H1N1 data still in short supply

When a British soldier dies in Afghanistan, we know within days the sex, age and region of residence of the fatality, together with the immediate cause of death. How different it is for swine flu.

The numbers, coincidentally, are very similar. Since 27 April 2009, when UK had its first confirmed case of swine-flu, 58 British soldiers, all male and aged between 18 and 42, have lost their lives in Afghanistan. In addition, there had been at least 64 serious (or very serious) non-fatal casualties to mid August.

There have been 65 deaths from swine flu – but about these we know much less. As pregnant women, doctors and nurses indicate they have doubts about whether they will agree to be vaccinated against H1N1 flu, this gap needs to be filled.

 The surveys in which these groups responded have low response rates, and constitute unreliable dence quantitatively.  But, qualitatively, they can raise issues that need proper quantitation. At next week’s 175th anniversary conference of the Royal Statistical Society in Edinburgh, Professor Sir John Savill (Edinburgh University’s professor of experimental medicine and Chief Scientist to the Scottish Government’s Health Directorates) will chair a hot-topic session on the issue.
Meanwhile, we need to know:

  • The age-distribution of those ever-hospitalised in England for confirmed H1N1 - lacking partly because virological testing, even for those in hospital with suspected swine-flu, is far from guaranteed.
  • The numbers of suspect/confirmed H1N1 maternities - defined as live-births or still-birth when foetus had reached at least 24 weeks of gestation - in May to August 2009. UK has around 700,000 maternities a year, has had at least two H1N1 maternal deaths, but how many suspect/confirmed H1N1 maternities have there been? This is not the first time we have called for this data, but it is still lacking. 
  • The numbers (by age-group) who have been randomized in controlled trials of H5N1 vaccines in UK and world-wide. European Medicines Evaluation Authority website gives an account of GSK’s pre-pandemic H5N1 vaccine as having been tested for effectiveness in dose-ranging studies in some 400 persons aged 18-60 years and in some 400 aged 60+ years. However, this account is unlikely to be the complete picture world-wide; it fails to offer 95% confidence intervals on effectiveness; and it does not concern itself with safety.
  • The numbers (by age-group) who are planned to be randomized in controlled trials of both the GSK and the Baxter H1N1 vaccines in UK and world-wide before these vaccines are sanctioned to be provided to priority groups who, in UK, include healthcare workers. Information that is available is limited.
  • Will the provision of H1N1 vaccine to priority groups be formally designed so that there is robust evidence about the infrequency of serious adverse events, and  real-world effectiveness? Currently, the website of UK’s Medicines and Healthcare Regulatory Authority suggests that a variant of its notoriously-basic yellow card scheme is all that is on offer

Perhaps today’s briefing by the Chief Medical Officer, Sir Liam Donaldson, will refer journalists to more authoritative immunization, pharmaceutical industry and regulatory sources than I, as statistician-member of the Scientific Pandemic Influenza Advisory Committee (which has not met since swine-flu hit the UK), have come up with.
In particular, where are protocol-outlines for randomized controlled trials of H1N1 vaccines registered which summarise the basic experimental designs and numbers to be randomized?
Scottish schools returned earlier than in England. Today’s update by Health Protection Scotland may signal if school-age swine-flu consultations in Scotland have begun to rise.