Human papillomavirus vaccine

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Contents

See also Human papillomavirus and Wikipedia HPV vaccine page for more details.

Two vaccines are currently licensed and available in the UK and Europe:

Cervarix contains the two genotypes of virus (genotypes 16 and 18) that cause most cases of cervical and anal cancer; Gardasil contains these as well as the two genotypes of virus (genotypes 6 and 11) that cause most cases of genital warts.

The bulk of the evidence currently available for HPV vaccines comes from two phase III trials: [2][3][4][5][6][7]

  • Future II trial (on Gardasil)[8]
  • PATRICIA study (on Cervarix)[9][10]

There have also been reports of efforts to develop vaccines covering more than four types of HPV,[11] and of therapeutic vaccines using a completely different technology.[12][13]

Human Papillomavirus vaccination campaign in England

There is information on this on a separate page - see Human Papillomavirus vaccination campaign in England. Cervarix has been chosen by the Department of Health for the campaign. [14]

Human Papillomavirus vaccination campaign elsewhere

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The European Union has published "Guidance for the introduction of HPV vaccines in EU countries".[15]

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Gardasil has been available in the UK since mid October 2006.[16] It was reported on 20 June 2007 that "The Department of Health has agreed, in principle, to accept JCVI advice that HPV vaccines should be introduced routinely for girls aged around 12-13 years, subject to independent peer review of the cost benefit analysis."[17] The recommendations from the Joint Committee on Vaccination and Immunisation were announced in their minutes of June 2007.[18]

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Australia has announced plans to add Gardasil vaccine to the national schedule for girls and women aged and women aged 12-26, starting in 2007,[19] and is reported to be considering also vaccinating males.[20] (The TGA approved Gardasil on 16 June 2006 for females aged 9 to 26 years and males aged 9 to 15 years.)

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Gardasil was aapproved for use in Canada for females 9-26 years of age. Recommendations for use, which come from the National Advisory Committee on Immunization (NACI), are awaited.[21] In the interim, individual provinces may decide to implement a local vaccination programme. [22]

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The US Food and Drug Administration, using its rapid approval process, approved Gardasil on 8 June 2006,[23] and on June 29 2006 the CDC's Advisory Committee on Immunization Practices (ACIP) recommended that the vaccine be routinely given to girls when they are 11-12 years old.[24][25] The ACIP recommendation also allows for vaccination of girls beginning at nine years old as well as vaccination of girls and women 13-26 years old.[26]

Vaccination against HPV raises various issues. For example:

  • Should we vaccinate males and females, in order to ensure herd immunity? Or, as the most significant disease prevented is cervical cancer, just females?
  • How should the vaccine be promoted? Should the prevention of cancer - a late effect - be emphasised; or will young people be more impressed by the vaccine's ability (if it contains genotypes 6 and 11) to prevent genital warts?
  • What age-group(s) should the vaccine be offered to, given that it is likely to be most effective if offered before sexual debut?

See below for further discussion of objections to vaccination.

England's decisions about HPV vaccination - 2011

The contract for HPV vaccine is due to be renewed in October 2012. The Department of Health has announced that from that date Gardasil will be used, rather than Cervarix.

Gardasil is a tetravalent vaccine, which provices protection against genital warts, as well as against cervical and other cancers.

The decision will have been informed by a number of studies, including Jit's 2011 BMJ paper[27] and others,[28][29][30] as well as by the prices offered by manufacturers.

England's decisions about HPV vaccination - 2008

See also the Human Papillomavirus vaccination campaign in England page.

According to a Department of Health press release[31] and CMO letter,[32] the government plans to introduce vaccination for all girls aged 12-13 (school year 8) from September 2008, based on JCVI reccomendations.[33] Starting the following year there will be a two-year catch-up programme, offering the vaccine to all girls up to the age of 18. Further details, including funding, have not yet been announced, but it is that a David Salisbury letter will be published at the department's immunisation website, and a new chapter for the Green Book will be available within days. Since the above was written a lot more information has been provided, and can be accessed via the department's immunisation website, and the new Green Book chapter is also available.

