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Meningococcal B - Protection For Younger Babies

Media Release

3 February 2005

Protection extended for younger babies in Meningococcal B Immunisation Programme

Ministry of Health Director-General Karen Poutasi announced today the licence for the MeNZBTM vaccine used in the Meningococcal B Immunisation Programme has been extended to include babies aged six weeks and older in some areas.

The original licence approved in July 2004 enabled the MeNZBTM vaccine to be given to babies as young as six months. The vaccine is being made available to children and young people aged up to 20 years to control the epidemic strain of meningococcal disease in New Zealand.

From today, the MeNZBTM vaccine can be given to babies aged from six weeks old in the Counties Manukau, Auckland and Waitemata District Health Boards (DHBs), where an intensive safety monitoring programme is in place.

The MeNZBTM vaccine is expected to be made available to this younger group of babies, from six weeks to six months, in the rest of the country, throughout the year later this year. "This licence extension enables health professionals to offer the vaccine and the best protection available against the epidemic strain of meningococcal disease to a high risk group of young babies in the Auckland region," Dr Poutasi says.

"It is also further confirmation of the safety of the MeNZBTM vaccine as independent experts have assessed data on the vaccine and recommended it for use in young babies.

"It is important for children to get all their usual childhood immunisations and the MeNZBTM vaccine. The MeNZBTM vaccine can be given at the same time as the other childhood immunisations.

"The Ministry of Health in partnership with DHBs is implementing New Zealand's largest ever mass immunisation programme aimed at controlling an epidemic that has killed 225 New Zealanders and affected more than 5600 others since it started in 1991."

"The Meningococcal B Immunisation Programme began in a region comprising Counties-Manukau DHB and some high-risk suburbs of eastern Auckland DHB. It has since rolled out to the rest of Auckland and Northland and in the next six months will continue to the rest of the country. To date, more than 460,000 doses of the MeNZBTM vaccine have been given. Everyone who receives the vaccine needs three doses.

"With parental consent, school students are immunised in schools. Pre-school children and those young people who are not at school receive the vaccine through their doctor.

"Even after immunisation, people should remain alert for signs and symptoms of meningococcal disease because there are many types of meningococcal disease and the vaccine can only protect against the most prevalent strain in New Zealand. No vaccine can give complete protection to every person," Dr Poutasi says. ends

For further information contact: Ministry of Health Media Advisor: Marama Ellis (04) 470 0689 or 021 802 622.

Background

What is the significance of this announcement?

Extending the licensure of the MeNZB? vaccine means that those young babies who are in the most at-risk under-one-year-old age group and who live in the high risk areas of Counties Manukau, Auckland and Waitemata District Health Boards (DHB) at-risk can be offered the vaccine.

How at risk are these babies?

The high risk for an under-six-month-old infant is similar to the risk of an infant aged six to 12 months old. Children aged under one have twice the risk of contracting meningococcal disease of a child aged one to four years old. This risk is nearly 10 times the national average which is already over four times the rate considered by the World Health Organization at epidemic levels (three cases per 100,000 population).

Between 1999 and 2003, 222 babies aged under six months of age contracted meningococcal disease and 232 babies aged between six and 12 months of age.

Why was this younger age group not included in the original licence?

In the epidemic situation faced by New Zealand, a routine vaccine licensure that would have included this younger age group would have been inappropriate, given the likely human cost of delay while waiting for clinicial trial data from the youngest babies. Sufficient clinical trial data for the youngest babies is now available for the decision to be made to extend the vaccine licence to babies aged from 6 weeks and up.

What was the original licence?

The original licence, approved in July 2004, meant authorised vaccinators could administer the vaccine to children and young people aged between six months and 20 years.

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 immunogenicity data about the vaccine and sought international peer review of its findings before presenting its recommendation to the Director-General of Health. Details of the licence for MeNZBTM 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 the New Zealand epidemic strain of group B meningococcal disease by stimulating the body to develop its immunity against the bacteria that causes the disease. However, just like with any vaccine, people will still need to watch out for the signs and symptoms of disease because no vaccine gives complete protection for every person. Also MeNZBTM vaccine will not protect against other strains of the meningococcal disease. There is no vaccine available that can protect against all strains of meningococcal disease.

Why will the vaccine be restricted for this younger group of babies, from six weeks to six months, to the Auckland area first?

Comprehensive monitoring needs to be in place for the beginning of any new roll out of a vaccine to a new age group. While we do not expect any problems we have restricted the vaccine for this younger age group, as we did for the roll out to the older age group, to the wider Auckland area where the most comprehensive level of monitoring is in place.

The Auckland area has also consistently had the highest rates of meningococcal disease in these young babies. Providing vaccine to this age group in this area first means that more cases of meningococcal disease can be prevented and the effect of the epidemic reduced.

Will people outside the age group be able to receive the vaccine or pay to receive the vaccine?

Not at this stage. The vaccine stock is being directed to immunise the age group most at risk of the disease: that is, those aged under 20 years.

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, Mäori 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 5600 cases of meningococcal disease since the epidemic began in 1991. To date, there have been 225 deaths caused by meningococcal disease.

Who is affected by meningococcal disease?

Meningococcal disease can affect anyone but about 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 Mäori and Pacific peoples are extraordinarily high. On average, Mäori 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.

Why should people remain vigilant for signs and symptoms of the disease when they have been immunised?

The MeNZB vaccine offers protection only against the specific NZ epidemic strain of group B meningococcal disease. Even if you have full protection against the epidemic strain of meningococcal disease, you may contract other strains of meningococcal disease. (eg, A, C, Y, W135 or other sub-strain of group B meningococcal disease.)

There is no vaccine available anywhere in the world that can protect against all types of meningococcal disease.

Also no vaccine is 100 percent effective. Some people vaccinated with MeNZBTM will not gain full protection against the epidemic strain of group B meningococcal disease. However, we expect the majority of those vaccinated will get protection.

True vaccine breakthroughs, where the person gets the epidemic strain of meningococcal disease after receiving all three MeNZBTM doses will be rare. Based on knowledge to date it is expected that in such cases the person may not get as severe a case of the disease as they would have if they had not been vaccinated.

With any vaccine it is more likely to get a vaccine breakthrough when the person has some pre-existing condition such as immune deficiency. Such conditions can make the person more susceptible to infections and less likely to respond to vaccination.

Meningococcal disease can progress extremely quickly, from a person feeling unwell to death in less than 24 hours. Not all cases present with classical features (including the rash) and sometimes it can be difficult to distinguish clinically from other types of meningitis. Specialist laboratory investigations are often required and these can take time.

Can the MeNZB? vaccine be given at the same time as usual childhood immunisations?

Yes the MeNZB? vaccine can be given at the same time as other childhood immunisations.

ENDS


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