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Standing at a crossroads

The ongoing HPV vaccine controversy is arguably the greatest challenge to hit the national immunisation system in over 15 years.

In 1999 publicity over an alleged, eventually completely discredited link between the MMR vaccine and autism impacted on vaccination rates in Ireland. It led to a significant drop in MMR uptake levels, leading to a large measles outbreak in north Dublin, with over 1,600 cases and three deaths. 

Each year in Ireland, around 300 women are diagnosed with cervical cancer. In Europe, 15,000 women die from cervical cancer each year. In Ireland, it results in over 80 deaths every year. The HPV vaccine protects against two high-risk types of HPV that cause 73 per cent of all cervical cancers.

The HPV (Gardasil) vaccine was introduced in secondary schools in 2010 to protect girls from developing cervical cancer when they are adults.

Recently, public HPV vaccine uptake levels hit a high of 87 per cent in 2014/15 in Ireland, but current unofficial rates have now fallen below 70 per cent, this newspaper has been informed.

Is the challenge posed by the rapid drop in HPV uptake one of the biggest immunisation issues faced since the MMR-autism controversy?

“Yes, it is of the same order,” Dr Brenda Corcoran from the HSE National Immunisation Office tells the Medical Independent (MI).

“We have a challenge here; I think we are at a crossroads. We had a very successful HPV programme, as they did in Denmark. But in Denmark, the uptake levels are now down to 25 per cent because of alleged safety concerns.

“So we have a huge challenge to persuade parents of the benefits of this vaccine and also of the safety of the vaccine, so that we can continue on the road as we had been doing.”

Dr Corcoran is responsible for the co-ordination of all national immunisation programmes, and is also a member of the National Immunisation Advisory Committee.

The National Immunisation Office’s uptake figures for some of the other vaccination programmes remain very positive. Earlier this year, statistics showed a 93 per cent uptake in the MMR vaccine, close to the 95 per cent ‘herd immunity’ target.

“Yes, and the uptake for six-in-one is over 95 per cent,” Dr Corcoran tells MI. “For the baby vaccines, the uptake is at or approaching WHO target levels, so we are very pleased with that. Obviously, parents understand the value and are getting the vaccines on time.

“For the school vaccines, the uptake levels have been at or are approaching target levels.”

Vaccine safety concerns

On numerous occasions, the Minister for Health, along with the Department of Health and HSE, have robustly defended the safety of the HPV vaccine.

“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,” Minister for Health Simon Harris told the Dáil in July. “This is done by both monitoring of individual adverse reaction reports received by competent authorities across Europe (including the HPRA) and periodic safety update reports submitted by the marketing authorisation holder (ie, license holder) for the vaccine on a regular basis.

“In November 2015, the European Medicines Agency completed a detailed scientific review of the HPV vaccine… The outcome of the review found no evidence of a causal link between the vaccine and the two conditions examined.

“On 12 January 2016, the European Commission endorsed the conclusion of the European Medicines Agency, stating that there is no need to change the way HPV vaccines are used or to amend the product information.”

However, the REGRET Support Group has publicly raised concerns about the HPV vaccine.

A spokesperson for REGRET told MI that Minister Harris has agreed to meet them

“The new Minister for Health has committed to a formal meeting with REGRET,” said the spokesperson. “We are eagerly awaiting a meeting date.”

The group says its “numbers are increasing continuously”.

The group has requested that “an urgent, independent investigation into the safety profile of the Gardasil HPV vaccine” take place.

The group also wants “recognition and acknowledgement of our daughters’ post-Gardasil conditions, followed up with holistic approach medical treatments by specialists in this area,” said the spokesperson.

The group would like to see “financial assistance… in meeting their children’s ongoing medical needs” and “that the Departments of Health, Education and Social Welfare urgently fast-track support for our daughters”.

REGRET has raised concerns over the amount of information provided to parents regarding the vaccination.

In response to queries regarding some of REGRET’s concerns, Minister Harris told the Dáil on 12 July that the HSE is working on a specific “clinical care pathway”.

“I am aware of claims of an association between HPV vaccination and a number of conditions experienced by a group of young women,” said the Minister.

“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.

“I want to make it quite clear that anyone who is suffering ill health is eligible to seek medical attention and to access appropriate health and social care services, irrespective of the cause of their symptoms. The individual nature of the needs of some children may require access to specialist services.

