Introduced in 2008, the primary objective of the HPV vaccine was to prevent cervical cancer. That's why adolescent girls have been the primary target of the vaccine over the last decade. Boys and gay young men are now also firmly in the HPV vaccine cross-hairs. Committees of experts and health authorities, many with strong ties to the vaccine industry, then get to decide on whether national vaccination programmes including HPV should be extended to adolescent boys, as well as girls.

It’s the UK’s turn to decide and the recent interim statement of the UK’s Joint Committee on Vaccination and Immunisation (JCVI) is of particular interest, as are the minutes of the JCVI meeting that underpin it. The JCVI is provisionally saying it thinks the HPV vaccine shouldn’t be extended to boys. Apparently, says the committee of vaccine industry-linked experts, it’s just not cost effective.

Cancer is a very emotive subject and there has, as is to be expected, a huge and very public outcry condemning the recommendation.

Boys are already offered the HPV vaccine in Australia, Canada, Israel, Switzerland and the US.

HPV vaccine – cancer prevention or money spinner?

Interest in the HPV vaccine is being fuelled by research suggesting that it’s not just cervical cancer that’s associated with the human papillomavirus (HPV). Some other cancers, such as some anal, penile, oropharyngeal and oral cavity cancers, may also be associated with HPV. Association, however, does not mean the virus is causative. There is also a link between HPV infection and non-life threatening anogenital warts.

Is this latest push to include boys in the HPV vaccine schedule really in the public‘s best interests or is it just another way for the vaccine industry to line its pockets? Let‘s not forget that the simple decision to include boys as well as girls as targets in national vaccination programmes virtually doubles Merck‘s Gardasil^® market overnight!

The knowledge base of HPV vaccine is itself clouded by conflicts of interest. Important research that the ‘let's HPV vaccinate boys and men‘ brigade are relying on has been led by a certain Dr Anna Guiliano, founder of the Center for Infection Research in Cancer (CIRC) at the Moffitt Cancer Center in Florida. A pivotal paper from Guiliano‘s group referenced in the JCVI interim statement refers to the safety of the 9-valent HPV vaccine in men.

It turns out that in 2009 Dr Giuliano received $44,550 from Merck educational and speaking engagements relating to the HPV vaccine. This is one of the largest amounts on Merck‘s disclosure register. Merck appears not to have put its disclosures into the public domain after this period. Dr Giuliano does however continue to benefit from Merck funding as her “institution receives consultancy fees from Merck, through a three-way agreement”. A conflict of interest? We think so!

The JCVI experts have long been closely linked to vaccine industry interests. The minutes of JCVI meetings are meant to declare conflicts of interest. The problem is that full minutes have not been published by the JCVI since 2014 - all the minutes after this time being in draft form, without annexes containing declaration of interests.

JCVI consultation

The JCVI’s interim statement , that in turn provides the basis for the consultation, justifies its decision to not extend HPV vaccine to boys in the UK on the grounds that it is ‘not cost-effective’ and the girls’ vaccine programme already provides herd immunity. Some equality!

The data that underpins these views does not originate from the real war. It comes from model simulations, one developed by Public Health England, the other by Warwick University, that are littered with assumptions, many of which cannot be validated as relevant because there is simply not enough knowledge either of the natural history of the diseases, their associations with HPV, or the long-term effects (both negative and positive) of the virus.

The JCVI’s consultation is about throwing the net into the public domain to get views on its decision, and to collect any new data that might affect the final decision.

So, what are the JCVI experts saying?

