Provided the following issues for consideration: 10 These issues will be addressed by TGA in their − assessment of the GM vaccines as therapeutic goods. Potential for residual vaccine/ build-up of vaccine in room after vaccine nasal spraying Potential for over-exposure of administrator due to aerosol build-up Potential for unintended exposure of subsequent room occupants to aerosol How does administrator ensure delivery of full vaccine dose Recommends that the Regulator consider: 11 Chapter 2 Potential for exposure to the GM flu vaccines would be Section 2, minimised by well-established procedures for import, transport, storage and disposal in the context of transport, storage and disposal of medical products. intended vaccine-delivery workforce and facilities Chapter 3 Relevant codes of practice required by the States and the need for labelling of packaging the TGA are designed to protect the workforce. the need for oversight of each new vaccine strain The TGA regulates the labelling of scheduled risk associated with incidental exposure medicines. The TGA will consider exposure through shedding by vaccinated individuals.
10 Provided the following issues for consideration: Potential for residual vaccine/ build-up of vaccine in room after vaccine nasal spraying Potential for over-exposure of administrator due to aerosol build-up Potential for unintended exposure of subsequent room occupants to aerosol How does administrator ensure delivery of full vaccine dose − These issues will be addressed by TGA in their assessment of the GM vaccines as therapeutic goods. 11 Recommends that the Regulator consider: transport, storage and disposal in the context of intended vaccine-delivery workforce and facilities the need for labelling of packaging the need for oversight of each new vaccine strain risk associated with incidental exposure Chapter 2 Section 2, Chapter 3 Potential for exposure to the GM flu vaccines would be minimised by well-established procedures for import, transport, storage and disposal of medical products. Relevant codes of practice required by the States and the TGA are designed to protect the workforce. The TGA regulates the labelling of scheduled medicines. The TGA will consider exposure through shedding by vaccinated individuals.
Risk%20Assessment%20and%20Risk%20Management%20Plan.docx