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WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?

 
Anonymous Coward
User ID: 80020127
United States
04/17/2021 08:52 AM
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WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?
WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?The United States FDA has made the Pfizer-BioNTech COVID-19 Vaccine available under an emergency access mechanism called an EUA. The EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. The Pfizer-BioNTech COVID-19 Vaccine has not undergone the same type of review as an FDA-approved or cleared product. FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that the product may be effective to prevent COVID-19 during the COVID-19 pandemic and that the known and potential benefits of the product outweigh the known and potential risks of the product. All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic.The EUA for the Pfizer-BioNTech COVID-19 Vaccine is in effect for the duration of the COVID-19 EUA declaration justifying emergency use of these products, unlessterminated or revoked (after which the products may no longer be used).

Taking an expermental shot and not reading the FDA website.
Has to be the ultimate form of stupidity.



[link to www.fda.gov (secure)]
Anonymous Coward (OP)
User ID: 80020127
United States
04/17/2021 09:02 AM
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Re: WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?
WHAT IS THE COUNTERMEASURES INJURY COMPENSATION PROGRAM?The Countermeasures Injury Compensation Program (CICP) is a federal program that may help pay for costs of medical care and other specific expenses of certain people who have been seriously injured by certain medicines or vaccines, including this vaccine. Generally, a claim must be submitted to the CICP within one (1) year from the date of receiving the vaccine.To learn more about this program, visit www.hrsa.gov/cicp/ or call 1-855-266-2427.





GLP