The medical humanitarian organisation Médecins Sans Frontières (MSF) has warned that vaccine prices are too high for many poorer countries.

In the last decade, MSF said, the cost of fully vaccinating a child has risen from $1.37 to $38.80, due largely to expensive new rotavitus and meningitis vaccines.

MSF has asked the GAVI Alliance, which makes discounted vaccines available to governments, to also make them available to humanitarian organisations.

Organisations such as MSF, which can reach children in vulnerable groups who are neglected by standard vaccination programmes, are currently unable to negotiate the cheapest vaccine prices.

“Urgent action is needed to address the skyrocketing price to vaccinate a child, which has risen by 2,700 percent over the last decade,” said Dr. Manica Balasegaram, Executive Director of MSF’s Access Campaign.

“Countries where we work will lose their donor support to pay for vaccines soon, and will have to decide which killer diseases they can and can’t afford to protect their children against.”

A recent press statement from MSF blamed the growing lack of access to vaccines in poorer countries on the “lack of transparency by companies on vaccine manufacturing costs and their focus on profits above ensuring sustainable prices”.

However, it also described GAVI’s new offer to reduce the price of pentavalent vaccine as “an excellent example of what GAVI can achieve, especially when there are multiple vaccine manufacturers in a market and healthy competition”.

MSF called on GAVI and the pharmaceutical industry to bring vaccine prices in poorer countries “much closer to the cost of production”. It noted that drug donations are not a long-term solution to the issues of global vaccine supply.

Vaccines are the most important breakthrough in modern medicine: the jewel in the crown of the pharma industry. What can the success of vaccines teach us about healthcare and the industry’s commercial model?

Out of the virus immunity comes.

Killing Joke’s lyric uses vaccines as a metaphor for the human ability to find a positive meaning in the darkest threat. The history of medicine has shown, time and again, that every disease holds the seeds of its own treatment – but to find the answer, you have to look deep inside the problem.

It has been said that no other health initiative, with the exception of clean drinking water, has done as much as vaccines to improve public health. Medical sales professionals love selling vaccines, for two reasons. Firstly, their potential to protect the young and the old against highly dangerous diseases is beyond reasonable doubt. Secondly, the sales model for vaccines is as dramatic as its medical impact: the supplier becomes responsible for securing the immunity of a population.

Yet, on the face of it, the public might wonder what the fuss is about. Vaccines are one-off medical treatments that protect against specific infections. Many are prophylactic: they don’t work if you have the disease. They are not 100% reliable, since pandemic infections have many competing strains. And they can have harmful side effects. So why should healthy people bother?

The answer lies in the list of deadly and disabling diseases that once cast a shadow over human life, but now are preventable: smallpox, polio, tuberculosis, measles, mumps, chickenpox, typhoid, cholera, bubonic plague, rabies, tetanus, diphtheria and pneumonia. For some viral infections, vaccines are the only effective treatment.

Vaccination programmes demand collaboration across disciplines and borders to protect populations and share medical innovations.  This collaboration model meets with scepticism on two sides: those who mistrust public health provision and those who mistrust the pharma industry. It’s not surprising, therefore, that vaccines meet with antagonistic campaigns and conspiracy theories from a coalition of unreason.

The body’s weapons

Vaccines are different from conventional medicines because they do not directly attack the disease: they provoke the body’s natural immune response against the disease, like a mock-invasion used as a military training exercise. A vaccine dose consists of dead or inactivated disease organisms, or biochemical agents derived from them. In designing a vaccine, scientists trade off risks and benefits.

The first vaccination was conducted by the rural English physician Edward Jenner in 1796. Hearing that local milkmaids who contracted a minor infection called cowpox never seemed to contract the deadly smallpox, he deliberately infected a farm lad with cowpox and then, when he had recovered, with smallpox. (Medical research ethics have improved somewhat since then.) The use of a live disease culture for immunisation is now called inoculation.

The first use of an artificial vaccine was conducted by Louis Pasteur in 1885, using a vaccine developed by his colleague Emile Roux by dessicating the spinal tissue of rabies-infected rabbits. Pasteur gave the vaccine to a boy who had been mauled by a rabid dog. He came to no harm.

