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This is an important moment for the Irish immunisation programme.
In recent weeks, vaccination teams have returned to secondary schools across Ireland to administer the second dose of the HPV vaccine to schoolgirls. With the latest reported uptake levels down to 50 per cent, officials are hoping that a recent publicity drive defending the safety of the vaccine will help increase the number of girls receiving it.
While this challenge remains in schools, the HPV vaccine will also be rolled-out to the men who have sex with men (MSM) community and people living with HIV in the coming months.
In 2009, the National Immunisation Advisory Committee (NIAC) recommended HPV vaccination for all 12-year-old girls to reduce their risk of cervical cancer and in September 2010, the HPV vaccination programme was introduced for all girls in their first year of second-level schools.
‘No scientific evidence’ for harm from vaccines
Both the Minister for Health Simon Harris and the HSE have emphasised that the scientific evidence is that the HPV vaccine is not linked to the symptoms of the young women who claim adverse health effects after receiving the vaccine.
The REGRET group claims that the girls they represent have developed various symptoms since receiving the HPV vaccine.
Last month in the Dáil, Minister Harris told Deputy Bobby Aylward that the HSE was working on “clinical care pathways appropriate to the differing medical needs of this group”, in reference to young women who say they have developed symptoms since receiving the vaccine.
However, he made clear that “there is no scientific evidence that the vaccine causes long-term illnesses; the HPV vaccine cannot be held responsible for these illnesses”. While there are a range of symptoms highlighted by parents and young women who say they have been affected, chronic fatigue is often mentioned.
The HSE told this paper that it is currently “developing a specific clinical care pathway appropriate to the medical needs of those with chronic disabling fatigue and their families”.
Speaking in detail about this topic in the Dáil last month, Minster Harris said that “while no medicine, including vaccines, is entirely without risk, the safety profile of Gardasil has been continuously monitored since it was first authorised, both nationally and at EU level.
“The vast majority of reports received by the HPRA have been consistent with the expected pattern of short-term adverse side-effects for the vaccine, as described in the product information.
“The most frequently reported side-effects are local redness and/or swelling at the point of injection and fever. These are usually mild and temporary reactions to any kind of vaccination. Fainting has occurred after vaccination with Gardasil, especially in adolescents.
“It appears that some girls first suffered symptoms around the time they received the HPV vaccine, and understandably, some parents have connected the vaccine to their daughter’s condition… The diverse nature of these symptoms, which can have both physical and psychological causes, are shared by many conditions, which has implications for both diagnostic and treatment services.
“The individual nature of the needs of some children may require access to specialist services and the HSE are currently working to put in place clinical care pathways appropriate to the differing medical needs of this group.
“As there is no scientific evidence that the vaccine causes long-term illnesses, the HPV vaccine cannot be held responsible for these illnesses.”
After having reached high uptake levels of 87 per cent in 2014-2015, this dropped to 72.3 per cent in 2015-2016. The most recent rates for the HPV vaccination programme in secondary schools has fallen to approximately 50 per cent, according to the HSE.
In recent years, allegations over medical side-effects among Irish girls who have received the vaccine have made media headlines. The REGRET group was established by parents of Irish teenage girls who developed health problems after entering secondary school; these parents believe that the HPV vaccine is the cause of their daughters’ illness. In the wake of publicity around these health concerns, the trend in HPV uptake is heading downwards.
However, the scientific safety record and positive health impact of the vaccine is robustly defended in Ireland by the National Immunisation Office (NIO), the Department of Health, HSE, Minister for Health, IMO, RCPI, Irish Cancer Society and others; internationally, it is defended by the World Health Organisation (WHO) and the Centres for Disease Control and Prevention (CDC) in America, among other medical and scientific bodies.
Speaking at the recent launch of a new document from the Irish Pharmaceutical Healthcare Association (IPHA), Vaccines for Life, Minister for Health Simon Harris said “unfounded, false claims have been made of an association between HPV vaccination and a number of conditions experienced by a group of young women.
“There is no scientific evidence that the HPV vaccine causes any long-term illness. However, this misinformation has led to a significant drop in uptake rates of the HPV vaccine. This means that a large cohort of girls are now at risk of developing cervical cancer later in their lives.”
Last month, school vaccination teams administered the second dose of the vaccine. However as first reported in January in the Medical Independent (MI), teams are also offering the first dose to any schoolgirl who missed out earlier in this school year.
“It is too early to have any indication on uptake yet,” a HSE spokesperson told MI.
At its recent annual congress, the Teachers’ Union of Ireland (TUI) passed a motion requesting the union’s executive “to explore the structures currently in place in relation to the provision of the HPV vaccine in second-level schools”.
