Protect against tetanus, diphtheria, whooping cough and most cancers caused by HPV - consent form - NIP8899

Rangatahi (young people) are being offered two FREE immunisations at school:

Boostrix – a booster vaccine to help protect them against infection from tetanus, diphtheria and whooping cough (pertussis)
Gardasil9 – a vaccine to help protect them against cancers caused by human papillomavirus (HPV).

This form has two sections

1. Information about immunisation
2. A consent form for you to fill out and return to school

What do the vaccines protect you from?

Tetanus is a rare but serious disease that can enter the body through a wound or cut. It is not transmitted from person to person. Tetanus bacteria causes weakness, stiffness, cramps and difficulty chewing and swallowing food. These symptoms can become worse and result in paralysis of the breathing muscles and can cause death for around 1 in 10 cases.

Diphtheria is a serious disease that can easily spread from person to person. It afects the throat, making it hard to breathe and swallow. It may also afect the nerves, muscles, heart and skin.

Whooping cough (pertussis) is a highly contagious respiratory disease which is spread by coughing and sneezing. Affected people may have spasms of severe coughing which can cause difficulty breathing, and vomiting.

Human papilloma virus (HPV) is a common virus that spreads through intimate skin to skin contact. Without immunisation, most people will have an HPV infection at some point in their lives. Most HPV infections get better on their own and don't cause any obvious symptoms. But some HPV infections don't get better, and can lead to cancer many years later if they aren't detected and treated first.

Cancers caused by HPV affect all genders. HPV can cause cancer in various parts of the body, particularly the genital area, throat or mouth. The most common is cervical cancer, which is cancer of the lower part of the uterus or womb.

Each year in New Zealand, around 160 women are diagnosed with cervical cancer and around 50 women die from it.

Immunisation is your best protection

Tetanus, diphtheria and whooping cough

The vaccine that protects against tetanus, diphtheria and whooping cough in New Zealand is Boostrix.

In New Zealand, babies (at six weeks, three and five months) and young children (four years old) are given vaccines to protect against tetanus, diphtheria and whooping cough. As children get older, this protection wears of, so at around age 10 to 12 years, rangatahi (young people) need the Boostrix vaccine to boost their protection against the three diseases.

HPV

The HPV vaccine is called Gardasil9. It protects against nine types of HPV – seven that are most likely to cause cancer and two that cause most genital warts. The vaccine cannot cause HPV infection or cancer.

The vaccines work by causing the body to make antibodies that fight the diseases. If an immunised person comes into contact with the diseases, the antibodies in their blood will fight the virus and protect them against being infected. It usually takes several weeks after vaccination to develop protection.

How effective are the vaccines?

Tetanus, diphtheria and whooping cough

After this booster dose, more than 97% of people are protected against tetanus and diphtheria, and around 84% are protected against whooping cough.

Protection against tetanus and diphtheria is expected to last for at least 20 years. Protection against whooping cough is expected to last up to 10 years. However, protection may start to reduce after five years.

HPV

The HPV vaccine is very effective in preventing infection from the nine types of HPV responsible for around 90% of the cancers caused by HPV. Protection is expected to be long-lasting. In studies, almost everyone who received the vaccine was protected against HPV infection and disease.

The number of HPV infections and diseases has fallen significantly among young people in countries offering HPV immunisation, including New Zealand.

For this vaccine to be most effective people should be immunised before they are exposed to HPV. Rangatahi (young people) also need to have all the recommended number of vaccine doses for their age. Those aged 14 or younger need fewer doses (two instead of three) of the vaccine to be protected because they respond better to the vaccine than older people.

How safe are the vaccines?

Both vaccines have an excellent safety record supported by studies in hundreds of thousands of vaccinated people. The best evidence to date shows no increase in reactions over any other childhood vaccine. For a list of possible reactions, see the side effects and reactions section.

How are the vaccines given?

Boostrix and HPV vaccines are safe to have on the same day. Each vaccine is given as an injection in the upper arm. A second dose of HPV vaccine is given with a minimum interval of 6 months between the two doses.

