On Aug. 5, 2020, Johnson & Johnson announced a $1 billion agreement with the U.S. government for the large scale domestic manufacturing and delivery in the U.S. of 100 million doses of Janssen’s SARS-CoV-2 investigational vaccine, Ad26.COV2.S, for use in the U.S. following approval or Emergency Use Authorization by the U.S. Food and Drug Administration (FDA).

The Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, in collaboration with the U.S. Department of Defense, is committing over $1 billion for this agreement. The vaccine will be provided at a global not-for-profit basis for emergency pandemic use. The U.S. government may also purchase an additional 200 million doses of Ad26.COV2.S under a subsequent agreement.

Johnson & Johnson’s efforts to develop a SARS-CoV-2 vaccine have been undertaken pursuant to an ongoing research and development collaboration with BARDA and under the oversight of the FDA. Based on the positive preclinical data recently published in the peer reviewed journal Nature, the Phase 1/2a first-in-human clinical trial of the vaccine candidate, Ad26.COV2.S, is underway in healthy volunteers in the United States and Belgium.