7 July 2004 Media Statement

Meningococcal B vaccine approved

New Zealand’s largest mass immunisation programme of 1.15 million young people is expected to start in August following today’s approval to use the MeNZB™ vaccine, says Health Minister Annette King.

“This is the fantastic news we have been waiting for,” Ms King says. “It shows that a small country can pro-actively respond to a serious public health issued caused by a terrible disease. It is a tremendous achievement.”

Ms King announced the $200 million meningococcal vaccine project in January 2002 to fund development of a specific vaccine to combat New Zealand’s strain of meningococcal group B bacterium. The epidemic has killed 220 New Zealanders and affected thousands of other young people since it started in 1991.

“New Zealand simply could not allow those sorts of statistics to continue. The epidemic has shown no signs of abating, but now the vaccine has received approval we can begin to fight back. I’m also pleased that approval has been given to an extended life for the current batch of vaccine so that it can all be used despite some earlier fears that some of it might be wasted,” she says.

“That’s a hugely successful result for the scores of dedicated people who have been involved with the project. I want to acknowledge just how much work they have done.

“I know some people have been impatient, and would have liked the vaccine yesterday. That is understandable, particularly if you have a had a child die or suffer, but the greater need has been to ensure that we have a vaccine that is going to do what we need it to do –-- to save the lives of New Zealanders.

“The vaccine has been licensed under Section 23 of the Medicines Act. Given the urgency of the situation and the demonstrated need to combat an epidemic, Medsafe is assured that the vaccine is safe and effective given all the information currently available to it. We also have in place a very strong monitoring programme to reinforce that safety."

The MeNZB™ vaccine has been specifically developed with scientists from biotechnology company Chiron Corporation. MeNZB™ has been approved by Medsafe for use in a national immunisation programme involving those aged between six months and 20 years.

The Meningococcal B Immunisation Programme will begin within weeks in a region comprising Counties-Manukau District Health Board and some high-risk suburbs of eastern Auckland District Health Board. It will then be rolled out across the country over the next year.

Ms King said that due to the scale of the programme, a large number of health providers would be involved in vaccinating different age groups.

“Students attending school will be immunised in a school-based campaign run by public health nurses. Children aged under five years, children not attending school and young people who have left school will be immunised by a variety of health services, such as GPs or medical clinics, Maori or Pacific health services, Plunket, student health services or occupational health clinics.

“To be successful, the programme will need the co-operation of all working in the primary health care sector, schools and the wider community. I know we are asking a great deal, but I have no doubt of the will to get the job done because so many New Zealanders have now seen for themselves the terrible effects of meningococcal disease. I am sure New Zealanders will work together to protect our young people.”

Background

What is the significance of this announcement?
Section 23 licensure of the MeNZB™ vaccine means authorised vaccinators can administer the vaccine to children and young people aged between six months and 20 years in a large-scale immunisation programme. The immunisation programme could not progress without the vaccine being licensed and approved for use.

What does licensure under Section 23 of the Medicines Act mean?

The Medicines Act allows products to be granted provisional consent to market under Section 23 where the data provided is insufficient to meet all of the requirements of Medsafe’s guidelines but the Medicines Assessment Advisory Committee (MAAC) and Medsafe accept that there is a clinical need for the medicine in New Zealand and the data available indicates that the risk:benefit profile for the medicine is acceptable. Approval under section 23 is valid only for two years and allows Medsafe to place restrictions on use of the product. An application for full consent can be made at any time when additional data required by the MAAC and Medsafe is available.

The Medicines Act allows products to be granted full consent to market under section 21 where all safety, quality and efficacy requirements have been met to the satisfaction of the MAAC and Medsafe.

In the past a number of products, such as new HIV/AIDS medications were first approved under section 23 when they first became available and have gone on to full consent as more data demonstrating safety and effectiveness became available.