Vaccines are still news, with global mobility and shifting demographics making the challenge of immunity more complex and urgent than before. In 2012, new vaccines were developed to treat meningitis, shingles, rotavirus (a cause of infant diarrhoea) and whooping cough. Vaccination against HPV, the cause of cervical cancer, is a new priority for health systems. The GAVI Alliance, dedicated to providing vaccination programmes for children in the developing world, has funding from the Bill & Melinda Gates Foundation and the support of many pharma companies.

A vaccine coalition

A leading company in the European vaccines field (and the only specialist firm) is Sanofi Pasteur MSD, a collaboration between two major pharma companies with a long history of investment in immunity. Sanofi Pasteur is founded on the work of the Pasteur Institute, while Merck’s Dr Maurice Hilleman developed vaccines for measles, mumps, hepatitis A and B, chickenpox, meningitis and pneumonia. The joint company protects half a billion European people against 20 major diseases.

Paul Hardiman, Communications Manager for Sanofi Pasteur MSD, told Pf about the company’s unique role in the European immunity landscape. There are three reasons for the collaboration, he explains: “It avoids a duplication of effort in the drive to develop new and innovative vaccines. It also allows a focus on the strengths and suitability of vaccines for different markets from both companies’ portfolios. This in turn gives flexibility and supports public health priorities.”

The two parent companies are both deeply involved in the global project of the GAVI Alliance. Both Sanofi Pasteur and MSD “use a policy of tiered pricing (linked to a country’s ability to pay) to enable access to vaccines in GAVI-eligible countries. This has included significantly reduced prices on vaccines against HPV and rotavirus and a pentavalent childhood vaccine against diphtheria, tetanus, pertussis, polio and Haemophilus influenzae type B.”

In the UK, Sanofi Pasteur MSD plays a major role in public health immunisation programmes for children, young adults and elderly people. These “are secured through competitive national tenders, requiring the consistent and timely supply of large volumes of high-quality vaccines”. The company has dedicated vaccine representatives selling directly to pharmacies and GP practices.

“Every year, the Joint Committee on Vaccination and Immunisation (JCVI) carries out a horizon scanning exercise to identify all potential new vaccines expected from manufacturers that may have an impact on public health over the following five years.”

As public health in the UK shifts to local authority provision, vaccine suppliers need to be fully aware of the economics and logistics of immunity. Sanofi Pasteur MSD’s UK sales force are “vaccine experts, engaging with practice nurses and GPs to support them in the areas of vaccine supply, campaign organisation and communication, and the education of vaccinating HCPs.”

The company is now supplying Gardasil for a schools-based vaccination programme to protect teenage girls against HPV and hence against cervical cancer. It is also preparing to supply Zostavax for a national programme, starting later this year, to immunise senior citizens against shingles. In the future, the company hopes to target, cancers, allergies, addictions and diseases of the central nervous system.

Immunisation programmes deliver savings both in the short term (by reducing the need for acute treatment) and in the long term (by reducing disability and chronic illness). As the focus of healthcare shifts further into the community, vaccines are increasingly crucial weapons in the HCP’s armoury. Their value, the company maintains, can be expressed in both health and economic terms.

Diplomatic immunity

In February 2013, nine female health workers responsible for delivering polio vaccination programmes in the Kano province of Kenya were murdered by gunmen after a local preacher condemned the vaccine as a plot to cause infertility. Similar killings have happened in Pakistan. In the US, ideologues opposed to public health programmes have accused the Obama government of spreading disease in order to experiment on the public with dangerous biological agents. The internet has given these conspiracy theorists a large audience.

In the UK, a spurious panic was created around the MMR vaccine by Andrew Wakefield’s article in The Lancet in 1998, which claimed the vaccine was a cause of autism. As the BMJ has recently reported, the article was scientifically discredited within a year, and has since been exposed as an “elaborate fraud” based on research that never took place. However, Wakefield’s claims are still declared to be accurate by the Daily Mail and its bizarre columnist Melanie Phillips.

Why do vaccines inspire so much mistrust? The reasons are complex. Some people believe that harnessing the body’s immune response is ‘interfering’ with nature. Others maintain that public health programmes violate the responsibility of the individual to determine their own healthcare. Still others claim that immunisation programmes are a form of covert surveillance, or even of biological warfare.

