Johnson & Johnson chairman and CEO Alex Gorsky

Johnson & Johnson (J&J) said today it expects to start Phase I human trials by September for a lead COVID-19 vaccine candidate, and has expanded its vaccine R&D and clinical testing partnership between J&J’s Janssen Pharmaceutical Cos. and the Biomedical Advanced Research and Development Authority (BARDA) that is valued at over $1 billion.

J&J said it aims to have clinical data available by year’s end on the safety and efficacy of its lead COVID-19 vaccine candidate, an accelerated development and testing timeframe it said would allow vaccine availability for emergency use in early 2021.

The company anticipates it can have the first batches of a COVID-19 vaccine available for FDA emergency use authorization in early 2021.

The lead candidate would progress quickly into first manufacturing steps, J&J said, as the company also plans to rapidly scale up its manufacturing capacity, with the goal of providing global supply of more than one billion doses of the COVID-19 vaccine.

That scale-up will include establishing new U.S. vaccine manufacturing capabilities and increasing capacity in other countries.

“Affordable” vaccine commitment

In addition, J&J plans to begin production at its own risk “imminently,” and has committed to bringing an “affordable” vaccine to the public on a not-for-profit basis for emergency pandemic use. Rolling out that vaccine is a key goal of the expanded partnership with BARDA, for which J&J said it will use its validated vaccine platform and is allocating resources, including personnel and infrastructure globally, as needed.

According to J&J, research teams at Janssen have partnered with Beth Israel Deaconess Medical Center (BIDMC), part of Harvard Medical School, to construct and test multiple vaccine candidates using Janssen’s AdVac® technology. Janssen has noted that research and preclinical collaboration with BIDMC’s Center for Virology and Vaccine Research was foundational to developing vaccines for Zika and HIV.

Through collaborations with multiple academic institutions, the company said, the vaccine constructs were then tested to identify those with the most promise in producing an immune response in preclinical testing. Janssen had said March 13 it planned to identify a COVID-19 vaccine candidate by the end of this month.

AdVac is based on the development and production of adenovirus vectors (gene carriers), and can be used together with Janssen’s PER.C6® technology to develop recombinant vaccines against life-threatening infectious diseases.

PER.C6 is designed to provide a cost-effective manufacturing system for high-yield, faster and large-scale production of vaccines and monoclonal antibodies. It is especially useful for vaccine manufacturing that requires the production of hard-to-grow viruses and could hold the key to making such vaccines affordable for the whole world, Janssen asserts.

Expanding antiviral partnership

Separately, BARDA and J&J will both provide unspecified additional funding intended to enable expansion of their ongoing work to identify potential antiviral treatments against COVID-19, the company said.

Janssen said it will accelerate its ongoing work in screening compound libraries, including compounds from other pharmaceutical companies, with the goal of identifying potential treatments against the novel coronavirus. These antiviral screening efforts are being conducted in partnership with the Rega Institute for Medical Research (KU Leuven/University of Leuven), in Belgium.

Janssen and BARDA said in February that they have been working closely with global partners to screen Janssen’s library of antiviral molecules to accelerate the discovery of potential COVID-19 treatments.

Not discussed by J&J and Janssen in today’s announcement is the status of efforts to expand the use of two marketed Janssen HIV protease inhibitors, Prezista® (darunavir) and  Prezcobix™ (darunavir and cobicistat), with an indication for COVID-19.

On March 26, Johnson & Johnson confirmed that it was screening its marketed HIV treatment Prezista and other antiviral compounds to determine potential in vitro effect against SARS-CoV-2—but decried “anecdotal, unsubstantiated reports” that Prezista has antiviral effect against COVID-19. J&J emphasized that the drug “should not be administered without a boosting agent (ritonavir or cobicistat).”

Janssen said January 29 that it donated 300 boxes of Prezcobix to the Shanghai Public Health Clinical Center and Zhongnan Hospital of Wuhan University for use in research to support efforts in finding a solution against SARS-CoV-2. Another 50 boxes were provided to the Chinese Center for Disease Control and Prevention for laboratory-based investigations. Prezcobix has been under study in a trial sponsored by Shanghai Public Health Clinical Center (NCT04252274), while a Chinese trial is assessing Prezcobix or the lopinavir-ritonavir combination combined with thymosin a1 (ChiCTR2000029541).

Janssen’s partnership with BARDA and efforts to study Prezcobix are two of 60 COVID-19 development programs that were highlighted in a GEN A-List published earlier this month. That list will be updated soon with additional treatments.

“The world is facing an urgent public health crisis and we are committed to doing our part to make a COVID-19 vaccine available and affordable globally as quickly as possible,” J&J chairman and CEO Alex Gorsky said in a statement. “As the world’s largest healthcare company, we feel a deep responsibility to improve the health of people around the world every day. Johnson & Johnson is well positioned through our combination of scientific expertise, operational scale and financial strength to bring our resources in collaboration with others to accelerate the fight against this pandemic.”

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