Diary Prequel Package — page 216

Aug. 7 just as I had predicted. Clinical trials in children started about 11 days later. We wanted to get some quick and dirty safety data on normal adults before going into children. Will start trials in pregnant women in early-mid September. I pushed hard for trials in pregnant women since they are included in the 5 target groups for HIN1 vaccination in the Fall. We expect first dose data from normal adults in mid-Sept. and second dose data by early to mid-October. This will be just in time since the first major bolus of vaccines will be ready for administration by Oct. 15. Of note, we had expected about 140 to 160 doses by Oct. 15, but the virus is growing slowly pushing back the schedule. Also, one of our suppliers is CSL, which is an Australian company. Since Australia in right now in the middle of their Winter Flu season, they are getting hit hard by HIN] and so the vaccine meant for us is being channeled to the Aussies (appropriately so). Mush press regarding the beginning and progress of the trials. Iam on TV and/or radio and quoted in print media virtually every day. Southern Hemisphere getting hit with many cases and we expect the same in the Fall. Real unknown is whether there will be a greater proportion of serious disease (particularly in the young0 or whether there just will be more cases and so the total number of serious cases will be more without an increase in the proportion. I am on conference call with the Pandemic Flu Task Force (of which I am a member) every day. Aug. 26, 2009 -- Sad day today. I was scheduled to appear on CNN's "American Morning" at 6:30 AM broadcast from the NIH TV studio. Was awakened by a call from the CNN producer in NYC at 4:50 AM telling me that the segment has been cancelled Aug 27 -- Sept. 9, 2009 -- Still the same nonsense going on with Jenny backus trying to completely control the HIN1 message and not letting me out to the press despite their insistence on having me on shows and in print. Also, she continues to want to know "what I am going to say" when she does approve me. She is really very bad news. Sept.. 10 - 12, 2009 -- Great news all around regarding HIN1 vaccines. NEJM came out online on evening of Aug. 9 with papers from CSL and Novartis on requirement for only 1 dose of 15 ugs unadjuvanted vaccine (CSL) or 1 dose of 7.5 adjuvanted vaccine (Novartis) for robust responses. NIAID data now showing with SP and CSL product that 15ugs of unadjuvanted product gives robust responses at 8-10 following a single dose in adults (18 to 64) and elderly (+65). This is fantastic and surprising. This strongly indicates that although there is no "measurable" cross-reactivity in serum from most people, particularly the young who have none, this still looks very much like a secondary response to a boost. Therefore, these subjects must have been exposed in the past to virus or vaccine that has primed them for the novel HIN1. So much for measurable antibody being a correlate and/or predictor of immunity/protection.