Paul Hardiman argues that vaccination may be a victim of its own success: “Anti-vaccine sentiment is thought to arise when people no longer fear the disease for which they are being encouraged to accept vaccination. As vaccine coverage increases, serious disease starts to disappear along with people’s fear of the disease. As people lose sight of the threat, so anti-vaccine sentiment may replace the good reasons for vaccinating – raising concerns in people’s minds.”

Doctor and writer Ben Goldacre, whose book Bad Science is strongly critical of anti-vaccine conspiracy theories, argues that the industry is not blameless: “I think it’s fair to say that anti-vaccine conspiracy theories are a kind of poetic response to the obvious regulatory failure in medicine and in the pharmaceutical industry. People know that there is something a little bit wrong here.”

For example, he notes, the recent murders in Nigeria took place in the same province where Pfizer had run the Trovan antibiotic trial in 1996 – a trial whose controversial nature led to Pfizer paying the Nigerian government £75 million to settle out of court, and inspired John le Carré’s novel The Constant Gardener.

Goldacre comments: “There’s something interesting happening when a very destructive anti-vaccine conspiracy theory built around fear and anxiety that drug companies are behaving badly arises in the same very small province in northern Nigeria where Pfizer have been running a trial which many regard as unethical.”

Biotechnology giant MedImmune has appointed Bahija Jallal, its current Executive Vice President for R&D, as its new President.

The former President of the Maryland-based company, Peter Greenleaf, will take over leadership of parent company AstraZeneca’s (AZ) Latin American business.

The transition accompanies the formal designation of MedImmune as the global biologics division of AZ, which acquired it for $15.6bn in 2007.

Bahija Jallal is a former researcher at the Max-Planck Institute of Biochemistry in Germany. While VP of Drug Assessment and Development at Chiron, she was headhunted by MedImmune in 2006, becoming its Head of Translational Science.

Commenting on that appointment, Jallal said: “I was struck by MedImmune’s history of innovation. And I looked at who they had on their board of directors and their executives. There were more women than you would see at other companies.”

The fortune paid by AZ to acquire MedImmune surprised many in the industry. The acquisition was followed by investment in its R&D capability, including the development of a new site in Cambridge, England, and the merger of the UK group with Cambridge Antibody Technology.

According to MedImmune spokesman Mike O’Brien, the biotech company’s commercial operation now formally belongs to AZ’s North American business, while its manufacturing operation is part of AZ’s global operations.

“The driver for these changes is not cost but even faster decision-making in key areas of the business and a need to reduce complexity,” he said.

Through MedImmune, AZ plans to deliver an average of one new biologic drug per year from 2013.

MedImmune’s past successes include two innovative vaccines: the first monoclonal antibody approved by the FDA for use against an infectious disease (Synagis, used to prevent the childhood lung disease RSV); and the first intranasal vaccine against influenza (FluMist).

A scheme that used bogus figures for investment in vaccine research to exploit a tax loophole has been exposed by HM Revenue and Customs (HMRC).

Matrix Securities sold a scheme to investors whereby they could gain tax relief at nearly twice their level of investment, using a tax break designed to encourage medical research.

However, HMRC exposed their investment figures as fraudulent and refused most of their tax relief claim, forcing the Matrix Group into administration.

The company raised £28m from 83 investors and borrowed another £86m from banks to fund research into vaccines against HIV, influenza and hepatitis B.

It claimed a first year trading loss of £193m and £77m tax relief, of which £50m would be paid to the investors.

However, HMRC established in a tribunal that only £14m had been spent on R&D and was therefore subject to tax relief.

Matrix Securities and other members of the Matrix Group have gone into administration – though another member, Matrix Asset Management, claims to have invested £107m in the development of a universal flu vaccine.

Clients who invested in the fraudulent scheme are claiming it was misrepresented to them.

David Gauke, Exchequer Secretary to the Treasury, commented that HMRC “will take decisive action to close down schemes with the sole purpose of avoiding paying tax.”

Andrea Rappagliosi, Sanofi Pasteur MSD’s Vice President of Market Access, Health Policy & Medical Affairs, has been appointed President of Vaccines Europe.

