- Johnson & Johnson and BARDA Together Commit More than $1 Billion to Novel Coronavirus Vaccine Research and Development; Company Expects to Initiate Phase 1 Human Clinical Studies of Vaccine Candidate at Latest by September 2020 - Johnson & Johnson Will Establish New U.S. Vaccine Manufacturing Capabilities and Additional Production Capacity Outside the U.S. to Begin Production at Risk to Help Ensure Global Vaccine Supply Johnson & Johnson (NYSE: JNJ) (the Company) today announced the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020; the significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA); and the rapid scaling of the Company's manufacturing capacity with the goal of providing global supply of more than one billion doses of a vaccine. The Company expects to initiate human clinical studies of its lead vaccine candidate at the latest by September 2020 and anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021, a substantially accelerated timeframe in comparison to the typical vaccine development process. Through a landmark new partnership, BARDA, which is part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, and Johnson & Johnson together have committed more than $1 billion of investment to co-fund vaccine research, development, and clinical testing. Johnson & Johnson will use its validated vaccine platform and is allocating resources, including personnel and infrastructure globally, as needed, to focus on these efforts. Separately, BARDA and the Company have provided additional funding that will enable expansion of their ongoing work to identify potential antiviral treatments against the novel coronavirus. As part of its commitment, Johnson & Johnson is also expanding the Company's global manufacturing capacity, including through the establishment of new U.S. vaccine manufacturing capabilities and scaling up capacity in other countries. The additional capacity will assist in the rapid production of a vaccine and will enable the supply of more than one billion doses of a safe and effective vaccine globally. The Company plans to begin production at risk imminently and is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use. Alex Gorsky, Chairman and Chief Executive Officer, Johnson & Johnson, said, "The world is facing an urgent public health crisis and we are committed to doing our part to make a COVID-19 vaccine available and affordable globally as quickly as possible. As the world's largest healthcare company, we feel a deep responsibility to improve the health of people around the world every day. Johnson & Johnson is well positioned through our combination of scientific expertise, operational scale and financial strength to bring our resources in collaboration with others to accelerate the fight against this pandemic." Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer, Johnson & Johnson, said, "We greatly value the U.S. government's confidence and support for our R&D efforts. Johnson & Johnson's global team of experts has ramped up our research and development processes to unprecedented levels, and our teams are working tirelessly alongside BARDA, scientific partners, and global health authorities. We are very pleased to have identified a lead vaccine candidate from the constructs we have been working on since January. We are moving on an accelerated timeline toward Phase 1 human clinical trials at the latest by September 2020 and, supported by the global production capability that we are scaling up in parallel to this testing, we expect a vaccine could be ready for emergency use in early 2021." Johnson & Johnson's Lead COVID-19 Vaccine Candidate Johnson & Johnson began efforts in January 2020, as soon as the novel coronavirus (COVID-19) sequence became available, to research potential vaccine candidates. Research teams at Janssen, in collaboration with Beth Israel Deaconess Medical Center, part of Harvard Medical School, constructed and tested multiple vaccine candidates using the Janssen AdVac(R) technology ( https://c212.net/c/link/?t=0&l=en&o=2763873-1&h=2093926773&u=https%3A%2F%2Fwww.janssen.com%2Finfectious-diseases-and-vaccines%2Fpatented-technologies&a=AdVac%C2%AE+technology ). Through collaborations with scientists at multiple academic institutions, the vaccine constructs were then tested to identify those with the most promise in producing an immune response in preclinical testing. Based on this work, Johnson & Johnson has identified a lead COVID-19 vaccine candidate (with two back-ups), which will progress into the first manufacturing steps. Under an accelerated timeline, the Company is aiming to initiate a Phase 1 clinical study in September 2020, with clinical data on safety and efficacy expected to be available by the end of the year. This could allow vaccine availability for emergency use in early 2021. For comparison, the typical vaccine development process involves a number of different research stages, spanning 5 to 7 years, before a candidate is even considered for approval. For more than 20 years, Johnson & Johnson has invested billions of dollars in antivirals and vaccine capabilities. The COVID-19 vaccine program is leveraging Janssen's proven AdVac(R) and PER.C6(R) technologies ( https://c212.net/c/link/?t=0&l=en&o=2763873-1&h=392506868&u=https%3A%2F%2Fwww.janssen.com%2Finfectious-diseases-and-vaccines%2Fpatented-technologies&a=AdVac%C2%AE+and+PER.C6%C2%AE+technologies ) that provide the ability to rapidly develop new vaccine candidates and upscale production of the optimal vaccine candidate. The same technology was used to develop and manufacture the Company's Ebola vaccine and construct our Zika, RSV, and HIV vaccine candidates which are in Phase 2 or Phase 3 clinical development stages. Expanded Antiviral Research In addition to the vaccine development efforts, BARDA and Johnson & Johnson have also expanded their partnership to accelerate Janssen's ongoing work in screening compound libraries, including compounds from other pharmaceutical companies. The Company's aim is to identify potential treatments against the novel coronavirus. Johnson & Johnson and BARDA are both providing funding as part of this partnership. These antiviral screening efforts are being conducted in partnership with the Rega Institute for Medical Research (KU Leuven/University of Leuven), in Belgium. As announced in February 2020, the Company and BARDA have been working closely with global partners to screen Janssen's library of antiviral molecules to accelerate the discovery of potential COVID-19 treatments. COVID-19 belongs to a group of viruses called coronaviruses that attack the respiratory system. There is currently no approved vaccine, treatment or cure for COVID-19. For more information on Johnson & Johnson's multi-pronged approach to combatting 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=2763873-1&h=4140229718&u=http%3A%2F%2Fwww.twitter.com%2Fjnjnews&a=%40JNJNews ). About the Janssen Pharmaceutical Companies 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=2763873-1&h=1986511987&u=https%3A%2F%2Ftwitter.com%2FJanssenGlobal&a=%40JanssenGlobal ). 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. Logo - https://mma.prnewswire.com/media/403394/Johnson_and_Johnson_Logo.jpg SOURCE Johnson & Johnson CONTACT: Media Contacts: Jake Sargent, + 1 202-569-5086, JSargen3@ITS.JNJ.com; Cristal Downing, +1 908-616-8833, cdowning@its.jnj.com; Seema Kumar, +1 908-405-1144, SKumar10@its.jnj.com; Katie Buckley, +44 7900-655-261, KBuckle8@its.jnj.com; Investor Relations: Chris DelOrefice, +1 732-524-2955; Lesley Fishman, +1 732-524-3922