Johnson & Johnson Launches Global Pivotal Phase 3 Clinical Trial of Janssen’s Investigational COVID-19 Vaccine

NEW BRUNSWICK, N.J., Sept. 24, 2020 /PRNewswire/ -- Johnson & Johnson today announced the initiation of a large-scale, pivotal Phase 3 trial (ENSEMBLE) of its COVID-19 vaccine candidate, JNJ-78436735, developed by its Janssen Pharmaceutical Companies. Based on interim analysis from the Company’s Phase 1/2a clinical studies, the safety and immunogenicity observed following a single-dose vaccination support the launch of the ENSEMBLE trial. These results have been submitted to medRxiv and will be published online shortly. Following these findings and discussions with the U.S. Food and Drug Administration, the Phase 3 ENSEMBLE clinical trial will enroll approximately 60,000 volunteers across three continents to conduct a comparative study of the safety and efficacy of the single-dose vaccine versus placebo in preventing COVID-19.

Johnson & Johnson is rapidly scaling up its production capacity with the aim of supplying one billion vaccine doses globally per year. The company has committed to providing affordable vaccines to the public on a not-for-profit basis for emergency use during the pandemic. If the COVID-19 vaccine proves to be safe and effective, the first batches are expected to receive Emergency Use Authorization in early 2021.

Johnson & Johnson will develop and test candidate vaccines for COVID-19 in accordance with rigorous ethical standards and sound scientific principles. The company commits that the Phase 3 ENSEMBLE trial includesStudy Protocolincluding the transparency and sharing of relevant information.

“The COVID-19 pandemic continues to impact the daily lives of people worldwide. Our goal remains unwavering—to leverage our company’s global reach and scientific innovation to end this global pandemic.”。”Johnson & Johnson Chairman and CEO Alex Gorsky stated, “As the world’s largest healthcare companyOne of, we uphold scientific thinking and stringent safety standards, collaborating with regulatory authorities to accelerate the fight against the pandemic. This significant milestone demonstrates our focus on the research and development of COVID-19 vaccines, which is based on collaboration and a solemn commitment to the scientific process. We are dedicated to transparency in clinical trials and will share research-related information, including details of the study protocols.”

“We remain dedicated to developing urgently needed, safe, and effective COVID-19 vaccines for the world.”。”Dr. Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson, stated, “We highly value the collaboration and support from our partners in the scientific community and the global public health sector. Our global team of experts is diligently working on vaccine development and increasing production capacity, with the goal of providing vaccines for Emergency Use Authorization by early 2021.”

Janssen's COVID-19 candidate vaccine utilizesAdVac® Technology Platform, the platform is also used for the development and production of the Janssen Ebola vaccine approved by the European Commission, as well as for constructing candidate vaccines for Zika, respiratory syncytial virus (RSV), and HIV. To date, more than 100,000 individuals have been vaccinated in relevant vaccine research projects leveraging Janssen’s AdVac® technology platform.

Powered by Janssen's AdVac^®technology, if successfully developed, the vaccine is expected to be stored at -20°C when put into useDegrees CelsiusRemains stable for two years when stored at 2-8°C.Degrees Celsiusat least three months of stability. This makes the candidate vaccine compatible with standard vaccine distribution channels and allows it to reach those in need of vaccination without requiring new infrastructure.

3Phase I Clinical Trial Study （ENSEMBLE）

The Phase 3 ENSEMBLE study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety and efficacy of a single-dose vaccine versus placebo in up to 60,000 adults aged 18 years and older, including a substantially representative population of individuals aged 60 years and older. Study participants will include both individuals with comorbidities that increase the risk of severe COVID-19 and those without comorbidities, with recruitment conducted in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States. To assess the efficacy of the Janssen COVID-19 vaccine, the trial will be conducted in countries and clinical trial sites with high incidence rates of COVID-19 and the capacity for rapid initiation.

Johnson & Johnson takes goal-oriented actions and, upholding its consistent commitment to diversity and inclusion, places significant emphasis on populations severely affected by the pandemic in the design and implementation of Phase 3 trials for its COVID-19 vaccine. In the United States, participants will prominently include African Americans, Hispanics/Latinos, and American Indians and Alaska Natives.

Pursuant to the Other Transaction Agreement (OTA) (HHSO100201700018C), the Phase 3 ENSEMBLE clinical trial was jointly initiated by the Biomedical Advanced Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID). BARDA falls under the Office of the Assistant Secretary for Preparedness and Response of the U.S. Department of Health and Human Services (HHS), while NIAID is part of the National Institutes of Health (NIH) within HHS.

Meanwhile, Johnson & Johnson has agreed in principle with the UK governmentCooperation, conducting independent Phase 3 clinical trials in multiple countries to explore additional possibilities for the Janssen candidate vaccine’s two-dose regimen.

Dr. Mathai Mammen, Global Head of Research and Development at Janssen, stated：“As our candidate vaccine now enters global Phase 3 trials, we are one step closer to finding a solution for COVID-19. In selecting our candidate vaccine, we have remained steadfastly committed to an evidence-based and scientific approach. We extend our sincere gratitude to our researchers for their tireless efforts and to all trial participants for their invaluable contributions. We will continue to work hand in hand with global partners to help combat the pandemic.”

Johnson & Johnson is currently engaging in discussions with numerous stakeholders, including national governments and global organizations, with the aim of supplying its candidate vaccine worldwide, contingent upon demonstrating safety and efficacy and obtaining regulatory approval.

For more information on the multiple initiatives launched by Johnson & Johnson to combat the coronavirus, please visitwww.jnj.com/coronavirusView