Rappagliosi, who has held senior roles in EuropaBio and Vaccines Europe, is one of the new management team appointed by Jean Paul Kress when he became President of Sanofi Pasteur MSD in 2011.

The appointment reflects the importance of Sanofi Pasteur MSD as a major partnership between firms, and the only company in Europe to develop and manufacture only vaccines.

Vaccines Europe represents vaccine manufacturers within the European Federation of Pharmaceutical Industries and Associations (EFPIA), including Sanofi Pasteur MSD, AstraZeneca, Novartis, GSK, Crucell, Pfizer, Abbott and Baxter.

Rappagliosi joined Sanofi Pasteur MSD from GlaxoSmithKline in 2012, where he was Vice President of European Government Affairs.

He has 20 years’ experience in the pharmaceutical industry, and has served as Vice President of Vaccines Europe and Chairman of biotechnology trade association EuropaBio.

Jean-Paul Kress, President of Sanofi Pasteur MSD, said: “Andrea's expertise will boost Vaccines Europe’s advocacy focus whilst highlighting Sanofi Pasteur MSD’s profile as a clear leader in vaccines in Europe.”

Sanofi Pasteur MSD is an alliance between Sanofi Pasteur, the vaccines division of Sanofi, and MSD (Merck Sharp & Dohme), combining the R&D capability of both companies to focus exclusively on vaccines.

After April 2013, who will commission which health services?

The new NHS structure is designed to promote integrated care by making the roles of a number of different commissioners interlock. The GP-led clinical commissioning groups (CCGs) are the core of the system, responsible for dealing with most areas of patient need in the local community. Around that, however, three other commissioning bodies are engaged with supporting patient health and wellbeing:

• the NHS Commissioning Board (NHSCB) is responsible for primary care and specialised services
• local authorities are responsible for improving public health
• Public Health England (PHE) is responsible for protecting and promoting health though intervention in health and social care services and public awareness.

A map of services

The Commissioning Board Authority’s Commissioning fact sheet for clinical commissioning groups maps the new health landscape by comparing the responsibilities of the four organisations. For each new commissioner, it lists the main functions and the similarities to other commissioners – thereby making the point that service integration is vital for effective care.

The fact sheet states that CCGs will need to work collaboratively with local authorities and the NHSCB – and that to do so, they may pool budgets or have joint commissioning arrangements. For example, it is suggested that responsibility for sexual health and for addiction-related services will need to be divided between the CCG and the local authority to avoid duplications or gaps in provision.

Clearly, the matrix of healthcare is a dynamic one that can be interpreted by local commissioners in a range of ways. The map is not a final one in any case: some details, including the specialised services covered by the NHSCB, are still to be confirmed by Parliament in the autumn.

Community healthcare

The fact sheet compares the responsibilities of CCGs and the NHSCB for commissioning patient care. It notes that local authorities will provide “public health advice” to CCGs, but will not commission at that level. The role of local authorities in commissioning social care is not covered, but is a further dynamic that CCGs will need to be aware of.

The core elements of CCG commissioning relate to: emergency care; out-of-hours primary medical care (where not covered by the GP contract); elective hospital care; community health (such as physiotherapy and continence services, but not health visiting or family nursing); rehabilitation; maternity and newborn care (except where intensive); paediatric care; mental health and learning disability care; and infertility treatment.

The core elements of NHSCB commissioning relate to: primary care through the GP contract; community pharmacy; primary ophthalmic care; all dental care; health services for people in prisons and other custodial institutions; health services for members of the armed forces; and specialised services.

The fact sheet draws out some detailed differences between the two lists in order to avoid confusion – for example, noting that health services for offenders in the community are covered by CCGs. Sometimes, as where the GP contract varies, certain services may be commissioned by the CCG in some localities and by the NHSCB in others. None the less, overall there is a clear division of responsibilities.

Public health services

With the commissioning of public health services, the picture is significantly more complex. Responsibility is divided between the NHSCB, the local authority and Public Health England. In some cases – notably immunisation programmes – these services can relate to provision of medication. In other cases – notably epidemic preparedness – they can relate significantly to medicines management and other aspects of primary and secondary NHS care.

