The US supply of Janssen’s investigational Covid-19 vaccine is subject to the regulatory approval or receipt of Emergency Use Authorisation by the US FDA
J&J agrees with US to supply 100 million doses of its Covid-19 vaccine candidate. (Credit: Willfried Wende from Pixabay.)
Johnson & Johnson has agreed with the US government to domestically manufacture and deliver 100 million doses of potential Covid-19 vaccine Ad26.COV2.S, developed by its subsidiary Janssen.
The supply of Janssen’s investigational Covid-19 vaccine in the US is subject to the regulatory approval or receipt of Emergency Use Authorisation by the US Food and Drug Administration (FDA).
A partnership between the Biomedical Advanced Research and Development Authority (BARDA), a part of the US Department of Health and Human Services, and the US Department of Defence is committed to providing more than $1bn for the agreement.
Also, the US government is expected to purchase an additional 200 million doses of Janssen’s potential Covid-19 vaccine, through a future agreement.
Johnson & Johnson executive committee vice chairman and chief scientific officer Paul Stoffels said: “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.”
Janssen leveraged AdVac technology to develop vaccine candidate Ad26.COV2.S
The company has been developing a SARS-CoV-2 vaccine under a research and development collaboration with BARDA and guidance from the FDA, and the vaccine development programme leverages Janssen’s AdVac technology.
Janssen has previously used the technology to develop European Commission-approved Ebola vaccine and construct its HIV, RSV and Zika vaccine candidates.
J&J has been evaluating the vaccine candidate Ad26.COV2.S, in a Phase 1/2a clinical trial in healthy volunteers in the United States and Belgium, based on the positive pre-clinical data published in a peer-reviewed journal.
In the clinical program, the vaccine is being evaluated in one, and two-dose regimens and the company is working towards global access to the vaccine after regulatory approval or authorisation.
If the vaccine is proven safe and effective, J&J intends to supply more than one billion doses around the world, during the year 2021. The company intends to offer the vaccine at a not-for-profit basis for emergency pandemic use.