Industry News

Pfizer + BioNTech Announce EUA Request to FDA for COVID-19 Vaccine

On November 20, 2020, Pfizer and BioNTech announced that they have submitted a request to the U.S. Food and Drug Administration (FDA) for an emergency use authorization (EUA) for BNT162b2, the companies’ COVID-19 mRNA vaccine candidate. If approved, some Americans could receive the vaccine as early as mid-December. 


Through an accelerated clinical trial process, the potential vaccine demonstrated a 95 percent efficacy rate with no serious safety concerns to date. The companies expect to produce up to 50 million doses globally in 2020 and up to 1.3 billion by the end of 2021. 


The companies have also initiated rolling submissions with regulatory agencies around the world. Upon authorization, the companies state that they will be ready to distribute the vaccine within hours. 


Read Pfizer's announcement. Find out more about Pfizer and BioNTech’s COVID-19 vaccine candidate from AP NewsNew York Times, and Washington Post


Posted 11/20/2020


1801 Research Boulevard Suite 400
Rockville, MD 20850
Tel: 301.984.9496 | Fax: 301.770.1949
ios-indiana.com
Email Us