COVID-19 Records

NHPs at IRF and DMID collaboration

Reading Room Production, pp.386-387 · reading_room:email:00397

Page text: p.386, p.387 · original PDF

Date
2020-03-28 09:01
Type
email · email
cc
Cassetti, Cristina, Bryant, Paula, Hewitt, Judith
sender
Emily Erbelding
to
Connie Schmaljohn
Topics
Vaccines
Connie, I learned yesterday that investigators on the IRF team weren't clear that the early NHP experiments done in collaboration with David O'Connor were related to the Moderna mRNA vaccine. If you didn't know this, it is a critical failure in communication on our part and we need to immediately address it. We think that the rate-limiting step in taking the Moderna vaccine into Ph2 trials by May/June, will be proving to the FDA that vaccine related enhancement won't be an added risk to participants. So starting these experiments at a basic level (and not doing refined natural history studies first) is NIAID's highest priority for these animals. I believe that Barney Graham has started doing the experiments in Ralph Baric's mouse model. The FDA has signaled that data from a second species of animals will be necessary. There wasn't time in the division directors meeting yesterday to get to this item on the agenda so I wanted to follow up now. To reiterate--getting the Moderna vaccine into Phase 2 trials is the highest priority for the vaccine effort (Quote from Tony Fauci to me this week: "I hope that you feel like my foot is on your neck right now to get this done.") Let me know if you want to discuss further. regards, Emily Emily Erbelding, M.D., M.P.H. Office: E-mail: = > 'idential and may contain sensitive information. It should t. If you have received this e mail in error please inform the ices. National Institute of Allergy and Infectious Diseases r's own and not expressly made on behalf of the NIAID by 2 AM

Extracted statements

Rule-extracted, not adjudicated. The grade says what may be done with each one; read the document above before relying on any of them.

StatementGradeAttributionStance
Connie, I learned yesterday that investigators on the IRF team weren't clear that the early NHP experiments done in collaboration with David O'Connor were related to the Moderna mRNA vaccine. quoted / not their view quoted_external message body appears to be pasted content asserts
We think that the rate-limiting step in taking the Moderna vaccine into Ph2 trials by May/June, will be proving to the FDA that vaccine related enhancement won't be an added risk to participants. quoted / not their view quoted_external message body appears to be pasted content asserts
To reiterate--getting the Moderna vaccine into Phase 2 trials is the highest priority for the vaccine effort (Quote from Tony Fauci to me this week: "I hope that you feel like my foot is on your neck right now to get this done.") Let me know if you want to discuss further. regards, Emily Emily Erbelding, M.D., M.P.H. quoted / not their view quoted_external sentence carries quotation marks asserts

In context

A single line often inverts meaning once you see what it answers, so neighbouring messages are always shown.

  1. 2020-03-28 09:01 Emily Erbelding
    Connie, I learned yesterday that investigators on the IRF team weren't clear that the early NHP experiments done in collaboration with David O'Connor were related to the Moderna mRNA vaccine. If you didn't know this, it is a critical failure in communication on our part and we need to immediately address it. We think that the rate-limiting step in taking the Moderna vaccine into Ph2 trials by May/June, will be proving to the FDA that vaccine related enhancement won't be an added risk to participants. So starting these experiments at a basic level (and not doing refined natural history studies first) is NIAID's highest priority for these animals. I believe that Barney Graham has started doing the experiments in Ralph Baric's mouse model. The FDA has signaled that data from a second species of animals will be necessary. There wasn't time in the division directors meeting yesterday to get to this item on the agenda so I wanted to follow up now. To reiterate--getting the Moderna vaccine into Phase 2 trials is the highest priority for the vaccine effort (Quote from Tony Fauci to me this week: "I hope that you feel like my foot is on your neck right now to get this done.") Let me know if you want to discuss further. regards, Emily Emily Erbelding, M.D., M.P.H. Office: E-mail: = > 'idential and may contain sensitive information. It should t. If you have received this e mail in error please inform the ices. National Institute of Allergy and Infectious Diseases r's own and not expressly made on behalf of the NIAID by 2 AM

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