Tag Archive for: emergency use authorization (EUA)

BioNTech, a German company specializing in mRNA-based vaccines, is facing its first lawsuit in Germany related to alleged side effects of its COVID-19 vaccine, developed in partnership with Pfizer and authorized for emergency use in 158 countries, Reuters reported last week. But in the U.S., vaccine makers are protected from any such liability until October 2024, thanks to a provision the federal government put forth at the start of the pandemic.

The FDA has granted emergency use authorization (EUA) to InflaRx’s vilobelimab, now to be marketed as Gohibic, for hospitalized adult patients with COVID-19, the German biotech announced Tuesday.

Federal investigators on Wednesday recommended that the U.S. Food and Drug Administration revise its emergency use authorization (EUA) policies for tests to ensure better availability and quality during future infectious disease outbreaks.