Government Funds Development Of Vaccine To Combat Killer Meningococcal Epidemic

Health Minister Annette King today announced a $100 million-plus initiative to combat New Zealand’s ongoing epidemic of meningococcal disease.

The money will be spent on developing a vaccine that will be used to immunise more than a million young New Zealanders over five years.

"I am absolutely delighted to announce this huge investment in protecting the health of young New Zealanders against this epidemic. In the past year alone, 26 New Zealanders have died, and the epidemic has affected the lives of thousands of young New Zealanders, and shows no sign of abating."

Ms King said clinical studies of a vaccine developed specifically for New Zealand would start this year, and if the outcome was successful, every New Zealander under the age of 20 would be vaccinated within the next five years.

“The Ministry of Health advised last week that in 2001 a person died every two weeks on average from meningococcal disease, making it the worst year on record since an epidemic started sweeping through New Zealand 11 years ago. There were 660 cases of meningococcal disease reported last year.

"These sorts of statistics cannot be allowed to continue. Meningococcal disease causes more hospitalisation and fatalities than any other notifiable infectious disease in New Zealand. There is a significant cost for survivors – the disabling effects can include limb amputations, massive skin grafts or brain damage.

"The estimated social cost of the disease is $75 million a year, including hospital and rehabilitation costs of about $29 million a year."

Ms King said Ministry of Health project leader Dr Jane O'Hallahan had flown to the United States this week to continue talks with the vaccine supplier, biotechnology company Chiron Corporation.

“The estimated cost of purchasing and delivering the vaccine to New Zealanders under 20 is expected to be more than $100 million over five years, but more details will be available by late March once negotiations with Chiron are complete.”

Ms King said that in developing the vaccine, specific to the strain of meningococcal group B bacterium responsible for the NZ epidemic, Chiron would collaborate with the Norwegian National Institute of Public Health (NIPH) and work with the Ministry of Health and Auckland University for the trial and vaccine delivery programme.

“An initial clinical study will be carried out with a small number of people in Auckland around mid-May. A team from Auckland University, Chiron and the ministry will oversee the study. The Norwegian involvement reflects Norway's experience in developing a vaccine to combat an epidemic of a different strain of group B meningococcal disease.

"The vaccine is going through a rigorous analysis according to international guidelines on vaccine development and the monitoring of participants. This will include assessment from the Standing Committee on Therapeutic Trials (SCOTT), Medsafe and regional ethics committees.”

Ms King said the Californian-based Chiron Corporation also has experience in developing vaccines for preventing various groups of meningococcal disease, including MenjugateTM, which was used in a universal vaccination campaign to prevent group C meningococcal disease in the United Kingdom. This vaccine has also been approved for use in Canada, Ireland and Hungary.

Ms King warned that until a vaccine was widely available in New Zealand, the public needed to be able to recognise the symptoms of meningococcal disease and to seek treatment early.

QUESTIONS AND ANSWERS

Who will be participating in the initial study?
Details are yet to be finalised, but it will involve volunteers.

What does the initial clinical study involve?
The clinical study will be overseen by a team consisting of the University of Auckland, Chiron and the Ministry of Health. Further details, including the number of volunteers, are yet to be finalised. However, there are national and international guidelines regarding clinical studies that must be met. The prime focus of these guidelines is the safety of volunteers in the study. The guidelines cover issues ranging from production, vaccine quality, guidelines of selection criteria for volunteers, ethics approval, monitoring and auditing. Before any study can proceed, ethics approval is required, as well as approval from the Ministry of Health.
Details of the guidelines are documented in the publication New Zealand Regulatory Guidelines for Medicines Volume 3: Interim Good Clinical Research Practice Guidelines August 1998. A full copy of this can be found on the Medsafe website www.medsafe.govt.nz

How much is the initial study costing New Zealand?
We still do not know what the total cost will be as this is dependent on the initial findings and peer review from national and international advisors.

What happens once the initial clinical study is complete?
The next steps will be determined pending the outcome of the study. Details of this initial study are yet to be finalised. The results will be assessed and planning for the next stage will be based on these results.

How does the situation in New Zealand compare internationally?
New Zealand has a very high number of people catching meningococcal disease compared with other countries. However, of these people the proportion who die from meningococcal disease is decreasing and among the lowest in the world. We credit this to high levels of community awareness about the need for speedy medical treatment, vigilance by parents and caregivers and rapid, effective treatment by health professionals.

