It's time for the FDA to fully approve the mRNA vaccines

Still, that leaves almost half of Americans without protection. Some people who understand that the “E” in “E.U.A.” stands for “emergency” are waiting for full F.D.A. approval before they receive a shot. Others may not get immunized unless their employers require it, and many organizations — including, reportedly, the military — are waiting for the vaccines to be fully approved before instituting such mandates.

In theory, full approval should be imminent, since Pfizer applied for full approval in early May, and Moderna asked for full approval on June 1. This process is often long, requiring the agency to inspect manufacturing plants and review considerable amounts of documentation for vaccine production. But in this case, because of the urgency of the pandemic, the vaccine makers began to submit this material, called a biologics licensing application, in late 2020, and they’ve continued to submit more information. The F.D.A. has already reviewed some of the submissions and has provided feedback to the manufacturers. The E.U.A.s were granted more than six months ago. That’s more than ample time for the F.D.A. to conduct plant inspections and review the applications.

The stakes could not be higher.