VBI Vaccines is committed to the development of vaccines and immunotherapeutic candidates designed to address significant unmet public health and medical needs, including significant, aggressive, and urgent infectious diseases and cancers. Our goal is to ensure access to our investigational immunotherapies at the appropriate time and in a clinically-appropriate manner for patients as determined by their physician.
Our Early/Expanded Access Policy (EAP) refers to the use of an investigational immunotherapy outside of a clinical trial for potential treatment of a serious condition in a patient. The U.S. Food and Drug Administration (FDA) and other regulatory agencies have set forth guidelines for when expanded access may be appropriate, which include but are not limited to:
– The patient has a serious disease or condition, or whose life is immediately threatened by their disease or condition
– There is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition
– Patient enrollment in a clinical trial is not possible
– The potential patient benefit justifies the potential risks of treatment
– Providing the investigational medical product will not interfere with investigational trials that could support a medical product’s development or marketing approval for the treatment indication
At this time, VBI believes that participation in one of our clinical trials, which are carefully designed to determine the safety and efficacy of an investigational immunotherapy, is the best and most appropriate way to access our investigational immunotherapies. We do not currently provide our investigational immunotherapies for use through expanded access. We encourage patients to speak with their physicians regarding participating in clinical trials.
If you are a patient who is interested in accessing our investigational immunotherapies, please speak with your physician. You may also learn more about ongoing clinical trials by going to https://www.clinicaltrials.gov/ and searching for VBI Vaccines.
If you are a physician who is interested in learning more about our investigational immunotherapies, or participating in our clinical trials, please submit a request to email@example.com.
Consistent with the 21st Century Cures Act, VBI may revise this policy at any time.
Last Updated: June 2021