J&J Selects COVID-19 Vaccine Candidate; Outlines Plan for Clinical Testing
Johnson & Johnson (J&J) has selected a lead vaccine candidate against the novel coronavirus (COVID-19) for which it expects to initiate Phase I clinical studies by September 2020 and has established a manufacturing plan.
The company provided an update on these key items: selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020; the expansion of an existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA) of the US Department of Health and Human Services; and the rapid scaling of the company’s manufacturing capacity with the goal of providing global supply of more than one billion doses of a vaccine. The company expects to initiate human clinical studies of its lead vaccine candidate at the latest by September 2020 and anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021, a substantially accelerated timeframe in comparison to the typical vaccine-development process.
Partnering with HHS’ BARDA
Through a new partnership, BARDA, which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at HHS, and J&J have committed more than $1 billion of investment to co-fund vaccine research, development, and clinical testing. J&J will use its validated vaccine platform and is allocating resources, as needed, to focus on these efforts. Separately, BARDA and J&J have provided additional funding that will enable expansion of their ongoing work to identify potential antiviral treatments against the novel coronavirus.
J&J is expanding its global manufacturing capacity, including through the establishment of US vaccine-manufacturing capabilities and scaling up capacity in other countries. The company says that the additional capacity will assist in the rapid production of a vaccine and will enable the supply of more than one billion doses of a safe and effective vaccine globally.
J&J’s lead COVID-19 vaccine candidate
J&J began efforts in researching for potential vaccine candidates against COVID-19 in January 2020. Research teams at Janssen, in collaboration with Beth Israel Deaconess Medical Center, part of Harvard Medical School, constructed and tested multiple vaccine candidates. 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.
Based on this work, J&J 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 I 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 five to seven years, before a candidate is even considered for approval.
The COVID-19 vaccine program is using Janssen’s 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, respiratory syncytial virus, and HIV vaccine candidates which are in Phase 2 or Phase 3 clinical development stages.
Antiviral drug research against COVID-19
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 company aims to identify potential treatments against the novel coronavirus. J&J 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.
As announced in February 2020, the company and BARDA have been working closely with global partners to screen Janssen’s library of antiviral molecules to accelerate the discovery of potential COVID-19 treatments.
Source: Johnson & Johnson