Drama not Documentary Response to Norwegian Programme Screened TV1 Sunday 5 November 2006.The Immunisation Advisory Centre is concerned that this programme did not present the full story of MeNZB™ vaccination. The following key points note some of the major shortcomings of this programme. CausalityThe programme presents the stories of 2 Norwegian teenagers who had health problems after they had been given the Norwegian or New Zealand vaccine. In no case were we told how often these conditions occur naturally. There is no scientific evidence that there are more cases of chronic fatigue in the vaccinated group as opposed to the unvaccinated group. We expect that at any one point in time there will be around 1/200 people with this condition and some estimates are higher. We would therefore expect quite a few cases (500+) in the vaccinated population just by chance. It is important to know how many people have this condition normally in the population. ACC is a no fault system. It is a distortion of data to say that an ACC payout proves the vaccine was the cause. Omitting Key DataThe programme states that 27 fully vaccinated people In New Zealand have contracted the disease. It has failed to mention that 158 unvaccinated or incompletely vaccinated people have contracted meningococcal disease in the same time period. The programme fails to mention the New Zealand clinical trials that helped establish data supporting the use of MeNZB™ in children. A Norwegian epidemiological study and on-going safety data in New Zealand have found no unexpected significant adverse events associated with the Norwegian vaccine or MeNZB™. There are always limits in scientific studies and the full body of data must be considered to draw reasonable conclusions. New Zealand Safety Monitoring New Zealand designed its own safety monitoring systems and has not exclusively relied on the Norwegian data. This safety system is world class. The New Zealand safety monitoring system has been actively looking for the types of events that occurred in Norway. These events were also noted on the MeNZB™ vaccine datasheet available freely to both health professionals and the public. There has been no increase over the normal rates of blood disorders or brain and other major neurological side effects in New Zealand. Data from other countriesThe programme continually suggests that Norway provided the sole data on which the NZ programme was based. This is not true. NZ also drew on data from trials of closely related vaccines from other countries across different age groups. These vaccines have been used for many years and have had over 60 million doses administered with excellent safety records. Phase 3 trials It would have been unethical for NZ to run phase 3 trials. This would have taken many years and over 100,000 participants when there was a vaccine that had considerable data from other counties to draw upon. Many more young people would have died and been disabled. New Zealand ran phase 1 and phase 2 trials to confirm what was already known about this vaccine. This is internationally accepted practice. During the roll out of the vaccine, safety was monitored under clinical trial conditions for the first 200,000 recipients.
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