Johnson & Johnson Announces Single-Shot Janssen COVID-19 Vaccine Candidate Met Primary Endpoints in Interim Analysis of its Phase 3 ENSEMBLE Trial
NEW BRUNSWICK, N.J., January 29, 2021 – Johnson & Johnson (NYSE: JNJ) (the Company) today announced topline efficacy and safety data from the Phase 3
ENSEMBLE
clinical trial, demonstrating that the investigational single-dose COVID-19 vaccine in development at its Janssen Pharmaceutical Companies met all primary and key secondary endpoints. The topline safety and efficacy data are based on 43,783 participants accruing 468 symptomatic cases of COVID-19. The Phase 3 ENSEMBLE study is designed to evaluate the efficacy and safety of the Janssen COVID-19 vaccine candidate in protecting moderate to severe COVID-19, with co-primary endpoints of 14 days and 28 days following vaccination. Among all participants from different geographies and including those infected with an emerging viral variant, Janssen’s COVID-19 vaccine candidate was 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination. The onset of protection was observed as early as day 14. The level of protection against moderate to severe COVID-19 infection was 72% in the United States, 66% in Latin America and 57% in South Africa, 28 days post-vaccination. “Johnson & Johnson embarked on the global effort to combat the COVID-19 pandemic a year ago, and has brought the full force of our capabilities, as well as tremendous public-private partnerships, to enable the development of a single-shot vaccine. Our goal all along has been to create a simple, effective...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Our Company Source Type: news
More News: Allergy | Allergy & Immunology | Anaphylactic Shock | Argentina Health | Brain | Brazil Health | Cancer & Oncology | Cardiology | Cardiovascular | Chemistry | Chile Health | Clinical Trials | Colombia Health | Contracts | Coronavirus | COVID-19 | Department of Health | Diabetes | Diabetes Type 2 | Eating Disorders & Weight Management | Ebola | Ebola Vaccine | Emergency Medicine | Endocrinology | Environmental Health | Flu Pandemic | Health Management | Heart | Hypertension | Infectious Diseases | Influenza | Influenza Vaccine | Intensive Care | International Medicine & Public Health | Israel Health | Laboratory Medicine | Learning | Legislation | Medical Ethics | Mexico Health | Middle East Health | National Institutes of Health (NIH) | Neurology | Neuroscience | Obesity | Pandemics | Partnerships | Peru Health | Pharmaceuticals | Pneomococcal Vaccine | Pneumonia | Profits and Losses | Pulmonary Hypertension | Pulmonary Thromboembolism | Respiratory Medicine | SARS | Science | South Africa Health | Study | Thrombosis | Universities & Medical Training | USA Health | Vaccines | WHO | Zika Virus