Johnson & Johnson and U.S. Department of Health & Human Services Expand Agreement to Support Next Phase of COVID-19 Vaccine Candidate Research and Development

Rhea-AI Summary

Johnson & Johnson (NYSE: JNJ) announced an expansion of its partnership with the Biomedical Advanced Research and Development Authority (BARDA) to further develop its investigational COVID-19 vaccine. Janssen will invest approximately $604 million, while BARDA will contribute $454 million, supporting the Phase 3 ENSEMBLE trial with up to 60,000 volunteers. This collaboration emphasizes the importance of public-private partnerships in addressing the COVID-19 pandemic. J&J reaffirms its commitment to ethical vaccine development and adherence to scientific standards.

Positive

• Expansion of partnership with BARDA supports vaccine development.
• Investment of approximately $604 million by Janssen signifies strong commitment.
• Phase 3 ENSEMBLE trial involves up to 60,000 volunteers, indicating large-scale testing.

Negative

• None.

NEW BRUNSWICK, N.J., Nov. 14, 2020 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) (the Company) announced the expansion to the partnership between its Janssen Pharmaceutical Companies (Janssen) and the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services for the ongoing development of Janssen's investigational COVID-19 vaccine candidate.

Under the amendment, Janssen will commit approximately $604 million and BARDA will commit approximately $454 million to support the ongoing Phase 3 ENSEMBLE trial evaluating Janssen's investigational COVID-19 vaccine candidate as a single-dose in up to 60,000 volunteers worldwide.

Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said, "We greatly value the ongoing confidence and support of our investigational COVID-19 vaccine candidate development program. Combined with our own significant investment, this agreement has enabled our vital research and development and underscores the importance of public-private partnerships to tackle the worldwide COVID-19 pandemic."

This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under OTA No. HHSO100201700018C.

Johnson & Johnson affirmed its commitment to develop and test its Janssen COVID-19 vaccine candidate in accordance with high ethical standards and sound scientific principles, as outlined in a pledge made by nine vaccine manufacturers earlier this year.

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 a potential preventive vaccine 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.

 

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SOURCE Johnson & Johnson

FAQ

What is the recent investment by Johnson & Johnson for COVID-19 vaccine development?

Johnson & Johnson is investing approximately $604 million in its COVID-19 vaccine development, alongside $454 million from BARDA.

What is the Phase 3 ENSEMBLE trial for JNJ's COVID-19 vaccine?

The Phase 3 ENSEMBLE trial aims to evaluate Janssen's COVID-19 vaccine as a single-dose solution in up to 60,000 volunteers globally.

When was the partnership between JNJ and BARDA expanded?

The partnership was expanded on November 14, 2020.

What role does BARDA play in JNJ's COVID-19 vaccine development?

BARDA provides funding and support for the ongoing development of JNJ's investigational COVID-19 vaccine.