What is the licensure process?
Before any medicine or vaccine can be used in New Zealand, the manufacturer must receive consent from the Minister of Health, or the person to whom she has delegated authority. Medsafe, New Zealand’s Medicines and Medical Devices Safety Authority, is the authority responsible for regulating all medicines in the country. Medsafe has assessed safety, quality and efficacy data about the vaccine and sought international peer review of its findings before presenting its recommendation to the Minister. Details of the licence for MeNZB™ vaccine are published in The Gazette, published by the New Zealand Gazette Office. When the licence has been gazetted, the medicine can be legally distributed and administered.

What does the vaccine do?
It helps to prevent meningococcal B disease by stimulating the body to increase its immunity to the bacteria that causes the disease. This requires three doses. However, people will still need to watch out for the signs and symptoms of meningococcal disease because the vaccine will not give protection from other strains of the disease and some people may not develop a high level of protection.

Why is the Counties Manukau area of Auckland the first to receive vaccine?
Since the epidemic began, this area has consistently had the highest rates of meningococcal disease. Providing vaccine to this area early in the immunisation programme means that more cases of meningococcal disease can be prevented and the effect of the epidemic reduced.

When will the immunisation programme begin in other areas?
As soon as everything is in place. It is expected that the programme will launch in greater Auckland later in 2004. The Ministry of Health has notified all District Health Boards in New Zealand about the meningococcal immunisation programme and each is responsible for planning in their own area. It is expected that Northland DHB will begin vaccinating later in 2004 and that all North Island DHBs will begin vaccinating in the first half of 2005. South Island DHBs are expected to start vaccinating in mid 2005.

Will people outside the age group be able to receive the vaccine or pay to receive the vaccine?
Not at this stage. The vaccine can only be given to people in this age group due to the limited vaccine stock being directed to the immunisation programme to control the epidemic. A further application will be made for a license to administer vaccine to children younger than six months, when clinical trials have been completed and results are analysed. The Ministry of Health will issue a media release and notify the health sector if there is any change or update to the licence details.

What happens next?
The Ministry of Health and the project team based at Counties-Manukau District Health Board will begin promoting the Meningococcal B Immunisation Programme in the Counties Manukau area of Auckland and some high-risk suburbs of eastern Auckland District Health Board. Advertising, a website and 0800 phone line will be launched to support the programme. Information for the public will be widely available through District Health Boards, primary health providers and schools.

What should people do to get the vaccine?
School students whose parents sign a consent form will be immunised by a public health nurse at school. Public health nurses are registered nurses who are trained and have experience with immunisation. The nurses will contact each school student through the school when the vaccine is available to them in their area. Children under five years, children not attending school and young people who have left school will be immunised by a doctor or practice nurse at their family doctor, Maori health service, Pacific health service, outreach service, student health service or occupational health clinic. They will be contacted when the vaccine is available in their area. If they are not enrolled with a Primary Health Organisation or general practitioner, they should contact one of these services to find out when the MeNZB™ vaccine will be available.

What is the 0800 free phone number?
0800 20 30 90.

What is the website address?
www.immunise.moh.govt.nz

What is meningococcal disease?
A bacterial infection that can cause serious illnesses including meningitis (an infection of the membranes that cover the brain) and septicaemia (a serious infection in the blood). For every 100 people that get meningococcal disease, on average, four will die, 20 will suffer a permanent and serious physical disability, and others will have ongoing behavioural or learning difficulties.

A person who has meningococcal disease can deteriorate very quickly (sometimes less than 24 hours), so it is important to get urgent medical help if meningococcal disease is suspected.

How many people have been affected?
There have been more than 5400 cases of meningococcal disease since the epidemic began in 1991. To date, there have been 220 deaths caused by meningococcal disease.

Who is affected by meningococcal disease?
Meningococcal disease can affect anyone but 80 out of every 100 cases occur in people aged 0-19 years. About half of all cases occur in children aged under five years. Babies are most at risk. Rates among Maori and Pacific peoples are extraordinarily high. On average, Maori contract meningococcal disease at double the rate of Europeans. Pacific peoples are affected at four times the rate of Europeans. People of other ethnicity make up a very low proportion of cases, but all are at high risk. The bacteria that cause meningococcal disease are carried by about one in every five people. It is not known why some people can carry the bacteria but don’t become sick, while other people suffer the disease.

ENDS

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