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HPV, MMR and what's next on the virus-vaccine hotlist

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With nurses across the UK on the frontline in delivering the first HPV vaccinations and others planning MMR catch-up campaigns Steve Ford investigates the upcoming virus candidates on the vaccine hotlist
New vaccines are continually being developed in an attempt to prevent a range of different conditions, from cancer to diarrhoea. Five potential vaccine candidates are currently waiting in the wings, with a view to being introduced widely over the next few years. All are at various levels of assessment or development.

The disease at the top of the list is probably chickenpox. Two vaccines for varicella are already licensed for use in the UK. The government has so far stopped short of recommending their addition to the routine immunisation schedule but this could be about to change. Click here for a timeline of key additions to the national vaccination schedule.

When it comes to vaccination policy in the UK, one body holds the power. The Joint Committee on Vaccination and Immunisation (JCVI) is an independent committee of the UK’s foremost experts on immunisation. It advises ministers on vaccine introduction, based on efficacy and cost.

The JCVI’s subgroup of experts on varicella and herpes zoster vaccine first met in December 2007. It is scheduled to report its findings on introducing the vaccine for all children later this year. A primary focus for analysis will be the current burden of the disease on the NHS.

According to research by Health Protection Scotland and Bristol University, published in 2007, around 100 children are admitted to hospital in the UK each year with complications caused by varicella – and around six of these die.

The authors concluded: ‘The majority of complications occur in otherwise healthy children and thus would be preventable only through a universal childhood immunisation programme.’

The JCVI has noted that much of the burden of varicella falls on the primary care sector and data on this is currently limited.

Experts can also look overseas for leads. Routine varicella vaccine was introduced in the US in 1995. Figures from the US Centers for Disease Control and Prevention show that by 2002, admissions due to varicella had declined by 88% – mostly among infants less than 12 months old.

According to Dr George Kassianos, the Royal College of GPs’ spokesperson on immunisation, a varicella vaccine could be combined with MMR and given as ‘MMRV’ in two doses – although this might prove hard to sell to a sceptical public (see box).

Marian Nicholson, who works for the Herpes Viruses Association and is an adviser to the British Association for Sexual Health and HIV, said: ‘We are following their deliberations with great interest. In particular we are very keen that zoster vaccine [to protect the elderly from shingles] should be introduced either with varicella vaccine or even before it.

‘We are concerned about the increased incidence of shingles, when the chickenpox vaccine is given and adults no longer “get boosters” from meeting the virus again when their children and grandchildren get it.’

This has been a major sticking point with universal varicella immunisation. Evidence from the US appears to support concerns that varicella vaccination alone could lead to an increase in shingles in older people.

As a result, the Health Protection Agency is currently developing models for the universal introduction of both zoster and varicella vaccines, which will be considered by the JCVI.

Perhaps one of the most exciting vaccines in the pipeline is one for meningitis B, the only remaining type of meningitis lacking an effective vaccine.

The MenB vaccine, being developed by Novartis, has been researched by a partnership from the HPA, Oxford University and Gloucestershire Royal Hospital.

The vaccine could potentially protect against 80% of mengicoccal B strains, which account for 90% of the 1,800 cases of meningitis recorded in the UK each year, and around 180 deaths annually. It could be ready to be considered for inclusion in the childhood immunisation programme within the next two or three years.

Dr Jamie Findlow, from the vaccine evaluation unit at the HPA’s North West Regional Laboratory in Manchester, said: ‘Phases I and II of the clinical trials have been successfully completed, proving that the vaccine is safe and that it stimulates the immune systems of infants when administered at two, four and six months of age.’

A second vaccine for the infection is also being developed by a consortium led by Cambridge company ImmBio and including Bristol University. However, as of September 2008, this work was not as advanced as the Novartis product.

The JCVI has noted that results from clinical trials on both vaccines look ‘promising’ and that it is on standby to start collecting the all-important data that will show whether or not routine vaccination is sufficiently cost-effective.

