Application to import GMO vaccine approved

30 April 2019

A genetically modified vaccine for the potentially deadly Japanese encephalitis virus (JEV) has been approved for importation and release into New Zealand, with its use subject to the Medicines Act 1981.

Manufacturer Sanofi SA applied to the Environmental Protection Authority (EPA) for approval to import and release the genetically modified, live-attenuated vaccine for JEV, called IMOJEV.

General Manager of Hazardous Substances and New Organisms, Dr Fiona Thomson-Carter, says “Japanese encephalitis is caused by a virus that is transmitted to humans by mosquitoes. This virus is not found in New Zealand.

“It’s important to note that as a new medicine which is not currently approved by Medsafe, IMOJEV will be regulated by the requirements of the Medicines Act 1981, as a prescription-only medicine and with conditions on how it can be supplied.”

According to the application, Sanofi intends to market and distribute the IMOJEV vaccine to healthcare providers in New Zealand mainly for the immunisation of travellers, including military personnel and emergency aid workers who are sent at short notice to regions where the virus is endemic.

The benefits of IMOJEV include that it is a single-dose vaccine and provides protection within three to seven days. The vaccine currently in use in New Zealand requires two doses, 28 days apart, in order to provide immunity.

The vaccine is approved in 16 other countries and jurisdictions, including Australia, and has an excellent environmental safety record.

For further information, see the application and decision documents

Background

Japanese encephalitis virus is mostly found in Asia, but also occurs in northern Queensland and parts of the Western Pacific. It is endemic to 24 countries, but is not found in New Zealand.

There is no treatment available for Japanese encephalitis, and death rates can range from 10-20 percent.