21 June 2004
Meningococcal vaccine use-by date not confirmed
News media reports of a deadline for using the first batch of vaccine in the proposed national programme to immunise
against meningococcal B disease are premature.
Expiry dates for each batch of MeNZB vaccine in the proposed immunisation programme have not been confirmed. The expiry
dates for each batch will not be determined before the vaccine is licensed for use in New Zealand.
Deputy Director General, Public Health Dr Don Matheson said: Safety is paramount and no children or young New Zealanders
will be given any vaccine that has expired.
Medsafe is currently considering an application to license MeNZB vaccine for use in New Zealand. The application is
supported by vast amounts of scientific and technical data, including information that can be used to establish a safe
expiry date.
Any reports of an expiry date being set at this stage are premature, as the expiry date can not be confirmed until the
vaccine is licensed for use Dr Matheson said.
Background questions and answers
What is the licensure process? Before any medicine or vaccine can be used in New Zealand, the manufacturer must receive
consent from the Minister of Health. Medsafe, New Zealand's Medicines and Medical Devices Safety Authority is the
authority responsible for regulating all medicines in the country. Medsafe is assessing data about the vaccine and is
seeking international peer review of its findings before presenting its recommendation to the Minister.
What is meningococcal disease? A bacterial infection that can cause serious illnesses including meningitis (an infection
of the membranes that cover the brain) and septicaemia (a serious infection in the blood). For every 100 people that get
meningococcal disease, on average: · 4 will die · 20 will suffer a permanent and serious physical disability · others
will have ongoing behavioural or learning difficulties.
A person who has meningococcal disease can deteriorate very quickly (sometimes in less than 24 hours), so it is
important to get urgent medical help if meningococcal disease is suspected.
Who is affected by meningococcal disease? Meningococcal disease can affect anyone but 80 out of every 100 cases occur in
people aged 0-19 years. About half of all cases occur in children aged under five years. Babies are most at risk.
The bacteria that cause meningococcal disease are carried by about one in every five people. It is not known why some
people can carry the bacteria and yet not become sick, while other people suffer the disease.
How many people have been affected? There have been more than 5400 cases of meningococcal disease since the epidemic
began in 1991. To date, there have been a total of 220 deaths caused by meningococcal disease.
ENDS