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Approval for GM vaccine trial

DEPARTMENT FOR ENVIRONMENT, FOOD AND RURAL AFFAIRS News Release (24/09) issued by COI News Distribution Service. 5 February 2009

Defra has added its approval to that of the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Department of Health's Gene Therapy Advisory Committee to allow MedImmune Inc to conduct a research trial for a GM vaccine against two respiratory tract infections, respiratory syncytial virus (RSV) and Parainfluenza Virus Type 3

Last year the arrangements for the clinical trial were approved by the MHRA and the ethical aspects were approved by the Department of Health's Gene Therapy Advisory Committee.

Before the trial could proceed, approval was required from Defra for the release of the live GMO into the environment. The application has been evaluated by the independent expert group the Advisory Committee of Releases to the Environment (ACRE). It is satisfied that this trial will not have any adverse effect on human health and the environment, providing the required precautionary measures are taken.

Reflecting ACRE's advice, precautionary conditions have been attached to the consent for the trial.

Notes for Editors

1. In September 2008, the Medicines and Healthcare Products Regulatory Agency (MHRA) gave approval for the clinical trial. The ethical review for the study was undertaken by the Dept of Health's Gene Therapy Advisory Committee, which gave approval for the study on 6th October 2008. Defra has been consulted on this because the trial involves the release of a live genetically modified organism, and it is therefore obliged to assess any risks to human health or the environment from the release and add its approval before the trial can go ahead.

2. The relevant ACRE advice is available at http://www.defra.gov.uk/environment/acre/advice/pdf/08-r43-01-medImmune.pdf

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