6 that vaccines would be manufactured Noted − overseas and distributed Australia-wide. Does not object to issue of licence. 7 Supports the Regulator’s conclusion that DIR 137 Noted − poses negligible risk of harm to human health and the environment. 8 Concerned that pregnant women / The TGA has regulatory responsibility for quality, − persons may receive the vaccine in efficacy and patient safety of therapeutic goods for error. Do not see need for a live virus vaccine use in Australia. This issue will be considered by the given availability of multiple inactivated vaccines. TGA in their assessment of the GM vaccines. 9 Supportive of the application as the indicates Noted − that the proposed release poses negligible risks to people or the environment. Notes that GM vaccines are also regulated by the other Australian Government agencies. 10 The Regulator should consider clarifying the Chapters 1, 2 has been modified to clarify the range of description of facilities in administration of the & 3 facilities where vaccines may be administered. GM vaccine may occur. Agrees with the overall conclusions of the RARMP Noted −
6 that vaccines would be manufactured overseas and distributed Australia-wide. Does not object to issue of licence. − Noted 7 Supports the Regulator’s conclusion that DIR 137 poses negligible risk of harm to human health and the environment. − Noted 8 Concerned that pregnant women / persons may receive the vaccine in error. Do not see need for a live virus vaccine given availability of multiple inactivated vaccines. − The TGA has regulatory responsibility for quality, efficacy and patient safety of therapeutic goods for use in Australia. This issue will be considered by the TGA in their assessment of the GM vaccines. 9 Supportive of the application as the indicates that the proposed release poses negligible risks to people or the environment. Notes that GM vaccines are also regulated by the other Australian Government agencies. − Noted 10 The Regulator should consider clarifying the description of facilities in administration of the GM vaccine may occur. Chapters 1, 2 & 3 has been modified to clarify the range of facilities where vaccines may be administered. Agrees with the overall conclusions of the RARMP − Noted