Johnson & Johnson Statement on U.S. COVID-19 Vaccine Manufacturing
New Brunswick, NJ (April 3, 2021) – Johnson & Johnson is assuming full responsibility regarding the manufacturing of drug substance for its COVID-19 vaccine at the Emergent BioSolutions Inc. Bayview facility. Specifically, the Company is adding dedicated leaders for operations and quality, and significantly increasing the number of manufacturing, quality and technical operations personnel to work with the Company specialists already at Emergent.
Additional information:
- All Johnson & Johnson COVID-19 vaccine doses distributed to date have met rigorous Company and regulatory quality standards.
- The Company continues to work closely with the U.S. Food and Drug Administration toward the Emergency Use Authorization (EUA) of the Emergent Bayview facility.
- The Company expects to deliver nearly 100 million single-shot doses of its COVID-19 vaccine to the U.S. Government by the end of May.
- The Company is committed to continuing its extensive collaborations and partnerships with governments, health authorities and other companies to help end this pandemic.
Cautions 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 Company, any of the other 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 January 3, 2021, 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.
Source: Johnson & Johnson
Posted: April 2021
Janssen COVID-19 Vaccine (SARS-CoV-2 vaccine) FDA Approval History
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