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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