Pfizer-BioNTech Has Requested Full Approval of Their COVID-19 Vaccine From the FDA

Pfizer-BioNTech announced on May 7 that they have requested that the U.S. Food and Drug Administration (FDA) start the process of fully approving their COVID-19 vaccine. The companies will continue to supply the agency with additional data on vaccination safety and effectiveness on a rolling basis over coming weeks. The FDA issued an emergency use authorization for the shot in December, based on short-term data on safety and efficacy. Now, the companies have the required six-month data on the vaccine to support a biologics license application, which the FDA will review over the next several weeks before making a decision. What difference would approval of the vaccine make over the current authorization? “It would be a total game changer for two reasons,” says Dr. Leana Wen, visiting professor of health policy and management at George Washington University’s Milken School of Public Health and former health commissioner for Baltimore City. “First, legal questions raised about whether employers can require it, or whether schools can mandate vaccination, are put to rest if the FDA gives it full approval because there is precedent for requiring other vaccines that are approved, like childhood vaccinations. “Second, one of the arguments perpetuated by anti-vaccine activists, and some who are hesitant, has to do with the idea that these are still ‘experimental vaccines’ since they have not received approval,” says Wen. “Full app...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 Source Type: news