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New England Journal of Medicine Article Credits Advarra as IRB for mRNA Vaccine Trial

The recent New England Journal of Medicine (NEJM) article An mRNA Vaccine Against SARS-CoV-2 — Preliminary Report described Advarra’s involvement as the institutional review board (IRB) of record for the phase I trial of the investigational mRNA-1273 vaccine.

Advarra served as the single IRB for the first-in-human dose-escalation study. The global research community has been engaged in an ongoing race to find a vaccine for the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). “Product development processes that normally require years were finished in about 2 months,” the authors stated. “Vaccine development was initiated after the SARS-CoV-2 genome was posted on January 10, 2020; manufacture and delivery of clinical trials material was completed within 45 days, and the first trial participants were vaccinated on March 16, 2020, just 66 days after the genomic sequence of the virus was posted.”

The preliminary report published in NEJM outlines the details and results from the first-in-human study. Findings support advancement of the investigational vaccine to later-stage clinical trials. A phase II trial is ongoing, and A large phase III efficacy trial is projected to begin in the summer of 2020.

Since early 2020, Advarra has provided guidance to the clinical research community on how to conduct safe and compliant research during the public health crisis. The organization’s Ask Advarra resource has provided rapid, customized guidance on emerging research issues during the pandemic. Advarra is committed to supporting the research community through the current crisis and has policies and processes in place to keep all operations functioning as normal.

The New England Journal of Medicine (NEJM) is recognized as the world’s leading medical journal and website. Published continuously for over 200 years, NEJM delivers high-quality, peer-reviewed research and interactive clinical content to physicians, educators, researchers, and the global medical community.

Contact Advarra for dedicated research compliance support during the COVID-19 pandemic.

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