A World Without Infectious Disease
Infectious diseases are among the leading causes of death worldwide. Vir Biotechnology is a commercial-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir’s current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus.
Expanded access (sometimes referred to as “compassionate use”) is a potential pathway for patients with an immediately life-threatening disease or condition to obtain investigational products outside of a clinical trial, assuming certain criteria are met by the manufacturer. At this time, Vir Biotechnology does not have an expanded access program for its investigational products, with the exception of a temporary program instituted for utilization of surplus sotrovimab clinical supply in the United States.
We recognize people may be in interested in accessing our investigational products prior to regulatory approval or outside of a clinical trial setting through expanded access programs, and we will continue to evaluate the possibility of an expanded access program in the future.
For information about our current clinical trials, please visit https://www.clinicaltrials.gov and search ‘Vir Biotechnology’ (under Other terms).
About the Temporary Program for Sotrovimab
Physicians treating patients with COVID-19 who do not qualify for ongoing clinical trials evaluating our investigational monoclonal antibody sotrovimab, may have the ability to obtain access via Emergency Use Authorization (https://www.sotrovimab.com/) or the Temporary Expanded Access Treatment protocol (https://www.clinicaltrials.gov). Patients who are seeking access to sotrovimab should speak with their physicians and discuss whether expanded access may be appropriate.
If you have any questions about this policy, please contact firstname.lastname@example.org. We anticipate an acknowledgement of receipt within two business days.
Consistent with the 21st Century Cures Act, the posting of this policy does not serve as a guarantee of access to any specific investigational products by any individual patient. Vir reserves the right to revise this expanded access policy at any time. To the extent we can accommodate expanded access requests at a later date, we will provide general criteria for evaluating such requests. This posting will be updated to reflect any policy change.