
Healthcare Product Manufacturers, Health Service Providers

Pharmaceutical R&D Developer

U.S. Food and Drug Administration

The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, provides a comprehensive, systematic approach to the development and procurement of necessary vaccines, drugs, therapeutics, and diagnostic tools for public health medical emergencies.
NEW BRUNSWICK, N.J., Aug. 6, 2020 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) (“the Company”) announced today that its Janssen Pharmaceuticals has reached an agreement with the U.S. government to manufacture and supply 100 million doses of Janssen’s investigational COVID-19 vaccine, Ad26.COV2, for large-scale use within the United States. The vaccine will be available for use in the United States following approval or Emergency Use Authorization by the U.S. Food and Drug Administration (FDA).
The Biomedical Advanced Research and Development Authority (BARDA), under the Office of the Assistant Secretary for Preparedness and Response of the U.S. Department of Health and Human Services,BARDA”), in collaboration with the U.S. Department of Defense, will invest more than $1 billion in this agreement. The vaccine will be provided on a non-profit basis globally for emergency epidemics. Under subsequent agreements, the U.S. government may also purchase an additional 200 million doses of Ad26.COV2.S.
Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson, stated, “Johnson & Johnson’s global team of experts has been working tirelessly with BARDA and its scientific partners to develop a coronavirus vaccine that helps stop the spread of COVID-19. We are deeply grateful for the confidence and support shown by the U.S. government in our R&D platform and efforts, as well as in the scalability of our vaccine technology. We are expanding production both in the United States and worldwide to provide coronavirus vaccines for emergency use.”
Under the supervision of the U.S. Food and Drug Administration, Johnson & Johnson is collaborating with BARDA on research and development efforts to develop a coronavirus vaccine. According to a recent publication in the peer-reviewed journal 《Nature》’s PositivePreclinical Data, a Phase 1/2a first-in-human clinical trial of the vaccine candidate Ad26.COV2.S is currently being conducted in healthy volunteers in the United States and Belgium.
The company is evaluating one-dose and two-dose regimens in its clinical programs and is working to ensure global access to the vaccine following regulatory approval or authorization. Johnson & Johnson aims to deliver more than 1 billion doses worldwide by 2021, contingent upon the vaccine’s safety and efficacy.
Johnson & Johnson’s COVID-19 vaccine program adopted Janssen’sAdVac®Technology. This technology has been used to develop the Janssen Ebola vaccine approved by the European Commission, and to construct its candidate vaccines for HIV, RSV (respiratory syncytial virus), and Zika virus. To date, more than 90,000 people have received vaccines based on the Janssen AdVac® platform.
Johnson & Johnson Profile
Johnson & Johnson firmly believes that health is the foundation of vibrant lives, thriving communities, and continuous progress. For this reason, for more than 130 years, Johnson & Johnson has been committed to helping people stay healthy at every age and stage of life. Today, as the world’s largest and most broadly diversified healthcare company, Johnson & Johnson leverages its extensive reach to advance human health and build a better society. The company strives to improve the accessibility and affordability of medicines, create healthier communities, and enable people around the world to enjoy healthy minds and bodies in supportive environments. By integrating compassion, science, and intelligence, Johnson & Johnson drives meaningful change in the advancement of global health. To learn more, please visitwww.jnj.com. Through@JNJNewsFollow this company.
Introduction to Janssen Pharmaceuticals
At Janssen, we are committed to creating a future free of disease. As the pharmaceutical company of Johnson & Johnson, we harness science to conquer disease, leverage insight to expand access, and deliver care that brings hope, striving tirelessly to enable people around the world to enjoy a better tomorrow. We focus on therapeutic areas where medicines can make the greatest impact: cardiovascular and metabolism, immunology, infectious diseases and vaccines, neuroscience, oncology, and pulmonary arterial hypertension. For more information, please visit www.janssen.co. Through@JanssenGlobalFollow this company.
Cautionary Note to Investors Regarding Forward-Looking Statements
This press release containsThese forward-looking statements, as defined by the U.S. Private Securities Litigation Reform Act of 1995, relate to potential prevention and treatment options for COVID-19. Readers are cautioned not to place undue reliance on these forward-looking statements. These statements are based on the Company’s current outlook regarding future events. If underlying assumptions prove inaccurate, or if known or unknown risks or uncertainties arise, actual results may differ materially from the expectations and forecasts of the Janssen Research & Development team and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: the inherent challenges and uncertainties in product development, including uncertainties regarding clinical success and regulatory approval; uncertainties regarding commercial success; manufacturing difficulties and delays; competition, including technological advances and new products and patents obtained by competitors; patent challenges; concerns about product efficacy or safety arising from product recalls or regulatory actions; changes in consumption patterns and behaviors of purchasers of medical products and services; changes in applicable laws and regulations, including global healthcare reform; and trends toward controlling healthcare costs. A further list and description 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 the sections titled “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” as well as in the Company’s most recently filed Quarterly Report on Form 10-Q and subsequent filings with the U.S. Securities and Exchange Commission. Copies of these documents are available fromwww.sec.gov andwww.jnj.comobtain, or request from Johnson & Johnson. Neither Janssen Pharmaceuticals nor Johnson & Johnson assumes any obligation to update any forward-looking statements based on new information or future events or developments.
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