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The MeNZBTM vaccine
The MeNZB™ vaccine
A new vaccine called MeNZB™ has been developed to help protect children and young people in New Zealand against the strain of meningococcal B disease that is causing an epidemic in this country.
What is in the MeNZB™ vaccine?
Production and trials of the MeNZB™ vaccine
How well does the MeNZB™ vaccine work?
The MeNZB™ vaccine will not protect against other strains of meningococcal disease
Possible reactions to the MeNZB™ vaccine
Are there some people who shouldn't have the MeNZB™ vaccine?
What is immunisation?
The body’s immune system fights illness and infection. When a harmful organism, eg, a virus or bacteria causing infection, enters the body, it is attacked by the immune system. The immune system makes antibodies from special blood cells to fight the infection.
The first time an organism enters the body the immune system is not prepared. It takes time for the body to make antibodies. During this time the person becomes ill. As the antibodies are made the person recovers. The immune system then remembers the organism. If it enters the body again, the infection is usually controlled before the person becomes ill because the body is immune to the illness or disease.
Immunisation is the use of vaccines to stimulate the body to make these antibodies.
In clinical trials of vaccination, the level of antibodies in the blood can be measured and used to predict whether the vaccine is likely to prevent the illness.
For more information on immunisation visit: www.moh.govt.nz/immunisation.html
What is in the MeNZB™ vaccine?
Only parts of meningococcal B bacteria are used when making the MeNZB™ vaccine. There are no live bacteria in the vaccine.
MeNZB™ vaccine contains:
- aluminium hydroxide to assist the body’s protective response
- a stabiliser (histidine)
- normal saline.
MeNZB™ vaccine does not contain:
- any blood products
- the preservative thiomersal.
Vaccine safety
As there are no live bacteria in the MeNZB™ vaccine it cannot cause meningococcal B disease. The vaccine has been manufactured to international standards.
The trials found that the vaccine was safe. Tests showed that individuals receiving the three doses of MeNZB™ vaccine developed the levels of antibodies expected to provide protection against the disease. The trials ran smoothly and no serious adverse events relating to the vaccine occurred.
In addition, overseas experiences with similar vaccines show that serious adverse events are unlikely. Millions of doses of vaccines similar to MeNZB™ have been used around the world, eg, for 20 years in Norway and Cuba. Serious side effects are very rare after vaccination with meningococcal B disease vaccine. However no vaccine is totally without reactions.
Immunisation and health records of all who are vaccinated may be used in checking the effects of the vaccine.
Production and trials of the MeNZB™ vaccine
- In 1998 the Ministry of Health worked with the World Health Organization (WHO) to raise research and manufacturing interest in producing a vaccine for the New Zealand strain of meningococcal B disease.
- In 2001 the Ministry of Health began working with a Californian-based biotechnology company Chiron Corporation to develop, trial and manufacture a vaccine for New Zealand. This is in association with the Norwegian Institute of Public Health who developed a vaccine for a strain of meningococcal B disease in the 1990s.
- Auckland University was selected to run clinical trials and complete a vaccine effectiveness evaluation, in association with Chiron.
THE CLINICAL TRIALS |
|
Dates |
Groups |
May 2002 |
Adults participated in the first trial in New Zealand. Scientists studied the vaccine for safety and side effects as well as determining the concentration needed for each dose of vaccine given. |
October 2002 to February 2003 |
This was followed by trials involving children aged 8-12 years. |
February to July 2003 |
The next group, toddlers aged 16-24 months, received the vaccine. |
May to December 2003 |
Trials involving infants aged 6-8 months, took place. |
2004 |
The final trials, involving infants aged 6-10 weeks, took place. |
The trials found that the vaccine was safe. Tests showed that individuals receiving the three doses of MeNZB™ vaccine developed the levels of antibodies expected to provide protection against the disease. The trials ran smoothly and no serious adverse events relating to the vaccine occurred.
In addition, overseas experiences with similar vaccines show that serious adverse events are unlikely. Millions of doses of vaccine similar to MeNZB™ have been used around the world, including in Norway and in Cuba, for 20 years. Serious side effects are very rare after vaccination with meningococcal B disease vaccine.
How well does the MeNZB™ vaccine work?
Most people who are immunised with MeNZB™ vaccine are expected to be protected, but the vaccine may not protect every person who receives the three doses.
Protection is expected to last for a few years but the exact period of protection is unknown. Ongoing studies will measure how long protection is likely to last.
The MeNZB™ vaccine will not protect against other strains of meningococcal disease
MeNZB™ vaccine has been developed to protect against the strain of meningococcal B causing the New Zealand epidemic. As the MeNZB™ vaccine will not protect against other strains of meningococcal disease you will still need to watch out for signs and symptoms of meningococcal disease.
Three doses
Three injections of the MeNZB™ vaccine, with an interval of about six weeks between each injection, will be given to:
- infants in the upper thigh
- young children either in the thigh or upper arm
- older children and young adults in the upper arm.
Three injections of the MeNZB™ vaccine will be needed for full protection. |
Possible reactions to the MeNZB™ vaccine
The table below explains what to do if reactions occur after you have left the clinic:
Mild |
Type of reactions |
What to do |
Temporary redness, pain or swelling where the injection was given. |
|
|
A headache, nausea, feeling unwell, muscle and joint pain. |
|
|
A slight fever (37.5 - 39°C). Babies and toddlers may feel drowsy or irritable. Older children may feel tired and not want to play. |
|
These are normal side effects and may last a day or so.
Serious |
A high fever, ie, over 39° C. This is very rare. |
|
Serious reactions are very rare.
In the trials some children had a day off school after the first vaccination, with fewer having a day off after the second or third dose. There were no children with long-term effects.
*When giving Paracetamol follow the instructions of your doctor or nurse or follow the manufacturer’s instructions. No more than four doses should be given in 24 hours.
If you have any concerns following the MeNZB™ immunisation, contact the health professional who gave the vaccination or your doctor. |
Everyone who receives the MeNZB™ vaccine will be asked to stay at the clinic for 20 minutes after the vaccine is given. This is to make sure that treatment is at hand if an allergic reaction called anaphylaxis occurs.
Anaphylaxis
- It is only on very rare occasions that anaphylaxis occurs after immunisation.
- In anaphylaxis, a skin rash, dizziness and noisy breathing start soon after the vaccine is given.
- Drugs to treat this allergic reaction work quickly and safely.
- Allergic reactions can also occur with some medicines, food or from bee stings, and not just from vaccines.
Are there some people who shouldn’t have the MeNZB™ vaccine?
MeNZB™ vaccine should not be given to anyone who:
- has an acute illness or high fever on the day of immunisation
- has previously experienced a severe allergic reaction
- is pregnant.
Flip Chart
A flip chart designed to help general practitioners and practice nurses explain the Meningococcal B Immunisation Programme to patients.
Download the Flip chart as a
PDF (861kB)
Consent Form
The consent form for the Meningococcal B Immunisation Programme's school-based campaign.
Download the Consent Form as a PDF (281 kB)
Post-Vaccination Information
What to expect after vaccination with the MeNZB™ vaccine.
Download the Post-Vaccination Information as a
PDF (116kB)