Johnson & Johnson Announces Lead Vaccine Candidate for COVID-19

Johnson & Johnson (New Brunswick, NJ, USA) has announced the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020, along with significant expansion of its existing partnership between the company’s Janssen Pharmaceutical Companies (Beerse, Belgium) and the Biomedical Advanced Research and Development Authority (BARDA), as well as rapid scaling of its manufacturing capacity with the goal of providing global supply of more than one billion doses of a vaccine. The company 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.

Johnson & Johnson began its efforts to research potential vaccine candidates in January 2020, as soon as the novel coronavirus (COVID-19) sequence became available. Research teams at Janssen, in collaboration with Beth Israel Deaconess Medical Center, part of Harvard Medical School, constructed and tested multiple vaccine candidates using the Janssen AdVac technology. Through collaborations with scientists at multiple academic institutions, the vaccine constructs were then tested to identify those with the most promise in producing an immune response in preclinical testing. Based on this work, Johnson & Johnson has identified a lead COVID-19 vaccine candidate (with two back-ups), which will progress into the first manufacturing steps. Under an accelerated timeline, the company aims 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, enabling vaccine availability for emergency use in early 2021.

BARDA, which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the US Department of Health and Human Services, and Johnson & Johnson have together committed more than USD 1 billion of investment to co-fund vaccine research, development, and clinical testing. Johnson & Johnson will use its validated vaccine platform and is allocating resources, including personnel and infrastructure globally, as needed, to focus on these efforts. Separately, BARDA and the company have provided additional funding that will enable expansion of their ongoing work to identify potential antiviral treatments against the novel coronavirus.

As part of its commitment, Johnson & Johnson is also expanding the company’s global manufacturing capacity, including through the establishment of new US vaccine manufacturing capabilities and scaling up capacity in other countries. The additional capacity will assist in the rapid production of a vaccine and enable the supply of more than one billion doses of a safe and effective vaccine globally. The company 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.

“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. As the world’s largest healthcare company, we feel a deep responsibility to improve the health of people around the world every day. Johnson & Johnson is well-positioned through our combination of scientific expertise, operational scale and financial strength to bring our resources in collaboration with others to accelerate the fight against this pandemic,” said Alex Gorsky, Chairman and Chief Executive Officer, Johnson & Johnson.

“We greatly value the US government’s confidence and support for our R&D efforts. Johnson & Johnson’s global team of experts has ramped up our research and development processes to unprecedented levels, and our teams are working tirelessly alongside BARDA, scientific partners, and global health authorities,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson. “We are very pleased to have identified a lead vaccine candidate from the constructs we have been working on since January. 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.”

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