The US Food and Drug Administration has expanded the Emergency Use Authorization (EUA) for Regeneron Pharmaceuticals’ antibody cocktail, REGEN-COV (casirivimab and imdevimab), to prevent Covid-19. The new authorisation is for post-exposure prophylaxis in individuals at increased risk of progression to severe Covid-19, and the cocktail can also be administered monthly to protect against ongoing exposure. The expanded authorisation in addition to the treatment’s previously granted approval for the treatment of non-hospitalised Covid-19 patients. Regeneron noted that the therapy is not indicated for pre-exposure prophylaxis.
The Russian Direct Investment Fund (RDIF) has reported preliminary data from a study of the AstraZeneca Covid-19 vaccine in combination with the Sputnik Light Covid 19 vaccine in the Republic of Azerbaijan. The world’s first study to assess this combination has revealed a favourable safety profile without any serious adverse events or Covid-19 cases following inoculation with a combination of the two jabs. Immunogenicity data from the study will be reported this month.
Emergent BioSolutions has received inquiries and subpoenas from multiple US authorities regarding the production of bulk drug substance for Covid-19 vaccines at its Baltimore facility, where contamination issues were reported in April. In this context, the Department of Justice, the Securities and Exchange Commission, the Financial Industry Regulatory Authority and Maryland and New York Attorneys General have asked the company to submit relevant documents. This development comes after the company obtained the FDA clearance last week to resume manufacturing at the Baltimore facility.