Public health services to be commissioned by the NHSCB include services for children from pregnancy to age 5. This responsibility will transfer to local authorities in 2015. It covers health visiting, family nurse partnership and responsibility for child health data. The NHSCB will also be responsible for immunisation and national screening programmes – both being areas of increasing NHS spend, as evidenced by recent investment in cervical cancer and prostate cancer screening and in vaccines against HPV and influenza. With hepatitis C vaccines on the market and HIV vaccines a real prospect, this area of medication will become increasingly crucial for the NHS.

Local authorities will be responsible for providing or commissioning a wide range of public health services that relate mostly to preventative measures and raising awareness, including: children’s public health for ages 5 to 19; sexual health; public mental health; obesity management; drugs, alcohol and smoking services; dental public health; and seasonal mortality. Active medical intervention, including medication, features strongly in the sexual health and drug, alcohol and smoking services to be provided; the transfer of sexual health services from NHS to local authority control is a major change in the provision of UK healthcare. Notably, however, HIV treatment will be commissioned by the NHSCB.

PHE is taking over the functions of the Health Protection Agency and will impact significantly on the health protection activities of CCGs, the NHSCB and local authorities. Sometimes all relevant health stakeholders will work together – for example, PHE has a strategic role in influenza and other epidemic preparedness, to which local authorities, CCGs and the NHSCB will contribute. PHE’s role also covers behaviour change campaigns around early diagnosis and other issues; public oversight of infection prevention and control; and general intelligence on health protection and improvement, including the current functions of the Cancer Registries. These initiatives will also impact on GP services.

Joined-up care

CCGs will be the glue in the new healthcare commissioning system: the first port of call when gaps or inequalities in service provision arise. While they cannot commission GP care, their close professional connection to it should ensure that what impacts on CCGs will be taken to heart by GPs. But given that austerity measures will dominate the NHS for the “foreseeable future” (in David Nicholson’s words), it is inevitable that funding and staffing shortages will create holes in the patchwork of the new health system. The pharmaceutical industry will thus need to be alert to partnership opportunities opening up at local and national levels.

GlaxoSmithKline (GSK) and Merck have agreed a deal to make their rotavirus vaccines available in the developing world for five years at a third of their standard price.

International vaccines group GAVI will make 132 million doses of GSK’s Rotarix and Merck’s Rotateq available to poorer countries at $5 per course.

The vaccines will help to combat the main cause of diarrhoea, a major killer of young children worldwide.

GAVI (the Global Alliance for Vaccines and Immunization) plans to distribute the vaccines in more than 40 economically deprived countries by 2016.

The new deal with GSK and Merck will enable GAVI to drop the price of its two-dose rotavirus vaccine courses from $15 to $5.

The WHO recommended in 2009 that all countries should target rotavirus – which kills half a million children every year – with national immunisation programmes.

A spokesman for GSK, which will supply 95% of the doses contracted by GAVI, said: “Rotavirus vaccine has demonstrated real-world, life-saving impact on reducing deaths. We have a chance here to collaborate in programs designed to protect millions of children.”

Based in Geneva, GAVI is a public-private partnership whose backers include the WHO, the World Bank, UNICEF, the Bill & Melinda Gates Foundation and a number of governments.

“Our market-shaping goal is to maintain supply security and strive to achieve the lowest price for currently available products,” commented Dr Seth Berkley, CEO of GAVI. “We have already taken an encouraging step forward towards this goal. GAVI Alliance members will continuously pursue these efforts to broaden competition and ensure the provision of quality vaccines at sustainable prices.”

GAVI’s procurement strategy offsets the cost to suppliers of heavy discounts by prepaying a portion of the fee and extending the deal period.

Pfizer has opened a new £7m cold storage facility near Portsmouth that will be among Europe’s largest vaccine stores.

The new facility at the company’s Havant packaging and distribution site can store up to 38.4 million doses of vaccines and injectable medicines.

Its vaccines packaging line is believed to be the world’s fastest complex syringe packaging system.

As Pfizer goes ahead with the plan to close its R&D facility in Sandwich, Kent, the new storage facility reflects a positive shift in its UK strategy.

Science Minister David Willetts, who opened the new facility, commented: “This £7 million investment from Pfizer will deliver a cutting-edge cold storage facility and comes on top of £26.3 million already invested in a state-of-the-art biotechnology packaging facility.

