Current FIP guidelines (published 15 July 2020 https://bit.ly/3hFsWcO) recommend against the use of interferon beta for the treatment of severely or critically ill patients with COVID-19 except in a clinical trial. Given the substantial morbidity and mortality associated with COVID-19, FIP welcomes the promising results with the trial medicine SNG001, which contains interferon beta delivered via an inhaler, and which has been found to significantly reduce hospital patients with COVID-19 needing to be put on a ventilator. Inhaled SNG001 was also found to reduced mortality.

Sufficient evidence of efficacy and safety is awaited before SNG001 is a recommended treatment outside of a clinical trial. Peer review and publishing of the trial data are necessary next steps. FIP will then consider the published evidence and update its guidance accordingly.

Regarding vaccinations, more than 140 candidate vaccines are being tracked by the World Health Organization. A total of 19 vaccines are currently in phase 1, 11 are in phase 2 and three are in phase 3 trials. FIP supports the need for a large phase 3 trial to generate the relevant efficacy and safety data. FIP agrees with the position of international regulators that vaccines should be assessed on a case by case basis (depending on how each vaccine is constructed and the totality of data available) and meet robust success criteria.

Read the full statement here.