What alternatives are there to having the immunisations at school?

If your rangatahi (young person) has missed out for any reason, they can easily catch up with a visit to your medical centre, vaccinator or healthcare provider. This is also an option if you would like to be with them when they get their vaccination.

Delaying HPV immunisation may mean your rangatahi (young person) needs more injections to be protected, as people aged 15 years and older need three injections.

Who shouldn’t be immunised?

There are very few people who shouldn’t be immunised. If your child has had a serious reaction to a vaccine in the past, you should talk to their doctor, vaccinator or healthcare provider before signing this consent form.

Side effects and reactions

Like most medicines, vaccines can sometimes cause reactions. These are usually mild, and not everyone will get them. Mild reactions are normal and show that your immune system is responding to the vaccine.

Common reactions that can occur, usually within one or two days, include:

• redness, swelling, a hard lump, soreness, bruising or itching around the injection site, or a skin rash
• a fever (feeling hot)
• nausea (feeling sick)
• fainting, dizziness (light-headedness). Having a good breakfast or lunch before immunisation can prevent this
• general discomfort (feeling unwell, aches and pains)

Allergic reactions

Serious allergic reactions (known as anaphylaxis) are extremely rare. Only about 1 in 1 million people will experience this.

The vaccinator is well-trained and knows what to look for and can treat an allergic reaction quickly if it happens. Serious allergic reactions normally happen soon after the vaccine has been given. This is why people need to wait for up to 20 minutes after immunisation.

Where can I get more information?

Speak to the vaccinator, your doctor or practice nurse.

• Immunisations for school-aged tamariki - Health Information and Services for more information about these immunisations.
• Immunisations - Health Information and Services for general information about immunisation.

Contact the vaccinator directly if you would like more information about filling in the school consent form.

Detailed information on the vaccines is published on the Medsafe website:

• HPV (Gardasil9): gardasil9.pdf (medsafe.govt.nz)
• Boostrix (Tdap): boostrix.pdf (medsafe.govt.nz)

Your rights

The Health and Disability Commissioner's Code of Rights applies to all consumers using a health or disability service in New Zealand.

For more information, visit www.hdc.org.nz or call 0800 555 050.

Privacy

Providing the information requested on this consent form is voluntary. However, if you do not submit the form with all required fields completed, we will not be able to vaccinate your child.

Schools may have provided some information such as students’ names, room numbers, dates of birth, addresses and ethnicities. Your school should have notified you before doing so. This information, together with the information you provide on the school consent form, is used to help administer this immunisation programme.

Information from the consent form and details of each immunisation given or declined will be recorded on a patient management system held by Health New Zealand | Te Whatu Ora (HNZ) for your district. The health number (National Health Index), demographic and vaccine details will also be recorded in the Aotearoa Immunisation Register (AIR), a national database administered by HNZ which records all immunisation activity for people in New Zealand.

Information recorded in the AIR will normally be shared with your child’s enrolled General Practice and available to other health care practitioners as required for your child’s health care. For more information about your and your child’s privacy in relation to AIR, including how information in the AIR is used, please see Aotearoa Immunisation Register (AIR) – Health New Zealand | Te Whatu Ora or contact hnzprivacy@tewhatuora.govt.nz

Vaccinators may use information provided on this form:

• to contact your doctor or health centre if they need to check which immunisations your child has already been given,
• identify if your child has any health concerns, and/or
  
• to refer your child to their health provider or another local health provider for the immunisation if they missed it at school.

Information may also be used for planning, analysis and research purposes, in line with usual HNZ processes and where this is permitted under law. Any reports produced will not contain any identifiable information about you or your child.

Parents/guardians have the right to seek access their child’s immunisation information (up to the age of 16 years) and to ask for it to be corrected if you think it is wrong. To request this please contact hnzprivacy@tewhatuora.govt.nz

For more information about school roll sharing, privacy and the use of information, see your health district’s privacy policies. If you have any questions about privacy, you can email enquiries@privacy.org.nz or contact the Privacy Commissioner’s free helpline on 0800 803 909.

