Johnson & Johnson Statement on FDA Observations at Emergent BioSolutions (Updated 4/30)
NEW BRUNSWICK, N.J., April 21, 2021 – The quality and safety of our COVID-19 vaccine is paramount. On April 3, 2021, Johnson & Johnson announced it would increase its oversight of drug substance manufacturing at the Emergent BioSolutions Bayview facility, including additional controls and personnel, to ensure the quality standards of our company and the U. S. Food & Drug Administration (FDA) are met. Since then, the Company has worked closely with the U.S. government, including the FDA, and with the European Medicines Agency (EMA), concerning the FDA inspection at Emergent Bayview, which concluded on Tuesday, April 20, 2021.
Johnson & Johnson will exercise its oversight authority to ensure that all of FDA’s observations with respect to the Emergent facility are addressed promptly and comprehensively. The Company will also continue to work toward securing Emergency Use Authorization in the United States for drug substance manufactured at Emergent Bayview as quickly as possible, so that the Company can help bring an end to this global pandemic.
To meet its commitments, the Company is establishing a global vaccine supply network, where, in addition to our internal manufacturing site in Leiden, the Netherlands, ten manufacturing sites will be involved in the production of the vaccine across different facilities, sometimes in different countries and continents, before the vaccine can be distributed globally. We are working around the clock to develop and broadly activate our manufacturing capabilities to supply our COVID-19 vaccine worldwide, and we appreciate the ongoing and extensive collaborations and partnerships we have 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.