BARDA is committing over $1 billion for the agreement, which is dependent on approval or emergency use authorization by the US FDA.
Johnson & Johnson announced that its drug development wing, Janssen Pharmaceutical, has reached an agreement with the US Biomedical Advanced Research and Development Authority (BARDA) for the large scale manufacturing and delivery of 100 million doses of Ad26.COV2.S, an adenovirus based SARS-CoV-2 investigational vaccine.
According to J&J, the vaccine “will be provided at a global not-for-profit basis for emergency pandemic use.” The government also has the option to purchase an additional 200 million doses under a subsequent agreement.
BARDA is committing over $1 billion for the agreement, which is dependent on approval or emergency use authorization by the US Food and Drug Administration (FDA).
Development of the vaccine has been conducted in tandem with ongoing research and development collaboration with BARDA and under the oversight of the FDA.
The purchase was made in part based on data published in Nature, and the phase 1/2a first-in-human clinical trial of the vaccine candidate is ongoing in healthy volunteers in the United States and Belgium.
“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,” Paul Stoffels, MD, Chief Scientific Officer, said in a company press release.
The technology behind the COVID-19 vaccine candidate was previously used to develop Janssen’s European Commission-approved Ebola vaccine.
Johnson & Johnson has set a target of supplying over 1 billion doses globally through the course of 2021, if the vaccine is proven safe and effective.