Learn More About the Phase 3 Studies of Our Investigational COVID-19 Vaccine Candidate and Our Commitment to Safety and Transparency

At Johnson & Johnson, there is no greater priority than the safety and wellbeing of the people we serve every day around the world. We are committed to providing transparent updates throughout the clinical development process of our vaccine candidate, in compliance with regulatory standards.

As recently announced alongside other biopharmaceutical companies, we pledged our ongoing commitment to our developing and testing a potential vaccine for COVID-19 in accordance with high ethical standards and sound scientific principles. Further, our COVID-19 clinical trials, and the development of all investigational products across Johnson & Johnson, are guided by protocols and standards that help ensure our trials are conducted professionally, ethically, and responsibly.

In addition to our standard oversight of safety during the course of our studies, during our Phase 3 COVID-19 vaccine candidate studies (ENSEMBLE and ENSEMBLE 2), independent, expert vaccine Safety Advisory Boards have been put in place for additional consultation and advice on safety risk management. Furthermore, the safety of the entire clinical program will be overseen by independent Data and Safety Monitoring Boards (DSMB), as described in the study protocols.

We are also committed to disclosing our data on external public registries, such as ClinicalTrials.gov and the EU Clinical Trials Register, as well as publishing our results and making both our Clinical Study Reports and clinical trial participant data available for sharing with researchers through the Yale University Open Data Access (YODA) Project.

More details on the Phase 3 studies of our COVID-19 vaccine, including the study protocol and our commitment to safety and transparency, are available below.