Johnson & Johnson’s (New Brunswick, NJ, USA) Janssen Pharmaceutical Companies have entered into an agreement with the US government for the large scale domestic manufacturing and delivery in the US of 100 million doses of Janssen's SARS-CoV-2 investigational vaccine, Ad26.COV2.S, for use in the US following approval or Emergency Use Authorization by the US Food and Drug Administration (FDA).

The Phase 1/2a first-in-human clinical trial of the vaccine candidate, Ad26.COV2.S, is underway in healthy volunteers in the US and Belgium. The company is evaluating one- and two-dose regimens in its clinical program. Johnson & Johnson's SARS-CoV-2 vaccine program leverages Janssen's AdVac technology which was also used to develop its European Commission-approved Ebola vaccine and construct its HIV, RSV and Zika vaccine candidates. More than 90,000 individuals have been vaccinated to date using the Janssen AdVac-based platform.

Johnson & Johnson's efforts to develop a SARS-CoV-2 vaccine have been undertaken pursuant to an ongoing research and development collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response, and under the oversight of the FDA. BARDA, in collaboration with the US Department of Defense, is committing over USD 1 billion for the new agreement. The vaccine will be provided at a global not-for-profit basis for emergency pandemic use. The US government may also purchase an additional 200 million doses of Ad26.COV2.S under a subsequent agreement. Johnson & Johnson is working diligently to ensure broad, global access to the vaccine following approval or authorization by regulators and aims to meet its goal to supply more than one billion doses globally through the course of 2021, provided that the vaccine is safe and effective.

"Johnson & Johnson's global team of experts has worked tirelessly alongside BARDA and scientific partners to pursue a SARS-CoV-2 vaccine that can help to stop the spread of COVID-19. We greatly appreciate the U.S. government's confidence in, and support for, our R&D platform and efforts and the scalability of our vaccine technology. We are scaling up production in the U.S. and worldwide to deliver a SARS-CoV-2 vaccine for emergency use," said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson.

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