The study will be conducted globally with up to 60,000 participants
Johnson & Johnson and its Janssen Pharmaceutical Companies announced that planning is underway for the company’s Phase 3 ENSEMBLE clinical trial of its SARS-CoV-2 vaccine candidate, Ad26.COV2.S, subject to the analysis of interim data from the Phase 1/2a trial and approval of regulators. Today, the company announced that Brazil, Colombia, Peru, Chile, Argentina, Mexico, will be part of the Phase 3 ENSEMBLE clinical trial. The trial is anticipated to be initiated in September pending discussions with regulators.
Epidemiology and modeling data were used to predict and plan where our studies should take place, and the final selection of these countries was determined in close collaboration with governments and local health authorities. The decision considered current disease prevalence, population demographics and regulatory authorities’ requirements, to ensure the study can be conducted appropriately and provide the relevant data to inform potential emergency use.
The Phase 3 trial will be conducted with up to 60,000 participants between the ages of 18 to 60 and over 60 years of age. The trial will be carried out by local research centers that will oversee the process of recruiting volunteers. In addition to Latinamerica, the study will also involve United States and South Africa.
The company plans to begin production of the vaccine candidate at risk and are committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use. Johnson & Johnson is committed to delivering a safe and effective vaccine, all while emphasizing the importance of diversity and inclusion throughout the process. This multilateral collaboration with Brazil, Colombia, Peru, Chile, Argentina, Mexico demonstrates the progress and commitment of collective efforts to find solutions for the COVID-19 pandemic.
For more information on Johnson & Johnson’s multi-pronged approach to combatting the pandemic, visit: www.jnj.com/coronavirus.
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.
Notice to Investors Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding development of potential preventive and treatment regimens for COVID-19. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 29, 2019, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.