The same week, the IMO was meeting in Galway for its AGM, where fulsome support for the HPV vaccine was expressed.
The union’s new President Dr Ann Hogan used part of her inaugural speech to defend the vaccine.
“Uptake rates for the HPV vaccine among young girls are declining to a worrying extent on the back of ‘fake news’ stories about non-existent risks from vaccinations,” said Ms Hogan, a public health doctor who oversees vaccination campaigns.
“As a result, we are putting the future health of young women at risk of cervical cancer and other ailments.”
IMO members passed a motion supporting the programme. However, the debate heard from Meath-based GP and member of the IMO’s GP Committee Dr Maitiú Ó Faoláin who, while supporting the vaccine as “safe and effective”, questioned whether the programme should be delivered through schools.
“At school gates, you have parents chatting, spreading fear among each other,” Dr Ó Faoláin told the AGM. “The relocation of this programme to areas where parents traditionally get vaccinations, dealing with people they know and people who they can have follow-up from, ie, the GP, would lead to much greater uptake and the irrational fears could be dealt with on a one-to-one basis,” Dr Ó Faoláin said during the motion debate.
“GPs know the girls, know the parents and can leverage the pre-existing relationship to encourage greater vaccination,” Dr Ó Faoláin told MI after the AGM.
He said he believes the programme should be “GP-based, entirely”.
“I think the sudden arrival of complete strangers to a school may feel to girls like they are being rounded up like sheep to be jabbed.
“It’s administratively attractive and superficially attractive to do mass vaccine programmes like that but it fits poorly with modern norms and preferences,” said Dr Ó Faoláin.
Dr Ó Faoláin added that “the public health programmes are scientifically sound and medically appropriate, but we live in an era of emotion, not fact, and the HPV programme jars with that mood.
“We [GPs] consistently have higher rates of vaccination than the HSE clinics ever achieve and do it at a lower cost per vaccine.”
However, there are no plans for a reappraisal of the school-based approach taken by the HPV vaccine campaign.
Speaking to MI at the launch of Vaccines for Life, Dr Brenda Corcoran, Head of the NIO, said it was unlikely that the programme would be moved from schools.
“The evidence is that if you give a school-based programme, the uptake is better, and that is the evidence in Ireland and in other countries,” Dr Corcoran told MI.
“And the countries that have the most successful outcomes from HPV and other vaccines, such as the UK and Australia, have school-based programmes.
“We work very closely with the Department of Education, school management bodies, with all relevant authorities and we have also met with the unions in the past. We are continuing to offer the vaccine at schools and we don’t see any reason to change.”
Separately, a spokesperson for the HSE told this newspaper that the Executive is “committed to the ongoing implementation of the HPV vaccine programme through a school-based approach, which was agreed at departmental level”.
The spokesperson also noted that the programme is a matter of Government policy so “any change or alteration is a matter for the Department of Health”.
MI reminded Dr Corcoran of an interview she gave to this newspaper last October, when she described the drop in HPV vaccine uptake as the greatest challenge to immunisation policy in more than 15 years.
She noted that, in recent months, leading medical charities, medical representative bodies and educational institutions have all made strong public statements in favour of the vaccine.
“I think people didn’t realise what was happening, that some people were turning against the vaccine,” said Dr Corcoran, looking back on last year.
“Concerned groups and relevant bodies have woken up to the fact that we all have to be saying the same thing and that we have to get the message out as loudly as we can about the vaccine safety and that message does seem to be getting out more.”
Millions of lives saved — WHO
Marking World Immunisation Week last month, the WHO said that “vaccines prevented at least 10 million deaths between 2010 and 2015, and many millions more lives were protected from illness”.
The WHO added that immunisation saves two-to-three million lives every year globally and that “there are still 19.4 million unvaccinated and under-vaccinated children in the world”.
“Vaccines are crucial in preventing infectious disease,” Prof Kingston Mills of the School of Biochemistry and Immunology, Trinity College Dublin, told last month’s launch of the IPHA document Vaccines for Life.
“They have eradicated smallpox and polio is soon to follow. Unfortunately, there appears to be an increasing amount of misinformation on the safety of certain vaccines.
“Much of this is being spread through social media and dedicated websites and is often not based on scientific facts. This appears to have gained some traction, as demonstrated in the alarming drop in the uptake of the human HPV vaccine that protects against cervical cancer. It is incumbent on all of us to assess the benefit versus risks and this should be based on sound scientific evidence.”
Dr Corcoran said the NIO does not underestimate the challenge that remains with the HPV vaccine.
“We haven’t won the battle by any means,” she said.
“The rate is only 50 per cent; we need it to be up to 80-odd per cent if we are going to protect girls’ lives. Parents of girls who have chosen not to get it [vaccine], if they change their mind, if they are still in school, they can get the vaccine. We just need to convince them of the vaccine’s safety.”
