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MOH Responds To Norwegian MeNZB Doco

Media Statement for Scoop
22 October 2006

The Ministry of Health's Director of the Meningococcal B Immunisation Programme, Dr Jane O'Hallahan, responds to claims made in recent articles on Scoop [Exported Controversial Vaccine and Norway Shocked by New Documentary ] regarding the programme and theMeNZB™ vaccine . This statement includes information provided by the Norwegian Institute of Public Health to Dr O'Hallahan to October 2006.

Claim 1: New Zealand began using theMeNZB™ vaccine while compensation was being paid to Norwegians for claims related to their Meningococcal B vaccine.

At the time when the roll-out of MeNZB™began, the Ministry of Health was not aware of any compensation paid out to participants in the Norwegian clinical trials. The Ministry of Health is now aware of two payments that have been made in Norway; one individual who received a settlement in the late 1980s after suffering transverse myelitis and a single case of chronic fatigue syndrome which received a settlement in 2003. The latter case was the subject of some media coverage in Norway earlier this year. Since the media coverage, more people have claimed that they too have developed chronic fatigue syndrome after vaccination. The Norwegian Institute of Public Health is undertaking a study to investigate these claims, with the results expected next year. None of these additional individuals have received compensation.

Both chronic fatigue syndrome and transverse myelitis (a neurological condition), were included as possible but rare adverse events on the data sheet provided with the MeNZB™ vaccine to all health professionals when the vaccine was rolled out.

To date, no cases of chronic fatigue syndrome associated with MeNZB™ have been recorded on the Centre for Adverse Reactions Monitoring database in New Zealand, the place where this would be expected to be recorded.

To date, there is no proven evidence of a link between chronic fatigue syndrome and vaccines in general.

The Ministry of Health is in regular contact with the Norwegian Institute of Public Health which is conducting the study into the Norway claims.

The New Zealand Meningococcal Team has reviewed the evidence available in the literature. This evidence does not support a link between vaccines and chronic fatigue syndrome. The team has also carefully considered the situation in Norway, met with its Norwegian colleagues and consulted with international experts. This will be an ongoing process where new information is assessed as it comes to light. All potential links to MeNZB™ will be thoroughly investigated.

Claim 2: There were serious adverse events that occurred during the Norwegian trials.

In Norway, there were 14 serious adverse events that occurred after receipt of the Norwegian meningococcal B vaccine. This does not mean that they were caused by the vaccine, rather that they occurred sometime after receiving vaccine. In a population of 149,000 children who took part in the trials, you would expect these conditions to occur just by chance. What is not mentioned is that in those who had not received the vaccine, a similar number to those vaccinated, there were 43 serious adverse events. For more information on adverse events following immunisation please refer to the Immunisation Advisory Centre (IMAC) website http://www.immune.org.nz/?T=720

New Zealand established a gold standard in safety monitoring according to immunisation experts. The introduction of MeNZB ™ was supported by research data from a number of countries over many years. As with other vaccines, MeNZB™ was subject to passive safety surveillance - where doctors and nurses voluntarily report possible adverse events to the Centre for Adverse Reactions Monitoring- but the programme also had extra checks which included daily and weekly monitoring in hospitals for adverse events. This meant that any child in the first area of roll-out who went into hospital with any condition that could be remotely or possibly related to a vaccine was very carefully assessed. This included monitoring for neurological and immunological conditions. There has been no increase in the incidence of monitored conditions since the immunisation programme started.

Throughout the immunisation programme we have made as much information as possible available on our website and provided regular updates to health professionals.

Claim 3: The information brochure given to teenagers prior to the Norwegian trials was inadequate.

Whatever informed consent process the Norwegians used for their trials in the 1980s is irrelevant to New Zealand and it is one best answered by the Norwegians. New Zealand had its own robust, informed consent process which conformed to our current ethics guidelines.

Claim 4: New Zealand did not test the vaccine properly and did not run phase 3 trials.

