2 November, 2004

Kedgley questions vaccine approval process

The Green Party is concerned that a meningococcal vaccine to be injected into more than a million children was approved in a teleconference so hastily convened that three members of the expert panel couldn't be contacted and others hadn't had a chance to read the clinical data.

"This is a vaccine to be administered to 1.15 million children and young people and it is vital that it is properly assessed on the basis of all clinical, safety and efficacy data," said Sue Kedgley, the Green Party Health spokesperson.

"Our concern is in no way meant to downplay the seriousness of the meningococcal disease but the public deserves to know why a mass vaccination campaign was launched before experts had an opportunity to examine the clinical safety data for themselves."

The minutes of the July 6th meeting of the Medicines Assessment Advisory Committee, obtained under the Official Information Act, are available on request.

Ms Kedgley is also questioning why more than a million New Zealand children and young people are to be injected with a vaccine that has only been given provisional approval for use on a restricted basis for the treatment of a 'limited' number of people.

"More than 200,000 doses of the Meningococcal B vaccine have already been administered," said Ms Kedgley. "Yet the vaccine has only been given provisional consent for the 'treatment of a limited number of patients'."

Ms Kedgley said that medicines are given provisional consent under Section 23 of the Medicines Act when the data provided is insufficient to meet all the requirements of Medsafe's guidelines and where the Minister of Health is of the opinion that medicine be available on a 'restricted basis for the treatment of a limited number of people'.

ENDS

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