8 June 2005

Lack of vaccine testing raises concerns

Confirmation by the Health Ministry today that no phase 3 clinical trials had been undertaken on the Meningoccocal vaccine is disturbing, Green MP Sue Kedgley says.

Public Health Deputy Director General Don Matheson told the Health Select Committee that the reason the Health Ministry had decided to proceed with the vaccine, despite the fact that it hadn't undergone phase three clinical trials, was because of the urgency of the situation and the fact that similar vaccines had been trialled overseas, Ms Kedgley says.

"Phase three clinical trials are normally considered to be essential to ensure safety and efficacy before a new medicine is introduced. I am concerned that they haven't been undertaken in the case of this new vaccine.

"The fact that a similar vaccine was fully tested in Norway 15 years ago does not justify introducing a new vaccine targeted at more than a million children without the proper safety and efficacy data," Ms Kedgley said.

"After all, this is a new vaccine produced for New Zealand, targeting a specific strain of bacteria."

Dr Matheson had suggested that the roll out of the vaccine, with its monitoring programme in place, was in essence a phase three clinical trial, but Ms Kedgley disputed this.

Ms Kedgley said Dr Matheson also confirmed that the reason the vaccine had only been given provisional approval to be administered 'on a restricted basis for the treatment of a limited number of people' was because there had been insufficient clinical data to allow a full approval of a new medicine.

However, she was pleased at the Health Minister's assurance that no parent or child should be pressured or coerced into having the vaccine, or given only 24 hours to make up their minds whether or not to give the vaccine to their children. She was also pleased by Ms King's promise she would follow up any cases where pressure had been exerted on parents or children.

"It is important that parental choice is not undermined and undue pressure exerted. I have been extremely concerned at feedback from parents that some children have been told in schools that they would die if they didn't have the vaccination, or told they would not be allowed on school camps if they weren't vaccinated."

She hoped Ms King's reassurance and promise to follow up complaints would put an end to these sort of pressures, which breached the Code of Health and Disability Consumer Rights.

ENDS

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