Meningococcal vaccine use-by date not confirmed

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

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