J&J Ramps Up Manufacturing Capacity To Produce 1 Billion Doses Of Candidate COVID-19 Vaccine
Executive Summary
Company expects clinical trials to begin by September and says first batches could be available for emergency use authorization in early 2021; J&J pledges vaccine will be available to public on not-for-profit basis.
Johnson & Johnson is going full throttle on twin fronts in hopes of getting a COVID-19 vaccine on the market by early next year. It has ramped up research and development processes to "unprecedented levels" and is expanding its global manufacturing capacity to be able to produce one billion doses of the vaccine.
The company announced on 30 March that it had selected a lead COVID-19 vaccine candidate from constructs it began working on in January, when it began characterizing the virus using a viral genome sequence released by Chinese scientists after the new strain first emerged in Wuhan in late December.
J&J said that in collaboration with Beth Israel Deaconess Medical Center at Harvard Medical School, Janssen's research teams constructed and tested multiple vaccine candidates using Janssen's AdVac technology. The constructs were then tested to identify those with the most promise in producing an immune response in preclinical testing. Based on this work, done through collaborations with scientists at multiple academic institutions, J&J identified a lead candidate and two back-ups to progress into the first manufacturing steps.
"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," J&J stated.
"Johnson & Johnson's global team of experts has ramped up our research and development processes to unprecedented levels, and our teams are working tirelessly alongside BARDA, scientific partners, and global health authorities," Paul Stoffels, vice chairman of J&J's executive committee and chief scientific officer, said in the release.
"We are moving on an accelerated timeline toward Phase I 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."
The company said its expansion of global manufacturing capacity will help in the rapid production of a vaccine and enable the supply of more than one billion doses globally. The expansion includes the establishment of new U.S. vaccine manufacturing capabilities and scaling up capacity in other countries. J&J did not immediately respond to questions as to how this would be done and if it would be hiring more employees.
Funding for vaccine production is included in the massive coronavirus response package that just passed the US Congress, but it is unclear how the funds will be be distributed or whether J&J will seek to avail itself of them. Regardless, the company's move to create manufacturing capacity in advance of the first human tests is an aggressive one, especially for a firm that has not been a traditional vaccine powerhouse.
J&J also made a point of addressing the pricing of a final vaccine.
"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," J&J stated.
Leveraging Existing Technology
In February, J&J's Janssen Pharmaceutical Cos. unit obtained funding to support accelerated development of a vaccine from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness Response at the US Department of Health and Human Services. J&J said it has expanded the partnership and together they have committed more than $1bn of investment to co-fund vaccine research, development and clinical testing.
BARDA also partnered with Sanofi Pasteur to develop a potential COVID-19 vaccine. Sanofi is utilizing the same recombinant DNA platform used in its influenza vaccine Flublok and in its previous vaccine candidate for severe acute respiratory syndrome (SARS). (Also see "Two Companies, Two BARDA Contracts, Two Approaches To Coronavirus" - Pink Sheet, 18 Feb, 2020.)
J&J is similarly leveraging its AdVac and PER.C6 technologies used to develop and manufacture its Ebola vaccine and to construct its Zika, RSV, and HIV vaccine candidates now in Phase II or III clinical development.
Several other companies are developing vaccine candidates, including Moderna Inc. and Inovio Pharmaceuticals Inc. According to the Pink Sheet's COVID-19 Pipeline Tracker, there are more than 90 product candidates in development worldwide for treatment and prevention of the coronavirus.
Enhancing Antiviral Research
J&J also noted that it has expanded its partnership with BARDA to accelerate Janssen's ongoing work in screening compound libraries, including compounds from other pharmaceutical companies, to identify potential treatments against COVID-19. J&J said these antiviral screening efforts are being conducted in partnership with the Rega Institute for Medical Research (KU Leuven/ University of Leuven) in Belgium.
J&J is also participating in a consortium with 14 other companies who are sharing their proprietary libraries of molecular compounds with the COVID-19 Therapeutics Accelerator to screen them for potential use against the novel coronavirus. The Therapeutics Accelerator was launched in March by the Bill & Melinda Gates Foundation, Wellcome and Mastercard. (Also see "Coronavirus Update: R&D Starts, Product Delays, Continuing Collaboration" - Pink Sheet, 29 Mar, 2020.)
Recognizing the growth in industry collaborations to deal with the pandemic, the Federal Trade Commission and Department of Justice recently issued a joint statement saying they would expedite review of alliances for any possible antitrust issues. (Also see "Biopharma COVID-19 Collaborations May Avoid Antitrust Hurdles, FTC And DOJ Suggest" - Pink Sheet, 30 Mar, 2020.)
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