Life-saving meningitis vaccine may be dumped

By JAMES GARDINER

Health officials may have to dump large quantities of the expensive new vaccine bought to combat the killer meningitis epidemic because of delays getting the vaccine licensed.

The Ministry of Health is awaiting approval to start a $200 million nationwide vaccination programme, which has been planned for two years but now delayed by more than a month.

Even if the drug is licensed by the specialists' panel of Medsafe, the country's medicines safety authority, in a fortnight as expected, the ministry and Counties Manukau District Health Board will have just 16 weeks to administer 390,000 doses to Aucklanders under 20 before the first batch of the vaccine is due to expire on October 31.

The problem is it will take a minimum of 12 weeks to administer the vaccine in three separate doses six weeks apart for it to be effective.

At the start of the programme the aim is to vaccinate 9000 children a week, starting with under-5s next month and moving to schoolchildren in August, with vaccination rates increasing as the programme continues.

There are 150,000 children under 20 in South Auckland and a group of eastern corridor Auckland suburbs - considered the highest risk area in the country - where the programme will start.

The ministry hopes Medsafe will agree to extend the expiry date set by the manufacturer, but has no guarantees.

"If the expiry date remains October 31, clearly there will be some vaccine that is not able to be used," said the ministry's meningococcal vaccine strategy director, Dr Jane O'Hallahan.

Nationally 1.1 million New Zealanders are under 20 and the aim is to vaccinate 90 per cent of them.

Last year 541 cases of meningococcal disease were notified and 13 people died.

Because of a confidentiality clause in the supply contract, the ministry will not say how much it is paying the multinational drug company Chiron for the MeNZB vaccine.

Dr O'Hallahan said it was a significant proportion of the total budget.

MeNZB was produced specifically to combat the strain of meningococcal B bacterium that hit New Zealand in 1981 and has been at epidemic levels for the past 13 years.

Maori, Pacific Islanders and the young are most at risk.

Dr O'Hallahan said they were the key targets of the life-saving vaccine, which will be administered in schools, homes and medical surgeries by public health nurses and doctors.

Advertising on radio, television and newspapers is ready to begin as soon as the vaccine is approved.

To be successful the vaccine must be administered to each person three times at six-weekly intervals.

Medsafe will decide whether the vaccine, which has already had clinical trials in Auckland without showing adverse side-effects, is safe and effective.

"Clearly there are still some outstanding issues," Dr O'Hallahan said.

Medsafe principal adviser Dr Stewart Jessamine said evaluation of the vaccine was being treated as a priority but a recommendation would be made to Health Minister Annette King only after the authority was satisfied that "all outstanding safety, quality and efficacy issues are resolved".

Dr O'Hallahan said the delays were disappointing "and one of the challenges of this programme", but it was accepted that the evaluation had to be rigorous and independent.

"If we hadn't gone down the track of ordering this vaccine [before getting the licence] we would be looking at a year's delay at least before starting the programme.

"We can plan but we have to remain flexible, as do the district health boards.

"We are clearly looking at how much to order in relation to how much we're using, so it will be very tightly managed."

The plan was to complete the programme in just over a year.

Dr O'Hallahan said the vaccine was closely based on one manufactured to combat the Norwegian strain of the disease, which had a two-year shelf life.

"It is our expectation that over time the expiry date will be extended, so this is really an issue that we face at the start of the programme."

Killer disease

* New Zealand has one of the world's worst rates of meningococcal disease, with an average 16 deaths a year.

* The disease kills 4 per cent of those who contract it, often within 24 hours, and seriously disables another 20 per cent.

* Since 1991, 218 have died from more than 5300 cases.

* A $200 million budget boost was announced two years ago to vaccinate everyone under 20.

* A significant portion of that money may be wasted as time runs out. The first batch of the Italian-made vaccine ordered by the Ministry of Health is due to expire on October 31.

* The programme is delayed because Medsafe has yet to approve the new vaccine.

* Medsafe, the nation's medicines regulator, is part of the ministry but operates independently.