As the push to increase the HPV vaccine uptake among schoolgirls continues, there is also a new programme rolling out.
A budget of €88,500 has been allocated this year for the extension of the HPV vaccine to men who have sex with men (MSM) and people living with HIV (PLWHIV), according to figures supplied to this newspaper.
A HSE spokesperson also told MI that three extra nurses should be employed in “the coming weeks” to “implement and evaluate” the new vaccination drive.
“Funding to extend HPV vaccination to people living with HIV and men who have sex with men, in line with National Immunisation Advisory Committee recommendations, has been secured for 2017 within HIV and public STI clinics,” said a HSE spokesperson.
“The vaccination budget allocated for 2017 is €88,500.”
The spokesperson added that progress was being made on the recruitment of new nurses needed for the extension of the vaccine programme.
“Funding has been granted from within the Health and Wellbeing Division to employ three nurses to work on implementation and evaluation of HPV vaccine to at-risk groups between Q2 2017 to end 2018,” said the HSE spokesperson.
“It is likely that these nurse posts will be taken up in the coming weeks in research and short-term contract capacities.”
The HSE says that the programme will be rolled-out on a phased basis .“In the first instance, it will be implemented through HIV (for people living with HIV) and STI (for men who have sex with men) clinics,” according to the Executive’s spokesperson.
Last December, Dr Fiona Lyons, Clinical Lead for Sexual Health, HSE Sexual Health and Crisis Pregnancy Programme, announced that the Executive would be making the HPV vaccine available to MSM and to people living with HIV.
“The vaccine will help to prevent HPV infection, which can cause HPV-associated cancers and genital warts,” said Dr Lyons at the announcement.
“It is important that MSM have access to the HPV vaccine because they do not benefit from the herd immunity conferred through vaccinating adolescent girls.”
Does the fall in uptake of HPV vaccine among school-aged girls have any impact on this plan?
“No,” was the definitive response from the HSE when asked by MI.
Those working in sexual health have told MI they welcome the extension of the HPV vaccine programme. However, experts also told this newspaper that a properly-run information campaign would be important to its success.
HIV Ireland said it welcomes the extension of the HPV to PLWHIV and MSM.
“Clinical evidence repeatedly shows that the HPV vaccine is of benefit to men who have sex with men, and people living with HIV, in the prevention of certain forms of cancer,” Mr Niall Mulligan, Executive Director, HIV Ireland, told MI.
“We welcome the decision by the HSE to provide PLWHIV and MSM the choice of availing of this vaccine.”
However, in order to ensure a successful uptake of the vaccine, Mr Mulligan emphasised “the need for a strong, consistent and targeted information campaign clearly explaining the benefits of the vaccine, alongside ensuring ease of access to the vaccine within the community”.
“The development of such a campaign must include input from PLWHIV and MSM from the outset.”
IFPA Chief Executive Mr Niall Behan also welcomed the HSE’s decision to extend the HPV vaccine programme.
Mr Behan said that the clinical evidence about the safety and effectiveness of the vaccine is so strong that MSM and PLWHIV NGOs have been advocating for the extension of the programme for a number of years.
Asked about concerns around the vaccine expressed in recent years, Mr Behan said public health officials and NGOs had a role to play in reassuring the community.
“Having MSM and PLWHIV NGOs as advocates for the HPV vaccination programme will provide additional reassurance about the safety of the vaccine,” Mr Behan told MI.
“However, it will still be important that the HSE includes an education and information programme as part of its implementation plan to respond to misinformation or misunderstandings.”
Asked if there were any plans to further extend the HPV vaccine in the coming years, the HSE said “any recommendations on extending the HPV vaccine to other groups will be made by the National Immunisation Committee. The programme will respond to these recommendations if and when they are made.”
Warning over measles complacency
Complacency in relation to vaccines could cause deaths in Ireland as large measles outbreaks and related deaths take place in Europe, Dr Brendan Corcoran of the NIO said during National Immunisation Week last month.
Many European countries are reporting measles outbreaks — over 4,000 cases and 18 measles-related deaths have been reported in Romania in the past six months, according to Dr Corcoran. “The only protection against measles is the MMR vaccine,” said Dr Corcoran. “Two doses of MMR vaccine (at 12 months and four-to-five years of age) are required to be fully vaccinated. While uptake in Ireland has remained steady at around 92 per cent, we need to increase uptake rates to the target of 95 per cent to make sure that measles does not circulate here. “This is important for everybody but is particularly vital to protect young babies, as they cannot receive the MMR vaccine until they are 12 months old so they are vulnerable to complications, including death, if they are exposed to measles infection.”