Johnson & Johnson has selected a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020, according to the company.
J&J expects to initiate human clinical studies of its lead vaccine candidate at the latest by September 2020 and anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021, a substantially accelerated timeframe in comparison to the typical vaccine development process, it said.
J&J is working with the Dept of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) and together have committed more than $1 billion of investment to co-fund vaccine research, development, and clinical testing.
J&J plans to begin production, at risk, imminently and is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use, according to a company statement.
“We are moving on an accelerated timeline toward Phase 1 human clinical trials at the latest by September 2020 and, supported by the global production capability that we are scaling up in parallel to this testing, we expect a vaccine could be ready for emergency use in early 2021,” said Paul Stoffels, MD, vice chairman of J&J’s Executive Committee and chief scientific officer.
Research teams at Janssen Pharma (which part of J&J) worked with Beth Israel Deaconess Medical Center to construct and test multiple vaccine candidates using the Janssen AdVac technology. The vaccine constructs were then tested to identify those with the most promise in producing an immune response in preclinical testing.
J&J then identified a lead COVID-19 vaccine candidate and two back-ups, which will progress into the first manufacturing steps.
Under an accelerated timeline, J&J is aiming to initiate a Phase 1 clinical study in September 2020, with clinical data on safety and efficacy expected to be available by the end of the year.
This could allow vaccine availability for emergency use in early 2021. For comparison, the typical vaccine development process involves a number of different research stages, spanning 5 to 7 years, before a candidate is even considered for approval.
“The world is facing an urgent public health crisis and we are committed to doing our part to make a COVID-19 vaccine available and affordable globally as quickly as possible,” said Alex Gorsky, chairman and CEO, Johnson & Johnson.
For more information on Johnson & Johnson’s multi-pronged approach to combatting the pandemic, visit: .