Since the end of 2019, the worldwide coronavirus disease 2019 (COVID-19) pandemic has affected tens of millions of people. The devastating morbidity, mortality, and economic and social impacts that resulted from the global spread of COVID-19 underscores the urgent need for safe and effective vaccines. To that end, our client wanted to report, as quickly as possible, the phase 2/3 data from a global phase 1/2/3 trial that evaluated the safety, immunogenicity, and efficacy of their severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine candidate.

The ICON Global Medical Communications team partnered with our client’s publication owner to ensure seamless publication management support throughout the manuscript development process. This included collating and incorporating comments, verifying data, developing graphics, and managing and overseeing compliance for 29 authors. ICON prepared all the submission files and managed the full submission process for the completed manuscript. In addition, our team supported the development of an accompanying Plain Language Summary of the manuscript.

Through close collaboration with our client, the ICON team provided the support necessary to advance this critical manuscript from outline through submission to acceptance in only 20 days. Under normal circumstances, this process would take three months or more. However, given the vital importance of this clinical trial and the need to disseminate the results rapidly, we put in place a robust process incorporating our US- and New Zealand–based colleagues to keep the manuscript development process moving around the clock, with minimal down time. Our client was first to announce positive efficacy results from a phase 3, late-stage study of a COVID-19 vaccine. The final manuscript was published online in the New England Journal of Medicine on December 10, 2020. www.nejm.org/doi/full/10.1056/NEJMoa2034577?query=featured_home