Recipients and Caregivers (708KB, updated October 19, 2022) Healthcare Providers (1.49MB, updated October 19, 2022) Novavax COVID-19 Vaccine, Adjuvanted (892KB) (Reissued August 19, September 12, and October 19, 2022)įor the prevention of Coronavirus Disease 2019 (COVID-19) for individuals 18 years of age and older Most Recent Letter of Authorization (PDF)įact Sheets and Manufacturer Instructions/Package Insert (PDF)Īdditional Information and Decision Memoranda (PDF) Vaccine EUA Questions and Answers for Stakeholders.Infographic: The Path for a COVID-19 Vaccine From Research to Emergency Use Authorization (PDF, 723 KB).Emergency Use Authorization for Vaccines Explained.Emergency Use Authorization Declaration (March 27, 2020)įor additional information about COVID-19 vaccines, see:.Amended Determination of a Public Health Emergency or Significant Potential for a Public Health Emergency Pursuant to Section 564(b) of the FD&C Act (effective MaFederal Register notice March 20, 2023). Determination of a Public Health Emergency and Declaration that Circumstances Exist Justifying Authorizations Pursuant to Section 564(b) of the FD&C Act (February 4, 2020). The EUAs subsequently issued by FDA are listed in the table below this blue box. The HHS Secretary declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to section 564 of the FD&C Act, effective March 27, 2020. Information About COVID-19 EUAs for Medical Devices.Ventilators and Ventilator Accessories EUAs.Remote or Wearable Patient Monitoring Devices EUAs.Decontamination Systems for Personal Protective Equipment EUAs.Continuous Renal Replacement Therapy and Hemodialysis Devices EUAs.COVID-19 EUAs for Medical Devices, including:.COVID-19 EUAs for Drugs and Non-Vaccine Biological Products.Detailed Information for all COVID-19 EUAs, including authorizations and fact sheets.Coronavirus Disease (COVID-19) updates from FDA.Read more about what happens to EUAs when a public health emergency ends. Existing COVID-19 EUAs will remain in effect, and the agency may continue to issue new EUAs if the situation meets the criteria to do so. The ending of the COVID-19 PHE will not impact FDA's ability to authorize medical countermeasures for emergency use. In addition, in January 2014, FDA issued a question and answer document (PDF, 762K) to respond to questions raised by public health stakeholders about PAHPRA’s amendments to the EUA authority and establishment of new authorities related to the emergency use of MCMs during CBRN emergencies.Ĭoronavirus Disease 2019 (COVID-19) EUA InformationįDA expects the COVID-19 public health emergency (PHE) declared by the Department of Health and Human Services under the Public Health Service Act to expire on May 11, 2023. For more information, please see the JanuFederal Register notice. In January 2017, FDA finalized the guidance: Emergency Use Authorization of Medical Products and Related Authorities. Information on terminated and revoked EUAs can be found in archived information. Subsequent HHS declarations supporting use of EUAs and based on this determination are described in the blue boxes below. On February 4, 2020, the HHS Secretary determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. Please note: a determination under section 319 of the Public Health Service Act that a public health emergency exists, such as the one issued on January 31, 2020, does not enable FDA to issue EUAs. The HHS declaration to support such use must be based on one of four types of determinations of threats or potential threats by the Secretary of HHS, Homeland Security, or Defense. Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives.
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