FOI 042-2022

Under the FOI Act, I would like request your response on the below questions:

• where can I obtain a copy of the initial phases of the trial preceding this human trial?
• when and where did the trial take place? which hospitals (including what specific areas of the hospital) and other clinical sites?
• is there notifications at the hospital and clinical sites' entrance stating the trial is taking place?
• how many participants started in the trial? and how many are still in the trial?
• where can I obtain a list of criteria for which this trial was approved?
• what are the specific ingredients of this trial vaccine?
• how were the participants selected? and what information were they given to be able to provide informed consent?
• how was the dispersion of the trial vaccine controlled to restrict the spread and persistence of the GM vaccine to persons not in the trial? eg.to restrict particles from trial GM vaccine travelling through air-conditioning vents.
• what adverse reactions have occurred since the commencement of the trial? what mechanism is in place for the recording of post-trial adverse reactions?