Johnson & Johnson Enters into Agreement to Provide its Single-Shot COVID-19 Vaccine for the World's Most Vulnerable People through Novel Humanitarian Buffer

COVAX Humanitarian Buffer ensures the world's most vulnerable people have access to COVID-19 vaccines

Approximately 167 million displaced people worldwide are at risk of exclusion from COVID-19 vaccination(1)

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Nov 10, 2021, 17:14 ET

NEW BRUNSWICK, N.J., Nov. 10, 2021 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) (the Company) has entered into an agreement with the U.S. Government and Gavi, the Vaccine Alliance (Gavi), to enable access to its single-shot COVID-19 vaccine through a novel mechanism – the COVAX Humanitarian Buffer – that will serve to protect the world's most vulnerable people. The first deliveries to the COVAX Humanitarian Buffer are anticipated to begin in the coming days.

The COVAX Humanitarian Buffer is part of the COVAX Facility and is designed to ensure that people in conflict zones or humanitarian settings can access COVID-19 vaccines, even if they live beyond the reach of traditional, government vaccination campaigns. Governments and national and international humanitarian agencies are eligible to apply to receive doses from the COVAX Humanitarian Buffer. If applications are granted and the doses allocated, the governments or humanitarian agencies that filed the application then carry out the vaccination campaigns to ensure people are protected from COVID-19.

"We believe our single-shot COVID-19 vaccine has a critical role to play in conflict zones and other humanitarian settings that can't be reached by government vaccination campaigns, and we are proud to be part of this effort to protect the world's most vulnerable people," said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer. "From the beginning of the pandemic, Johnson & Johnson has recognized that no one is safe until everyone is safe and has worked to develop and deliver a vaccine that can protect the health of people everywhere."

The establishment of the COVAX Humanitarian Buffer is of critical importance to global health and ending the COVID-19 pandemic for everyone, everywhere. The Inter-Agency Standing Committee, the longest-standing and highest-level humanitarian coordination forum of the United Nations system, estimates that approximately 167 million people, including an estimated 60-80 million people in areas beyond the reach of national health authorities, are at risk of exclusion from COVID-19 vaccination. Vaccinating these people, who represent some of the world's most vulnerable populations, is crucial given that many of them may lack access to other healthcare resources should they be sickened by COVID-19.

Equitable Global Access to the Johnson & Johnson COVID-19 Vaccine
Johnson & Johnson is committed to facilitating equitable global access to its COVID-19 vaccine, and believes it is critical to protect as many people as possible against hospitalization and death. The Company has committed to providing its vaccine on a not-for-profit basis globally for emergency pandemic use, and is making available up to 900 million doses of its vaccine to the COVAX Facility and the African Union through 2022.

The Company firmly believes that inequitable access to COVID-19 vaccines will only prolong the pandemic, and is strongly advocating that governments with available doses follow the example of the U.S., the U.K. and other countries, and immediately ramp up dose sharing, particularly through the COVAX Facility.

About the Johnson & Johnson COVID-19 Vaccine
The Johnson & Johnson COVID-19 vaccine was developed and is being manufactured using Janssen's proprietary AdVac^® viral vector technology. The AdVac® vaccine platform is also used for the Company's Ebola vaccine regimen, and its candidates for preventing respiratory syncytial virus (RSV) and HIV.

The profile of the COVID-19 vaccine enables delivery to remote areas. The vaccine is estimated to remain stable for two years at -20 °C (-4 °F). It can be kept at temperatures of 2-8 °C (36-46 °F) for a maximum of six months of that two-year period, based on local labelling requirements. This enables the vaccine to be shipped using the same cold chain technologies used to transport other medicines and vaccines in routine use.

The Johnson & Johnson single-shot COVID-19 vaccine received an Emergency Use Authorization (EUA) in the United States on February 27, 2021, and on October 20, 2021, the FDA authorized for emergency use a booster shot of the Johnson & Johnson COVID-19 vaccine for adults aged 18 and older at least two months following primary vaccination with the Company's single-shot vaccine.

In addition, the European Commission granted Conditional Marketing Authorization (CMA) on March 11, 2021, the WHO issued Emergency Use Listing on March 12, and the Company received an interim recommendation from the Strategic Advisory Group of Experts (SAGE) on Immunization for the WHO on March 17. Many more authorizations have been granted in countries worldwide, and regulatory submissions are ongoing.

For more information on the Company's multi-pronged approach to helping combat the pandemic, visit: www.jnj.com/covid-19.

About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology and Pulmonary Hypertension.

Learn more at www.janssen.com. Follow us at @JanssenUS and @JanssenGlobal. Janssen Research & Development, LLC is part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

About Johnson & Johnson
At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That's why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world's largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity. Learn more at www.jnj.com. Follow us at @JNJNews.

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 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.

¹ Inter-Agency Standing Committee. Frequently Asked Questions: The COVAX Humanitarian Buffer. 8 November 2021. Available at: https://interagencystandingcommittee.org/system/files/2021-11/Frequently Asked Questions- The COVAX Humanitarian Buffer%2C 8 November 2021.pdf. Accessed 9 November 2021.

SOURCE Johnson & Johnson