Tweet
Swine flu: A shot in the dark
Published Date: 26 July 2009
By Eddie Barnes
CHLOE Gibbons might count herself as one of the lucky ones. The 22-year-old Adelaide resident was one of the first in the queue last week to receive the world's first swine flu vaccine when her local hospital came out looking for volunteers. Australia has been among the countries worst hit by the swine flu virus which has swept the globe since Easter and is the first to prepare a vaccine.
Offering herself up as a human guinea pig earned Chloe 400 Australian dollars (?200). "I'm just happy to do my part and help out," she said. "The money's an incentive as well, but people are dying from it so I'm happy to help."
In Scotland, Falkirk parent Marianne Dryburgh has a different story to tell. The mother of an 11-year-old boy with special needs, she is acutely aware of the danger he faces. "He falls into the category of having underlying health issues. He has already had pneumonia," she said. Her family's concerns were heightened when her husband's secretary came down with the virus recently. "It is about making an intelligent approach and not getting too emotional, but parents will always make emotional decisions. And as soon as we knew someone who had had it, then your reaction changes."
The response from the health authorities so far has failed to reassure her. "They don't know enough about what is going on. When I go on to their website I'm not seeing anything that is allaying my fears." And as for the arrival of the promised vaccine for British patients? "They just don't know. I have asked repeatedly at my doctor's practice and they don't know, they can't tell me."
Like Marianne, many parents and families will be forgiven for feeling confused. Daily reports of the latest swine flu deaths and the story of a patient being rushed to Sweden for treatment clashed with claims that the current wave of the virus was actually receding. The fear is that, come September and the return of the traditional flu season, the virus will return with a vengeance. The World Health Organisation warned on Friday that the virus would, like all viruses, circulate more widely in colder weather and possibly mutate. As the days get shorter, so the need for the vaccine will grow.
Last week, canvassing in the Glasgow North East by-election, Scottish Health Secretary Nicola Sturgeon found herself being hailed by a passing driver demanding to know when a vaccine would be ready. Anti-viral drugs such as Tamiflu can only help once the virus has been contracted. The key to halting the spread of the virus to the general population at large and to vulnerable groups in particular is a vaccine. So when will a vaccine be here in the UK and when will the whole population be covered? And as in all mass vaccination programmes, will we have to accept that as well as millions of beneficiaries there will be a number of casualties, especially when the vaccines are being rushed through clinical trials to help stop the global swine flu pandemic?
MUCH of the attention is currently centring on the NHS's ability to manage the spreading virus which, according to officials, infected 100,000 Britons last week, a near doubling of the rate the previous week. But, as GPs and call centres struggle to deal with the current cases, the bigger picture lies elsewhere. Five manufacturers ? CSL Ltd, Baxter International, GlaxoSmithKline, Novartis AG and Sanofi-Aventis ? are now working flat-out to produce the fluid which could save thousands of lives across the world.
The five firms have been preparing for this mammoth task for years. But progress is going slower than expected, with the strains provided by the World Health Organisation for the companies to work with only so far yielding about half as much vaccine as expected. Whether it will be effective is still open to question. In Australia, the 540 people enrolled in two trials of a vaccine will only know whether or not it is successful in six to eight weeks' time.
In the US, the health authorities expect the first trials to begin in the middle of next month. Here, the outlook is unclear. Earlier this month, Kevin Woods, the chief executive of NHS Scotland, wrote to NHS boards suggesting that the first batch of vaccines "could be available from mid-August". Initially, 30 million double doses have been ordered ? enough for almost half of the population ? to be delivered by injection three weeks apart. But last week GlaxoSmithKline, one of the two suppliers, along with Baxter, which is producing vaccines for the UK, suggested those low yields were delaying matters. Even if the first vaccines arrive by September, there will still have to be a period while safety trials, however limited, are conducted. Dr William Schaffner, a vaccine specialist at Vanderbilt University in Tennessee, said: "Some of us are sceptical that very much will be available by mid-October."
But once the vaccine finally arrives, another difficulty emerges. In his letter to NHS boards, a copy of which has been passed to Scotland on Sunday, Woods does not shy away from the potential difficulties. "Delivery of the H1N1 vaccination programme will be a significant challenge to the NHS in Scotland, unprecedented in scale and scope," he declares. Once the vaccine is ready, a military-style operation which will test the NHS to its limits will begin.
The country's eight boards will take charge of their own areas, with GPs and nurse practitioners expected to take the lion's share of work. The vaccine will be given out according to priority need, with those at the front of the queue including people already at risk of seasonal flu, pregnant women in their second and third trimester, health workers and young children. Woods believes that enough vaccine to cover half of Scotland's population could be here before the end of the year. But he warns that those in the lowest priority groups could be waiting until November 2010 before an inoculation is ready.
