When a new vaccine or treatment is made urgently available to a vulnerable patient(s) before it has completed all the phases of development in clinical trials.
In some cases, this means a treatment or vaccine is made available for patients who are not eligible for clinical trials, for various reasons including age or comorbidity. The use of a treatment or vaccine on compassionate grounds has to be authorised by the regulatory authority in a country.
During the COVID-19 pandemic, compassionate use of the antiviral drug remdesivir was approved in some European countries by the EU’s regulatory authority. In the United States, medicines used compassionately are sometimes referred to as investigational drugs.
The compassionate use of medicines is carefully monitored, and data gathered in this way contributes to bigger decisions about how the treatment or vaccine will be used in the long term.
Another term often used for compassionate use is emergency use authorisation.