New vaccines schedules from the DH and Public Health England include offering a nasal flu vaccine for all children aged two years in England from September.

The NHS will also vaccinate primary school and pre-school aged children from 2014, and secondary school aged children from 2015.

New vaccination programmes for rotavirus, shingles and meningitis C are also planned in the strongest demonstration to date of the priority of disease prevention in the new public health system.

Providing the nasal flu vaccine to all children aged two years, in time for the late autumn seasonal outbreaks, will protect some 650,000 infants.

In addition, babies aged less than four months will be vaccinated against rotavirus – a common cause of diarrhoea and vomiting in infants – from July.

It is estimated that the vaccine will halve the number of cases of rotavirus infection in infants (currently 140,000 per year).

According to Mary Ramsay, Head of Immunisation at Public Health England, the introduction of oral rotavirus vaccine “has had a major impact” on protecting young children from the disease”, resulting in “rapid and sustained reductions in childhood rotavirus hospitalisations”.

At the opposite end of the age scale, an NHS shingles vaccination programme for people aged 70 is planned from September, as well as a catch-up programme for those aged up to 79.

The two programmes will protect some 800,000 elderly people this year from a disease that can cause prolonged neuralgia and disability.

A US study found that vaccinating adults aged 70 or older halved the incidence of shingles and reduced post-herpetic neuralgia by 40%.

Vaccination against meningitis C is also changing from September: a new booster jab at age 12–13 will replace the current booster at four months.

The Government has launched a ‘catch-up’ programme to give the MMR vaccine to a million children in England who lack full protection against measles.

The campaign, in which Public Health England and NHS England will work together, was provoked by the recent outbreak of measles in Swansea.

Most of the children targeted are aged 11–16, a group made vulnerable by a steep decline in uptake of the MMR vaccine following the publication of a medical paper in 1998 claiming it was linked to autism.

The paper has since been exposed as fraudulent, though its claims are still supported by some anti-NHS tabloids.

In the mid-1990s, measles had almost been eradicated in the UK. But by the year 2000, uptake of the MMR vaccine had dropped to 80%, allowing the virus to circulate widely.

In 2012, there were nearly 2,000 cases of measles in England – the highest level in two decades. This year, an outbreak in Wales has infected over 900 people.

The million children in England targeted by the new NHS campaign form three similar-sized groups: children aged 11–16 who have received no vaccine; children aged 11–16 who have received one vaccine dose without the ‘booster’ jab; and children in other age groups who lack protection.

Local area teams will use general practice case registers to identify children at risk and ensure their vaccination in schools and GP surgeries.

Mary Ramsay, Head of Immunisation at Public Health England, said that although take-up of the MMR vaccine had returned to a high level, there was a “legacy of under-vaccinated children” who needed protection.

MMR vaccines, which protect against measles, mumps and rubella, are available from GSK and Sanofi Pasteur MSD.

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.

The current outbreak of measles in Swansea has prompted calls for more effective NHS vaccination strategies across England and Wales.

As the number of children diagnosed with measles in Swansea (620) nears the number diagnosed in the North-West England outbreak last year, concern is rising that older children who missed the MMR vaccine are now those most at risk.

The steep decline in uptake of the MMR vaccine in the late 1990s, following false claims of a link to autism, means that most children now aged 10–17 were not vaccinated – and this age group has been most affected by the recent outbreaks.

US-based measles expert Dr Paul Offit, speaking on the BBC’s Newsnight, said the US policy of mandatory vaccination was the best way to protect children against highly dangerous diseases such as measles.

In the US, he noted, families can opt out of vaccination programmes on grounds of personal belief – but “we just don’t think it’s your inalienable right to catch and transmit a potentially fatal infection”.

The NHS in England and Wales relies on families opting into vaccination programmes, which can leave them vulnerable to unreliable ‘scares’ such as the autism claim.

NHS responses to the Swansea and North-West England measles epidemics have included: letters to all parents of children in the affected areas; hospital drop-in vaccination clinics; special GP surgery vaccination sessions; and school-based vaccination programmes.

Measles can lead to complications including sight loss, hearing loss and death. The MMR vaccine, which comes in two doses a month apart, gives 99% protection against the virus.

Scientist Lord Robert Winston commented: “We need to encourage people to understand that this is a safe vaccine and it’s been widely tested and there’s no evidence at all of autism with it.”

A new quadrivalent (four-strain) vaccine for seasonal influenza has been approved by the MHRA for use in the UK.

Fluarix Tetra from GSK, which has also been approved for use in Germany, is the first vaccine of this type to gain regulatory approval in Europe.

The vaccine is approved by the MHRA for the immunisation of adults and children aged over three years, and was approved in the US in December 2012.

It offers protection against two subtypes of the influenza A virus and two of the B virus, widening the scope of the trivalent flu viruses currently in use.

GSK commented: “As only one influenza B strain is selected for inclusion in trivalent vaccines, there have been seasons when the predominant circulating influenza B strain was different from that chosen for the vaccine.”

The new vaccine is expected to be available to the NHS by autumn 2013, the start of the flu vaccination season.

Sanofi Pasteur and Novartis are both working on quadrivalent flu vaccines, while AstraZeneca has one on the market in the US.

Vaccines against two deadly tropical viruses that are spreading worldwide have been developed by Austrian biotech company Themis Bioscience.

Preclinical studies have shown both vaccines to be effective in improving survival rates in people suffering from Dengue and Chikungunya fever.

Based on a technology platform licensed by the Pasteur Institute in Paris, the Themis vaccines introduce lengthy gene sequences from the pathogen into the patient’s immune system.