There are options that could eke out the vaccine. Scientists are studying whether certain groups of people could get away with just one jab, in a move which would substantially ease the burden on the health service. Other existing vaccination programmes might have to be scaled down in the face of the greater threat, as there is a question mark over whether overstretched GPs will be able to manage their routine flu and childhood vaccine inoculations on top of all the extra work incurred by swine flu. Officially, such routine work is "under review".
GPs say it may be the case that high-risk groups will have to receive their swine flu and seasonal flu jabs at the same time. But the prospect of such a heavy dose is likely to cause concern. Meanwhile, NHS boards are working to increase the number of competent vaccinators who have sufficient training to give people their jabs.
There is also the question of who is going to pay for it all. The SNP government now appears to have lost its bid for the UK government to meet the estimated ?100 million cost of delivering the vaccine. Instead, it will have to meet the cost from its own coffers. Whitehall sources have expressed irritation at the squabble, pointing out that it is only the spending power of a country of 60 million people which has ensured a good deal for the taxpayer. One insider said: "Why is the vaccine competitively priced? It is because you are buying it for 60 million people, not five million people."
The drug companies are set for a windfall whoever pays: the ?600m GlaxoSmithKline is expected to earn from its Relenza flu treatment is likely to be dwarfed by the eventual sum it makes on the vaccine once it is ready. Some estimates go as high as ?3 billion.
All the cost and hassle lead some to question the entire exercise. In 1976, when cases of swine flu emerged in the US, health officials hastily moved to vaccinate 40 million Americans. The pandemic never materialised, but thousands who got the shots filed injury claims, claiming they had suffered side-effects. Thirty people died. As we report today, the UK government has signed agreements with both GlaxoSmithKline and Baxter granting them immunity from any legal cases which could occur, should people suffer side-effects. One medical legal expert said: "It shows that they want a get-out-of-jail-free card. These companies aren't daft."
Safety issues are also rearing their head amid fears that the vaccine could be rushed through testing and into production without the usual, painstaking trials.
GlaxoSmithKline, which is developing the vaccine at its sites in Germany and Canada, said it would be tested on a limited number of people to allow mass production to start as soon as possible. But Professor Hugh Pennington, one of Britain's leading microbiologists, said: "I think we have to look very carefully at any kind of plan to rush through the implementation of vaccination before we have the full results of testing. The real problem is do we know how good the vaccine is?"
Dr Richard Halvorsen, a central London GP, medical director of BabyJabs, a children's immunisation service, and author of a book, The Truth About Vaccines, to be published on 7 August, believes some recipients will suffer serious side-effects from a mass vaccination programme. "To be properly tested for safety, a vaccine needs to be given to tens of thousands of people and followed up for several months to detect uncommon but serious side-effects," he argued. "This is clearly not going to happen with the swine flu vaccine, which is being fast-tracked at unprecedented speed. The little safety testing that does occur is likely to be in healthy people, and not those with health problems, who are in greatest need of the vaccine but probably also at greatest risk from side-effects."
The British Medical Association insists that in Scotland the pandemic is at manageable levels, with the massive rises in cases as seen in London and Birmingham in the last week not coming this far north. "In Scotland we are still advising people that if they think they have swine flu they should phone their GP, and if it is out of hours then phone NHS 24. If we reach huge numbers then NHS 24 will be taking all the calls and more call handlers will be drafted in. But we are not nearly at that stage yet."
He added: "You have to remember that most people are just getting a minor illness and are getting over it."
Such reassurances are unlikely to satisfy parents like Marianne Dryburgh. "I just want my children to get the vaccine as soon as possible," she said. Across the world, the firms contracted to get that vaccine to her are working feverishly round the clock. But the message is clear: any instant cure for swine flu will have to wait a few more weeks yet.
Cross-border differences
Health authorities in Scotland and England are dealing with swine flu differently
The advice in Scotland remains that people who are worried about flu-like symptoms should contact their GP directly or call NHS 24 on 08454 24 24 24.
Scotland ? together with Wales and Northern Ireland ? has not joined the National Pandemic Flu Service launched for England last week.
The Scottish Government judges that demands on NHS 24 and GPs from people concerned about the illness are not yet at levels that would make that necessary.
On 1 June, early on in the outbreak, Scotland set up the Scottish Flu Response Centre (SFReC), a dedicated team within NHS 24. This service provides vital information to the public and health professionals concerned about swine flu and how it may affect them.
SFReC now receives between 1,200 and 1,300 calls a day from people who believe they have flu symptoms, and a further 1,000 callers accessing the recorded advice line.
Assuming England's new computerised National Flu Pandemic Service has not crashed due to overuse ? as it did temporarily last week ? those who suspect they have flu-like symptoms are told to stay at home.
Users are told they can phone one of two helpline numbers or take part in a computerised self-assessment exercise. Those who receive a positive diagnosis are allocated a unique number which then entitles them to access antiviral medicines.
The service is being staffed by 1,500 call centre workers who do not have medical training. They should be capable of dealing with 200,000 calls a day.