Norway plans review into vaccine claims

The Ministry of Health welcomes a planned independent Norwegian review which it hopes will provide a greater degree of reassurance to the public in Norway and in New Zealand.

Norway's Minister of Health has announced that an independent two or three-member panel of experts will report on three key areas;

The organisation and structure of the Meningococcal B vaccine trial in Norway from 1988 to 1991;

An acceleration of a Norwegian Institute of Public Health study into possible links between Norway's Meningococcal B vaccine and myalgic encephalomyelitis or chronic fatigue syndrome;

An explanation from the Norwegian Institute of Public Health on why it expressed little concern about transferring the experiences from Norway's Meningococcal B vaccine trial involving teenagers in the late 1980s to a programme for babies in New Zealand.

Dr Jane O'Hallahan, Director of New Zealand's Meningococcal B Immunisation Programme, said it was hoped that the review would answer any doubts held by not only Norwegian but also New Zealand parents.

"We understand that there is likely to be considerable public concern about any information about adverse reactions claimed to be linked to the Norwegian Meningococcal B vaccine, the basis of New Zealand's MeNZB™ vaccine," Dr O'Hallahan said.

"However some of the claims that are currently being circulated about New Zealand's Meningococcal B Immunisation Programme are misleading and are likely to cause parents unwarranted alarm. This independent review in Norway is an opportunity to investigate some of these claims and provide the basis for greater reassurance to the public."

New Zealand's Ministry of Health would be happy to assist the inquiry if asked. The Ministry will continue to monitor the situation in Norway and will provide information to health professionals and the public about any significant developments, Dr O'Hallahan said.

The design of the MeNZB™ vaccine programme was reviewed by an independent panel of experts, and the vaccine was thoroughly assessed and scrutinised by Medsafe prior to being introduced for use in New Zealand.

Scientific and medical evidence collected throughout the programme gives us confidence that the MeNZB™ vaccine has an excellent safety profile and is effective. The most common side effects reported were mild temporary reactions, similar to those recognised in other well-established vaccination programmes. More serious adverse events were extremely rare, and occurred at no greater rate than following other immunisations.

All medical interventions have side effects and immunisation is no exception, but considering that we still see cases of meningococcal disease, which can maim or kill children, the independent expert opinion is that the protection offered by immunisation far outweighs the very small risks of harm that might be associated with the MeNZB™ vaccine, Dr O'Hallahan says.

MeNZB™ vaccine is helping reduce the harm from the epidemic strain of Meningococcal B disease. We used to have 213 epidemic strain cases a year in under-20s, now we see around a quarter of that. We used to have seven deaths a year. So far this year there have been two.

For more information please go to www.moh.govt.nz or www.immunise.moh.govt.nz, www.immune.org.nz , phone 0800 IMMUNE or 0800 466 863. Anyone with health concerns should talk to their GP.

ENDS

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