On Monday, Johnson & Johnson announced they had selected a lead COVID-19 vaccine candidate to help fight the virus.
The company stated they had been working on various candidates for a vaccine since January; the goal is to provide a global supply of more than one billion doses. The company expects to conduct human clinical studies of its lead vaccine candidate at the latest by September 2020 and estimates it could start delivering the vaccine by early 2021, which it notes is “a substantially accelerated timeframe in comparison to the typical vaccine development process.”
The statement from the company read:
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 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.
Johnson and Johnson has partnered with BARDA, a part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services; they plan to spend over $1 billion 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, the company stated.
Alex Gorsky, Chairman and Chief Executive Officer, Johnson & Johnson, said, “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.”
Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, added, “We greatly value the U.S. 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. 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.”
In the past, Johnson and Johnson created an Ebola vaccine and has Zika, RSV, and HIV vaccine candidates which are in Phase 2 or Phase 3 clinical development stages.