Johnson & Johnson is moving forward with a vaccine candidate for COVID-19. The healthcare giant said it selected a lead vaccine candidate and plans to begin human testing in September, with first batches available under potential emergency use authorization in the first part of 2021.
Johnson & Johnson began developing a potential vaccine for COVID-19, the disease caused by the novel coronavirus, in January, as soon as the sequencing became available. Researchers from J&J’s pharmaceutical subsidiary Janssen, along with those at Beth Israel Deaconess Medical Center, part of Harvard Medical School, tested multiple candidates before settling on its lead asset, as well as two backup candidates. The company aims to enter the clinic in September and hopes to have safety and efficacy data by the end of the year to support potential emergency use authorization in early 2021. If the vaccine is approved for use, the company said it is committed to affordable pricing on a “not-for-profit basis for emergency pandemic use.” In its announcement, J&J noted the speed with which it is bringing the vaccine candidate to the clinic. What it has done in months due to the urgent concerns of COVID-19 typically takes five to seven years, the company said.
The COVID-19 vaccine program is leveraging Janssen’s proven AdVac and PER.C6 technologies that provide the ability to rapidly develop new vaccine candidates and upscale production of the optimal vaccine candidate. The same technology was used to develop and manufacture the Company’s Ebola vaccine and construct its Zika, RSV, and HIV vaccine candidates which are in Phase II and Phase III.
In addition to fast-forwarding its vaccine development program, J&J announced an expansion of its partnership with 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.
Under the partnership with BARDA, J&J and the government agency have committed more than $1 billion of inve
stment to co-fund vaccine research, development, and clinical testing of vaccines. 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, J&J said.
In addition to the vaccine development efforts, BARDA and J&J have also expanded their partnership to accelerate Janssen’s ongoing work in screening compound libraries, including compounds from other pharmaceutical companies. The aim is to identify potential treatments against the novel coronavirus.
“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,” J&J Chief Executive Officer Alex Gorsky said in a statement.