"Some time after the experiment was over, I came to a conclusion that there were serious side effects to this vaccine. And, the number was relatively high. I was worried. At the same time, I felt that project leaders were trying to tone down the danger of vaccine," said Guldberg.

Results of the vaccine trial were compiled 1991. The vaccine was providing protection in 57% of cases. That was not enough to add it to the Norwegian vaccination program. As the meningococcus b epidemic was dying out, the vaccine was never used in Norway the way it was meant to be.

After the request from the World Health Organization (WHO), the vaccine was exported to New Zealand, during 2001. Using the same technology and the same methodology from the 1980s, researchers from the Norwegian Institute of Public Health tailored a new vaccine for New Zealand. The multinational pharmaceutical company Chiron was awarded rights to mass produce the vaccine.

Usually, a vaccine is supposed to pass different tests before it is approved for mass use on the population. But, this vaccine was tested in record time. Phase III trials were completely dropped. Rare side effects are often not discovered before the phase III trials. Phase III trials are randomized, placebo controlled trials. Instead of testing this new vaccine through a new phase III trial, safety data and affectivity data were just taken from the Norwegian vaccine and assumed valid for the New Zealand vaccine. Because safety data of this vaccine were incomplete, the vaccine was not officially approved in New Zealand. Instead, mass vaccination of 1.1 million New Zealand kids started with a temporary approval.

Breach of the international research ethics

In New Zealand, the Norwegian vaccine was used as a guaranty that the New Zealand vaccine is safe and effective. It was the Norwegian Institute of Public Health that was the guarantor.

"First: Norwegian vaccine was not safe! Second, it is a serious overstatement to say that vaccine is effective. Third: it is against international regulations and against research ethics to start to vaccinate small children on New Zealand with a vaccine that was tested on a different group of people, Norwegian school kids. To say it nice, they enlisted hundreds of thousands of small kids into a gigantic experiment," says Jan Helge Solbakk, professor in medical ethics.

Quote: "Some time after the experiment was over, I came to the conclusion that there were serious side effects to this vaccine. And, the number was relatively high. I was worried. At the same time, I felt that project leaders were trying to tone down the danger of the vaccine." 

Hans Cato Guldberg, professor of medicine, was a member of a committee that was to evaluate side effects during the experiment.