Another vaccine candidate that has been assessed by the JCVI is for rotavirus – the most common cause of severe diarrhoea in young children and infants. A subgroup of the committee met for a final time last March to discuss its potential.

There are currently two vaccines – Rotarix, which is manufactured by GSK, and RotaTeq, developed by Sanofi Pasteur MSD. Both have been shown in trials to offer significant protection against the five rotavirus types that cause more than 98% of rotavirus diseases in Europe – G1, G2, G3, G4 and G9.

Dr Mary Ramsey, one of the HPA’s most senior immunology experts, studied the impact of rotavirus on both primary care consultations and hospital admissions about 10 years ago. Her team estimated that just under a third of the 520,000 cases of infective diarrhoea seen in general practice each year were caused by rotavirus gastroeritintes and that at least 17,000 admissions for under-fives in England and Wales were attributable to the virus.

Implementation of a rotavirus vaccination programme could substantially reduce the incidence of childhood diarrhoea. But the JCVI’s own subgroup on rotavirus has admitted to having ‘differing views on whether rotavirus vaccination should be recommended in the UK’.

The main problem is one of economics. For it to meet the government’s criteria for universal introduction, the price of the vaccine would have to be slashed.

‘The cost of the vaccine would need to be reduced by at least half before it could be considered to be cost-effective under the majority of scenarios,’ the JCVI has previously said. But it agreed in June to ‘reconsider rotavirus vaccination if there were a change in the price of vaccines’.

However, on going to press, neither of the vaccine manufacturers was able to tell Nursing Times whether they would consider a reduction in their vaccine’s price.

Another disease high on the government’s hitlist is respiratory syncytial virus. RSV
is the leading cause of lower respiratory tract infection in infants and can lead to hospital admission, particularly in babies who are premature or have chronic lung disease or congenital heart disease. A JCVI subgroup is to assess the possible introduction of the vaccine palivizumab, to protect children against RSV.

Top of the subgroup’s agenda will be the NHS Health Technology Assessment on palivizumab, carried out by Birmingham University and published last month. The assessment, which looked at three systematic reviews and 18 studies, was tough. While it found that the vaccine halved admissions among the three groups of high-risk children, it said it: ‘does not represent good value’ except for premature babies with one or both of the other conditions.

Last but not least is the increasing threat from hepatitis B, which can lead to liver cirrhosis and cancer. Current government policy is to immunise only at-risk groups – such as injecting drug users and migrants from certain countries – in spite of 1991 World Health Organization recommendations to introduce universal vaccination.

The Hepatitis B Foundation UK estimates that more than 325,000 people are chronically infected with the virus in the UK – nearly double the Department of Health’s 2002 estimate of 180,000.

The JCVI is assessing a variety of options to step up the use of the vaccine. It is looking at the attractiveness of either a routine infant, routine adolescent or selective infant – infants with one or more parents born in a country where the virus is endemic – immunisation programme.

On a practical level Lynn Young, primary health care adviser at the RCN, warned that any addition to the immunisation schedule would inevitably lead to increases in nurse workload. Additionally, Dr Kassianos said that while immunisation against meningitis B and RSV would be ‘very welcome’, each would involve another injection. ‘So on each thigh a nurse will be injecting two or even three vaccines and this may be seen as a negative point,’ he explained.

Joanne Ashmore, the HPA’s nurse consultant in health protection, added that the successful introduction of any new vaccine depended on health promotion activities ‘at the right level’, with support and ongoing educational programmes.

‘If community practitioners are ambivalent to the process and do not truly believe in the public health benefit of immunisations, the delivery of local national programmes will remain substandard,’ she warned.

But while the experts continue their analysis, the NHS Constitution, published last week in its final form, has put added pressure on the government.

It states: ‘You [the patient] have the right to receive the vaccinations that the Joint Committee on Vaccination and Immunisation recommends that you should receive under an NHS-provided national immunisation programme.’

MMR: The lessons

MMR coverage has never fully recovered since Dr Andrew Wakefield (pictured below) went public in 1998 with his explosive claims that the combined vaccine was linked to autism.

