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FDA Roundup: July 8, 2022

For Immediate Release:

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

  • Today, the FDA approved COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent Coronavirus Disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 through 15 years of age. The approval follows a rigorous analysis and evaluation of the safety and effectiveness data conducted by FDA. The Pfizer-BioNTech COVID-19 Vaccine has been, and will continue to be, authorized for emergency use in this age group since May 2021. COMIRNATY (COVID-19 Vaccine, mRNA) has been approved for use in individuals 16 years of age and older since August 2021.
  • On Wednesday, the FDA finalized the Guidance for Industry (GFI) #245: Hazard Analysis and Risk-Based Preventive Controls for Food for Animals to help animal food facilities subject to the FDA Food Safety Modernization Act (FSMA) Hazard Analysis and Risk-Based Preventive Controls for Animal Food requirements develop a food safety plan to prevent or significantly minimize hazards that could cause illness or injury to people or animals.
  • The FDA will continue hosting virtual town halls for test developers for SARS-CoV-2 on July 27 and August 24 from 12:05 p.m. – 1 p.m. ET. Registration is not required. During the virtual town hall, the FDA will share information and answer questions about the development and validation of tests for SARS-CoV-2. Recordings and transcripts will be available online for viewing after the live event.
  • COVID-19 testing updates:  
    • As of today, 438 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 303 molecular tests and sample collection devices, 85 antibody and other immune response tests, 49 antigen tests, and 1 diagnostic breath test. There are 80 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 17 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
    • The FDA has authorized 27 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1021 revisions to EUA authorizations.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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