June 10 Quick Takes: Moderna submits COVID vaccine for adolescents in U.S., EU; plus Ocugen, NIH, BMS, Verona-Nuance and more
As FDA continues to grapple with questions of what safety data would support an emergency use authorization or licensure of COVID-19 vaccines in pediatric populations under 12 years old, Moderna Inc. (NASDAQ:MRNA) said it has submitted applications for an EUA from FDA and conditional marketing approval from EMA for its COVID-19 vaccine in adolescents 12-17 years old based on data from the Phase II/III TeenCOVE study.
Ocugen Inc. (NASDAQ:OCGN) shed $2.62 (28%) to $6.69 Thursday after announcing plans to pursue a BLA rather than an EUA for its Covaxin COVID-19 vaccine candidate based on feedback from FDA, which requested additional information and data. The company, which is co-developing the inactivated virus vaccine in the U.S. and Canada under a February deal with Bharat Biotech International Ltd., expects to conduct an additional trial to support its BLA submission. ...