Following approval for Emergency Use Authorisation by the US Food and Drug Administration (FDA), Johnson & Johnson announced this week its Janssen Pharmaceutical Companies have entered 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.
The vaccine will be provided at a global not-for-profit basis for emergency pandemic use.
Based on positive preclinical data published in Nature, 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, working diligently to ensure broad, global access to the vaccine following approval or authorisation by regulators.
Johnson & Johnson aims to meet its goal to supply more than one billion doses globally through the course of 2021, provided the vaccine is safe and effective.
“Johnson & Johnson’s global team of experts has worked tirelessly alongside BARDA [Biomedical Advanced Research and Development Authority] and scientific partners to pursue a SARS-CoV-2 vaccine that can help 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,” says Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, Paul Stoffels M.D.
Johnson & Johnson’s efforts to develop a SARS-Cov-2 vaccine have been undertaken pursuant to an ongoing research and development collaboration with BARDA under the oversight of the FDA.
Reportedly, BARDA is committing $1 billion for this agreement.