Innovation in Analysis
The pandemic serves as a clear reminder that clinical trials provide only the initial data needed for public health decision-making. Routine monitoring of vaccine effectiveness is a key component of an immunization program, in order to evaluate effectiveness against novel strains, among specific groups, in diverse settings, and with modified dosing schedules. Our projects focus on methodological innovation for evaluating real-world performance of vaccines, including vaccine effectiveness, indirect effectiveness, and overall effectiveness.
post-licensure evaluation, cohort studies, test negative studies
Evan Anderson, Natalie Dean, Michael Haber, Ben Lopman, Liz McQuade
The primary purpose of the KidCOVE Study is to test the safety and effectiveness of the study vaccine, called mRNA-1273, that may protect children between the ages of 6 months to < 12 years from getting sick if they encounter SARS-CoV-2, which causes COVID-19. Moderna will be recruiting multiple age groups from 6 months to < 12 years and staggering the recruitment of each group. The goal of this study is to evaluate the safety and effectiveness of different dose amounts and regimens, including a three-dose regimen in children 6 to < 12 years.
Evan Anderson, MD
Emory Vaccine and Treatment Evaluation Unit (VTEU)
- Creech CB, Anderson E, Berthaud V, Yildirim I, Atz AM, Melendez Baez I, Finkelstein D, Pickrell P, Kirstein J, Yut C, Blair R, Clifford RA, Dunn M, Campbell JD, Montefiori DC, Tomassini JE, Zhao X, Deng W, Zhou H, Ramirez Schrempp D, Hautzinger K, Girard B, Slobod K, McPhee R, Pajon R, Das R, Miller JM, Schnyder Ghamloush S; KidCOVE Study Group. Evaluation of mRNA-1273 Covid-19 Vaccine in Children 6 to 11 Years of Age. N Engl J Med. 2022 May 26;386(21):2011-2023.
Vaccines are one of the most effective tools to control the COVID-19 pandemic, yet questions remain about when vaccine doses should be given to maximize impact. The goal of the project is to compare the effectiveness of different intervals between vaccine doses among individuals in Georgia to inform the optimal timing of booster doses.
Emory COVID-19 Response Collaborative
Liz McQuade, PhD, Allison Chamberlain PhD, Ben Lopman PhD
Georgia Department of Public Health
This project develops methods for evaluating the efficacy and effectiveness of vaccines targeting emerging infectious disease threats. This includes elucidating the statistical properties of observational vaccine studies, with a focus on the test negative design. The research considers settings with time-varying healthcare seeking behavior, rapid changes in force of infection, and variability in pre-existing immunity.
Natalie Dean, PhD
University of Florida, Fred Hutchinson Cancer Research Center, Northeastern University
- Dean NE, Hogan JW, Schnitzer ME. Covid-19 Vaccine Effectiveness and the Test-Negative Design. N Engl J Med. 2021 Oct 7;385(15):1431-1433.
- Dean NE, Halloran ME, Longini IM Jr. Temporal Confounding in the Test-Negative Design. Am J Epidemiol. 2020 Nov 2;189(11):1402-1407.
- Lipsitch M, Dean NE. Understanding COVID-19 vaccine efficacy. Science. 2020 Nov 13;370(6518):763-765.
In this project, investigators estimate the effectiveness of COVID-19 vaccines used in Brazil, including the inactivated CoronaVac vaccine. The team uses cohort and test negative designs to assess vaccine waning, performance against new viral variants, the effectiveness of boosters, and protection conferred by prior infection.
Natalie Dean, PhD
Fiocruz, Yale University, University of Florida
- Cerqueira-Silva T, Andrews JR, Boaventura VS, Ranzani OT, de Araújo Oliveira V, Paixão ES, Júnior JB, Machado TM, Hitchings MDT, Dorion M, Lind ML, Penna GO, Cummings DAT, Dean NE, Werneck GL, Pearce N, Barreto ML, Ko AI, Croda J, Barral-Netto M. Effectiveness of CoronaVac, ChAdOx1 nCoV-19, BNT162b2, and Ad26.COV2.S among individuals with previous SARS-CoV-2 infection in Brazil: a test-negative, case-control study. Lancet Infect Dis. 2022 Jun;22(6):791-801.