Decision criteria

We can assume that the decision was based at least in part on economic analyses of the costs and benefits of HPV vaccination. (See the economic analysis page for an overview of economic analysis in health care, and Human papillomavirus vaccination economics for some thoughts on the economics of this particular vaccine.)

The criteria for the decision about the choise of vaccine were described by the Secretary of State on 2 July 2008. The quotation from Hansard is as follows. (The criteria are not numbered in Hansard, but given as a single sentence, separated by semicolons.[34] For ease of reference they are quoted here as a numbered list). A subsequent statement on 17 December 200 added the maximum number of points used to weight the criteria. A sentence in the text accompanying the table in that statement - "These do not include criteria regarding experience in other countries" - implied that there may have been additional criteria that have not been made public.[35]

Criteria and their weighting, based on parliamentary written statements[36][37]

"Cervarix, the human papilloma virus (HPV) vaccine manufactured by GlaxoSmithKline was selected because the bid from this company scored higher in the adjudication process against the pre-agreed award criteria than the competitor.The pre-agreed award criteria, as follows, were shared with the manufacturers during the process so that they were fully informed of the criteria against which their bids would be evaluated. Award criteria for the evaluation of the contract to supply HPV vaccine:

Example Table
Criterion Maximum weighting points
Quality of protection against cervical cancers caused by HPV strains 16/18 5,000
Duration of protection against cervical cancers caused by HPV strains 16/18 for more than 10 years duration 3,000
Quality of protection against anogenital warts caused by HPV strains 6/11 1,300
Duration of protection against anogenital warts caused by HPV Strains 6/11 for more than 10 years duration 500
Quality of protection against HPV strains not included in the vaccine formulation 1000
Other evidence of additional clinical benefits 500
Effective price per dose excluding VAT Commercially confidential
Supply of the vaccine as single pre-filled syringe pack presentation 10
Quality of labelling, leaflets and presentation 5
Shelf life 120
Flexibility in the vaccine dosage schedule 70
Offers that reduce the risk of wastage if the vaccine is subject to temperatures above 8°C (this include the provision of temperature indicators and evidence based guidance on the stability of the vaccines at higher storage temperatures and subsequent safe administration.) 200
Closeness of proposed delivery schedule to Authority requirements 200
Pallet configuration including a preference for the use of Euro pallets 5
Impact of proposed amendments to the terms and conditions -500 (Offerors [sic] may lose up to 500 points)
Quality/Robustness of manufacturing contingency arrangements 10
Quality/Robustness of the risk Management of storage and distribution 10
Information provided relating to pack sizes, Cold Chain Delivery, Batch Numbering systems and production capacity 5

It is interesting that, not only is the "Effective Price per dose excluding VAT" commercial in confidence, but the weighting given to it is, too.

Much of the information is published e.g. as part of the products' Summary of product characteristics; but the effective price per dose (item 7 in the list above) is "commercial in confidence" and thus not in the public domain. It is interesting to note that there appear to be minimal differences between the products for nearly all the characteristics stated, other than for:

  • Item 2 above - duration of protection against cervical cancers caused by HPV strains 16/18 for more than 10 years duration, where there is a possibility that Cervarix might have a marginally greater duration of efficacy (although it is unclear whether this will be significant, if it turns out to be the case).
  • Items 3 & 4 above - quality and duration of protection against anogenital warts caused by HPV strains 6/11, where Cervarix has no efficacy, in contrast to Gardasil

The process has been criticised for the way that information about this decision has dribbled out, hinted at in a letter to the BMJ,[38] and in parliamentary answers.[39][40]

We learned in the BMJ letter that "The scoring system had been shared in advance with the manufacturers". So we could deduce that a scoring system had been used.

We now know the maximum number of points each product could have earned in the process. We don't, however, know:

  • How that weighting was arrived at;
  • How they decided how many points to award to each product;
  • How many points were awarded to each product
  • And the precise reasons for all of the above.

The decision about the vaccine was announced on June 18. A little more detail emerged through a parliamentary written answer on July 2.[41] A paper was published on July 17[42] which, we were told on November 19,[43] was used (precisely how, we were not told) to allocate the points.

The decision-making process might have been entirely robust (although it would be good to know more about the inputs, as many suspect that some of them might be disputed).

