Statement on Boosting with the Johnson & Johnson COVID-19 Vaccine

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NEW BRUNSWICK, N.J., August 18, 2021 – We are engaging with the U.S. FDA, CDC and other health authorities and will share new data shortly regarding boosting with the Johnson & Johnson COVID-19 vaccine.

In July, Johnson & Johnson shared data demonstrating that our single-shot COVID-19 vaccine generated strong, persistent immune activity against the rapidly spreading Delta variant and other highly prevalent SARS-CoV-2 viral variants. Interim results from a Phase 1/2a study published in the New England Journal of Medicine also showed that the durability of the immune response was strong, with no waning for at least eight months, the length of time that had been evaluated to date.

Ensuring long-term and durable protection against hospitalization and death are critical in curbing the COVID-19 pandemic.

Cautions Concerning Forward-Looking Statements

This statement 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 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

Ad26.COV2-S (SARS-CoV-2 vaccine) FDA Approval History

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