COVID-19 Vaccine Candidate To Launch Study by September
New Jersey based Johnson & Johnson (J&J) announced it expects to initiate human clinical studies of its lead vaccine candidate targeted against the COVID-19 disease by September 2020.
Furthermore, J&J said in a press release issued on March 30, 2020, that it anticipates the first batches of a COVID-19 vaccine could be available for the US Food and Drug Administration to grant an Emergency Use Authorization in early 2021.
J&J said this vaccine candidate is from constructs it has been working on since January 2020.
And, it will use its previously validated vaccine development platform ob Janssen Pharmaceutical Companies to focus on this effort.
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.
This is the same technology that was used to develop and manufacture the Company’s Ebola vaccine and construct our Zika, RSV, and HIV vaccine candidates, which are in Phase 2 or Phase 3 clinical development stages.
And, there is a significant expansion of the existing partnership between the Janssen of J&J and the Biomedical Advanced Research and Development Authority (BARDA); and the rapid scaling of J&J’s manufacturing capacity with the goal of providing a global supply of more than 1 billion doses of a COVID-19 vaccine.
Through a landmark new partnership, BARDA, which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, and J&J together have committed more than $1 billion of investment to co-fund vaccine research, development, and clinical testing.
As part of its commitment, J&J is also expanding the Company’s global manufacturing capacity, including through the establishment of new U.S. vaccine manufacturing capabilities and scaling up capacity in other countries.
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.
The Company plans to begin production at risk imminently and is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use.
Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, J&J, said in the press release, “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.”
Vaccine 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.
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.
For comparison, 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.
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’s aim is to identify potential treatments against the novel coronavirus SARS-CoV-2.
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 for COVID-19.
For more information on J&J’s multi-pronged approach to combatting the pandemic, visit Johnson & Johnson Novel Coronavirus, SARS-CoV-2.
COVID-19 disease vaccine development news published by Precision Vaccinations.