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Johnson & Johnson expects to initiate human clinical studies for its lead COVID-19 vaccine candidate by September 2020.
In partnership with the Biomedical Advanced Research and Development Authority (BARDA), Johnson & Johnson announced the development of a COVID-19 vaccine candidate, according to a company press release.
The manufacturer expects to initiate human clinical studies of its lead candidate at the latest by September 2020. First batches of a COVID-19 vaccine could be available for emergency use by early 2021.
Together, BARDA, which is part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, and Johnson & Johnson have committed more than $1 billion of investment to co-fund vaccine research, development, and clinical testing.
Efforts to develop a vaccine for COVID-19 began in January 2020. Research teams at Janssen, along with Beth Israel Deaconness Medical Center, constructed and tested multiple candidates.
Additionally, the collaboration also includes working with global partners to screen Janssen’s library of antiviral molecules to accelerate the discovery of potential COVID-19 treatments.
“We are moving on an accelerated timeline toward phase 1 human clinical trials at the latest by September 2020 and, supported by global production capability that we are scaling up in parallel to this testing, we expect a vaccine could be ready for emergency use in 2021,” Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer, Johnson & Johnson, said in a statement.
According to Johnson & Johnson, it is also expanding global manufacturing capacity, with new US vaccine manufacturing capability and additional production capacity outside of the United States, in order to assist with the rapid production of a vaccine.
“The additional capacity will assist in the rapid production of a vaccine and will enable the supply more than 1 billion doses of a safe and effective vaccine globally,” Johnson & Johnson said in the release.
The first trial in humans for a COVID-19 vaccine was launched on March 16, with volunteers receiving the first injection. The investigational vaccine called mRNA-1273, developed by Moderna, is being studied over a 6-week period in a phase 1 federally sponsored study of 45 participants.
1. Johnson & Johnson Announces a Lead Vaccine Candidate for COVID-19; Landmark New Partnership with US Department of Health & Human Services; and Commitment to Supply One Billion Vaccines Worldwide for Emergency Pandemic Use [news release]. Johnson & Johnson’s website. https://www.jnj.com/johnson-johnson-announces-a-lead-vaccine-candidate-for-covid-19-landmark-new-partnership-with-u-s-department-of-health-human-services-and-commitment-to-supply-one-billion-vaccines-worldwide-for-emergency-pandemic-use. Accessed March 30, 2020.