Medsafe responds to claims made in PR - Meningococcal Vaccine Fails International Tests

Media Statement
20 October 2006

Medsafe stands behind the quality of New Zealand's Meningococcal B Vaccine

Medsafe, the unit of the Ministry of Health responsible for assessing and approving medicines and vaccines, has no concerns about the quality of the vaccine used in New Zealand's Meningococcal B Immunisation programme.

The comments follow misleading statements made by critics of the immunisation programme.

Medsafe's principal technical specialist, Dr Stewart Jessamine, says it is important to clarify that New Zealand's Meningococcal B Vaccine, MeNZB, approved by Medsafe and used in New Zealand, is different from the vaccine referred to in a recently published statement.

"Medsafe assessed the quality of the manufacturing site of the New Zealand MeNZB vaccine when the vaccine was first approved, and continues to be satisfied that it meets the international standards for best practice and quality manufacturing," Dr Jessamine says.

International expert advice from the World Health Organization, the Centers for Communicable Disease Control in the United States and the medicine regulator in the United Kingdom supported the vaccine's licensing processes used in New Zealand.

The MeNZB vaccine was licensed under The Medicines Act under Section 23.

The MenBvac vaccine made by the Norwegian Institute of Public Health is not approved for general use in New Zealand and is not used in the New Zealand Meningococcal B Immunisation Programme.

"There is simply no connection in quality of production between the MeNZB vaccine used in the New Zealand Meningococcal B Immunisation Programme and the vaccine MenBvac, which has been assessed by overseas jurisdictions," Dr Jessamine says.

A copy of the minutes of the expert committee that assessed the safety, quality and efficacy of the New Zealand MeNZB vaccine are available from the Medsafe website http://www.medsafe.govt.nz/hot.htm

ENDS