“The HSE are currently working to put in place a clinical care pathway appropriate to the medical needs of this group. I hope to be in a position to meet representatives from REGRET in the near future.”

The Irish Cancer Society recently launched a political education campaign in defence of the safety and positive impact of the vaccine. 

“We are concerned that misinformation about the life-saving and cancer-preventing HPV vaccine is being circulated and wish to provide our legislators and policy-makers with the facts about the efficacy and safety of the HPV vaccine, which has the potential to effectively eradicate cervical and other cancers,” a Society spokesperson told MI.

“We have had a very positive and supportive reaction from all Oireachtas members who have been in touch with us.”

The Society says it has already held meetings with members of the Oireachtas and expects to speak with a cross-party delegation in the coming weeks. 

“All Oireachtas members we have had contact with have shown great interest in the work we are doing and have exhibited strong support for the vaccine.”

On its website, REGRET raises the fact that the Society receives donations from pharmaceutical companies as a possible conflict of interest.

However, a Society spokesperson rejected this.

“The Irish Cancer Society receives some funding from pharmaceutical companies, as do many organisations such as ours, and companies from which we receive grants are thoroughly vetted as part of our corporate partner policy to ensure no conflict of interests,” the spokesperson told MI.

“All the money we receive from any of our corporate partners is used in the interests of cancer patients for cancer research, prevention and support.

“We have not received any funding from any pharmaceutical company in respect of the HPV vaccine.”

Problems

However, problems with HPV vaccine uptake levels are growing.

“The target uptake is 80 per cent. The most recent published information is for 2014/15 and the uptake then was 87 per cent. And some parts of the country actually achieved over 90 per cent, so there was kind of a universal acceptance of the vaccine,” says Dr Corcoran.

“That figure was the highest recorded and obviously if the uptake continued at that rate, then we would see the impact of the vaccine programme, as has been seen in Australia, where there has been a 50 per cent reduction in the level of high-grade cancers of the cervix.”

The safety record and positive health impact of the vaccine is robustly defended by the National Immunisation Office, the Department of Health, the HSE, the Minister of Health, the IMO and the Irish Cancer Society, among others (see panel on right).

However, in recent years, allegations over medical side-effects among Irish girls who have received the HPV vaccine have made newspaper headlines, TV documentaries and Dáil debates. The REGRET Support 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.

Dr Corcoran tells MI that the preliminary HPV vaccine figures the Office has for 2015/16 show that uptake has dropped to about 70 per cent and the early information so far for 2016/17 points to a figure “even less than that”.

With strong support for the HPV vaccine expressed by the IMO at its AGM earlier this year, along with the recent intervention of the Irish Cancer Society into the debate, is Dr Corcoran hopeful that public concerns can be allayed?

“We all have our parts to play, all healthcare professionals. And this is a serious message that we would like to get out,” states Dr Corcoran.

“It’s well known scientifically that the general public get their information from, and listen to healthcare professionals, particularly from those they meet on a one-on-one basis.

“We have been working very closely with the ICGP, faculties of the colleges and also talking to the nursing bodies to make sure that healthcare professionals know the importance and the responsibility that they have to make sure that parents get the correct information.

 “The challenge is how we communicate the message. I think we have lots of information but the challenge is to communicate it to parents, so they take that information on board, that they trust that information, and that they realise that this information is based on fact.”

The public seems to be increasingly sourcing information regarding vaccination and other medical matters from the Internet and wider sources, however.

“I don’t think it’s peculiar to vaccines. I do think there are lots of issues in general society that the general public are questioning and they are turning away from experts, if you like, and trying to find out information for themselves,” says Dr Corcoran.

“Obviously that is something that everyone is entitled to do, but they need to get that vaccine information from scientifically accurate sites and that is the challenge.”

Knock-on impact on other vaccines?

There are public health concerns that a fall in the HPV uptake levels could have a knock-on impact on other vaccinations.

A HSE spokesperson admitted to MI that a drop in HPV uptake is already having a “slight” impact on other vaccinations.

“Uptake figures for Tdap and Men C vaccines which are given at the same time as HPV vaccine are not yet available, but there are anecdotal reports that the uptake is slightly reduced,” said the spokesperson. 