But the process should also be open to public scrutiny. As it is, the information has trickled out, raising as many questions as it answers. Why couldn't all of these bits of information, and the detailed questions they raise, have been shared, promptly and in full, with the taxpayers who'll be paying for the vaccine? Who or what is being protected by keeping any details secret after the contract has been signed? If there are good reasons for the secrecy, why won't anybody stand up and justify it? This is not, IMO, the way a tax-payer-funded service should be run. The days of "the government [or DH, or any other government or EU body or quango] has made the decision, and it isn't conceviable that they could possibly have made anything other than the right decision" have long since passed, if they ever existed; and we live in an era of accountability in which we, rightly, expect to be able to know how and why decisions are made on our behalf.

Can and should HPV vaccine be provided outside the planned vaccination programme?

Various LMCs have advised on this.[44][45][46][47] Primary care trusts have also advised, some allegedly seeking to inappropriately restrict the use of vaccination.[48]

It has been argued that HPV vaccination should be offered, outside the programme if it will not be offered via the programme within the next month or so, to:[49]

  • Younger girls who are likely to have an early sexual début including those with risk factors (e.g. looked-after children,[50][51] eating disorder[52]) as well as those who attend family planning clinics or who say that they intend to start having sex.
  • Older girls and women who have had little or no sexual experience.
  • Boys who are likely to have homosexual experiences.[53][54][55]
  • Possibly, if further data support 2012 findings that vaccination of women undergoing treatment for cervical lesions reduces the risk of recurrence, vaccination should be considered for these women.[56]

The facts are as follows:

  • There are two vaccines available: Gardasil, and Cervarix. The two vaccines are both available, on the NHS, and can be prescribed if clinically indicated.
  • There is a vaccination programme underway - see http://www.immunisation.nhs.uk/Vaccines/HPV for details of the England programme; I think it's the same in Wales; Scotland's a little bit different.
  • Cervarix uses a novel adjuvant. US' FDA was anxious about this, and it's delayed licensing in USA. GSK, who make it, think it's the bees' knees and referred to it as "our knight in shining armour" at a recent conference (ESPID, 2008). It seems to increase antibody levels slightly more than Gardasil does; but both produce an excellent antibody response, well above the minimum necessary, so it's unclear if this has any clinical significance. It is just possible that it will prevent or delay the need for a booster - but it's unlikely that either vaccine will need a booster for many years.
  • Both vaccines protect against HPV types 16 and 18. Type 16 is both the commonest type in circulation, and the most carcinogenic.
  • Gardasil also protects against HPV types 6 and 11, and thereby prevents over 90% of genital warts; Cervarix doesn't prevent genital warts (GWs).
  • GWs are the commonest STI, cause a lot of distress, and are expensive to treat. They are becoming increasingly common.
  • DH won't tell us any details of the negotiations, but they presumably negotiated a much better price for Cervarix with GSK than they were able to negotiate with Sanofi Pasteur MSD for Gardasil - so much better that the difference exceeded the value of treating GWs.
  • This price ONLY applies to vaccine obtained for the programme.
  • The list price (paid by the NHS when prescribed on an FP10) for the two vaccines is very similar.
  • Since both vaccines have a very similar price (and cost to the NHS) if prescribed on an FP10, and Gardasil prevents GWs and Cervarix doesn't, Gardasil is probably the vaccine of choice if prescribed this way.
  • Studies showed that it was cost-effective to use the vaccine, even at pre-discount prices.
  • Once infected with a vaccine-preventable type of human papillomavirus (HPV), vaccines have little if any efficacy against that virus type. So it's clearly more cost-effective to vaccinate girls before they've been infected. that's one of the reasons the age (year 8) was chosen for the routine programme.
  • Girls don't become infected with all the virus types the moment they start to have sex. There are data on the proportion of women who have been infected at various times after their sexual debut (as it's rather coyly known); but for any individual it's more stochastic than that. The more sex they have had with the more partners, and the more sex their partners have had, the lower the likelihood that vaccination will protect them.

And here you start to get into opinion... The following arguments may be sound, but make up your own mind...

