J&J agrees to manufacture 100 million doses of COVID-19 vaccine for US

Johnson & Johnson (J&J) has announced that Janssen has entered into an agreement with the US government for the manufacturing and delivery of 100 million doses of the company’s COVID-19 vaccine.

The investigational vaccine, Ad26.COV2.S, will be used in the US following the approval or emergency use authorisation (EUA) from the US Food and Drug Administration (FDA).

The US 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, in collaboration with the US Department of Defense, is committing over $1 billion for this agreement. According to J&J, the vaccine will be provided at a global not-for-profit basis for emergency pandemic use. The government may also purchase an additional 200 million doses of Ad26.COV2.S under a subsequent agreement.

“J&J’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 Dr Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer at J&J.

The Phase I/IIa first-in-human clinical trial of Ad26.COV2.S is currently underway in healthy volunteers in the US and Belgium.

The company is evaluating both one- and two-dose regimens in its clinical programme and working towards global access of the vaccine following either approval or authorisation by regulators. J&J says it aims to meet its goal to supply goal of more than one billion doses globally throughout the course of 2021, provided the vaccine is safe and effective.