J&J says clinical trials for COVID-19 vaccine candidate will begin by September
Posted: 31 March 2020 | Victoria Rees (European Pharmaceutical Review) | No comments yet
Following the selection of a COVID-19 vaccine lead, Johnson & Johnson (J&J) aims to begin clinical trials in humans later this year while also scaling up its manufacturing facilities.
Johnson & Johnson (J&J) has announced that is has selected its lead candidate for a COVID-19 vaccine, after pre-clinical research. The company will now focus on its efforts to test the vaccine in clinical trials and increase its manufacturing capabilities.
Through collaborations with scientists at multiple academic institutions, J&J’s vaccine constructs were pre-clinically tested to identify those with the most promise in producing an immune response. The company is also developing two back-up vaccine options.
J&J and the US Biomedical Advanced Research and Development Authority (BARDA) have overall committed more than $1 billion towards the R&D of the novel coronavirus vaccine.
J&J says it will also scale up its manufacturing facilities around the world, while opening up a new production site in the US with the goal of providing more rapid, global supply of more than one billion doses of the vaccine.
The company says it is expecting to initiate human clinical studies of its lead vaccine candidate by September 2020 at the latest. It anticipates the first batches of the COVID-19 vaccine to be available for emergency use authorisation in early 2021.
Alex Gorsky, Chairman and Chief Executive Officer of J&J, 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. J&J 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.”
Dr Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer at J&J, said: “We greatly value the US government’s confidence and support for our R&D efforts. J&J’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 I human clinical trials at the latest by September 2020.”
Big Pharma, Drug Development, Industry Insight, investment, Manufacturing, Preclinical Research, QA/QC, Research & Development (R&D), Vaccines, Viruses
Biomedical Advanced Research and Development Authority (BARDA), Johnson & Johnson (J&J)