  • It is cost-effective to vaccinate girls up to the age of 18 (or older), because they haven't (on average) had sex - or not enough to have been infected with the vaccine preventable types of HPV.[57][58][59][60]
  • But since is it clearly most likely to be effective if they haven't started to have sex, or haven't had much sex, it must be much more cost-effective to vaccinate them before or as soon after their sexual debut.
  • It must, therefore, be better value for the NHS to vaccinate a girl asap if she says she is expecting to start having sex soon, or has already started, rather than waiting for her turn to come around in the programme.
  • So, it must be appropriate for GPs to prescribe vaccine to such girls (and, given the small cost differential if prescribed on FP10, and the added benefits of GW prevention, Gardasil is then the vaccine of choice).
  • The age is only a proxy for sexual activity: older women who have had little or no sex will also benefit from the vaccine. Although there is a very small decline in vaccine efficacy with age, and cervical maturation might also decrease the risk a little, any woman who has had no more sexual experience than an average 18 year old, and is still young enough that she's likely to be alive in 10-20 years (when cervical cancer could develop) will surely benefit just as much as a girl aged <18, and should also be vaccinated on the NHS.

Counter-arguments include:

  • This means prescribing on an FP10, which costs more than giving the discounted drug available for the programme. In other words, it will cost more, at least in the short term. You may feel that this argument is negated by the fact that the likelihood of benefit will be so much greater. And of course, girls who have already been vaccinated won't have to be vaccinated again through the programme. See Human papillomavirus vaccination economics for a more detailed discussion of this issue.
  • If there is a great demand, we might not have enough vaccine to do this. You may doubt that this is true; and we can face that if it becomes true. It's less likely to be a problem if Gardasil is used for off-programme vaccination.
  • Information. It's important for public health to know which girls have been vaccinated. This is true: if vaccinating out of programme, names of girls vaccinated and the brand and batch number of the vaccine used should be sent to the PCT or child health information computer system manager.
  • Equity. Girls from less deprived are more likely to ask for the vaccine, so prescribing for them increases inequalities in health. This argument seems to imply that if we can't provide a quality service for everybody, then nobody should be allowed access to it, even if it's cost effective. You may or may not feel that this is a valid argument: opinions differ on this one.
What about vaccinating boys?

Unless boys are vaccinated, HPV will continue to circulate amongst men who have sex with men.

Studies show, however, that the additional value of preventing more genital warts and (through better and earlier herd immunity) more cases of cervical cancer does not justify the considerably greater expense.

Targetted vaccination on a case-by-case basis may be justified, however. Rates of anal cancer in men who have sex with men (MSM) are (according to some studies) greater than rates of cervical cancer in women. Furthermore, a higher proportion (>90%) of anal cancers is caused by vaccine-preventable types (types 16 and 18). If we could identify boys who are going to become MSM, we would certainly offer them the vaccine (unless the decision is influenced by homophobic views). Unfortunately, of course, there is no systematic way of identifying future MSM.

This does not mean, however, that boys will not be identified who are likely to become MSM.

It is quite justifiable, therefore, to consider HPV vaccination to be clinically indicated for boys who, for example, state that they have (or have concerns about) homosexual leanings, and to prescribe it for them on the NHS.

Objections to HPV vaccination

QuotationMarkLeft.png While there is indeed a vaccination against genital warts, it is evil because reducing the dangers of having sex encourages more sex. It doesn't matter that it would be safer sex, it would still be more sex, and therefore this vaccination must be stopped QuotationMarkRight.pnguncyclopedia

As with any vaccine, Anti-vaccinationists have found ways to attack HPV vaccine.

Apart from those based on cost, objections to vaccination per se, generally don't stand up to serious scrutiny. (Cost objections need to be addressed by economic analyses.) One form of attack has been to suggest that the vaccine will promote promiscuity. The argument runs that if teenagers think they are immune to one sexually transmitted infection, they will be more inclined to indulge in unsafe sex. This idea, widely touted by the religious right has been satirically paraphrased thus:

  • "While there is indeed a vaccination against genital warts, it is evil because reducing the dangers of having sex encourages more sex. It doesn't matter that it would be safer sex, it would still be more sex, and therefore this vaccination must be stopped!"[61]