The Themaxyn platform has enabled the company to develop a vaccine that is effective against all four strains of Dengue fever. This is vital for effective protection, as immunisation against only one strain increases vulnerability to the others.

Themis will start clinical studies for the two vaccines by the end of 2013, and is also developing a vaccine against yellow fever.

All three viral diseases are endemic in tropical regions, causing many deaths, and are now spreading worldwide due to increased international travel.

Themis CEO Dr Erich Tauber commented on the tetravalent Dengue fever vaccine: “We are actually using this vaccine as a kind of Trojan horse: gene sequences of the pathogens with a length of up to 5,000 base pairs are ‘smuggled in’ and ultimately lead to the immunisation of the vaccinated individual.”

Successful drug candidates will be licensed to pharmaceutical companies and the revenue invested by Themis in further R&D.

Based in Vienna, Themis Bioscience specialises in developing vaccines against tropical infectious diseases that are currently emerging in the West.

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.”

Sanofi’s new paediatric six-in-one vaccine, the first in liquid form, has been recommended by the European Medicines Agency (EMA).

The new vaccine will be marketed as Hexyon by Sanofi Pasteur MSD in western Europe and as Hexacima by Sanofi Pasteur in eastern Europe.

It confers protection against pertussis (whooping cough), hepatitis B, diphtheria, poliomyelitis, tetanus and the HIB bacterium.

GSK’s Infanrix Hexa is currently the only six-in-one child vaccine on the market, with global revenues of £775m last year.

The EMA’s approval of Sanofi’s previous vaccine, Hexavac, was withdrawn after its effectiveness in protecting against hepatitis B was questioned.

According to Sanofi Pasteur, Hexyon has “a similar high immunogenicity profile for all antigens” to Infanrix Hexa, while its liquid formulation makes it more convenient for injection.

It will be used for primary and booster vaccination of infants aged six weeks to 24 months.

Jean-Paul Kress, President of Sanofi Pasteur MSD, said the recommendation “validates the clinical data supporting the vaccine’s effective and safe use for infants. Furthermore, its unique ready-to-use formulation will provide healthcare professionals with a simpler, more convenient vaccination process."

Olivier Charmeil, the head of Sanofi Pasteur, predicted the new vaccine would be a “key growth driver” for the company in 2013.

Nine female health workers at a Nigerian clinic providing vaccinations against polio have been murdered by religious extremists.

The fatal shootings at two health centres are thought to have been provoked by Nigerian Muslim leaders claiming that vaccines cause polio and sterility.

While religious opposition has slowed the adoption of polio vaccination programmes in Nigeria, this is the first time that health workers delivering the vaccine there have been killed.

Due to the religious opposition to vaccination, Nigeria is one of only three counties in the world where polio remains endemic.

Vaccines are among the greatest breakthroughs of modern medical science, but in recent years global vaccination programmes have been dogged by ideological objections and hostile myths.

Last week, an influential Islamic cleric in Nigeria claimed that polio is caused by vaccination. In Pakistan, where polio health workers have also been recently killed, the Taliban has claimed that immunisation causes sterility.

Extremist anti-vaccine movements have grown in the US in recent years, fuelled by political opposition to public health strategies.

In the UK, anti-vaccine prejudice may have driven the ‘MMR panic’, sparked by a research paper that was later exposed as fraudulent (though the Daily Mail still supports it).

Polio is an incurable viral disease that can cause permanent paralysis, and used to be a major cause of disability in Europe. It mostly affects young children. Repeated doses of polio vaccine can confer lifelong protection against the virus.

The incidence of throat and mouth cancer caused by the human papilloma virus (HPV) in the UK is predicted to exceed the incidence of cervical cancer by 2020.

The steepest increase is among young men and women, with incidence in young men rising most dramatically, though incidence in young women is higher.

The Throat Cancer Foundation (TCF) has called for the HPV vaccination of boys from age 12 to accompany the existing immunisation programme for girls.

The most prevalent route of HPV infection of the mouth and throat is oral sex, and the throat cancer statistics reflect the changing sexual habits of British teenagers.

Several years ago, the BMJ reported that the incidence of HPV-related oral and throat cancer in young American women was correlated with age at loss of virginity.

The HPV vaccination programme in the UK focused on prevention of cervical cancer – but in 2011 the DH shifted from GSK’s Cervarix, which only protects against the HPV strains that cause cervical cancer, to Sanofi Pasteur MSD’s Gardasil, which also protects against genital warts.

HPV also causes 25% of mouth cancers and 35% of throat cancers.

According to the TCF, the vaccine could be provided for £45 per person, whereas treatment of throat cancer costs as much as £45,000 per patient.

Professor Christopher Nutting, lead clinician at the Head and Neck Unit, Royal Marsden Hospital, London, said: “We are seeing a rising number of cases of throat cancer in our clinics in the UK. At the moment girls are routinely vaccinated against HPV but boys are not, meaning they are routinely being exposed to a virus that can cause life-threatening cancers.”

Professor Margaret Stanley, Director of Research, Department of Pathology, University of Cambridge, told Parliament: “The annual number of HPV-positive oropharyngeal cancers is expected to surpass the annual number of cervical cancers by the year 2020.”

However, a DH spokesperson said there were no plans to extend HPV vaccination to males, because “Once 80% coverage among girls has been achieved [which it has been], there is little benefit in vaccinating boys to prevent cervical cancer in girls.”

It is likely, however, that the steep increase in HPV-related throat cancer among young men reflects a high incidence of inter-male transmission – especially in male boarding schools, where ‘situational’ oral sex is prevalent. The DH’s apparent ignorance of this factor might be considered surprising.