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Approval for GM vaccine trial

Information bulletin

Ref: 210/09
Date: 17 September 2009

Defra has approved a new consent for a GM vaccine trial which supersedes a previous one granted in February, adding a doctor’s surgery in Wandsworth, London, to 9 hospital sites already approved in England. 

The approval allows MedImmune LLC to include the surgery in its research trials for a GM vaccine against two respiratory tract infections, respiratory syncytial virus (RSV) and Parainfluenza Virus Type 3. The trials also have the approval of the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Department of Health’s Gene Therapy Advisory Committee.

Before the new 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 to editors

1. The Medicines and Healthcare Products Regulatory Agency (MHRA) and the Dept of Health’s Gene Therapy Advisory Committee gave approval for the vaccine trials in 2008. Defra was 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 give its approval before the trial can go ahead. Defra’s responsibility is to assess the safety of people who are independent of the trial, not those taking part.

2. Defra granted consent in February 2009 for the trial to take place at 9 hospitals (see
http://www.defra.gov.uk/environment/quality/gm/regulation/registers/consents/index.htm
and the press release at http://www.defra.gov.uk/news/2009/090205b.htm
MedImmune subsequently asked to add a doctor’s surgery so was asked to submit a new application.  

3. The relevant ACRE advice is available at: http://www.defra.gov.uk/acre/pubs.htm

End

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Page published: 17 September 2009