Meningitis jabs safe, says ministry

The Ministry of Health has rejected accusations that inadequate clinical trials were carried out on the meningococcal B vaccine before it was given to New Zealand children.

Green Party MP Sue Kedgley said it was "disturbing" that the ministry had not done Phase 3 clinical trials of the vaccine before launching its $200 million campaign to vaccinate all those under 20 against meningococcal B.

"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.

But Director-General of Health Dr Karen Poutasi said the MeNZB vaccine had gone through the required clinical trials.

The ministry had relied on anti-body data from Phase 1 and 2 clinical trials, involving 1703 New Zealanders aged 6 weeks to 19 years.

The data indicated about 75 per cent of those who received three vaccinations would be protected against meningococcal B.

Dr Poutasi said the ministry had sought advice from international experts, including the World Health Organisation, the US Centre for Communicable Disease Control and the medicine regulator in Britain, and all supported the processes followed in New Zealand.

Otago University Bioethics Centre director Professor Donald Evans said it was unrealistic to call for a Phase 3 trial, which could take years, in the face of an epidemic of meningococcal disease.

He said the vaccination campaign was the equivalent of a Phase 3 trial, and he compared it with the flu vaccine, which was modified each year but did not go through additional Phase 3 trials.

Professor Evans believed the ministry had acted ethically and responsibly and according to best international standards.

"I think it would be unethical not to carry out this programme."

Dr Nikki Turner, director of the Immunisation Advisory Centre, said undertaking a Phase 3 trial could have extended the current epidemic by years.

A large Phase 3 trial, involving 172,000 teenagers, had already been conducted on the "parent" vaccine in Norway, she said.

Dr Poutasi said safety and quality data had been assessed by Medsafe and was internationally peer-reviewed before the recommendation that the vaccine be distributed.

Ms Kedgley said she had received feedback from parents that some schoolchildren had been told they would die if they were not vaccinated or would not be allowed on school camps.

"It is important that parental choice is not undermined and undue pressure exerted," she said.

Dr Poutasi said the ministry was working with district health boards to ensure parents could make an informed choice about whether to vaccinate.

Vaccine tests

* Phase 1: Small numbers of people take the same vaccine using different methods of delivery and/or dosage. Assesses safety and immune response.

* Phase 2: Uses larger numbers of people, compares new treatments with current standards or placebos. Continues to assess safety and immune response.

* Phase 3: Large, randomised trial to test the effect of a new vaccine against a control group. Tests safety and efficacy (the percentage of people that the vaccine protects from catching the disease).

Source: Immunisation Advisory Centre