The U.S. federal government via Operation Warp Speed’s “BARDA” continues deal making at unprecedented levels, now entering into an arrangement with U.S. pharmaceutical giant Johnson & Johnson’s Janssen Pharmaceuticals Group, to procure 100 million doses of Ad26.COV2.S, Janssens’s SARS-CoV-2 vaccine candidate. For use only within the United States, this purchase is triggered by U.S. Food and Drug Administration (FDA) approval or Emergency Use Authorization (EUA) by the FDA. Behind the scenes, one of the most sophisticated operators in the global pharmaceutical industry, Paul Stoffels, spearheads what could be a game changer with Ad26.COV2.S. They have committed to distribute the vaccine on a “not-for-profit” basis during the pandemic.
The Top Guns
On June 10, TrialSite reported that the Johnson & Johnson COVID-19 vaccine pursuit was a formidable one. Good leadership represents a fundamental ingredient for any successful endeavor in the complex, politicized world of drug development in normal times; in these pandemic times, it’s that on steroids. With the announcement that company Vice Chairman and Chief Scientific Officer Paul Stoffels, MD, would be actively managing the effort, the combination of potential with the science, R&D sophistication, market prowess and leadership sophistication represented the entry of a formidable competitor into this high stakes COVID-19 vaccine development race.
TrialSite suspects that the reputation and influence Mr. Stoffel carries led to the $1+ billion award. Mr. Stoffels is perhaps the most savvy and sophisticated of pharmaceutical executives in the world. He serves as a co-chair, along with Pfizer’s Mikael Dolsten and Roche’s William Pao, on the highly influential ACTIV initiative sponsored by the NIH. This group vets all major COVID-19 clinical trials vying for federal dollars.
Another Billion Dollar BARDA Deal
The key player behind Operation Warp Speed, the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (BARDA), along with the U.S. Department of Defense (DOD), will commit over $1 billion for this agreement. According to the Johnson & Johnson issued press release, the vaccine will be offered at a global not-for-profit basis for emergency pandemic use. BARDA and DOD included a contract option to secure an additional 200 million doses of the Ad26.COV2.S under a subsequent agreement.
The Investigational Vaccine
Johnson & Johnson initiated the research and development effort involving the SARS-CoV-2 investigational COVID-19 vaccine Ad26.COV2.S along with BARDA under the oversight of the FDA. The company recently reported positive preclinical data, peer reviewed and published in the journal Nature. Now a Phase 1/2a first-in-human clinical trial of the vaccine candidate launched in healthy volunteers both in the United States and Belgium. The Company is evaluating one- and two-dose regimens, in its clinical program and working diligently to ensure broad, global access to the vaccine following approval or authorization by regulators. Johnson & Johnson aims to meet its goal to supply more than one billion doses globally through the course of 2021, provided the vaccine is safe and effective.
Johnson & Johnson’s SARS-CoV-2 vaccine program leverages Janssen’s AdVac® technology. The same technology was used to develop Janssen’s European Commission-approved Ebola vaccine and construct its HIV, RSV and Zika vaccine candidates. More than 90,000 individuals have been vaccinated to date using the Janssen AdVac®-based platform.
About Johnson & Johnson
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at www.jnj.com. Follow us at @JNJNews.
About the Janssen Pharmaceutical Companies
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Learn more at www.janssen.com. Follow us at @JanssenGlobal.
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