Pfizer, BioNTech say their COVID-19 vaccine is more than 90% effective
Pfizer Inc on Monday said its experimental vaccine was more than 90% effective in preventing COVID-19 based on initial data from a large study, a major victory in the fight against a pandemic that has killed over 1million people, roiled the world’s economy and upended daily life.
Pfizer and German partner BioNTech SE are the first drugmakers to show successful data from a large-scale clinical trial of a coronavirus vaccine. The companies said they have so far found no serious safety concerns and expect to seek U.S. emergency use authorization later this month.
------------------
Novavax's experimental coronavirus vaccine gets U.S. FDA's 'fast-track' status
Novavax Inc NVAX.O said on Monday its experimental coronavirus vaccine had gained the U.S. Food and Drug Administration's "fast-track" status.
The U.S. drug developer, which is testing the drug in a late-stage trial in the UK, said a U.S. and Mexico-based late-stage trial was on track to begin by the end of November, and data from that trial could support U.S. authorization.
The fast-track status makes companies eligible to submit sections of a marketing application on a “rolling” basis as soon as some data becomes available, rather than wait for all the data before submitting the application.
Reference: Reuters