Moderna's COVID-19 vaccine is expected to become the second to get the Food and Drug Administration's green light. A decision could come within days.
But compared with pharmaceutical giant Pfizer, which was granted emergency use authorization last week, upstart Moderna doesn't have a track record when it comes to mass production.
Pfizer makes hundreds of medicines and vaccines and operates at least 40 manufacturing facilities registered with the FDA around the world. Despite being founded a decade ago, Moderna has never had a product win FDA approval. And it only has one factory registered with the FDA — and the registration occurred just this week.
"As the CEO I am always thinking about the next game, and the next game is manufacturing," Moderna's Stéphane Bancel told Technology Review. "This is a big week at the FDA. But I am not worried about the EUA [emergency-use authorization], because the data is the data. I am worried about making more product."