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Application to import GMO vaccine approved

MEDIA RELEASE

TUESDAY, APRIL 30, 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 approval by Medsafe.
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.

The EPA’s 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 IMOJEV can only be used in New Zealand with approval from Medsafe, and – if approved – the vaccine would be regulated by the requirements of the Medicines Act 1981, as a prescription-only medicine.”

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.



Read the decision document

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.

ends

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