• High coverage in girls provides substantial herd protection for boys therefore vaccination of boys brings little additional benefit
• HPV virus is associated with a number of cancers affecting both sexes. Evidence indicates the HPV vaccine would provide direct protection against many of these cancers
• The risk of non-cervical cancers is higher in men that have sex with men (MSM) than heterosexual men
• Data suggests there has been a significant decrease in infection rates of the two main cancer-causing HPV viruses in women linked to the national vaccination programme targeting adolescent girls
• Evidence does not support a link between HPV vaccine and a range of chronic illnesses
• Safety data shows the new 9-valent vaccine (Gardasil9®) is well tolerated in both girls and boys (it should be noted that this is from pharma funded research)
• Data presented by the manufacturer shows immunogenicity is similar in boys and girls and is safe to use in boys
• In order to prevent one HPV associated cancer in males you would need to vaccinate 795 boys when uptake of the vaccine in girls is 60% or 1735 boys when uptake is 90% in girls
• The Committee has concluded it has no concerns over the safety of the HPV vaccine

Our Concerns

• The JCVI experts have not publicly declared their conflicts of interest in the minutes of their June 2017 meeting, so it is essential that no final decision is made until ample time is given for the public to consider the implications of any conflicts
• Much of the scientific evidence being used to determine the effectiveness, risks and cost-effectiveness of extending HPV vaccine to boys comes from scientists who have declared conflicts of interest and so cannot be regarded as independent
• Evidence, on which the UK decision to extend HPV vaccination to boys is based, is from mathematical models that in turn rely on multiple assumptions, such as duration of immunogenicity, rates of transmission, sexual acts likely to result in transmission, natural history of the disease, etc
• Neither the JCVI nor the National Health Service (NHS) (through Public Health England) should make decisions that involve the mass vaccination of the entirety of the adolescent population on the basis of mathematical models based on untested assumptions, throwing out the entire basis of evidence-based medical decision-making that the National Institute for Health and Care Excellence (NICE) and other medical establishments have long espoused
• The public has been convinced that public health advice on disease prevention is based on use of an evidence-based medicine approach relying largely on randomised controlled trials (RCTs) and systematic reviews and meta-analyses of these. When was it OK for health authorities to no longer rely on RCTs and use mathematical models that aim to predict future benefits and downgrade risks?
• HPV is a sexually transmitted infection and therefore any models that aim to evaluate potential benefits and risks should include the effects of improving the quality and adoption of sex education in adolescent boys and girls
• Approximately 90% of cases of infection resolve naturally within 2 years and it needs to be determined the extent to which specific natural immunity interventions, healthy diets and lifestyles can improve the rate of clearance of HPV and immunogenicity
• Parents and eligible children are not being given information on alternatives such as safe sex, not having sexual intercourse early and limiting the number of sexual partners
• HPV infection and cervical cancer risk is significantly higher in developing countries with around 85% of deaths from cervical cancer occurring in developing countries
• The HPV vaccine is a genetically modified vaccine containing virus like particles (VLPs) made using “recombinant DNA technology”
• We’re told the vaccine is safe and effective, but it’s only been in use for 10 years and these assertions are based on immunogenicity and not actual reductions in cancer cases
• We are now on the 3^rd type of HPV vaccine, with others in the pipeline. Health authorities should not rely on studies of the earlier vaccines and promote safety and effectiveness of these vaccines as if they all had the same safety and benefit profiles.
• It is clear from the scientific evidence that aluminium used as an adjuvant in HPV vaccines is an active ingredient that mediates a specific range of side effects that can be particularly dangerous to sensitive children.

A more detailed discussion of our concerns can be found in ANH-Intl founder, Rob Verkerk’s recent very personal piece — HPV vaccine – the risk of uninformed consent?

We continue to hear more and more reports of girls who are suffering from serious debilitation following the HPV vaccine. Reports, that unfortunately are largely ignored by the health authorities or dismissed. Do we really want to expose young boys to this deadly vaccine and its potential to seriously damage their health?

What can you do?

Please share your concerns around the HPV vaccine and its possible extension to boys with the JCVI as part of their consultation.

The consultation is open for 4 weeks until the end of August 2017.

All responses should be sent to:

[email protected]

or by post to

JCVI Secretariat

Immunisation Department

Public health England,

Wellington House,

133-155 Waterloo Road

London SE1 8UG