Johnson & Johnson’s (J&J) Janssen Pharmaceutical Companies have entered into a $1-billion 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 for COVID-19, Ad26.COV2.S, for use in the US following approval or emergency use authorization by the US Food and Drug Administration (FDA) for COVID-19.

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

Johnson & Johnson’s efforts to develop a vaccine against COVID-19 vaccine is part of an ongoing research and development collaboration with BARDA and under the oversight of the FDA. Based on positive preclinical data recently published in the peer-reviewed journal Nature, a Phase I/IIa 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.

J&J says it 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 SARS-CoV-2 vaccine program uses Janssen’s AdVac technology, which uses an adenovirus as a vector (a carrier), which has been genetically modified so that it can no longer replicate in humans and cause disease. The same technology was used to develop Janssen’s Ebola vaccine, which was approved the European Commission last month (July 2020) and is now under FDA review, and is being used in the company’s vaccine candidates for HIV, respiratory syncytial virus, and Zika.

Source: Johnson & Johnson