Recently the Joint Committee for Vaccination and Immunisation (JCVI) made an interim recommendation to change the United Kingdom's HPV immunisation for children from a two-dose to a one-dose schedule in the NHS vaccination programme. In March we submitted a testimony to the JCVI citing our concerns with their recommendation, and this week I wrote to the Secretary of State for Health and Social Care, strongly urging them to leave the two-dose policy in place until there is definitive evidence that one-dose HPV immunisation protects children, both girls and boys, from HPV cancers.
You can read my letter below:
The Rt Hon Sajid Javid MP
Secretary of State for Health and Social Care
Department of Health
39 Victoria Street
14th June 2022
Re: JCVI interim decision to recommend one-dose HPV immunisation
Dear Secretary of State,
We are writing regarding the JCVI interim advice to change HPV immunisation for children from a two-dose to one-dose schedule in the NHS vaccination programme. We strongly urge you to the leave the two-dose policy in place until there is definitive evidence that one-dose HPV immunisation protects UK children, both girls and boys, from HPV cancers.
HPV precancer and cancer morbidity is a significant burden – physically, emotionally, and financially – on patients and the healthcare community. In fact, the UK has at least 7000 cases of HPV cancers a year and globally the virus causes 5% of all cancers.
Over the past decade the UK has established itself as a global leader in the fight to eliminate all HPV cancers. To this end, it has provided gender-neutral two-dose vaccination to all children as well as screening to women and people with a cervix for cervical cancer. These efforts are working – there is now evidence that the two-dose regimen is decreasing cervical precancer and cancer by 87%. The boy’s program has only recently begun, and we expect similar results for cancers that affect males after the program has existed for a similar timeframe. We do not want to lose these hard-fought gains in the UK’s endeavours to eliminate all HPV cancers.
Policy changes should be made on data. The JCVI’s proposal to move to a one-dose schedule is premature due to the lack of conclusive evidence. Specifically, more evidence is needed to establish (1) the efficacy of one-dose in males and (2) the longevity of protection in females and males. We additionally have concerns about the evidence of funds saved, the evidence of needle burden, the schedule change for MSM, the global implications of the UK moving to one dose, and the off-label usage of the vaccine.
We write extensively of our concerns on these points in the enclosed testimony submitted to the JCVI. In brief, before changing recommendations from two-dose to one-dose, we need more robust data that establishes:
The efficacy of one dose in males. Not one of the studies cited by JCVI includes males. At present, HPV immunisation is the sole mechanism to prevent HPV cancer in males as there are no routine screening guidelines for this population.
The longevity of protection in both females and males for one dose. HPV cancers take decades to develop after exposure. The studies currently cited by JCVI as evidence for longevity are based on short-term, interim, or non-randomised results.
There is solely one randomized controlled trial specifically designed to evaluate the effectiveness of two-dose vs. one-dose HPV vaccination. The study is called the ESCUDDO trial, it follows participants for a medium-term of four years, and is expected to complete in 2024. While we prefer even longer-term studies and research that include males, we urge you, at a minimum, to postpone your decision until the results of this randomized controlled study are published and evaluated.
It is vital that we await further evidence before making a decision that will affect the diagnosis of men and women with cancer and precancer for decades to come. A move to a one-dose regimen in the future has quite rightly excited the world about the opportunity to eliminate HPV cancers globally, particularly in low resource settings. While we hope that one dose will prove as effective as two, there is currently insufficient evidence to draw such a conclusion.
I’m attaching our full response to the JCVI for your consideration.
David Winterflood Chief Executive Officer, United Kingdom