support on ebola
15 messages over 13h 58m, 2014-08-07 – 2014-08-08.
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gatesfoundation.org] Dear Francis and Tony, It is clear that the problem, concern and media attention surrounding the treatment of the two individuals now in Atlanta add further weight to the Ebola outbreak concerns, which we have discussed by email over the past week or so. Although the overall burden of disease due to Ebola is not of the magnitude of the conditions we address strategically, we recognize that the current situation calls for action and places considerable pressure on your agency and WHO and others of our key partners. For these reasons we have provided emergency funds to WHO and UNICEF to support public health measures as well as on the ground human resources in the target countries as one in kind contribution to the problem. We would also like to be supportive of your efforts, if doing so can add value. One challenge is that we believe that interventions that could help to interdict the current epidemic are needed the most. Interventions that are not ready to give to patients in the relatively near term will not be of help for this emergent situation. We understand that there are efforts with GSK and the VRC to scale up the lot of the ChAd3 vaccine, which is due to go into FIH studies this fall and for which additional doses might be available for evaluation in at risk individuals by early 2015; we believe that Wellcome may be interested in supporting this effort. We also understand that there are very limited supplies of ZMapp (~12 courses of therapy). Assuming an appropriate approach can be designed with input from relevant stakeholders (i.e., one which provides for equity in opportunity for participation in an interventional trial that extends beyond foreign health workers to include indigenous individuals), we would be willing to assist with partial funding to generate more product in partnership with NIH and other relevant agencies. We can also provide in-kind CMC expertise through two MAb manufacturing experts with considerable industry experience on our team. Please let us know if this would be useful to you. We appreciate your frontline efforts to address this problem and look forward to helping where we might. Warm regards, Trevor <image001.png> Trevor Mundel, MD, PhD President, Global Health Program v F E gatesfoundation.org Amissa Cormier Senior Progr tant Global Health Office of the President v M E gatesfoundation.org Bill & Melinda Gates Foundation www.gatesfoundation.org 2.
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We should discuss how we are going to respond to Trevor From: Trevor Mundel [mailto NO gatesfoundation.org] Sent: Thursday, August 07, 2014 7:17 PM To: Collins, Francis (NIH/OD) [E]; Fauci, Anthony (NIH/NIAID) [E] Subject: Support on Ebola Dear Francis and Tony, It is clear that the problem, concern and media attention surrounding the treatment of the two individuals now in Atlanta add further weight to the Ebola outbreak concerns, which we have discussed by email over the past week or so. Although the overall burden of disease due to Ebola is not of the magnitude of the conditions we address strategically, we recognize that the current situation calls for action and places considerable pressure on your agency and WHO and others of our key partners. For these reasons we have provided emergency funds to WHO and UNICEF to support public health measures as well as on the ground human resources in the target countries as one in kind contribution to the problem. We would also like to be supportive of your efforts, if doing so can add value. One challenge is that we believe that interventions that could help to interdict the current epidemic are needed the most. Interventions that are not ready to give to patients in the relatively near term will not be of help for this emergent situation. We understand that there are efforts with GSK and the VRC to scale up the lot of the ChAd3 vaccine, which is due to go into FIH studies this fall and for which additional doses might be available for evaluation in at risk individuals by early 2015; we believe that Wellcome may be interested in supporting this effort. We also understand that there are very limited supplies of ZMapp (~12 courses of therapy). Assuming an appropriate approach can be designed with input from relevant stakeholders (i.e., one which provides for equity in opportunity for participation in an interventional trial that extends beyond foreign health workers to include indigenous individuals), we would be willing to assist with partial funding to generate more product in partnership with NIH and other relevant agencies. We can also provide in-kind CMC expertise through two MAb manufacturing experts with considerable industry experience on our team. Please let us know if this would be useful to you. We appreciate your frontline efforts to address this problem and look forward to helping where we might. Warm regards, Trevor i Trevor Mundel, MD, PhD President, Global Health Program Vv F E }gatesfoundation.org Amissa Cormier Senior Program Assistant Global Health Office of the President v M E {®gatesfoundation.org, Bill & Melinda Gates Foundation www.gatesfounda Ike}
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We should discuss how we are going to respond to Trevor
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We should discuss how we are going to respond to Trevor From: Trevor Mundel [mailto gatesfoundation.org] Sent: Thursday, August 07, 2014 7:17 PM To: Collins, Francis (NIH/OD) [E]; Fauci, Anthony (NIH/NIAID) [E] Subject: Support on Ebola Dear Francis and Tony, It is clear that the problem, concern and media attention surrounding the treatment of the two individuals now in Atlanta add further weight to the Ebola outbreak concerns, which we have discussed by email over the past week or so. Although the overall burden of disease due to Ebola is not of the magnitude of the conditions we address strategically, we recognize that the current situation calls for action and places considerable pressure on your agency and WHO and others of our key partners. For these reasons we have provided emergency funds to WHO and UNICEF to support public health measures as well as on the ground human resources in the target countries as one in kind contribution to the problem. We would also like to be supportive of your efforts, if doing so can add value. One challenge is that we believe that interventions that could help to interdict the current epidemic are needed the most. Interventions that are not ready to give to patients in the relatively near term will not be of help for this emergent situation. We understand that there are efforts with GSK and the VRC to scale up the lot of the ChAd3 vaccine, which is due to go into FIH studies this fall and for which additional doses might be available for evaluation in at risk individuals by early 2015; we believe that Wellcome may be interested in supporting this effort. We also understand that there are very limited supplies of ZMapp (~12 courses of therapy). Assuming an appropriate approach can be designed with input from relevant stakeholders (i.e., one which provides for equity in opportunity for participation in an interventional trial that extends beyond foreign health workers to include indigenous individuals), we would be willing to assist with partial funding to generate more product in partnership with NIH and other relevant agencies. We can also provide in-kind CMC expertise through two MAb manufacturing experts with considerable industry experience on our team. Please let us know if this would be useful to you. We appreciate your frontline efforts to address this problem and look forward to helping where we might. Warm regards, Trevor <image001.png> Trevor Mundel, MD, PhD President, Global Health Program v F E gatesfoundation.org Amissa Cormier Senior Program Assistant Global Health Office of the President Vv M E gatesfoundation.org Bill & Melinda Gates Foundation www.gatesfoundation.org
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I was thinking exactly the same thing. Do you see ways that BMGF could be helpful? FC
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I was thinking exactly the same thing. Do you see ways that BMGF could be helpful? FC
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I was thinking exactly the same thing. Do you see ways that BMGF could be helpful? FC
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I have allocated enough money to do the VRC vaccine trial and so we do not need Gates money. I believe that BARDA has enough money to accelerate the zMapp production. I will give John Mascola a call and find out if he can think of any way that Gates can help with his trial.
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I have allocated enough money to do the VRC vaccine trial and so we do not need Gates money. I believe that BARDA has enough money to accelerate the zMapp production. I will give John Mascola a call and find out if he can think of any way that Gates can help with his trial.
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I have allocated enough money to do the VRC vaccine trial and so we do not need Gates money. I believe that BARDA has enough money to accelerate the zMapp production. I will give John Mascola a call and find out if he can think of any way that Gates can help with his trial.
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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
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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
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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
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Inline-Images: image001.png As per my prior e-mail.
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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.