04-01-2021, 04:59 PM
Also look at the fact sheet for the Moderna vaccine https://www.modernatx.com/covid19vaccine...pients.pdf
WHAT IS THE MODERNA COVID-19 VACCINE?
The Moderna COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There
is no FDA-approved vaccine to prevent COVID-19.
The FDA has authorized the emergency use of the Moderna COVID-19 Vaccine to prevent
COVID-19 in individuals 18 years of age and older under an Emergency Use Authorization
(EUA).
WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?
The United States FDA has made the Moderna 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 Moderna 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, and available alternatives. In addition, the FDA
decision is based on the totality of the 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 during the COVID-19 pandemic.
WHAT IS THE MODERNA COVID-19 VACCINE?
The Moderna COVID-19 Vaccine is an unapproved vaccine that may prevent COVID-19. There
is no FDA-approved vaccine to prevent COVID-19.
The FDA has authorized the emergency use of the Moderna COVID-19 Vaccine to prevent
COVID-19 in individuals 18 years of age and older under an Emergency Use Authorization
(EUA).
WHAT IS AN EMERGENCY USE AUTHORIZATION (EUA)?
The United States FDA has made the Moderna 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 Moderna 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, and available alternatives. In addition, the FDA
decision is based on the totality of the 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 during the COVID-19 pandemic.