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Activity Number: 150 - COVID-19 Vaccine Statistics: A Reflection on a Year at Warp Speed
Type: Invited
Date/Time: Tuesday, August 10, 2021 : 10:00 AM to 11:50 AM
Sponsor: Biometrics Section
Abstract #317663
Title: Inference for Natural Mediation Effects Under Case-Cohort Sampling with Applications in Identifying COVID-19 Vaccine Correlates of Protection
Author(s): Ivan Diaz*
Companies: Weill Cornell Medical College
Keywords: vaccines; COVID-19; one-step estimation; efficiency theory

Combating the SARS-CoV2 pandemic will require the fast development of effective preventive vaccines. Regulatory agencies may open accelerated approval pathways for vaccines if an immunological marker can be established as a mediator of a vaccine's protection. A rich source of information for identifying such correlates are large-scale efficacy trials of COVID-19 vaccines, where immune responses are measured subject to a case-cohort sampling design. We propose two approaches to estimation of mediation parameters in the context of case-cohort sampling designs. We establish the theoretical large-sample efficiency of our proposed estimators and evaluate them in a realistic simulation to understand whether they can be employed in the analysis of COVID-19 vaccine efficacy trials.

Authors who are presenting talks have a * after their name.

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