The Food and Drug Administration is aiming to fully approve the Pfizer-BioNTech COVID-19 vaccine by Labor Day or sooner, people familiar with the matter told The New York Times.
Because of the highly contagious Delta variant, coronavirus cases are on the rise across the United States, and the hope is that a full approval will push skeptics to get inoculated. In late 2020, the FDA granted emergency authorization to the Pfizer vaccine, and the company applied for full approval on May 7. Moderna also received emergency authorization for its vaccine, and submitted its application for final approval on June 1.
As part of the approval process, FDA employees will review hundreds of thousands of documents, looking at data on vaccine efficacy, immune responses, and breakthrough infections. Once a coronavirus vaccine is fully approved, it's expected that many schools and hospitals, as well as the city of San Francisco and the Department of Defense, will mandate that workers and students get vaccinated, the Times reports. As of Tuesday, 58 percent of Americans have received at least one dose of a COVID-19 vaccine.