The newest angle in the partnership between Johnson & Johnson and the U.S. federal government, part of the company’s $1 billion commitment to COVID-19 R&D, is designed to drive its lead candidate into the clinic by year-end and to increase its vaccine manufacturing worldwide.
J&J, along with the Biomedical Advanced Research and Development Authority (BARDA), said the massive commitment includes creating new capabilities in the U.S. and scales up its capacity in other countries so that J&J could supply more than 1 billion doses of a vaccine around the world.
This follows the recent assessment by Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases, that even if a vaccine candidate could be ready to go within 18 months, it could take longer than that to produce it in large enough quantities if there are no production facilities.
“The federal government is not going to be able to make hundreds of millions of doses. It’s going to have to be in partnership with the private sector,” Fauci said.
J&J, of New Brunswick, N.J., also said that it has been on the hunt for a potential candidate since January and has now placed its lead COVID-19 candidate onto an accelerated timeline for a phase I trial in September, with safety and efficacy data following by year-end. The process would make the vaccine available for emergency use in early 2021, the company added.
Moving the candidate into a phase I study is the result of a collaboration by teams at the Janssen Pharmaceutical Co.’s arm of J&J, and the Beth Israel Deaconess Medical Center, which is part of Harvard Medical School, by testing to identify the vaccine constructs most likely to produce an immune response in preclinical testing. The selected candidate also has two backup vaccine candidates.
J&J said it was committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use. The company’s stock (NASDAQ:JNJ) rose 8% on the day, to $133.01 per share.
The Janssen/BARDA collaboration began in February as they worked to screen Janssen’s antiviral molecules in the search for a potential COVID-19 treatment. The agreement was designed for both to contribute to R&D costs, with BARDA providing funding to support a vaccine’s accelerated development into phase I, with options for more funding. The technology is the same used in developing and manufacturing Janssen’s investigational Ebola vaccine, which is being used in the Democratic Republic of the Congo and in Rwanda. The technology was also used to construct its Zika, respiratory syncytial virus and HIV vaccine candidates that are now in phase II and phase III studies.
J&J and BARDA are also providing funding for Janssen’s ongoing work to screen compound libraries. Those libraries also include compounds from other pharmaceuticals companies. The goal is to find potential COVID-19 treatments. The screening is being done in a partnership with the Rega Institute for Medical Research at the University of Leuven in Belgium.
The $2.2 trillion stimulus bill signed by President Donald Trump late last week is designed to provide emergency relief and to help pay for the response to the coronavirus pandemic. Much of that money is for the FDA and the NIH to develop medical countermeasures and vaccines and to advance domestic manufacturing for medical products. The NIH received $945.5 million to research COVID-19, including looking closely at underlying risks to cardiovascular and pulmonary conditions.
BioWorld is tracking development of both vaccines and therapeutics to tackle the COVID-19 pandemic.