The MeNZB™ vaccine went through all the phases that were required - phase 1 testing in adults and phase 2 clinical trials involving about 1700 New Zealand children.

At New Zealand's request, international experts, including World Health Organisation (WHO) and world leading public health researchers reviewed the body of research on meningococcal B vaccines. They concluded that it was not necessary for New Zealand to conduct phase 3 trials for MeNZB™ as there was already sufficient applicable data that showed vaccine safety and efficacy in large populations. Following this, the Ministry of Health concluded that the size of the epidemic and quality of data available meant it would be unethical to delay the introduction of the vaccine further.

Given the data that had been collected in Norway, and also on other similar vaccines that had been rolled out around the world, a phase 3 trial was unwarranted. Such a trial would have delayed getting a safe and effective vaccine to New Zealand children who were suffering, being maimed and dying from the epidemic strain of meningococcal B disease.

As with all new medicines and vaccines, the rarest events, because they are very rare, will not be seen until the medicine or vaccine has been used in very large numbers of people. This is why surveillance continues after a mass immunisation programme.

Claim 5: The vaccine was not officially approved in New Zealand.

In New Zealand, a 'provisional consent' allows for a vaccine or medicine to be used in the event of an epidemic. The MeNZB™available information was assessed and there was sufficient data to grant the vaccine provisional consent. This is still considered 'official approval'.

Claim 6: The Norwegian vaccine was used as a guarantee that the New Zealand MeNZB™ vaccine was safe and effective. The Norwegian vaccine is not safe or effective.

The MeNZB™ vaccine's safety profile and the intensive safety monitoring undertaken throughout the roll-out of the MeNZB™ vaccine gives us confidence about the safety of this vaccine. The Independent Safety Monitoring Board (ISMB), a panel of international and New Zealand experts established by the Health Research Council of New Zealand, reviewed safety data throughout the programme. The ISMB advised, based on the data it had seen, that it had found no evidence of any significant adverse health event associated with the vaccine. No vaccine is completely without side effects. The most common side effects from the MeNZB™ vaccine are mild temporary reactions, such as redness at the site of the injection, a headache, nausea, a slight fever, feeling unwell, drowsy or irritable.

Findings from a Victoria University study show that MeNZB™ is effective. This study will be published in a scientific peer-reviewed journal. The study found children and young people who were not immunised had a five times higher risk of getting the epidemic strain than those who were fully immunised. MeNZB™ vaccine was developed to protect against the particular strain of meningococcal B causing the New Zealand epidemic. As of October 9, 2006, there had been 187 epidemic strain cases since the programme began in July 2004 - 158 cases were in children and young people who were not vaccinated at all or only partly vaccinated while 29 cases had had three or more doses of MeNZB™ . Since January 2006, there has been 19 epidemic strain cases among almost 1 million children and young New Zealanders who were fully immunised. There has been 15 epidemic strain cases among about 200,000 children and young people who were not vaccinated at all or only partly vaccinated. Findings from the Victoria University study showed MeNZB™ to be 80 per cent effective against the epidemic strain. Sadly, no vaccine is 100 per cent effective. Parents must remain vigilant to the signs and symptoms of meningococcal disease.

Claim 7: The roll-out of MeNZB™ was an experiment.

This claim is untrue. The clinical trials had already been completed in each age group before the roll-out started in each of those age groups. Sufficient information was available from the clinical trials to say that MeNZB™ was both safe and effective.

Claim 8: It is unethical to vaccinate small children with a vaccine that was tested on teenagers.

Clinical trials for MeNZB™ were carried out in all age groups that were to be vaccinated.

Claim 9: Thousands of doses of Norway's MenBvac were used in the roll-out.

MenBvac was not used in the roll-out of New Zealand's mass immunisation programme. This vaccine was only used in the early clinical trials until the Chiron-produced MeNZB™ vaccine became available.

ENDS

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