The U.S. FDA has revised the EUA authorizing REGEN-COV for emergency use as post-exposure prophylaxis for prevention of Coronavirus (Covid-19) in adults and pediatric individuals, who are at high risk for progression to severe COVID-19. REGEN-COV is not authorized for pre-exposure prophylaxis to prevent Coronavirus (Covid-19) before being exposed to the SARS-CoV-2 virus – only after exposure to the virus.
REGEN-COV remains authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients with positive results of RT-PCR testing, and who are at high risk for progression to positive patients in COVID-19
REGEN-COV with Prophylaxis is not a substitute for the vaccination against COVID-19. FDA has only authorized three vaccines to prevent Coronavirus and serious clinical outcomes
Souce : US FDA
