J&J, with the government’s help, races to bring COVID vaccine to market.
As the world scrambles to try and circumvent the spread of COVID-19, Johnson & Johnson (J&J) has announced that human testing of its experimental vaccine for the coronavirus will begin by the fall and it could be available for emergency use authorization in early 2021. The company has also entered into a $1 partnership with the Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) which will co-fund its research and is developing the solution on a non-for-profit basis.
“J&J’s lead vaccine candidate will enter a phase 1 human clinical study by September,” the company said. By the end of 2019, the company plans to have available the preliminary results. Like many other companies who have shifted operations to focus solely on the production of anti-COVID supplies, J&J also plans to add on to its manufacturing space in the U.S. by adding new square footage as well as renovating existing facilities in other countries. This way the vaccine will be able to be produced and disseminated as quickly as possible.
“We have very good early indicators that not only can we depend on this to be a safe vaccine base but also one that will ultimately be effective based on all the early testing and modelling we’ve been doing,” Chairman and CEO Alex Gorsky said. “This is a bit of a moonshot for J&J going forward, but it’s one we feel is very, very important for use to be doing at this period in time.”
Gorsky added that the company has two back-up candidates for a vaccine in the works as well and plans to develop a workable solution more quickly than the typical five to seven years it normally takes to bring a new drug to market. However, experts are warning that a vaccine will likely take more than a year to develop and have it ready in the market. According to the World Health Organization (WHO), China-based CanSino Biological is also in a phase 1 trial for a viable vaccination.
Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at J&J, stated of the partnership with BARDA, “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.”
Gorsky added, “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.”
Johnson & Johnson Announces a Lead Vaccine Candidate for COVID-19; Landmark New Partnership with U.S. Department of Health & Human Services; and Commitment to Supply One Billion Vaccines Worldwide for Emergency Pandemic Use