Covid19 Vaccines are not “FDA Approved”

Covid19 Vaccines are not “FDA Approved”

On 12/11/2020 the U.S. Food and Drug Administration (FDA) announced^[1] that they had issued an Emergency Use Authorization (EUA) to permit the emergency use of the “unapproved product”, Pfizer-BioNTech COVID-19 Vaccine.^[2]

On 12/18/2020 the U.S. Food and Drug Administration (FDA) announced^[3] that they had issued an Emergency Use Authorization (EUA) to permit the emergency use of the “unapproved product”, Moderna COVID-19 Vaccine.^[4]

Federal law requires recipients are informed that they have “the option to accept or refuse the EUA product”.^[5]

^[1] https://www.prnewswire.com/news-releases/fda-takes-key-action-in-fight-against-covid-19-by-issuing-emergency-use-authorization-for-first-covid-19-vaccine-301191524.html

^[2] https://www.fda.gov/media/144413/download

^[3] https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid

^[4] https://fda.gov/media/144637/download

[5] https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities