Emmes Announces its Role in Phase 1 COVID-19 Vaccine Trial
Three Employees Co-Author Preliminary Report for the New England Journal of Medicine.
Emmes today announced that it provided the data and statistical analysis support for the Phase 1 clinical trial of the investigational COVID-19 vaccine mRNA-1273. Three Emmes employees were co-authors on the Preliminary Report about the clinical trial, “An mRNA Vaccine against SARS-CoV-2,” published in the New England Journal of Medicine on July 14.
The employees are Jim Albert, lead project manager; Dr. Mat Makowski, senior biostatistician; and Kaitlyn Cross, senior biostatistician.
According to Albert, “Emmes launched the trial’s electronic data collection system in about a month. Our team was driven to do everything we could to contribute to this critical human health challenge.”
The vaccine was co-developed by researchers at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and at Moderna, Inc., which was involved in trial design discussions and provided the vaccine candidate. Emmes served as the statistical and data collection and coordination center, developed the statistical analysis plan, and performed the analysis.
The Phase 1 trial began in March 2020 to determine the safety of the mRNA-1273 vaccine and its ability to induce an immune response. The open-label trial included 45 healthy adults, ages 18 to 55, who received two vaccinations, 28 days apart. The vaccine resulted in anti-SARS-COV-2 immune responses in all participants, and there were no trial-limiting safety concerns.
“It has been a privilege to collaborate with Moderna and with NIAID in developing a vaccine for COVID-19,” said Dr. Anne Lindblad, Emmes president and chief executive officer. “The successful Phase 1 trial has paved the way for the subsequent clinical trials.”
The company has supported research for infectious diseases such as H1N1 influenza, SARS, Ebola and Zika, among others, and now for COVID-19.
About the Research
This project has been funded in whole or in part with federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201500002C.
Emmes is a leading Contract Research Organization working with both public and private sector organizations. We collaborate with our clients to produce valued, trusted scientific research, and our team members are passionate about making a difference in the quality of human health. Emmes has supported more than a thousand studies across a diverse range of diseases since our formation in 1977. Our research is contributing to a healthier world. For more information, visit the Emmes website at www.emmes.com.