NEW BRUNSWICK, NJ, July 30, 2020 / PRNewswire / – Johnson & Johnson (NYSE: JNJ) (the Company) announced today that its leading vaccine candidate protects against infection with SARS-CoV-2, the virus that causes COVID-19, in preclinical studies. The data, published in Nature, show that the Company’s investigational adenovirus vector-based vaccine 26 (Ad26) elicited a robust immune response as demonstrated by “neutralizing antibodies”, successfully preventing subsequent infection and providing complete or near-complete protection in the lungs against the virus in human primates (NHP) in the preclinical study. Based on the strength of the data, a first phase 1 / 2a human clinical trial of the vaccine candidate, Ad26.COV2.S, in healthy volunteers, has now begun in the United States and Belgium.
“We are excited to see these preclinical data because they show that our SARS-CoV-2 vaccine candidate generated a strong antibody response and provided single-dose protection. The findings give us confidence as we move forward in the development of our vaccine. and luxury manufacturing in parallel, having started a Phase 1 / 2a trial in July with the intention of moving to a Phase 3 trial in September, “he said. Paul Stoffels, MD, Executive Committee Vice President and Chief Scientific Officer, Johnson & Johnson.
The robust Janssen COVID-19 clinical trial program, which includes the phase 1 / 2a clinical trial and the phase 3 clinical trial program, will evaluate single and two dose regimens of Ad26.COV2.S in parallel studies. The Phase 1 / 2a trial will assess the safety, reactogenicity (expected reactions to the vaccine, such as swelling or pain) and immunogenicity of Ad26.COV2.S in more than 1,000 healthy adults aged 18 to 55, as well as adults of 65 years. years and older. Planning is also underway for a Phase 2a study in The Netherlands, Spain and Germany and a Phase 1 study in Japan. For more information on these studies, visit www.clinicaltrials.gov.
As the Company plans its COVID-19 Phase 3 clinical development program, partners are being discussed with the aim of starting a pivotal Phase 3 clinical trial of the single vaccine dose versus placebo in September, pending provisional data. of Phases 1 and 2 tests and regulatory approval. Simultaneously, the company also plans to start a phase 3 parallel clinical trial of a two-dose regimen versus placebo.
The Company will also emphasize representation of populations that have been disproportionately affected by the pandemic when designing and implementing its COVID-19 Phase 3 test program. the United StatesThis would include a significant representation of blacks, Hispanics / Latinos, and participants age 65 and older.
The preclinical studies were conducted by researchers at the Beth Israel Deaconess Medical Center (BIDMC) in collaboration with Janssen Pharmaceutical Companies of Johnson & Johnson and others, as part of their ongoing collaboration to accelerate the development of a SARS-CoV-2 vaccine.
Dan Barouch, MD, Ph.D., Director of the Virology and Vaccine Research Center at BIDMC and the Ragon Institute, stated: “The preclinical data, generated in collaboration with the Johnson & Johnson team, highlights the potential of this SARS-Candidate to the CoV-2 vaccine. In addition, the data suggests that antibody levels may serve as biomarkers for vaccine-mediated protection. ”
In the studies, the researchers first immunized NHPs with a panel of vaccine prototypes, and then challenged them with SARS-CoV-2 infection. Scientists discovered that, of seven vaccine prototypes tested in the study, Ad26.COV2.S (mentioned in Nature article as Ad26-S.PP), caused the highest levels of neutralizing antibodies against SARS-CoV-2. The level of antibodies was correlated with the level of protection, confirming previous observations and suggesting that they could be a potential biomarker for vaccine-mediated protection. The six NHPs who received a single immunization with Ad26.COV2.S showed no detectable virus in the lower respiratory tract after exposure to SARS-CoV-2, and only one of the six showed very low levels of the virus in a nasal swab at the two time points.
“As we collectively fight this pandemic, we remain deeply committed to our goal of providing a safe and effective vaccine to the world. Our preclinical results give us reason to be optimistic when starting our first human clinical trial, and we are excited to enter the next stage in our research and development towards a COVID-19 vaccine. We know that, if successful, this vaccine can be rapidly developed, produced on a large scale and administered worldwide, “he said. Mathai Mammen, MD, Ph.D., Global Director, Janssen Research & Development, LLC, Johnson & Johnson.
The Company’s primary responsibility is to provide patients, consumers and healthcare providers with products that are as safe and effective as possible. Johnson & Johnson takes an evidence-based and science-based approach, based on ethics and values for medical safety, putting the well-being of the patient and the consumer above all in their decision-making and actions, with an emphasis on transparency.
As Johnson & Johnson progresses in the clinical development of SARS-CoV-2, the Company continues to increase manufacturing capacity and is in active talks with global strategic partners to support global access. Johnson & Johnson aims to meet its goal of supplying more than one billion doses worldwide throughout 2021, provided the vaccine is safe and effective.
This project has been funded in whole or in part with federal funds from the Office of the Assistant Secretary for Preparedness and Response, Advanced Biomedical Research and Development Authority, under Other Transactions Agreement HHSO100201700018C.
For more information on Johnson & Johnson’s multiple approach to fighting the pandemic, visit: www.jnj.com/coronavirus.
About Johnson & Johnson
At Johnson & Johnson, we believe that good health is the foundation of vibrant lives, prosperous communities and progress forward. That is why for over 130 years, our goal has been to keep people well at all ages and in all stages of life. Today, as the largest and most powerful healthcare company in the world, we are committed to using our scope and size forever. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body, and environment within everyone’s reach, everywhere. We are combining our hearts, science and ingenuity to profoundly change the path of health for humanity. Find out more at www.jnj.com. Follow us on @JNJNews.
About Janssen Pharmaceutical Companies
At Janssen, we are creating a future where illness is a thing of the past. We are the Johnson & Johnson pharmaceutical companies, working tirelessly to make that future a reality for patients around the world by fighting disease with science, improving access with ingenuity, and curing despair with the heart. We focus on areas of medicine where we can make the most difference: cardiovascular and metabolism, immunology, infectious diseases and vaccines, neuroscience, oncology, and pulmonary hypertension. Find out more at www.janssen.com. Follow us on @JanssenGlobal.
Notice to investors on 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 possible preventive and treatment regimes for COVID-19. The reader is cautioned not to trust these forward-looking statements. These statements are based on current expectations of future events. If the underlying assumptions prove to be inaccurate or known or unknown risks or uncertainties materialize, actual results could materially vary from the expectations and projections of Janssen Research & Development LLC., 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 obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advancements, new products and patents achieved by competitors; challenges to patents; Product efficacy or safety issues that result in product recalls or regulatory actions; changes in the behavior and spending patterns of buyers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward containing health care costs. A list and additional descriptions of these risks, uncertainties and other factors can be found in the Johnson & Johnson Annual Report on Form 10-K for the ended fiscal year December 29, 2019, including the sections titled “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors”, and in the most recently filed Quarterly Report on the company’s Form 10-Q, and the company’s subsequent submissions to the Securities and Exchange Commission. Copies of these presentations are available online at www.sec.gov, www.jnj.com or upon request from Johnson & Johnson. Neither Janssen Pharmaceutical Company nor Johnson & Johnson agrees to update any forward-looking statement as a result of new information or future events or developments.
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