly via the illegal movement of birds. The peak of the disaster was in 2006, and a conservative estimate is that 400 million domestic poultry have been culled or killed, at a cost of more than $20 billion. There are in excess of 560 confirmed human cases with a mortality rate of around 60 per cent. Of the eight human infections in Cambodia this year, all patients died. These H5N1 viruses are extremely virulent in mammals, including lab mice, ferrets, and naturally infected cats and leopards.

Though partial control has been achieved and there has been evidence of eradication from domestic poultry in some countries, HP H5N1 keeps coming back. Vaccination does not seem to be the solution, and it is thought that large chicken populations serve as ‘incubators’ for the selection of resistant mutants. Whether such mutants are indeed being spread by migratory water birds is less clear, though the pattern of sporadic re-introductions in remote locations is suggestive. One high-tech solution that is being pursued in research laboratories is to engineer a spectrum of resistance/interference genes into domestic poultry. If that works, it could provide a solution though it would, of course, require that those in the affected regions overcome any qualms they might have concerning the consumption of GM chickens.

This is a dangerous situation, both from the economic/social aspect of lost high quality protein production in developing countries, and from the possibility that the continued exposure of humans (and pigs) could lead to the emergence of a mutant, or a reassorted (with a current human strain) H5N1 virus that could spread between people and trigger a global pandemic. The recent H1N1 “swine ‘flu” pandemic was caused by the reassortment of genes from two pig viruses. That virus was incredibly infectious and went around the world in six months though, fortunately, it was not especially virulent as it took about six months before we started getting vaccine into peoples’ arms. If, however, a pig became infected simultaneously with an HP H5N1 virus and the 2009 pandemic strain, it is possible that an extremely virulent variant that spreads readily between humans could emerge. That is one of the many reasons why the current, global effort to develop much more cross-reactive influenza vaccines for production ahead of time (perhaps as a strategic reserve) is so important.”

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Professor George Milne is from the University of Western Australia’s School of Computing Science and Software Engineering. He has done research on disease spread modelling.

“The emergence of new strains of H5N1 avian influenza is not surprising due to the constant change inherent in influenza viruses. The concern for humans is that previous H5N1 strains which infected humans have had a high case fatality rate (60% plus has been estimated).

Furthermore, and significantly, experiences with H1N1 swine flu in 2009 and 2010 indicated difficulty in containing and controlling its spread. Recent modelling conducted by ourselves and others in Australia has given guidance as to which intervention strategies may be most effective (and cost-effective) in containing an outbreak. For a highly pathogenic strain which becomes transmissible between humans the UWA modelling suggests that a strict regime of social distancing measures (home quarantine coupled with sustained school closure) together with the rapid and comprehensive use of antiviral drugs would be the most effective and cost-effective strategy to adopt.”

Today, the government released this report which contains Professor Horvath’s findings, and recommendations to improve the Australian reporting and response system. In case you missed it earlier today, we are sending you links to the report and a comment from an expert.

A press release for the Horvath report can be found here, and the report itself here.

Feel free to use these quotes in your stories.  Any further comments will be posted here. If you would like to speak to an expert, please don’t hesitate to contact us on (08) 7120 8666 or by email.

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Professor Robert Booy is an infectious diseases and immunisation expert based at the University of Sydney

“The Horvath report addressing safety of flu vaccination in Australia’s children is welcome and raises some crucial points. There is no doubt that improving communication about health matters with the public and profession, as well as increasing the transparency of the regulatory agency, the TGA, will be of benefit.

The report calls for the establishment of a number of working parties or committees, so in a sense is just the start of our thinking process on this important topic. I suggest that the seventh and last recommendation around improving and developing e-planning particularly needs to be fleshed out.

The best way we could get early signal of a safety concern would be to have active surveillance; linking records generated about vaccine uptake, GP presentation and hospital admission in real time. This  could allow very early recognition of a problem.

Improved post-marketing surveillance with active elements may cost more but in the long term be cost effective.”

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These comments on the bird flu epidemic in Japan come from the new Science Media Centre in Japan and have been translated into English with support from the Australia- Japan Foundation. The SMCJ has compiled some comments from experts on the outbreak:

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Professor Koichi Otsuka, Director of the Avian Influenza Research Centre, Kyoto Sangyo University

“High pathogenic avian influenza means that of all of the influenzas which affect birds, the majority of chickens who get infected by this highly lethal influenza will die.  While bird flu itself will not kill a bird, birds who live in close quarters, such as chickens in poultry farms, repeatedly infect one other.  This can lead to the virus changing into a more lethal strain.  Now when a bird is infected with this dangerous virus, it usually dies within three to four days.    The highly pathogenic avian influenza is only lethal to birds.  Mammals are affected differently.  Bird flu can infect humans, but in countries such as Japan where there is a high level of awareness towards hygiene, this rarely happens.

To date, avian influenza types which have caused Japan problems were H5 and H7 viruses.  These had outbreaks in the Taisho period (1912 – 1926), but over the last 79 years there have been no reported outbreaks.

To stop any widespread infections, Japan has chosen to slaughter all of the chickens in the poultry farm where the outbreak was first reported, and follows up with thorough disinfection processes.  This is the best way to create a clean, virus-free environment, and is also carried out in other developed countries.  What is important is that as soon as symptoms are noticed, the necessary precautions are carried out to stop the virus from getting out of hand.

