Johnson & Johnson’s Janssen Pharmaceutical Companies have entered into an 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 FDA.
The Biomedical Advanced Research and Development Authority (BARDA), in collaboration with the U.S. Department of Defense, is committing more than $1 billion. 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.
Based on the positive preclinical data, the Phase 1/2a first-in-human clinical trial of the vaccine candidate, Ad26.COV2.S, is underway in healthy volunteers in the U.S. and Belgium.
The Company is evaluating one- and two-dose regimens and working to ensure broad, global access to the vaccine following approval. J&J aims to supply more than one billion doses globally through the course of 2021, provided the vaccine is safe and effective.
The SARS-CoV-2 vaccine program leverages Janssen's AdVac technology, which was used to develop Janssen's EU-approved Ebola vaccine and construct its HIV, RSV and Zika vaccine candidates.