Chiron has received a license for its new meningococcal B vaccine for New Zealand

Jul 7 2004

Chiron Corporation today announced that it has received a license for its new meningococcal B vaccine for New Zealand, MeNZB(TM).

Meningococcal disease results from infection caused by the bacterium Neisseria meningitidis, known as meningococcus. Meningococcal disease usually affects the membranes around the brain and spinal cord or the bloodstream, causing meningitis or septicemia, respectively. Meningococcal disease can result in brain damage, blindness, deafness, limb amputations and death. Infection may be fatal even if diagnosed early, making prevention essential.

Chiron developed the vaccine, in close collaboration with the New Zealand Ministry of Health and the Norwegian Institute of Public Health, to protect against the specific meningococcal B strain responsible for a 13-year epidemic in the country. Prior to the New Zealand regulatory authorities issuing the license, no other vaccine was available to protect against this strain of meningococcal B disease.

"Approval from the New Zealand authorities is the final milestone before roll-out of this important vaccine," said John Lambert, president, Chiron Vaccines. "Vaccination represents the best chance of ending the meningococcal B epidemic that has struck New Zealand for more than a decade, affecting in excess of 5,000 people and leaving hundreds dead or permanently disabled.

"Through the hard work of the entire multinational team, we have developed, tested, scaled-up, manufactured and achieved regulatory approval for this New Zealand strain vaccine in just three years, a fraction of the time usually required. This accomplishment builds on Chiron's leadership position in the meningococcal field, established through the contribution of our Menjugate(R) vaccine to the meningococcal C eradication campaign in the United Kingdom."

Since the signing of the initial 2001 agreement with the New Zealand Ministry of Health, Chiron has supplied vaccine for clinical studies conducted in collaboration with the Ministry of Health and the University of Auckland. The study results, which demonstrate MeNZB's favorable safety and immunogenicity profile, comprised part of the license application that was recently approved by the New Zealand regulatory authority, Medsafe. In parallel with the clinical program, Chiron scaled up production to industrial levels. Subsequently, Chiron completed several large-scale manufacturing runs, producing vaccine for the nationwide vaccination campaign to begin in South Auckland in the coming days.

"Developing this vaccine in such a short time frame is a great achievement, and we must congratulate the whole team for their hard work," said Annette King, New Zealand's Minister of Health. "With our country bearing some of the developed world's highest rates of meningococcal disease, ensuring that our children and young people receive this vaccine is currently one of our most important public health priorities. I therefore welcome Medsafe's rapid review and approval of MeNZB that allow us to begin a nationwide immunization program and congratulate Chiron for their effort and dedication to this project."