The Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to the Pfizer-BioNTech vaccine, the Moderna vaccine, and the Johnson & Johnson vaccine. Additional vaccines are in Phase 3 of clinical trials and maybe submitting data for review with the FDA soon.
Emergency Use Authorization exists to allow the FDA more flexibility to review and authorize products for use during public health emergencies, like a pandemic. In order to grant an EUA, the FDA must determine that a vaccine can effectively prevent infection or disease and that its benefits outweigh potential risks (like serious side effects). While the EUA allows people to start receiving the vaccine, vaccine developers will continue to submit data to the FDA to achieve full FDA approval through a standard Biologic License Application (BLA). The BLA approval represents the FDA’s highest standard, but it requires a longer period of evaluation.
