Company working to ensure broad global access to COVID-19 vaccine candidate, following approval from regulators
Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ) (the Company), has agreed in principle to collaborate with the United Kingdom of Great Britain and Northern Ireland (the UK Government) on a global Phase 3 clinical trial to explore the two-dose regimen of Janssen’s SARS-CoV-2 vaccine candidate, Ad26.COV2.S. This global study will run in parallel to the Phase 3 trial investigating the single-dose regimen of Ad26.COV2.S.
In addition, Janssen has agreed in principle to supply the UK Government with doses of its SARS-CoV-2 vaccine candidate, Ad26.COV2.S. The availability of the vaccine candidate is subject to its successful development and regulatory approval.
“We are delighted to work with the UK Government on the global Phase 3 clinical programme for our COVID-19 vaccine candidate, and to ensure it is made available to citizens around the world, if proven to be effective with a good safety profile. Ending the current COVID-19 pandemic will take a global effort, and this agreement is an important example of how we can begin to address this significant challenge through collaborative research,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson.
The parties will negotiate a final advance purchase agreement in due course under which the UK Government would initially purchase 30 million doses of Janssen’s Ad26.COV2.S vaccine candidate on a not-for-profit basis for emergency pandemic use. The agreement will also provide the option for an additional purchase by the UK Government of up to a further 22 million vaccine doses.
The Phase 1/2a first-in-human clinical trial of the vaccine candidate, Ad26.COV2.S, is underway in healthy volunteers in the United States and Belgium. Planning is underway for the Phase 3 programme which is subject to interim data of the Phase 1 trials and approval of regulators.
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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.