These include:
The EUAs made these vaccines immediately available to the public.
This made it the first COVID-19 vaccine to be granted FDA approval.
With the approval, the vaccine is marketed under the name Comirnaty.
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This article looks at the difference between emergency use authorization and full FDA approval.
How is an EUA Different Than an Approval?
The EUA programwas established in 2004 after the terror attacks of September 11, 2001.
The program put new rules in place for the use of certain medical products during a public health emergency.
Under this program:
COVID-19 was declared a public health emergency in the U.S. on January 31, 2020.
Joshua Sharfsteinis a former principal deputy commissioner at the FDA.
EUA program Requirements
Manufacturers usually have to obtain formal approval for a new vaccine.
To start this process, they submit a biologic licensing program (BLA).
The FDA must decide if the known and potential benefits of the vaccine outweigh its risks.
The IAC is an advocacy group that works to increase immunization rates in the U.S.
But that is not to say that the clinical trials are compromised in design," he says.
According to the FDA, products submitted for an EUA must still go through rigorous testing.
The FDA also expects manufacturers who receive an EUA to continue their clinical trials.
Ultimately, each manufacturer will need to file for a BLA.
An EUA is no longer valid once the public health emergency declaration ends.
This means full approval will be needed for the vaccine to continue to be used.
This can speed up the time it takes to get a vaccine approved.
For the most recent updates on COVID-19, visit ourcoronavirus news page.
Food and Drug Administration.Comirnaty and Pfizer-BioNTech COVID-19 vaccine.
Food and Drug Administration.Coronavirus (COVID-19) update: FDA takes key action by approving second COVID-19 vaccine.
Food and Drug Administration.FDA in brief: FDA issues guidance on emergency use authorization for COVID-19 vaccines.
