COVID-19 Records

RE: Support on Ebola

Gates Package, p.79 · gates:email:00048

Page text: p.79 · original PDF

Date
2014-08-08 09:15
Type
email · email
sender
Richard Koup
to
John Mascola, Anthony S. Fauci
Topics
Vaccines

This text appears inside a quoted reply chain — it is evidence that the message was circulating, not necessarily a new message.

John and Tony: Here is the latest I know. We have been getting a lot of additional clarifying questions from BARDA subsequent to our telecom, so I am fairly confident they will fund production of 1 "lot" of vaccine, but I remain unclear as to when we will hear definitively. Wellcome Trust seems willing to provide half the funds for another lot, but only if GSK or some other source partners for the other half of the funds. GSK leadership is not interested, but Rip Ballou is checking with MRC and others to see what can be done. WHO is anxious to start additional small phase 1 trials in Africa (20 subjects per country, at MRC sites). We currently have adequate vaccine stock for our NIH-based phase 1, an expanded phase 1 in Uganda (100 subjects with MHRP), and 1 or 2 other African phase 1 trials. Whether the funding comes to us or GSK, we will both use a contract mechanism to have the vaccine produced at Advent, which is the Okairos facility that made the first lot for us under contract. Our pilot plant would do the vialing and lot release would be shared by us and Okairos. Maybe more info than you wanted. Rick Richard A. Koup, MD Chief, Immunology Laboratory Deputy Director Vaccine Research Center, NIAID, NIH 40 Convent Drive, MSC 3022 Building 40, Room 3502 Bethesda, MD 20892 mail. The information in this e-mail and any of its attachments is confidential and may contain sensitive information. It should not be used by anyone who is not the original intended recipient. If you have received this e-mail in error please inform the sender and delete it from your mailbox or any other storage devices. The National Institute of Allergy and Infectious Diseases shall not accept liability for any statements made that are sender's own and not expressly made on behalf of the NIAID by one of its representatives.

Extracted statements

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StatementGradeAttributionStance
We have been getting a lot of additional clarifying questions from BARDA subsequent to our telecom, so I am fairly confident they will fund production of 1 "lot" of vaccine, but I remain unclear as to when we will hear definitively. quoted / not their view quoted_external sentence carries quotation marks questions
We currently have adequate vaccine stock for our NIH-based phase 1, an expanded phase 1 in Uganda (100 subjects with MHRP), and 1 or 2 other African phase 1 trials. quoted / not their view quoted_external attribution frame: 'per' asserts
Whether the funding comes to us or GSK, we will both use a contract mechanism to have the vaccine produced at Advent, which is the Okairos facility that made the first lot for us under contract. quoted / not their view quoted_external attribution frame: 'per' asserts

In context

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  1. 2014-08-08 08:49 John Mascola open
    Tony, Several relevant items. 1. We heard from GSK that Welcome trust is willing to help support expanded international trials and this is being pursued. Rip Ballou of GSK is coordinating with Rick Koup. 2. We discussed with Nelson Michael and colleagues yesterday, a trial in Uganda that would be run by African investigators and generate data in African volunteers. Some funding to support this may be helpful., but there may be existing NIAID/DoD funds existing to support this. There are many moving parts here and several fairly imminent decisions. Rick has been on all the calls with BARDA, GSK, WHO etc. A first key step in to find out what BARDA plans to do, and based on that, decide if there are other funding gaps. Rick, do you know when we will hear specifically what BARDA will fund, how much and when this will be announced. Will they support some GSK manufacturing activities? John Apple iPad
  2. 2014-08-08 08:49 John Mascola open
    Tony, Several relevant items. 1. We heard from GSK that Welcome trust is willing to help support expanded international trials and this is being pursued. Rip Ballou of GSK is coordinating with Rick Koup. 2. We discussed with Nelson Michael and colleagues yesterday, a trial in Uganda that would be run by African investigators and generate data in African volunteers. Some funding to support this may be helpful., but there may be existing NIAID/DoD funds existing to support this. 3. GSK is close to final decision about making larger lot of vaccine. BARDA or Gates funding could play a role here. There are many moving parts here and several fairly imminent decisions. Rick has been on all the calls with BARDA, GSK, WHO etc. A first key step in to find out what BARDA plans to do, and based on that, decide if there are other funding gaps. Rick, do you know when we will hear specifically what BARDA will fund, how much and when this will be announced. Will they support some GSK manufacturing activities? John Apple iPad On Aug 7, 2014, at 9:50 PM, "Fauci, Anthony (NIH/NIAID) [€]" <{@ niaid.nih.gov> wrote: John: See e-mail string below. Is there any way that you can think of where Gates can be of assistance to us in the ChimpAd Ebola vaccine development? Tony
  3. 2014-08-08 08:56 Anthony S. Fauci open
    Inline-Images: image001.png Francis: I will forward to you in another e-mail the response of John Mascola when I asked him if Gates could help. Stay tuned. Tony
  4. 2014-08-08 08:57 Anthony S. Fauci open
    Inline-Images: image001.png As per my prior e-mail.
  5. 2014-08-08 09:15 Richard Koup
    John and Tony: Here is the latest I know. We have been getting a lot of additional clarifying questions from BARDA subsequent to our telecom, so I am fairly confident they will fund production of 1 "lot" of vaccine, but I remain unclear as to when we will hear definitively. Wellcome Trust seems willing to provide half the funds for another lot, but only if GSK or some other source partners for the other half of the funds. GSK leadership is not interested, but Rip Ballou is checking with MRC and others to see what can be done. WHO is anxious to start additional small phase 1 trials in Africa (20 subjects per country, at MRC sites). We currently have adequate vaccine stock for our NIH-based phase 1, an expanded phase 1 in Uganda (100 subjects with MHRP), and 1 or 2 other African phase 1 trials. Whether the funding comes to us or GSK, we will both use a contract mechanism to have the vaccine produced at Advent, which is the Okairos facility that made the first lot for us under contract. Our pilot plant would do the vialing and lot release would be shared by us and Okairos. Maybe more info than you wanted. Rick Richard A. Koup, MD Chief, Immunology Laboratory Deputy Director Vaccine Research Center, NIAID, NIH 40 Convent Drive, MSC 3022 Building 40, Room 3502 Bethesda, MD 20892 mail. The information in this e-mail and any of its attachments is confidential and may contain sensitive information. It should not be used by anyone who is not the original intended recipient. If you have received this e-mail in error please inform the sender and delete it from your mailbox or any other storage devices. The National Institute of Allergy and Infectious Diseases shall not accept liability for any statements made that are sender's own and not expressly made on behalf of the NIAID by one of its representatives.

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