If you have any questions about the Aotearoa Immunisation Register or would like to request a copy of your immunisation details held in the Aotearoa Immunisation Register please speak to your healthcare provider or contact hnzprivacy@health.govt.nz

Consumer medicine information

Boostrix is a vaccine used for booster vaccinations against tetanus, diphtheria and whooping cough (pertussis). The Boostrix vaccine is sometimes called Tdap (tetanus/diphtheria/acellular pertussis).

The active ingredients of Boostrix are non-infectious substances from tetanus and diphtheria bacteria and purified proteins from the pertussis bacteria. The vaccine cannot cause any of these diseases. Each 0.5 ml dose of Boostrix contains 2.5Lf units of diphtheria toxoid, 5Lf units of tetanus toxoid and the pertussis antigens: 8 micrograms (mcg) of pertussis toxoid, 8 mcg of filamentous haemagglutinin and 2.5 mcg of pertactin.

Each 0.5 ml dose also contains tiny amounts of aluminium (as aluminium hydroxide and aluminium phosphate), 2-phenoxyethanol, sodium chloride and water. These ingredients are all commonly used in other medicines and vaccines.

Gardasil®9 is a vaccine that helps prevent the following diseases caused by Human Papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52 and 58: cervical vulvar, vaginal and anal cancer, abnormal and precancerous cervical vulvar, vaginal, genital and anal lesions, genital warts, HPV infection and other HPV cancers.

 Each 0.5 mL dose contains 30 micrograms (mcg) of HPV 6 L1 protein, 40 mcg of HPV 11 L1 protein, 60 mcg of HPV 16 L1 protein, 40 mcg of HPV 18 L1 protein, 20 mcg of HPV 31 L1 protein, 20 mcg of HPV 33 L1 protein, 20 mcg of HPV 45 L1 protein, 20 mcg of HPV 52 L1 protein, and 20 mcg of HPV 58 L1 protein. Each 0.5 mL dose also contains sterile water and tiny amounts of aluminium, salt (sodium chloride), L-histidine, polysorbate 80, and sodium borate. These ingredients are all used commonly in other medicines and vaccines.

The vaccine does not contain preservatives, antibiotics, or any human or animal materials. The vaccine is manufactured using yeast culture and may contain traces of yeast (Saccharomyces).

The safety of Gardasil®9 in pregnancy is unknown. Published data have not found any safety concerns among pregnant women who have been inadvertently vaccinated.

Your child should not have the vaccine if they have an allergy to Boostrix or Gardasil®9 or to any of their ingredients.

Your child should not have the vaccines if they:

• have had blood clotting problems or problems with the nervous system following earlier immunisation against diphtheria and/or tetanus or HPV 
• currently have a severe infection with a high temperature 
• have experienced an inflammation/disease in the brain, which occurred in the seven days following a previous vaccination with a whooping cough (pertussis) vaccine 
• have a neurological disorder that is not stable (Boostrix only). 

If your child has any of the following conditions, please discuss the immunisation with your family doctor, practice nurse, or the vaccinator before consenting to it: 

• a bleeding disorder 
• an immune deficiency condition (eg, your child is HIV positive) 
• a brain disease or a disease of the central nervous system, such as epilepsy or a tendency to febrile convulsions (seizures/fits due to a high fever)
• allergies to any other medicines or substances, such as dyes, foods and preservatives
• a previous serious reaction after receiving another vaccine containing tetanus, diphtheria and/or pertussis, or HPV
• is receiving any other medication or vaccines
• has never been given a vaccine for tetanus, diphtheria or pertussis or has not completed the full course of vaccinations for tetanus and diphtheria. 

Common reactions are listed overleaf. Other adverse effects, such as allergic reactions, might rarely occur. These possible adverse effects are listed in the full Consumer Medicine Information and Datasheet available from Medsafe.

If there are any unusual or severe symptoms after vaccination, please contact your doctor or health care provider immediately. Health professionals should report reactions that happen after immunisation to the Centre for Adverse Reactions Monitoring (CARM). You can also report them directly through the CARM website (www.otago.ac.nz/carm).