Only in extreme cases have there been records showing humans had been infected with bird flu, so details about why or how these people were infected remain unknown.  The WHO’s reports are only the tip of the iceberg and I think it is necessary to send a team into the outbreak zone to pin point the cause.

In Japan, responsibilities are split between the Ministry of the Environment who deal with wild birds, and the Ministry of Agriculture who deal with poultry.  However, there is only one pathogen. The virus in this case has been reported to have been brought in by a bird outside the country, but the H5N1 avian flu strain is one broken out from a chicken.  This makes wild birds the victim.  The ministries need to go beyond their boundaries and take the necessary moves to get bird flu under control.  They need to get support from wild bird societies and share information in order to figure out the best way to block the virus from spreading between wild birds and domestic chickens.  Because the situation is different in every region, it would be important to take measures suited to the community.”

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Yuya Kimura, Vet, Hokkaido University Graduate School of Medicine

“Not only does the highly pathogenic avian influenza threaten chickens and quails in the poultry industry, but it could also reduce the number or rare birds.  We still remember what swine flu was like and cannot forget that there is a danger the flu might change into something that could infect humans.

It might sound like a big story, but there are ways people can help individually.

The possibility of house and school animals coming in contact with infected birds is not impossible, so try to keep your animals away from wild birds and keep their habitats clean.  With proper hygiene control, you can reduce the chances of infection.  There’s also no need to stop breeding programs because you’re scared of the disease.

Please refrain from bringing wild animals together by doing things such as feeding wild birds.  When animals gather in one place, it can help spread the disease.  There shouldn’t be a problem with bird watching from a distance, but try to stay as far away as possible as people can act as carriers by stepping on the virus with their shoes, transporting it to another location.  Try to stay away from where the initial outbreak was.

Currently, if a domestic chicken is discovered to have been infected, the last resort is to cull all of the chickens in the area that might also be infected.  There is only a small chance that infected products would make it to store shelves, and even if humans were to eat contaminated chicken or eggs, it’s unlikely that they’d be infected.”

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Prof Robert Booy, a Paediatrician and infectious diseases expert at the Children’s Hospital at Westmead, University of Sydney, responds to reports that the swine flu pandemic is over and that the threat was overplayed.

Feel free to use this blog in your stories. If you would like to speak to an expert, please don’t hesitate to contact us on (08) 7120 8666 or by email.

“Last year, only two months after the evolving threat of a world pandemic of influenza was recognized, the new virus had well and truly hit Australian shores. Intensive care units around the nation were filled to capacity with young people beset by severe respiratory complications. This virus was shown in leading scientific journals concurrently to be much more severely affecting the lungs in mice, monkeys and ferrets, thus the evidence at the end of June 2009 was clearly supporting a real problem that needed dealing with.

Indeed the propensity for the virus to severely affect young people around the world meant that although fewer lives were lost, the number of life years lost due to this pandemic became very comparable to that of both the two previous pandemics in 1957 and 1968.

It was recognised early on that the elderly were much less commonly affected due to pre existing antibody acquired fifty or more years earlier. Indeed the age group of over ’80s which is normally floored by the annual flu virus infection, seemed to be especially protected, perhaps by exposure to the previous H1N1 pandemic in the 1920s or before.

It is totally inappropriate to make comparisons between 191 Australian deaths in 2009 from pandemic H1N1 with the mathematically modeled figure of about 2500 deaths annually from seasonal influenza. Many deaths from influenza are never proven by laboratory diagnosis. If one examines data from death certificate records and laboratory proof of influenza in Australia over the past decade, the annual number is usually well below 50. The 191 deaths in 2009 are all laboratory proven. Any good scientist would recognise that we paid much better attention to diagnosis in the wake of this pandemic.

As Professor Bishop, our Chief Medical Officer has emphasized, for the first time we had effective anti viral treatment which undoubtedly mitigated the impact of this pandemic. Importantly those treated recovered more quickly and more often but still largely developed immunity. In addition other sensible public health measures promulgated such as hand washing and cough etiquette undoubtedly also contributed.  

The Australian vaccination campaign has probably vaccinated at least 20% of the at risk population. This in addition to at least 20% being immune due to infection means that a large proportion of the population is now protected, so large that mathematical modeling shows that a huge stop has been put on the viruses spread. This winter we are seeing a ripple of influenza rather than a wave. Even so most influenza cases remain pandemic H1N1 and deaths and intensive care admissions are occurring, albeit at a low level.

Were the Australian government to have delayed its action, or ordered less vaccine, it is conceivable that enough would not have become available to knobble this virus and the front pages would be full of concern about a second wave.  Antigenically, the 2009 virus has many similarities to the 1918 virus that killed 50 million. Both predominantly affected the young and both appear to particularly affect the lungs and induce strong immunity after infection. Academics, clinicians and public health officials should deal in fact and logic, not conjecture or the making of aspersions about funny smells.”

Conflicts of interest: Prof Robert Booy does not hold shares in vaccine companies and does not accept payment from them for consultation. For some years he has produced educational material for the public and health professionals on a pro bono basis. He does vaccine research trials with government and industry. He has been a vaccine researcher for over 20 years, the last 10 focusing on influenza. He is the author of over 25 scientific publications on influenza and a member of national committees devoted to influenza pandemic planning and response.