The pharmaceutical giant Johnson & Johnson has identified a lead candidate vaccine for Covid-19 and says it could be ready for emergency use in January 2021.
The company, which has a major presence in Ireland, says it has been working on vaccines since January 2020 through a significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA). It has also been working toward the rapid scaling of the company’s manufacturing capacity.
The company says it expects to initiate human clinical studies of its lead vaccine candidate at the latest by September 2020 and anticipates the first batches could be available for emergency use authorisation in early 2021, a substantially faster than the typical vaccine development process.
Johnson & Johnson says it is expanding the company’s global manufacturing capacity, including through the establishment of new US vaccine manufacturing capabilities and scaling up capacity in other countries. It says the additional capacity will assist in the rapid production of a vaccine and will enable the supply of more than one billion doses globally. The company plans to begin production at risk imminently and says it is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use.
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, MD, Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said: "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.”
Johnson & Johnson began efforts in January 2020, as soon as the novel coronavirus Covid-19 sequence became available, to research potential vaccine candidates. 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.
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 & Johnson says it has invested billions of dollars in antivirals and vaccine capabilities over the past 20 years. The company says it is using technology that was used to develop and manufacture the company’s Ebola vaccine and construct Zika, RSV, and HIV vaccine candidates which are in Phase 2 or Phase 3 clinical development stages.
In addition to the vaccine development efforts, BARDA and Johnson & Johnson have also expanded their partnership to accelerate Janssen’s ongoing work in screening compound libraries, including compounds from other pharmaceutical companies.
The companies aim is to identify potential treatments against the novel coronavirus. Johnson & Johnson and BARDA are both providing funding as part of this partnership. These antiviral screening efforts are being conducted in partnership with the Rega Institute for Medical Research (KU Leuven/University of Leuven), in Belgium.
Covid-19 belongs to a group of viruses called coronaviruses that attack the respiratory system. There is currently no approved vaccine, treatment or cure.
The Johnson & Johnson family of companies has been operating in Ireland for 80 years, employing in excess of 2,850 people across three business sectors. It has plants in Cork and Limerick mainly run under the Janssen name.