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Younger Babies Can Now Get MeNZB Vaccine

Media release

9 May 2005

Younger babies can now get MeNZB vaccine protection

All babies aged from six weeks are now eligible for the MeNZB vaccine to help protect them against meningococcal disease.

The risk of a child under the age of one year catching meningococcal disease is 10 times greater than the national average.

The Independent Safety Monitoring Board (ISMB) has recommended that the vaccine designed to protect young New Zealanders from the epidemic strain of meningococcal B disease should be extended to all children aged six weeks and older.

The ISMB has reviewed the data from the first 4600 doses administered to babies aged from six weeks up to six months in the Auckland region. The board says it has no safety concerns about vaccinating infants.

The Meningococcal B Immunisation Programme is currently being rolled out across New Zealand and once it starts in a district all children and young people aged from six weeks up to 20 years will now be eligible. The minimum age previously was six months.

Meningococcal B Immunisation Programme director Dr Jane O'Hallahan says the recommendation is great news because it enables doctors and nurses to offer protection to those most likely to contract meningococcal disease.

"The more of these babies we can protect from this disease the better," Dr O'Hallahan says.

"The recommendation is yet another endorsement for the safety of this vaccine, which was developed to combat the specific strain of group B meniningococcal disease that has caused 76 percent of the meningococcal disease cases in the current epidemic."

To date, about 700,000 doses of the MeNZB vaccine have been given. Everyone who receives the vaccine needs three doses spaced about six weeks apart.

The Ministry appreciates the huge workload of general practitioners and practice nurses especially as the winter season approaches and with flu vaccinations taking place in many districts at the same time as vaccinations with the MeNZB vaccine.

Since 1991, meningococcal disease has killed 229 people and affected more than 5700 in New Zealand, leaving many survivors with amputated limbs and other injuries. The Ministry of Health urges people to vaccinate their children and at the same time stay vigilant for signs and symptoms of meningococcal disease, as no vaccine is 100 percent effective and there are other strains of the disease.

The Meningococcal B Immunisation Programme is being rolled out across the country with the MeNZB vaccine now available from Hutt Valley north in the North Island. From Monday vaccination will begin in the Capital and Coast District Health Board (DHB) and from May 23 in the Wairapapa DHB. During June and July vaccinations begin in the South Island DHBs.

The Meningococcal B Immunisation Programme is the largest immunisation programme ever undertaken in New Zealand.

http://www.immunise.moh.govt.nz/index.html

Background

What is the significance of this announcement?

It offers protection to those children in the most at risk age group for contracting meningococcal disease.

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 more than three 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 clinical trial data from the youngest babies. Sufficient data on vaccinating these younger babies is now available for the decision to be made to extend the vaccine access to all babies aged from 6 weeks and up.

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 MeNZB 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 was the vaccine 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 did not expect any problems we 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 was 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.

The data from the intensive safety monitoring of the first 4600 doses given to more than 4000 babies in Auckland has now been reviewed and the Independent Safety Monitoring Board has no safety concerns.

Will people outside the eligible 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 5700 cases of meningococcal disease since the epidemic began in 1991. To date, there have been 229 deaths caused by meningococcal disease. The epidemic strain causes about 76 percent of meningococcal disease in New Zealand.

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-strains 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 MeNZB 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 MeNZB 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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