Trial Release Vaccines

5.1 For human clinical trials, what arrangements are proposed to dispose of waste containing any vaccine organisms?

Clinical trials are not part of this application. They are already under way in Europe.

5.2 Will the subjects carry live vaccine organisms at the end of the trial? If so:

5.2.1 Will they be likely to disseminate the live vaccine organisms to the general population?

5.3 On the basis of data obtained in contained experiments (please supply), what effects are expected when the vaccine organism interacts with target and nontarget species in the test area and surrounding environment?

5.4 What is the existing evidence regarding level and duration of immunity produced in the target species?

These data are being collected.

5.5 What challenge or other tests using virulent field strains are to be carried out on vaccinated animals?

5.6 Is there likelihood that the host vaccine organism would be used in other human or animal vaccines?

Yes.

5.7 Would the use of this vaccine preclude the future use of the host vaccine organism for immunization purposes?

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