MMR coverage at 24 months fell in the UK from 92% in 1997 to a low of 81% in 2003. Coverage had only recovered to 84.5% by September last year – still well below the 95% recommended by the World Health Organization.

The unfortunate, but not unexpected, result has been that measles cases have risen sharply. Latest figures for last year show that up to the end of November, 1,217 cases of measles were confirmed in England and Wales. In August last year the Department of Health released funding to PCTs for a national catch-up campaign, aimed at all children up to the age of 18.

This prompted nurses in some parts of the country to take innovative measures to reach their patients.

NHS Kirklees in West Yorkshire, where more than 7,000 children have not received MMR, has launched a new campaign that includes trying to make the vaccine more accessible by offering it at nurseries and children’s centres.

Ann Brady, children’s community matron for the area, said: ‘We have learnt that we need to chase up parents more vigorously than we have in the past if they don’t bring their children for their MMR vaccine and that we need to make it as easy as possible for them to take up the vaccine.

‘We have increased the number of clinics where vaccinations are offered and we have arranged with private nurseries for our staff to offer the MMR there so it is easier for working parents to access.

‘To support the campaign we have gained editorial coverage in our local media and we are producing posters for display in nurseries and supermarkets s well as the usual venues such as playgroups. We are also exploring a number of other promotional options including bus advertising.’

Joanne Ashmore, the Health Protection Agency’s nurse consultant in health protection, backed opportunistic immunisations, which she said should be encouraged and supported by PCTs’.

‘If a community practitioner cannot verify previous scheduled MMR immunisations for whatever reason, it is safe to give two doses of MMR a month apart. If in doubt, consult the Green Book and vaccinate,’ she said.

She added that one of the lessons learnt from MMR was the negative impact that the internet could have, though she suggested that equally the availability f information could be an advantage.

‘The availability of poor quality information via the internet has negatively influenced parents and it is then very difficult to reverse this disbelief in the scientific evidence,’ Ms Ashmore said.

But she added: ‘The high quality and quality of international research supporting the MMR is phenomenal.

‘It is available and accessible to both community practitioners and the general public. The challenge for any time constrained frontline community practitioner is the skill and opportunity to relay this information in a parent friendly way.’

HPV: The story so far

The latest addition to the routine schedule was the vaccine for human papillomavirus (HPV) – a common cause of cervical cancer. Rollout began in September 2008.

It is offered to all girls in the UK aged 12 –13, while those aged 13–17 will be offered the vaccine in the 2009–2010 school year as part of a catch-up campaign.

So far the programme appears to be going very well. DH figures, released last month, show that more than 70% of 12 to 13-year-old girls in England have had their first jab. Three doses are needed in total over six months.

Overall 148 of the 152 PCTs have already started vaccinating young girls, the DH said, with 24 trusts reporting uptake of 90% or more and 124 having already started giving the second dose of HPV.

However, it has not been all plain sailing. As has been well documented, there are two vaccines for HPV available on the market, Gardasil and Cervarix.

Both protect against HPV types 16 and 18, which are responsible for around 70% of cervical cancer cases. But Gardasil also protects against HPV types 6 and 11, which cause 90% of cases of genital warts. The government controversially opted for the bivalent cheaper option.

There have also been questions over ‘acceptability’ in some sections of society. Concerns were raised that because HPV can be sexually transmitted, vaccination would encourage promiscuity.

So far the moral issue has been isolated to a few cases. St Monica’s Catholic School in Bury, Greater Manchester, hit the headlines in September when its board told parents that it would not allow the jab to be given on its premises. It claimed the reason was medical – arguing that a school was not a suitable place to give injections – but one of its governors had previously raised moral objections.

Meanwhile, overseas a board that controls Catholic schools in the Canadian city of Calgary said that it would not allow
the vaccine to be given in its schools – in line with the moral guidance of its bishop who did not want to appear to be condoning premarital sex.

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