Pfizer Applies for COVID-19 Vaccine EUA

Today, Pfizer and BioNTech submitted an emergency use authorization (EUA) request to the U.S. Food and Drug Administration (FDA) for its mRNA vaccine candidate for use against the COVID-19 virus. According to Pfizer, today’s FDA filing would potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of December 2020.

The EUA submission is based on a nearly 95 percent vaccine efficacy rate with no serious safety concerns that was recently demonstrated in the companies’ Phase Three clinical study. The company expects to produce up to 50 million doses worldwide in 2020 and up to 1.3 billion doses by the end of 2021. According to Pfizer, vaccines will be ready to distribute within hours of receiving approval from the FDA.

A full joint announcement between Pfizer and BioNTech is available here.