JAMA Netw Open. 2023 Jan 03; 6(1):e2251974.

PubMed ID: 36689221

Rapid development of an integrated network infrastructure to conduct phase 3 COVID-19 vaccine trials

Mena Lora AJ, Long JE, Huang Y, Baden LR, El Sahly HM, Follmann D, Goepfert P, Gray G, Grinsztejn B, Kotloff K, Rouphael N, Sobieszczyk M, Walsh SR, Andriesen J, Shah KA, Zhang Y, Gilbert P, Janes H, Gay CL, Falsey AR, Tripp RL, Gorman RL , Tong T, Marovich M, Neuzil K, Corey L, Kublin JG, COVID-19 Prevention Network

The COVID-19 pandemic has caused millions of infections and deaths and resulted in unprecedented international public health social and economic crises. As SARS-CoV-2 spread across the globe and its impact became evident, the development of safe and effective vaccines became a priority. Outlining the processes used to establish and support the conduct of the phase 3 randomized clinical trials that led to the rapid emergency use authorization and approval of several COVID-19 vaccines is of major significance for current and future pandemic response efforts.