Johnson & Johnson Announces European Commission Approval of Agreement to Provide 200 Million Doses of Janssen's COVID-19 Vaccine Candidate

10 October 2020

Johnson & Johnson announced that the European Commission (EC), acting on behalf of the member states of the European Union ( EU), approved an advance purchase agreement in which the Janssen Pharmaceutical Companies will provide 200 million doses of their vaccine candidate against COVID-19 to the member states, once approval or authorization is obtained from the entities regulators. EU member states also have the option of securing another 200 million additional doses.

"The COVID-19 pandemic continues to threaten communities around the world, and we have a responsibility to ensure access to our vaccine as soon as possible. We appreciate the support we have received from the Commission and member states. for our COVID-19 vaccine candidate and on our development efforts, "said Dr. Paul Stoffels , vice chairman of the executive committee and chief scientific officer of Johnson & Johnson.

This contract comes after the conclusion of exploratory talks with the EC . The company is in discussions with other stakeholders, including national governments and global organizations, as part of its efforts to fulfill its commitment to make the vaccine candidate accessible globally, as long as it is proven to be safe, effective, and obtained the Approval or corresponding authorization by the regulatory entities.

Independent of the agreement with the EC, as part of a larger commitment by the company to act in the face of the COVID-19 pandemic, Johnson & Johnson also announced  plans to allocate up to 500 million doses of the vaccine for international initiatives, seeking to ensure that low-income countries can have access to it, and with deliveries expected around the middle of next year, once approval or authorization is obtained from the regulators. Aware of the exceptional global demand for the COVID-19 vaccine, we are working tirelessly to further increase the number of doses available.

Johnson & Johnson is developing and evaluating Janssen's COVID-19 vaccine candidate in accordance with its customary rigorous ethical standards and sound scientific principles. The company is evaluating a single-dose regimen in its pivotal phase 3, large-scale, multinational trial (ENSEMBLE) , which began in September. A second phase 3 study with a two-dose regimen is planned to begin later this year. The company is committed to transparency and sharing information related to the ENSEMBLE phase 3 study, including the  study protocol .

Janssen's experimental COVID-19 vaccine is supported  by Janssen's proprietary AdVac ® technology . This same technology was used to develop the EC approved Ebola vaccine regimen and is the basis for its candidate vaccines against HIV, RSV and ZIKV. To date, more than 100,000 people have received an AdVac ® based Janssen vaccine . Based on our knowledge of the stability of our vaccines, we anticipate that our COVID-19 vaccine candidate will be compatible with standard distribution channels, with no need for a new distribution infrastructure.

For more information on Johnson & Johnson's multi-dimensional approach to help fight the pandemic, visit: www.jnj.com/coronavirus .

About Johnson & Johnson 
At Johnson & Johnson, we believe that good health is the foundation for energetic lives, thriving communities, and progress. That is why we have been focused for more than 130 years on improving the well-being of people of all ages at all stages of life. Today, as the world's largest and most internationally active healthcare company, we are committed to using our magnitude and reach for the common good. We strive to improve access and affordability, create healthier communities, and make healthy physical, mental, and environmental conditions available to everyone, everywhere. We seek to combine our heart, our scientific capacity and our ingenuity to generate a profound change in the trajectory of health for humanity. Learn more at www.jnj.com . Follow us  @JNJNews .

About Janssen Pharmaceutical Companies 
At Janssen we are creating a future where disease is a thing of the past. We are the Pharmaceutical Companies of Johnson & Johnson, the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients around the world by fighting disease with science, improving access with inventiveness, and curing disease. hopelessness with the heart. We focus on the areas of medicine where we can make the greatest impact: the cardiovascular system and metabolism, immunology, infectious diseases and vaccines, neuroscience, oncology, and pulmonary hypertension. Learn more at  www.janssen.com . Follow us  @JanssenGlobal .

Notice to Investors Regarding Forward-Looking Statements 
This press release contains "forward-looking statements" as defined in The Private Securities Litigation Reform Act of 1995 regarding the development of potential treatment and prevention regimens for COVID-19. The reader is advised not to refer to these forward-looking statements. These are based on current expectations of future events. If the underlying assumptions become inaccurate or if known or unknown risks or uncertainties materialize, actual results may vary significantly from the expectations and projections of Janssen Pharmaceuticals Inc. or Johnson & Johnson. Risks and uncertainties include, but are not limited to, difficulties and uncertainties inherent in research and product development, including uncertainty about clinical success and obtaining regulatory approvals; uncertainty about business success; difficulties and delays in production; competition, including technological advances, new products and patents obtained by the competition; patent challenges; concerns about the efficacy or safety of the product leading to its recall or regulatory action; changes in the behavior and spending patterns of buyers of health products and services; changes in applicable laws and regulations, including global health reforms, and trends towards containing health spending. An additional list and descriptions of these risks, uncertainties and other factors can be found in the Johnson & Johnson Annual Report. Johnson on Form 10-K for the fiscal year ended December 29, 2019, including the sections "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors". 1A. Risk Factors), and in the company's most recent quarterly report, filed on Form 10-Q, and in other company filings with the Securities and Exchange Commission. Copies of these presentations can be obtained online at and in the company's most recent quarterly report, filed on Form 10-Q, and in other company filings with the Securities and Exchange Commission. Copies of these presentations can be obtained online at and in the company's most recent quarterly report, filed on Form 10-Q, and in other company filings with the Securities and Exchange Commission. Copies of these presentations can be obtained online atwww.sec.gov , www.jnj.com or from Johnson & Johnson. None of the companies that are part of the Janssen Pharmaceutical Companies or Johnson & Johnson makes any commitment to update any of the forward-looking statements as a result of new information or future events or developments.