What is meningococcal disease?
Meningococcal disease is a serious bacterial infection caused by a bacterium (germ) Neisseria meningitidis, known as a meningococcus. It usually affects the membrane around the brain (meningitis) or the blood (blood poisoning). It is a serious disease and can sometimes cause death or permanent disability such as deafness.

What are the symptoms?
Symptoms in a very young child can include a fever and vomiting, or the child may refuse drinks or feeds, be excessively sleepy, or cry and be unsettled. A rash that looks like blood spots under the skin may also appear at a later stage. The symptoms in an adult are similar.

What are the benefits of immunisation?
Immunising all people under the age of 20 nationwide would see 3860 cases averted and 194 lives saved over the 10 years that the epidemic would expect to run without a vaccine. Eighty-five percent of cases occur in people under 20 years of age, so it is important that all people at serious risk of this disease are immunised.

Are different ethnicities at greater risk of contracting meningitis?
Rates in Maori are almost three times higher than in the European population, while the rate in Pacific people is almost six times higher than people of European ethnicity. In 2001, of the 26 people who died, nine were Maori and four were Pacific Islanders.
Rates of disease in all ethnic groups were particularly high among those under age five. Since mid-1991, when the current epidemic started, there have been 4226 cases reported and 184 deaths from meningococcal B disease.

What has been the involvement of the World Health Organisation?
The WHO has been actively involved and provided support to the New Zealand Ministry of Health in the development of a strain specific meningococcal vaccine since 1998. The WHO supports the strategy of vaccinating all under 20 year olds in New Zealand to control the current epidemic. The WHO will be providing advice to the New Zealand Government in assisting with the clinical trial process and the implementation of a mass vaccination campaign.

How is meningococcal disease spread?
Up to 20 percent of the population or 750,000 New Zealanders carry the meningococcal bacterium in their nose and throat and while not all carriers get sick, babies and young children are particularly at risk of developing blood poisoning or meningitis (swelling of the brain) from this bacterium.
The bacterium can be spread by close contact with someone who is carrying it, such as living in the same household or sharing food, drink or utensils, so those in accommodation such as student hostels are also more susceptible.

KEY MESSAGES FOR MENINGOCOCCAL DISEASE
 Don't wait – take action: see a doctor if you or your child is sick
 If your child is sick check them often
 Your child may be seriously ill if they:
o Have a fever
o Refuse drinks or feeds
o Are sleepy or floppy – or harder to wake
o Vomit
o Are crying or unsettled
o Have a rash/spots
o Have a headache
 Doctor's visits are free for children under six
 Anyone can get meningococcal disease – though those at greatest risk are children under five and young adults
 If your child gets worse – take them straight back to the doctor.

REGIONAL BREAKDOWN OF MENINGOCOCCAL CASES IN NEW ZEALAND
Region 2000 2001
Northland 26 37
North West Auckland 39 37
Central Auckland 77 80
South Auckland 118 126
Waikato 45 76
Eastern Bay of Plenty 13 15
Rotorua 10 26
Tauranga 12 15
Gisborne 12 11
Taupo 2 12
Ruapehu 3 2
Hawke's Bay 18 28
Taranaki 5 10
Manawatu 8 20
Wanganul 8 6
Wellington 18 24
Wairarapa 6 11
Hutt 10 17
Nelson-Marlborough 5 12
Canterbury 19 20
South Canterbury 4 3
West Coast 0 3
Otago 17 55
Southland 5 12

LOCATION OF MENINGOCOCCAL DEATHS BY HEALTH DISTRICT BY YEAR

Health District 1996 1997 1998 1999 2000 2001
Canterbury 1 2 2 1 1
Central Auckland 1 1 3 3 2 2
Eastern Bay of Plenty 1
Gisborne 1 1
Hawkes Bay 2 1 2 1
Hutt 2 2 2 1
Manawatu 1 1 1
Nelson-Malborough 1 3 2
North West Auckland 3 2 1 1 1
Northland 3 2 3 1
Otago 1 1 1 2
Rotorua 1 1
Ruapehu 1 2
South Auckland 3 8 2 5 2 4
South Canterbury 1 1 2 1
Southland 1 1 1 1
Taranaki 2 1
Taupo 1
Tauranga 1 1 1 3
Waikato 1 3 5
Wairarapa 1
Wanganui 1
Wellington 3 1
West Coast 1
Total 18 24 23 22 17 26

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