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PATIENT CONSENT FORM FOR EMERGENCY USE AUTHORIZATION (EUA

PATIENT CONSENT FORM FOR EMERGENCY USE AUTHORIZATION (EUA 2025

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The document is a Patient Consent Form for the Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine. It outlines the recipient's acknowledgment of the vaccine's emergency use status, potential allergic reactions, side effects, and the necessity of receiving two doses. The form also includes a release of liability for Texas Children's Hospital and consent for vaccination, along with information on data sharing related to vaccination.

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What does EUA stand for in FDA?

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nations public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the availability and use of medical countermeasures (MCMs) needed during public

Is the EUA still in effect?

Existing emergency use authorizations (EUAs) for products will remain in effect and the agency may continue to issue new EUAs going forward when criteria for issuance are met. For additional resources from HHS, see: COVID-19 Public Health Emergency (PHE).

What is the difference between EUA and FDA approval?

Put simply, an emergency use authorization (EUA) is a tool the Food and Drug Administration (FDA) can use to expedite the availability of medical products, including drugs and vaccines, during a public health emergency.

Is Pfizer still under the EUA?

On August 22, 2024, the Food and Drug Administration amended the emergency use authorization (EUA) of Pfizer-BioNTech COVID-19 Vaccine to include the 2024-2025 formula.

What is the EUA explained?

Under an EUA, FDA may allow the use of unapproved medical products, or unapproved uses of approved medical products in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when certain statutory criteria have been met, including that there are no adequate, approved, and

What does for use under emergency use authorization mean?

A: Under section 564 of the Federal Food, Drug, and Cosmetic Act (FDC Act), when the Secretary of Health and Human Services declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products for emergency use.

PATIENT CONSENT FORM FOR EMERGENCY USE AUTHORIZATION (EUA 2025

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