Astra Zeneca Summary of RIsk Assessment

Risk assessment

The risk assessment concludes that risks to the health and safety of people or the environment from the proposed supply, either in the short or long term, are negligible. No specific risk treatment measures are required to manage these negligible risks.

The current assessment focuses on risks posed to people other than the intended vaccine recipient and to the environment, including long term persistence of the GMOs, which may arise from the import, transport, storage or disposal of the GMO. The risk assessment process considers how the genetic modification and activities conducted with the GM vaccine in the context of import, transport, storage and disposal might lead to harm to people or the environment. Risks are characterised in relation to both the seriousness and likelihood of harm, taking into account information in the application, relevant previous approvals, current scientific knowledge and advice received from a wide range of experts, agencies and authorities consulted on the preparation of the RARMP. Both the short and long term risks were considered.

Note ~ The parent organism is Chimpanzee adenovirus Y25, GMO.

3 pages.

Astra Zeneca Summary of RIsk Assessment and Risk Management Plan (consultation version)

 


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