Documentary raises doubts over meningococcal vaccine

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There was a documentary aired in Norway which raised doubts about meningococcal vaccine safety.

"To say it nice, they enlisted hundreds of thousands of small kids into a gigantic experiment,"
..project leaders knew that subjects might suffer serious complications during the trial..[but] Trial subjects were not properly informed about the possibility of serious side effects during the trial..

A documentary screened in Norway has raised doubts about the safety of the vaccine being used in New Zealand's campaign against the epidemic strain of meningococcal B.

But Dr Jane O'Hallahan, director of New Zealand's Meningococcal Vaccine Programme, is backing the MeNZB vaccine being used in this country.

"When you're following up a vaccine, things are recorded as serious adverse events that may or may not be related to the vaccine," she said last night.

"Subsequently, following investigation, (they) are shown definitely not to be related to the vaccine."

The documentary alleged that at the same time Norwegian authorities were paying compensation to vaccine victims, the same vaccine was exported to New Zealand and used on children.

"To say it nice, they enlisted hundreds of thousands of small kids into a gigantic experiment," it quoted Jan Helge Solbakk, professor in medical ethics, as saying.

In 1988 the Norwegian Institute for Public Health started its largest ever experiment when 180,000 school teenagers were used as test subjects in the trial of a new vaccine against meningococcal B. It lasted from 1988 to 1991.

Prof Solbakk was working on the ethical side of the trial.

He said that project leaders knew that subjects might suffer serious complications during the trial, "statistically speaking".

"Trial subjects were not properly informed about the possibility of serious side effects during the trial," he said. "We encouraged the project leaders, during an open meeting, to do it in a better way, an informative way."

During the trial 512 side effects were reported during the trial – 14 were considered serious and five children developed serious neurological diseases.

During a second trial, involving 53,000 children, 10 serious side effects were reported, while one child developed serious neurological disease, the documentary claimed.

A member of a committee that evaluated side effects during the experiment, professor of medicine Hans Cato Guldberg, said that sometime after the experiment was over, he came to a conclusion that there were serious side effects to the vaccine.

"And, the number was relatively high," he said.

The documentary said that after a request from the World Health Organisation (WHO), vaccine was exported to New Zealand, during 2001.

Using the same technology and the same methodology from 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.

The documentary said that usually a vaccine was supposed to pass different tests before it was approved for mass use on population. But this vaccine was tested in a record time.

Instead of testing the 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 was incomplete, the vaccine was not officially approved in New Zealand. Instead, mass vaccination of New Zealand children started with a temporary approval.

The Norwegian vaccine was used as a guarantee that the New Zealand vaccine was safe and effective. It was the Norwegian Institute of Public Health that was the guarantor.

The documentary claimed the Norwegian vaccine was not safe, it was a serious overstatement to say it was effective, and it was against international regulations and against research ethics to start to vaccinate small children in New Zealand with a vaccine that was tested on a different group of people, Norwegian school children.

Dr O'Hallahan said last night that some things happened to people after vaccination that were not necessarily caused by vaccination but they were all recorded as being potentially linked.

She said New Zealand started vaccinating on July 19, 2004, and up to June 30, 2006, the period of the mass campaign more than 3 million doses had been given to 1.06 million children and young people.

"During that two-year period 2212 spontaneous reports of events to the Centre for Adverse Reaction Monitoring," she said.

"Most of these records are for local reaction, so clearly they are related to the vaccine, that is 925 of those. Then the next one is skin reaction almost certainly related to the vaccines, then you get fever – 705 – and they may or may not be related to the vaccine. Some of them definitely are because vaccines do raise temperatures.

"The next one down is gastrointestinal symptoms," Dr O'Hallahan said.

"Again, particularly in this age group we vaccinate, kids often have gastic problems, so these ones may or may not be related to the vaccine.

"This is of the order of reporting that we would expect from a new vaccine."

Dr O'Hallahan said there was an intensive monitoring system for the first 100,000 who received MeNZB in the Auckland area to look for serious adverse events, events that would cause somebody to go to hospital

"So we monitored for a number of conditions that have been proposed to be associated with vaccines.

"If any of these kids who were vaccinated went to hospital then a report form was filled out with any of these particular conditions – about 10 – that we're monitoring for, then their vaccination status would be ascertained.

"When we looked at, say neurological abnormalities, we looked at the rates for these diseases pre-vaccination and the rates post-vaccination and there was no increase in rate during the vaccination programme.

"Frequently one doesn't know what causes some of these abnormalities, but what we do know is that there was no increase in these conditions during the vaccination campaign," she said.

Meanwhile the the Meningitis Trust will be marching through the streets of Wellington tomorrow in a plea for the Government to put a new vaccine on the free list for 2008.

The trust says the vaccine, Prevenar, would virtually eliminate the deadly pneumoccocal disease and other disabilities including cerebral palsy, pneumonia, bacterial otitis media (glue ear) and sinusitis.

The trust is making a final plea to the Immunisation Technology Working Group who meet next week to make recommendations to the Government as to whether the pneumococcal vaccine should be given funding in 2008.

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Scary.