“This is also of concern, as these boosters are needed to protect students from serious diseases such as meningitis, tetanus and whooping cough (pertussis).”

Dr Corcoran told MI that this is an issue the National Immunisation Office is aware of.

“There is a concern,” she confirmed.

“I think we need to be very aware of the fact that the vaccine is given at the same time, and they are also for very serious diseases, and that they [parents] need to make sure that they get those even if they choose to defer the HPV vaccine until hopefully sometime in the very near future.

“We have had a slight drop-off, but certainly nothing of the same-drop off that we have had for the HPV.”

At a meeting of the National Immunisation Office in the summer, the role of GPs in the HPV vaccine was discussed, and minutes of the meeting have been seen by MI following a Freedom of Information request.

It was decided by the Office to distribute a two-page leaflet for GPs to assist with queries from parents about the HPV vaccine.

“Yes, this leaflet has been produced and sent to all GPs in the country,” a HSE spokesperson told MI.

“The leaflet is available at www.hse.ie/eng/health/immunisation/pubinfo/schoolprog/HPV/HPV%20Factsheet%20GPs.pdf. 

“A further leaflet has also been produced, which has been sent via the Department of Education to all school principals, school management bodies, etc.

The HSE told MI that the total costs of the printing and distribution of these leaflets was €3,000. “Additional copies are available to order at www.healthpromotion.ie.”

Asked whether it intends to undertake any significant new promotion campaign for the HPV vaccine, the Executive only said that it is “currently running a social media campaign to highlight the benefits and safety of HPV vaccine”.

Although there are issues around the HPV vaccine, the overall positive impact of immunisation is still one of the great stories of public health, maintains Dr Corcoran, and a recent measles outbreak in Cork and Kerry is a reminder of this.

“Many parents fortunately haven’t seen the diseases that we now have vaccines for,” says Dr Corcoran.

“People who have been around quite a while would have seen these diseases and know the devastation they can cause. I can remember patients with iron lungs in Cherry Orchard Hospital, I’ve seen measles infection, Men C — again, a devastating disease, all now prevented by vaccination.

“We now have the Men B vaccine coming in that will prevent the terrible scourge of meningococcal disease B.  

“The impact of vaccinations is hugely beneficial. We have to remember the value of it. 

“We know when we have a measles outbreak most recently, and measles is extraordinary infectious. So we have to be vigilant, we have to keep the uptake rates up to the targets, or otherwise these diseases can come back. So we can’t be complacent. We have to keep managing to promote vaccination, encouraging parents, getting the right information to healthcare professionals and having the whole system in place in terms of vaccine supply, delivery website, etc.

“This whole panoply of activity needs to take place to have an effective vaccination programme. We are very fortunate that we have the funding to do so. But we all need to value vaccination, because it is a very valuable resource.”

Low flu vaccine uptake among health staff

Figures released by the Health Protection Surveillance Centre (HPSC) last month show that the flu vaccine uptake level among healthcare workers is well below the target of 40 per cent.

The overall uptake was just 22.5 per cent of medical staff last winter. This is despite a number of years of campaigning by the HSE, highlighting the importance of the vaccine.

Dr Corcoran said that there would be a renewed push to increase the uptake in the coming months.

“There has been a huge amount of work done and funding provided to increase the uptake of the vaccine among healthcare workers,” said Dr Corcoran.

“There are a lot of issues. Some of them are myths, like that healthcare workers don’t get flu. In fact, many healthcare workers contract flu; some of them might not be that sick with it, but the issue is that they can spread it to vulnerable patients. It is a patient safety issue.

“Every year there are a number of flu outbreaks in hospitals and long-term care institutions. In many of these cases, the healthcare worker may not be vaccinated, although the residents may be. That shows that the diseases can often be transmitted by someone who is caring for the patient.

“Other issues are accessibility; some staff may have to travel, which is not ideal. That is being looked at with a view to make the vaccine more accessible. A huge amount of work is being done behind the scenes for this year, so we hope uptake rates will improve significantly across all areas.

“It has to be said there are some units which do actually achieve the target, so there are some areas which are doing the programme very well and we are learning from them on how they manage to get uptake levels at a high level.

“They have well-organised services, they bring the vaccine to the staff and provide information and there is an ethos in the unit that this is the right thing to protect the patient and also their families as well.”

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