Minister you need to take note of information difference between manufacturer and HSE……….

Minister to allow you to understand the scenario that parents are in presently we have decided to look at the information booklet given to parents by the HSE in the information packs. Such material we have been told has been accredited “The HSE information
on HPV vaccine is amongst the best and most detailed from any country worldwide.” We would also like you to note some major differences.

Let’s take it page by page:

HSE information: “The human papillomavirus (HPV) vaccine protects girls from
developing cervical cancer when they are adults. This leaflet contains factual information to answer your questions. Please read it and then fill in the enclosed consent form.”

Manufacturers PIL“Vaccination with Gardasil is intended to protect against diseases caused by Human Papillomavirus (HPV) types 6, 11, 16, and 18.”

HSE information: “Does the vaccine work?Yes. In Australia, Sweden and
Finland the vaccine has prevented up to 3 in every 4 pre-cancers.
In Australia the vaccine has prevented 1 in every 2 cervical cancers.”

The information given can be taken as misleading given that the vaccine is being given to 12 year old girls and smear test are not given until the age of 25. So how has this conclusion come to fore when the most vulnerable age is peak in the 25-29 age group.

While we may not dispute the effectiveness of the vaccine we have not seen the evidence anywhere to back the fact that the vaccine has prevented 1 in every 2 cervical cancers. Show us the proof and where are the studies !!!

HSE Information: Is the vaccine safe? Yes. For more than 13 years the safety of the HPV vaccine has been strictly monitored and frequently reviewed by many international bodies including:
• The World Health Organization;
• The European Medicines Agency; and
• The Centers for Disease Control and Prevention in the USA.
All international bodies have continually reported that the vaccine is safe with no known long-term side effects.

We note the wording in this as continually reported. It goes on to state the vaccine is safe with no known long-term side effects. Also, they are stating that there is no known long-term side effects but that can be taken that there may be long-term side effects there but that they may be currently unaware of same.  The manufacturer has covered themselves by asking you to report any possible side effects not listed in the PIL and not as stated by the HSE.  

 Manufacturers PIL:   Reporting of side effects
“If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.”

HSE Information: Can the vaccine have any side effects?
Side effects that can happen but pass in a day or two include:  

  • Occasionally girls faint after getting any injection. Girls will be advised to sit down for 15 minutes after vaccination which helps prevent fainting. 
  • 1 in 10 girls will have pain, swelling and redness at the injection site and/or headache
  • 1 in 100 girls will have nausea, pain in the vaccinated arm and mild fever
  • Between 1 in 1000 and 1 in 10,000 girls will get an itchy rash or hives.  
  • Between 1 in 10,000 and 1 in 100,000 girls will have wheezing(bronchospasm).
  •  1 in 1 million girls will have a serious allergic reaction.   ( So this now suggest that there are serious allergic reactions)  

Manufacturers PIL: Possible side effects
Like all vaccines and medicines, Gardasil can cause side effects, although not everybody gets them.
The following side effects can be seen after the use of Gardasil:

Very commonly (more than 1 in 10 patients), side effects found at the injection site include: pain, swelling and redness. Headache was also seen.
Commonly (more than 1 in 100 patients), side effects found at the injection site include: bruising, itching, pain in extremity. Fever and nausea have also been reported.
Rarely (less than 1 in 1000 patients): hives (urticaria).
Very rarely (less than 1 in 10,000 patients), difficulty breathing (bronchospasm) has been reported.
When Gardasil was given with a combined diphtheria, tetanus, pertussis [acellular, component] and poliomyelitis [inactivated] booster vaccine during the same visit, there was more headache and injection-site swelling.

Side effects that have been reported during marketed use include:
Fainting, sometimes accompanied by shaking or stiffening, has been reported. Although fainting episodes are uncommon, patients should be observed for 15 minutes after they receive HPV vaccine.
Allergic reactions that may include difficulty breathing, wheezing (bronchospasm), hives and rash have been reported. Some of these reactions have been severe.
As with other vaccines, side effects that have been reported during general use include: swollen glands (neck, armpit, or groin); muscle weakness, abnormal sensations, tingling in the arms, legs and upper body, or confusion (Guillain-Barré Syndrome, Acute disseminated encephalomyelitis); dizziness,vomiting, joint pain, aching muscles, unusual tiredness or weakness, chills, generally feeling unwell, bleeding or bruising more easily than normal, and skin infection at the injection site.

Finally at the bottom of the back page of the HSE Information Booklet the slogan:

I’m protected now for the future

Can the HSE give a guarantee that all those girls who have received the HPV vaccine are protected for the future? Well parents are only reading what is written.

The exercise of this post is to highlight the variations and the differences in the content of information from the manufacturer of the vaccine to that given by the HSE to parents. While the HSE are posting the PIL on the website it should be included in the information pack. In fairness, they didn’t ask parents to download the consent form from the website.

Parents must be given all the information so that they can make an informed decision. This in turn will allow them to make an informed consent which is most important.

Patient Information Leaflet

US Patient Product Information 9883616

HSE hpv-vaccine-information-for-parents

Gardasil Brochure 2017

All the HSE information is available on the link below: Booklets