Executive Summary




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Risk Assessment and

Risk Management Plan for

DIR 097


Limited and controlled release: Clinical trial of a candidate vaccine against Human respiratory syncytial virus and Human parainfluenza virus type 3


Applicant: PPD Australia Pty Ltd


January 2010


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Executive Summary

Introduction


The Gene Technology Regulator (the Regulator) has made a decision to issue a licence in respect of licence application (DIR 097) from Pharmaceutical Product Development Australia Pty Ltd (PPD) involving the limited and controlled release of genetically modified (GM) Bovine Parainfluenza virus type 3 into the environment.

The Gene Technology Act 2000 (the Act), the Gene Technology Regulations 2001 and corresponding state and territory law govern the comprehensive and highly consultative process undertaken by the Regulator before making a decision whether to issue a licence to deal with a GMO. The decision is based upon a Risk Assessment and Risk Management Plan (RARMP) prepared by the Regulator in accordance with the requirements of the legislation. RARMP’s apply the Risk Analysis Framework and are finalised following consultation with a wide range of experts, agencies and authorities, and the public1.

The application


PPD have applied for a licence for an intentional release of a genetically modified (GM) vaccine for prevention of selected childhood respiratory diseases into the Australian environment on a limited scale and under controlled conditions.

The GM candidate vaccine is based on Bovine parainfluenza virus type 3 (bPIV3) which has been modified to contain genes from two common childhood respiratory pathogens Human parainfluenza virus type 3 (hPIV3) and Human respiratory syncytial virus (RSV). Expression of these genes is expected to elicit a protective immune response in vaccinated children. PPD will conduct a clinical trial of the GM vaccine in children to evaluate its safety and efficacy against hPIV3 and RSV.

The trial will take place in six specified hospitals in ACT, NSW, QLD, SA, VIC and WA and involves a maximum of 70 children aged 2 – 24 months. The trial is expected to be completed by March 2012.

PPD proposes a number of control measures to restrict exposure to the GM vaccine that were considered during the evaluation of this application.

Confidential Commercial Information


Some details, including vector maps and unpublished results of ongoing clinical trials, have been declared Confidential Commercial Information (CCI) under section 185 of the Act. The confidential information was made available to the prescribed experts and agencies that were consulted on the RARMP for this application.

Risk assessment


The risk assessment took into account information in the application (including proposed containment measures), relevant previous approvals and current scientific knowledge and advice relating to risks to human health and safety and the environment provided in submissions received during consultation on the RARMP. No new risks to people or the environment were identified from the advice received on the consultation RARMP.

Initially, risk identification was used to postulate potential pathways that might lead to harm to people or the environment as a result of gene technology (risk scenarios) and determine those that warrant detailed characterisation.

Five risk scenarios were identified. This included consideration of whether, or not, expression of the introduced genes could result in products that are toxic or allergenic to people or other organisms; alter characteristics that may impact on the disease burden due to the GM virus; or produce unintended changes in viral characteristics. Gene transfer to other organisms and its effects if this occurred was also assessed.

A risk is only identified when a risk scenario is considered to have some chance of causing harm. Pathways that do not lead to an adverse outcome, or could not reasonably occur, do not advance in the risk assessment process.

The characterisation of the five risk scenarios in relation to both the seriousness and likelihood of harm, in the context of the control measures proposed by the applicant, did not give rise to any identified risks that required further assessment.

Any risks of harm to the health and safety of people, or the environment, from the proposed release of the GM virus into the environment are assessed to be negligible. Hence, the Regulator considers that the dealings involved in this limited and controlled release do not pose a significant risk to either people or the environment.
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