“This reflects the enormous importance Pfizer attaches to its UK operations and its ability to serve the global pharmaceutical community.”

Jon Tucker, site leader for Pfizer at Havant, noted that the site was already recognised as a Centre of Excellence for cold chain packaging and distribution.

“We have a specialist team here that have developed technologies that are leading the way in this complex area of supply and logistics,” he said.

“It all goes together to make something very special, a £7 million building that has 3,500 pallet spaces to store life-changing and life-saving medicines. These get shipped to 122 destinations around the world.”

Oxford BioMedica, a leading gene-based biopharmaceutical company, has appointed Tim Watts to its Board as Chief Financial Officer and Company Secretary.

The appointment follows the resignation of Andrew Wood as CFO. He will continue as an employee of the company for the immediate future to ensure a successful transition.

Tim Watts has over 30 years’ experience as a financial executive, and has worked within the pharma industry for the last 21 years. His areas of expertise include managing corporate transactions, M&A activity, fundraising and strategic implementation.

With a background in accountancy, Watts joined the pharmaceuticals division of ICI in 1990 and rose to become Finance Director of Zeneca Pharmaceuticals. Following the company’s merger with Astra, he became Group Financial Controller of AstraZeneca in 2001 before leaving to become CFO of Archimedes Pharma.

John Dawson, CEO of Oxford BioMedica, said: “We thank Andrew for his substantial contribution to Oxford BioMedica since its IPO in 1996. His commitment to the Company has been invaluable. I would like to welcome Tim to the executive management team and am confident that his expertise will support Oxford BioMedica’s strategy to secure corporate and commercial success.”

Oxford BioMedica develops gene-based medicines and therapeutic vaccines aimed at addressing serious unmet medical needs. The company’s current partners and licensees include Sanofi, Pfizer, GSK and Biogen Idec.

Bioscience holds out the prospect of medical breakthroughs that can transform our lives – but it has to contend with traditional fears about ‘interfering with nature’. Maxine Vaccine asks whether fear itself might not be the greatest danger.

Everybody’s talking about biotechnology and its implications for medicine. Even the UK Government, hardly the brightest light on the Christmas tree, recently identified stratified medicine as a crucial area for medical innovation. The idea that drugs can be tailored to the specific genetic characteristics of a patient group is powerful and opens up a new vision of ‘personalised medicine’.

But with that comes the familiar fear among doctors and patients that the new therapies are ‘interfering with nature’. It’s a fear that runs through the history of medicine. Before the invention of the microscope, some doctors who argued that diseases could be spread by ‘germs’ were hounded out of their profession. Body fluids are ‘natural’ – how could they possibly pose a danger? The argument ‘it’s not natural’ has been used against hygiene, antiseptics, antibiotics, vaccines, transplants, transfusions, hormonal treatments...

But that’s all long in the past, you might say. These days we’re enlightened, we have evidence, we don’t listen to superstition. Well... maybe. Back in 1998 a doctor fabricated evidence that the MMR vaccine caused autism. He has now been convicted of fraud, but thousands of doctors believed him. Only this year, a critical analysis of the Million Woman Study by scientists who are not clinicians concluded that it had failed to prove a causal link between hormone replacement therapy (HRT) and increased risk of breast cancer – a causal link that had been broadly accepted by the medical profession across Europe and the USA, despite the persistent voices of a sceptical minority.

Is it just possible that where biopharmaceuticals are concerned, a significant proportion of clinicians are primed to believe scare stories because, at a deep level, they suspect that such therapies are ‘against nature’? Where HRT was concerned, after all, many thousands of women had been enabled to continue successful midlife careers without being nudged by the menopause and its traumatic sequels into early retirement. How could that be right?

Many people – and doctors are not only not immune to this, they may be more prone to it than patients – are driven by an uncritical reverence for ‘nature’s way’ to fear and resist the changes we can make to our own lives as our scientific knowledge develops. The recent decision of a European court to deny patents to medical therapies developed from stem cell research shows that the power of fear is still sometimes greater than the will to heal.

Of course there are valid fears about potential harm arising from science and technology. But the danger lies in the abuse of scientific knowledge for purposes of exploitation and social control. Where valid questions need to be asked about the ethics of medical science, those are not questions about the dangers of scientific knowledge. They are questions about us.