The Environmental Risk Management Authority has asked that a cholera vaccine be recalled because it contains a genetically modified organism (GMO) and it has not been approved under the Hazardous Substances and New Organisms Act.

The Ministers handling this issue, Marian Hobbs, Annette King and Phillida Bunkle, confirmed the recall in a joint statement today.

The vaccine, Orochol Berna, involves live bacteria that have been genetically modified. It has been imported since 1998 and given to New Zealanders going into high risk cholera areas overseas for long periods, such as aid workers, sailors and some tourists. Australia, Canada and Switzerland are among countries that have approved its use.

ERMA New Zealand was formally advised about the vaccine by the Ministry of Health after Medsafe had approved the vaccine for use under the Medicines Act.

"But HSNO Act approval was not sought at that time and that is a matter of considerable legal concern," the Ministers said. "Given the Medsafe approval, officials have advised there is no reason to suppose the vaccine poses any risks, but we cannot be sure until the particular criteria of the HSNO Act have been applied."

Under normal circumstances, when alternatives are available, the response would be total withdrawal of the vaccine until or unless an HSNO approval had been obtained. The Government has initiated urgent action to obtain alternative stocks to be made available as soon as possible. Total withdrawal would leave New Zealand without any access to a suitable vaccine.

“That would be unacceptable,” the Ministers said. “We have reluctantly agreed that access should be maintained through the interim period. "

The Ministry of Health will therefore ask the importer, Pharmabroker Sales Ltd, to cease importing and distributing the vaccine and to arrange for the recall of all vaccine stocks in the country. But existing stocks will be retained in secure containment and made available to GPs for use in emergencies, until an alternative is available.

The Ministers were adamant that this situation should not be allowed to happen again. This view had also been strongly communicated to them by ERMA New Zealand.

“We endorse the advice from ERMA New Zealand that any recurrence will be dealt with strictly in terms of the HSNO Act," they added. "In this case New Zealand can probably survive without this vaccine, but we don't want to be in the situation of New Zealanders not being able to take advantage of advances in medicine that could save lives."

The Ministry of Health and ERMA are aware of the need to provide workable arrangements which meet both public health needs and environmental needs through the HSNO Act, the Ministers said. Both agencies were committed to working as quickly as possible to agree arrangements to make this happen.

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