- Up to 400 million doses of the Company's single-shot vaccine candidate will be made available to African Union member states - Availability of the vaccine is subject to national regulatory approvals - Data have demonstrated vaccine candidate protects against COVID-19 related hospitalization and death in broad geographic regions, including those with variants of significant concern Janssen Pharmaceutica NV, one of the Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE: JNJ) (the Company), has entered into an agreement with the African Vaccine Acquisition Task Team (AVATT) to make available up to 220 million doses of its single-shot COVID-19 vaccine candidate to African Union's 55 member states with delivery beginning in the third quarter of 2021. AVATT also has the potential to order an additional 180 million doses, for a combined total of up to 400 million doses through 2022. The availability of the vaccine candidate is subject to its successful approval or authorization by the national regulatory authorities of AU member states. "From the beginning of this pandemic, Johnson & Johnson has recognized that no one is safe until everyone is safe, and we have been committed to equitable, global access to new COVID-19 vaccines," said Alex Gorsky, Chairman and Chief Executive Officer of Johnson & Johnson. "Our support for the COVAX Facility, combined with supplementary agreements with countries and regions, will help accelerate global progress toward ending the COVID-19 pandemic." Johnson & Johnson is committed to ensuring equitable global access to its single-shot COVID-19 vaccine candidate on a not-for-profit basis for emergency pandemic use. In December 2020, the Company entered into an agreement in principle ( https://c212.net/c/link/?t=0&l=en&o=3111303-1&h=145622612&u=https%3A%2F%2Fwww.jnj.com%2Four-company%2Fjohnson-johnson-announces-agreement-in-principle-with-gavi-to-supply-janssens-covid-19-vaccine-candidate-to-lower-income-countries-in-2021&a=agreement+in+principle ) with Gavi, the Vaccine Alliance (Gavi) in support of the COVAX Facility, which is supporting the initial vaccination needs of 190 participating economies, including many countries in Africa. The Company and Gavi expect to enter into an Advance Purchase Agreement (APA) that would provide up to 500 million doses of the Company's vaccine to COVAX through 2022. Additionally, Johnson & Johnson recognizes the increasingly severe impact of COVID-19 in Africa, as well as the emergence and continued spread of a SARS-CoV-2 variant in the Republic of South Africa that demonstrates increased transmissibility. Data from the Phase 3 ENSEMBLE study showed that the Johnson & Johnson COVID-19 vaccine was well tolerated and demonstrated a 67 percent reduction in symptomatic COVID-19 disease in participants who received the vaccine in comparison to participants given the placebo. The onset of protection was observed from day 14 and was maintained 28 days post-vaccination. The data also demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied and showed protection against COVID-19 related hospitalization and death across countries with different variants, beginning 28 days after vaccination. Variants observed in an ongoing analysis in the ENSEMBLE study included the B.1.351 variant which was identified in 95 percent of the COVID-19 cases in South Africa. Manufacturing and Supply Chain Information Johnson & Johnson has established a global manufacturing and supply network for its COVID-19 vaccine, collaborating with nine partners across four continents, including Aspen Pharmacare in South Africa. Aspen will support vaccine shipments to the AU and will also contribute to global availability of the vaccine. The Johnson & Johnson COVID-19 single-shot vaccine is compatible with standard vaccine storage and distribution channels enabling delivery to remote areas. The vaccine is estimated to remain stable for two years at -25 to -15 degrees C, a maximum of three months of which can be at routine refrigeration at temperatures of 2 degrees-8 degrees C. This enables the vaccine to be shipped using the same cold chain technologies used to transport other medicines and vaccines in routine use. Johnson & Johnson's COVID-19 Vaccine The Johnson & Johnson COVID-19 vaccine uses the AdVac(R) vaccine platform ( https://c212.net/c/link/?t=0&l=en&o=3111303-1&h=4187432995&u=https%3A%2F%2Fwww.janssen.com%2Finfectious-diseases-and-vaccines%2Fvaccine-technology&a=AdVac%C2%AE%C2%A0vaccine+platform ), a proprietary technology that was also used to develop and manufacture Janssen's European Commission-approved Ebola vaccine regimen and construct its investigational Zika, RSV, and HIV vaccines. Regulatory Filings The Johnson & Johnson single-shot COVID-19 vaccine was granted Emergency Use Listing ( https://c212.net/c/link/?t=0&l=en&o=3111303-1&h=3757565975&u=https%3A%2F%2Fwww.jnj.com%2Fjohnson-johnson-single-shot-covid-19-vaccine-granted-emergency-use-listing-by-the-world-health-organization&a=Emergency+Use+Listing ) from the World Health Organization (WHO) on March 12, Conditional Marketing Authorization ( https://c212.net/c/link/?t=0&l=en&o=3111303-1&h=3945659433&u=https%3A%2F%2Fwww.jnj.com%2Fjohnson-johnson-single-shot-covid-19-vaccine-granted-conditional-marketing-authorization-by-european-commission&a=Conditional+Marketing+Authorization ) from the European Commission on March 11 and Emergency Use Authorization ( https://c212.net/c/link/?t=0&l=en&o=3111303-1&h=2141813688&u=https%3A%2F%2Fwww.jnj.com%2Fjohnson-johnson-covid-19-vaccine-authorized-by-u-s-fda-for-emergency-usefirst-single-shot-vaccine-in-fight-against-global-pandemic&a=Emergency+Use+Authorization ) by the U.S. Food and Drug Administration on February 27, 2021. The single-shot COVID-19 vaccine has also been granted Interim Order authorization ( https://c212.net/c/link/?t=0&l=en&o=3111303-1&h=3533767168&u=https%3A%2F%2Fwww.janssen.com%2Fcanada%2Fsites%2Fwww_janssen_com_canada%2Ffiles%2Fjohnson_johnson_covid-19_vaccine_granted_authorization_under_interim_order_by_health_canada_for_emergency_use.pdf&a=Interim+Order+authorization ) in Canada, and additional rolling submissions have been initiated in several countries worldwide. For more information on the Company's multi-pronged approach to helping combat the pandemic, visit: www.jnj.com/coronavirus. 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 ( https://c212.net/c/link/?t=0&l=en&o=3111303-1&h=3419396970&u=http%3A%2F%2Fwww.twitter.com%2Fjnjnews&a=%40JNJNews ). 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 @JanssenGlobal ( https://c212.net/c/link/?t=0&l=en&o=3111303-1&h=1265564495&u=https%3A%2F%2Ftwitter.com%2FJanssenGlobal&a=%40JanssenGlobal ). 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. Logo - https://mma.prnewswire.com/media/403394/Johnson_and_Johnson_Logo.jpg SOURCE Johnson & Johnson CONTACT: Media Contacts: Jake Sargent, +1 732-524-1090, JSargen3@its.jnj.com, or Seema Kumar, +1 908-405-1144, SKumar10@its.jnj.com, or Ronan Collins, +47 488-425-00, RCollin5@its.jnj.com, or Investor Relations: Chris DelOrefice, +1 732-524-2955, or Jennifer McIntyre, +1 732-524-3922