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Why is considering a pivot to half-dose regimen different than proposed UK dosing strategy?
We will have a rigorous analysis of correlates data to help inform the decision.
https://twitter.com/nataliexdean/status/1345860364202876928
We will have a rigorous analysis of correlates data to help inform the decision.
https://twitter.com/nataliexdean/status/1345860364202876928
Correlates data = data on post-vaccination immune response collected in an efficacy trial.
We link the correlates to COVID outcomes to determine the mechanisms by which the vaccine works.
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We link the correlates to COVID outcomes to determine the mechanisms by which the vaccine works.
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Once you understand (a large fraction) of the vaccine’s mechanisms, you can use this information to *bridge* vaccine efficacy. That is, estimate what a vaccine’s effect is likely to be based only on the immune responses that it generates.
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We can use this (in combination with animal challenge studies and other, observational data) to understand the efficacy of a half-dose regimen.
This is generally how new flu vaccines are studied.
It’s also likely it will be how all COVID vaccines are studied beyond 2021.
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This is generally how new flu vaccines are studied.
It’s also likely it will be how all COVID vaccines are studied beyond 2021.
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It has always been a tenet of OWS to generate the best possible data on correlates. Precisely so we can rigorously answer questions like this!!!
We have been working with every OWS company to ensure harmonized data captures and a pre-specified plan to analyze the data.
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We have been working with every OWS company to ensure harmonized data captures and a pre-specified plan to analyze the data.
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The pre-specification is crucial here. It’s what distinguishes the strength of evidence between this approach and the UK spaced dosing. The UK decision is based on what I would consider to be exploratory analysis.
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Not pointing fingers at Oxford/UK. We’re in the middle of a pandemic and tough decisions have to be made based on limited evidence.
But the fact that we can answer a half-dose question with correlates using pre-specified analyses is huge for generating reliable inference.
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But the fact that we can answer a half-dose question with correlates using pre-specified analyses is huge for generating reliable inference.
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We have tried to be “radically transparent” in the development of the correlates analysis plan.
You can see the SAP as it’s being developed in real time here:
https://figshare.com/articles/online_resource/CoVPN_OWS_COVID-19_Vaccine_Efficacy_Trial_Immune_Correlates_SAP/13198595
We’ll even have a GitHub repo up in the next couple weeks with all our analysis code.
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You can see the SAP as it’s being developed in real time here:
https://figshare.com/articles/online_resource/CoVPN_OWS_COVID-19_Vaccine_Efficacy_Trial_Immune_Correlates_SAP/13198595
We’ll even have a GitHub repo up in the next couple weeks with all our analysis code.
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I can guarantee that any analyses generated to support the decision to move to a half-dose regimen based on the phase 3 trial will be completely transparent.
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Data-driven policy making is going to be what gets us out of this pandemic. Fortunately, we will soon have strong data to help inform the decision of whether a half-dose regimen should be used.
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