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The company is working to ensure broad global access to its COVID-19 vaccine candidate, following approval from regulators.
The Janssen Pharmaceutical Companies of Johnson & Johnson (J&J) have entered into an agreement with the US government for the large-scale domestic manufacture and delivery of 100 million doses of Janssen’s investigational vaccine against SARS-CoV-2, Ad26.COV2.S. The vaccine will be supplied for use in the United States, following approval by FDA or Emergency Use Authorization given by the agency, J&J stated in an Aug. 5, 2020 press release.
The US government is committing over $1 billion for this agreement through 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 in collaboration with the US Department of Defense. J&J will ultimately provide the vaccine at a global not-for-profit basis for emergency pandemic use, and the US government may also purchase an additional 200 million doses under a subsequent agreement.
J&J developed the SARS-CoV-2 vaccine under an ongoing research and development collaboration with BARDA and under the oversight of FDA. Based on positive preclinical data recently published in the peer-reviewed journal Nature, the Phase I/IIa first-in-human clinical trial of the vaccine is underway in healthy subjects in the US and Belgium.
The company is evaluating one- and two-dose regimens in its clinical program. J&J aims to supply more than one billion doses globally through the course of 2021, if the vaccine is proven safe and effective.
The company’s SARS-CoV-2 vaccine program uses Janssen’s AdVac technology, which is the same technology used to develop Janssen’s Ebola vaccine (approved by the European Commission) and to construct its human immunodeficiency virus, respiratory syncytial virus, and Zika vaccine candidates. More than 90,000 individuals have been vaccinated to date using the Janssen AdVac-based platform, according to J&J.
“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 US 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 US and worldwide to deliver a SARS-CoV-2 vaccine for emergency use,” said Paul Stoffels, MD, vice-chairman of the executive committee and chief scientific officer, Johnson & Johnson, in the press release.
Source: Johnson & Johnson