ur Credo is unique to Johnson & Johnson and states: “We believe our first responsibility is to the patients, doctors and nurses, to mothers and fathers and all others who use our products and services. In meeting their needs everything we do must be of high quality.” This serves as a constant guide to our decision-making – particularly as it relates to safety – and reinforces our commitment to the health of patients and customers as we seek to break new ground with advances in science and technology.
During clinical development of our medicines and vaccines, clinical research physicians in Janssen’s Research & Development (JRD) organization as well as safety physicians in the Johnson & Johnson Global Medical Organization – which is functionally independent of Janssen’s R&D and Commercial organizations – monitor safety during clinical trials. These internal J&J groups, as well as the independent external expert groups described below, also oversee the safety of the Phase 3 studies of our COVID-19 vaccine.
As background, clinical studies and the participants who volunteer for these studies play a critical role in the development of new vaccines and medicines. During clinical studies, including those studying vaccines, it is both common and expected that some participants will experience adverse events (AEs), which are unfavorable or unintended effects that may or may not be caused by the medicine or vaccine under study.
Global Health Authorities, including the United States Food and Drug Administration (FDA), require that companies conducting clinical trials thoroughly evaluate and report safety findings which occur during the course of any clinical study. AEs experienced by participants and reported to the company are thoroughly reviewed by internal medical and medical safety experts to determine whether there is a possible association with the investigational medicine or vaccine.
It is important to recognize that when large populations are vaccinated, some serious adverse events that occur rarely with or without vaccination will be observed coincidentally following vaccination. Any adverse event, including those that could be completely unrelated to the medicine or vaccine being tested, such as an accidental fall, is evaluated by expert physicians overseeing the study. All adverse event reports that are unexpected, considered serious in nature, and suspected to be related to administration of the investigational medicine or vaccine are reported in an expedited timeframe to participating investigators (physicians at hospitals or clinics who conduct the study investigations) and to Health Authorities, as is required by regulations.
In addition, these same adverse event reports are submitted to external and independent safety review bodies that are put in place to monitor the safety of the clinical study. Institutional Review Boards (in the United States) and Ethics Committees (outside of the United States), which monitor the safety and ethical conduct of clinical studies on behalf of participating medical study sites, review the data and assess whether the study should continue at a particular site.
OUR COVID-19 VACCINE STUDY SAFETY PROCESS
In addition to this standard, site-based oversight of safety during the course of our studies, during our Phase 3 COVID-19 vaccine candidate studies, 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 Phase 3 program, including trends and findings across all sites, will be overseen by independent Data and Safety Monitoring Boards (DSMB), as described in the ENSEMBLE study protocol* and ENSEMBLE 2 study protocol**.
The independent DSMB and our own internal medical safety experts can recommend that the study be paused if, for example, a concerning adverse event is reported and requires investigation to determine if it might be related to administration of the vaccine. Pausing a study is not uncommon during the course of a new vaccine program, and the diligence that goes into the investigation of any adverse event which results in a study pause would be a sign that the safety of study participants is our highest priority. In addition to pausing a study to investigate the significance of an adverse event, our safety experts, the independent DSMB or a health authority (e.g. the FDA) could, if necessary, require that the study be put on hold or permanently discontinued if they feel there is evidence to suggest that administration of the vaccine might put the safety of study participants at risk.
In all clinical studies, study participants are provided with a summary of all known, important safety information about the investigational medicine or vaccine during the Informed Consent process, which occurs prior to receiving any study medicine or vaccine. The Informed Consent Form (ICF), which must be agreed to by study participants and which also outlines study objectives, processes and safety information, is updated if new and important safety issues are identified during the study. Additionally, other documents, such as the study protocol and the instructions for investigators, also provide important safety information to study investigators to assist them in the care of the participants during the study.
After the studies are completed, and assuming the vaccine is approved for use, ongoing monitoring of safety continues. This includes the ongoing assessment of potential adverse events, appropriate reporting to health authorities and necessary updates to the risk profile.
* This link will take you to the version of the study protocol as of December 14, 2020. Please note any amendments and updates to the protocol will be made according to local requirements and relevant information from the protocol will be available on regional registries such as www.ClinicalTrials.gov.
** This link will take you to the version of the study protocol as of December 18, 2020. Please note any amendments and updates to the protocol will be made according to local requirements and relevant information from the protocol will be available on regional registries such as www.ClinicalTrials.gov.