Covid-19 Vaccine EUA Consent
The FDA has made the COVID-19 vaccine available under an emergency use authorization (EUA). The EUA is used when circumstances exist to justify the emergency use of drugs and biological products during an emergency such as the COVID-19 pandemic. This vaccine has not completed the same type of review as an FDA-approved or cleared product. However, the FDA’s decision to make the vaccine available under an EUA is based on the existences of a public health emergency and the totality of scientific evidence available, showing the known and potential benefits of the vaccine outweigh the known and potential risks.
Johnson & Johnson Fact Sheet: https://www.fda.gov/media/146305/download
Moderna Fact Sheet: http://www.modernatx.com/covid19vaccine-eua