Health Secretary Jeremy Hunt is facing demands to ditch a medical funding formula that has prevented a life-saving vaccine from reaching children.
Approved by the European Medicines Agency last year, the Bexsero vaccine would prevent child deaths and devastating limb amputations caused by meningitis B (MenB), but its use has been halted by a mathematical, rather than a medical, evaluation.
Health academics believe that had the same cost-driven formula been applied to other vaccines already in use, such as the meningitis C vaccine, they would not be protecting families in the UK today.
The calculation used by government health economists includes a discounted valuation of a child's life, at only 27 years. The figure is linked to a "quality-adjusted life years" and takes into account the financial implications of medical intervention, the subsequent quality and quantity of years lived. Also not taken into account are the severe effects of the disease on parents' lives, and the millions in NHS litigation costs linked to meningitis, leading to underestimations of the potential economic benefits.
An October meeting of the Joint Committee on Vaccination and Immunisation (JCVI), an advisory body to the Department of Health, decided against recommending the MenB vaccine for the UK-wide immunisation programme. But leading physicians who gave evidence to the committee claim that the raw value-of-life calculations used to reject the vaccine on cost-efficiency grounds "[discriminate] against children and effectively [punish] them for being a child".
The JCVI is scheduled to re-evaluate the vaccine over the next month but no U-turn on the October decision is expected. Mr Hunt is under pressure to veto the advisory body and accept that the lives of children are at stake.
If the Bexsero vaccine, produced by the Swiss multinational Novartis after 20 years of research, is shelved because of the Department of Health's controversial efficiency formulation, the development of other future vaccines is likely to suffer.
David Cameron is said to be aware of the potential damage to the Government's NHS record if the MenB vaccine is available only privately. Details of alleged spending excesses by officials at the health guidance authority Nice, including bills for luxury hotel rooms, will also do little to demonstrate where health priorities lie.
Over the past decade there have been more than 10,000 cases of meningococcal B diseases recorded in England and Wales. The death rate for these has been 5 per cent, and those who survive often face neurological damage, the surgical removal of limbs and severe damage to the skin. Although vaccines and immunisation programmes for other strains of the disease have been successful, MenB remains a major source of parental fear because of its speed when it attacks children and adolescents.
Official minutes of the October JCVI meeting at the Department of Health's Skipton House, in south London, show wide-ranging concerns from many of the leading doctors and scientists attending.
One clinical researcher, who asked not to be named for professional reasons, told The Independent on Sunday that there was "a sense of unease that science and health issues were being overwhelmed by government health economists. Costs and saving dominated. Everything else was ruled less important".
The official record acknowledges concern from attending experts and observers that "quality of life losses of IMD [invasive meningococcal disease] had not been fully captured within the cost-effectiveness analysis". The minutes also note that leading researchers wanted the "impact of IMD on close family members" to be taken into account, as well as "the considerable cost of litigation to the NHS following diagnosis or misdiagnosis of IMD".
Part of the Department of Health's efficiency algorithm for the vaccine involved a "discounted" value for the quality and quantity of life of a child who had survived MenB, measured against the cost of the vaccine's introduction.
Health professionals consulted by the JCVI are said to be angry that a manipulated figure of 27 years for a child's "life" is being used. Despite years of analysis for parallel adult measurement, there is still no stand-alone paediatric evaluation.
One leading physician said: "This is nothing more than pseudo-science; a pretence at cost-efficiency. It is a political and economic decision."
Although the JCVI is currently re-examining the decision to reject the MenB vaccine, many in the UK medical research community fear that unless Mr Hunt personally intervenes over the next few weeks, the efficiency calculation will simply deliver a repeat conclusion.
Recent health statistics estimate that an annual 1,200 cases of MenB result in 120 deaths. However, the JCVI's calculations were roundly criticised for not taking into account "significant non-cyclical fluctuations" and the "unpredictability" of MenB disease rates in the UK. A longer-term average, taking into account the historically high peaks resulting from MenB outbreaks, rather than the current relatively low rates, would have substantially altered the Department of Health's sums and its decision to reject a life-saving immunisation programme.
The Bexsero vaccine is estimated to cover 88 per cent of MenB disease in the UK. Although it is available privately from NHS GPs, with doses costing £75 each, bills for parents of children aged between two and six months would be £300 or £225 for children aged from six months to two years. However, without the vaccine being available to all young children in the UK, any "herd immunity" will be absent.
A recent letter to The Lancet by Dr Matthew Snape of the Oxford Vaccine Group at Oxford University said: "There seems little doubt that the public will react strongly to the continuing deaths and disabilities from meningococcus B that will occur in the absence of immunisation."
At the end of last year, the Bexsero vaccine, which is not yet licensed in the United States, was offered to thousands of students at Princeton University after a string of meningitis B cases hit the Ivy League institution.
With the formal blessing of the US Center for Disease Control and Prevention in Atlanta, about 5,500 vaccines were made available to all graduate and undergraduate students living in the college's dorms and annexes.
As well as young children, young adults have an increased risk of contracting meningitis, especially when they live and work close to each other. The first dose of the vaccine was given in December last year. The second will be administered at the beginning of February.Reuse content