EPA approves GM cholera vaccine

The Environmental Protection Authority (EPA) has approved a new vaccine for the potentially deadly infectious disease cholera.

The approval will allow the importer, Biocelect Pty Ltd, to import and release the genetically modified vaccine, VAXCHORA, in New Zealand.

The vaccine is already approved in other countries, including Australia, the United States and the European Union.

General Manager of Hazardous Substances and New Organisms, Dr Chris Hill, says: "While cholera is not present in New Zealand, it is a concern for Kiwis travelling overseas.

"This approval will help ensure New Zealand travellers, including military personnel and emergency aid workers, will have access to another cholera vaccine."

Biocelect Pty Ltd says doctors have faced vaccine shortages over the past year, potentially leaving travellers without protection against the disease.As a new medicine not currently approved by Medsafe, VAXCHORA will be regulated under the Medicines Act 1981 as a prescription-only medicine and with conditions on how it can be supplied.

Dr Hill says: "In considering this application, we reviewed the scientific data and evidence to ensure we continue to protect people’s health and our unique environment.

"We have previously approved other genetically modified vaccines and are confident there is no risk to the public or the environment."As this application relates to a medicine, it was made under the EPA’s rapid assessment pathway, which means the decision was provided to the applicant within ten working days.

The EPA currently regulates the use of genetically modified organisms in New Zealand under the Hazardous Substances and New Organisms Act 1996. VAXCHORA is a single-dose oral vaccine and provides protection within ten days.

For more information, see the decision documents.

Background

Cholera is not found in New Zealand although there is an occasional case in New Zealand, usually in travellers from Asia.

It is an infectious disease that is spread through contaminated water and food and causes severe diarrhoea and dehydration.

Data from the World Health Organisation (WHO), shows there are currently cholera outbreaks in countries such as Yemen, Afghanistan, Pakistan, Sudan, Democratic Republic of Congo, Ethiopia, Somalia.