| On March 18, 2021, the U.S. Food and Drug Administration (FDA) authorized revised fact sheets for health care providers to include additional information on susceptibility of SARS-CoV-2 variants to each of the monoclonal antibody (mAb) therapies that are available through an Emergency Use Authorization (EUA) for the treatment of COVID-19. FDA is providing this information to equip health care providers with the most current data so they can make informed decisions and provide appropriate care to patients with COVID-19. Health care providers should review the fact sheets for details regarding specific variants and potential resistance that may make the authorized mAb therapies less effective. The mAb therapies listed below are currently authorized by FDA to treat mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization. Like other infectious organisms, SARS-CoV-2 can mutate over time, resulting in genetic variation in the population of circulating viral strains. Some variants can cause resistance to one or more of the mAb therapies authorized to treat COVID-19. The revised fact sheets are for: The fact sheet revisions provide additional information to health care providers concerning how certain variants of SARS-CoV-2, known to be circulating within the United States, may impact the effectiveness of the authorized mAb therapies. The revisions include information on the following variants: B.1.1.7 (UK Origin), B.1.351 (South Africa Origin), P.1 (Brazil Origin), B.1.427/B.1.429 (California Origin), and B.1.526 (New York Origin). FDA is required to regularly review the circumstances and appropriateness of an EUA, and the agency continues to review emerging scientific information associated with the emergency uses for the authorized mAb products, including information on viral variants. FDA is committed to providing updated information on variants and their potential impact on the authorized mAb therapies as new information becomes available. FDA will continue to ensure health care providers and health officials have the best information so patients may receive the most appropriate treatment available. Additional Information on EUAs The EUA authority allows FDA to help strengthen the nation's public health protections against chemical, biological, radiological, and nuclear threats by facilitating the availability and use of medical countermeasures needed during public health emergencies. The issuance of an EUA is different than an FDA approval. In determining whether to issue an EUA, the FDA evaluates the totality of available scientific evidence and carefully balances any known or potential risks with any known or potential benefits of the product for use during an emergency. For additional information on the EUA authority and EUAs for COVID-19, please visit https://go.usa.gov/xs8x4. To promote public confidence in FDA's scientific review process and in ultimately appropriately using products authorized for emergency use, FDA's Center for Drug Evaluation and Research (CDER) recently launched a new webpage to facilitate access to information from CDER's scientific review documents supporting EUAs for drug and biological therapeutic products that the Agency has disclosed. This webpage compiles the scientific review documents supporting EUAs for COVID-19 drug and biological therapeutic products that the Agency has disclosed into one location to make documents easier to find and can be accessed at https://go.usa.gov/xsHzW. | 
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