Johnson & Johnson has joined with a U.S. government agency to commit $1 billion to development of a COVID-19 vaccine. J&J plans to have a vaccine in the clinic by September, win emergency use authorization early next year and add capacity to make more than 1 billion doses.
Last month, J&J expanded its alliance with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to cover the development of a vaccine against the novel SARS-CoV-2 coronavirus. The virus has spread quickly since then, leading J&J to commit to big plans for the vaccine research it began in January.
Having selected a lead candidate from the constructs it began working on in January, J&J has teamed up with BARDA to provide the resources needed to move the vaccine forward quickly. The partners have committed more than $1 billion to novel coronavirus vaccine R&D.
Spending on the vaccine program is set to ramp up in the coming months. J&J plans to start testing its COVID-19 vaccine in humans by September at the latest, post data by the end of 2020 and go on to land an emergency use authorization early next year. The authorization pathway allows the FDA to clear unapproved vaccines for use in public health emergencies in the absence of adequate approved alternatives.
In trying to hit that timeline, which is very short by historical standards, J&J will commit personnel and infrastructure around the world to the vaccine program. Other teams at J&J will work in parallel to ensure there is capacity to make the vaccine widely available if it clears the tests of its safety and efficacy.
Notably, J&J plans to open a new vaccine manufacturing plant in the U.S. and scale up capacity in other parts of the world. In doing so, J&J plans to equip itself to make more than 1 billion doses of the vaccine available globally on a not-for-profit basis.
With Moderna already in the clinic, a University of Oxford group aiming to start human testing next month and other companies including J&J, Pfizer and Sanofi advancing candidates, it is possible that multiple vaccines against COVID-19 will be available, at least on a limited basis, by this time next year. However, it is also possible that some or all of the first crop of vaccines will fail to generate the safety and efficacy data needed to support widespread use. J&J has two backup COVID-19 vaccines.
The work on preventive vaccines is advancing alongside efforts to develop treatments for COVID-19. J&J and BARDA are also collaborating on the development of antivirals against the coronavirus and have committed additional funding to that effort.