It is particularly improbable that this vaccine will have a significant impact on sexual behaviour.[62][63] As Katha Pollitt puts it:

  • "Raise your hand if you think that what is keeping girls virgins now is the threat of getting cervical cancer when they are 60 from a disease they’ve probably never heard of."[64]


Although this view has been likened to a belief that insulin will lead to cupcake binges[65], or that tetanus jabs encourage people to jab themselves with rusty nails, it seems to have stopped at least one Roman Catholic school in Manchester, UK, from permitting HPV vaccination on school premises.[66]

Most faith schools in the UK have not taken this attitude, taking a similar line to that promulgated by the UK's Catholic Education Service, and the US's Catholic Medical Association:

"The availability of vaccination against Human Papilloma Virus (HPV) offers the prospect of saving hundreds of lives each year and protecting the health of many more women and the well being of their families. It makes sense to take a relatively simple medical step to protect females from this life threatening disease. Human Papilloma Virus leads to squamous cell cervical cancer, which kills nearly 1,000 women each year but which seriously damages the health of very many more annually.
"Vaccination against the disease should not be seen as any sort of encouragement to promiscuity but rather a sensible move to protect against an avoidable disease. There is no evidence to suggest that concerns about the risk of contracting this virus influences sexual activity of either males or females. HPV is transferred to females from males who are unlikely to be aware that they carry the virus as they remain free of symptoms. It would be inhumane to deny females the opportunity to be protected against this potentially devastating infection.
"Such early vaccination should help to ensure that it is made widely available to all well before the time when young people are most vulnerable to sexual pressure. Sadly, abuse, exploitation and other pressures are all too prevalent. Whilst no parent wants to think that their daughter would be susceptible, offering vaccination to all helps to protect from longer term dangers and there are benefits to society from making it available to all teenagers, subject to the agreement of their parents. We note that the vaccine is not being provided for teenage boys and question the wisdom of this, if the virus is to be successfully eradicated over time.
"There is nothing in Catholic teaching to suggest that there is anything wrong with the use of vaccination against this disease, nor does it undermine the Church’s teachings in regard to human relationships and sexual activity. It remains important that all safe and moral steps are taken to protect people from the virus. This includes good relationships education in both home and at school, and also the opportunity to have this optional vaccination whilst a teenager."[67]

And:

"The fact that HPV is spread primarily by sexual contact does not render vaccination against it unethical. Healing and preventing diseases, no matter what their source, are acts of mercy and moral good. Prevention of HPV infection is distinct from, and should not be construed as encouraging, the behaviour by which HPV is spread."[68]

Which vaccine should I give my child?

Both vaccines will reduce the risk of cervical and other cancers caused by HPV (although not to the extent that screening is no longer necessary).

Cervarix will not reduce the risk of genital warts, whereas Gardasil will do so, dramatically. In 2011 the BMA called for the UK to use Gardasil instead of Cervarix in the national programme, when this is recommissioned.[69]

If your child is a daughter of the right age (and a UK resident), she will be eligible for Cervarix, free, as part of the national programme. In this situation you will have to ask yourself - is it worth paying for Gardasil privately (given that you'd have to pay the full cost of three injections), in order to reduce her risk of getting genital warts?

If your child is not eligible for cervarix as part of the national programme, you may be able to persuade your GP that there is a clinical indication for them to be vaccinated (e.g. they are too young to be included, but already sexually active, or likely to become sexually active before they get the jabs through the programme; or they are a boy who is more attracted to boys than to girls...).[70] If you can't, then you may choose to have them vaccinated privately, in which case the cost difference is minimal.

Differences between the vaccines

  • Both vaccines will reduce the risk of cervical and other cancers caused by HPV (although not to the extent that screening is no longer necessary).
  • Cervarix will not reduce the risk of genital warts, whereas Gardasil will do so, dramatically.
  • Cervarix uses an adjuvant which may slightly increase minor adverse reactions and discomfort, and which increases the antibody levels attained following vaccination - although, since both vaccines stimulate antibody levels far in excess of that needed for immunity, the significance of this is not clear. It may mean a marginally longer duration of protection - we can only speculate, but perhaps 25 years protection instead of 20.

References

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