EUA is only valid when there are no other effective treatments. Further, EUA must be withdrawn when an effective treatment is available.
Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives.
Emergency Use Authorization (EUA) is authorized under 21 U.S. Code Section 360bbb-3(c)(3) if, among other things, "there is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition."
On August 23, 2021, the FDA approved "[T]he first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA)."
The FDA's approval letter for this vaccine states that Pfizer is "approved to manufacture COVID-19 Vaccine, mRNA drug substance at Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC, 1 Burtt Road, Andover, Massachusetts. The final formulated product will be manufactured, filled, labeled and packaged at Pfizer Manufacturing Belgium NV, Rijksweg 12, Puurs, Belgium and at Pharmacia & Upjohn Company LLC, 7000 Portage Road, Kalamazoo, Michigan." And Pfizer "may label [this] product with the proprietary name, COMIRNATY[.]"
The FDA in a January 3, 2022 letter to Pfizer, however, states on page 20 that "[i]f the Pfizer-BioNTech COVID‑19 Vaccine is exported from the United States," then Pfizer must inform regulatory authorities of the country in which the vaccine will be used "that this vaccine is subject to an EUA and is not approved or licensed by FDA."
The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) and the EUA authorized formulations of Pfizer-BioNTech COVID-19 Vaccine for ages 12 years and older are not the same and, according to Congressman Thomas Massie, Comiraty is not available in the United States.
Even the FDA concedes that Comiraty and the EUA formulatios of Pfizer-BioNTech COVID-19 Vaccine for ages 12 years and older are "legally distinct."
If Comiraty is the only FDA approved vaccine, and if Comiraty is not available in the U.S., then Biden has mandated people take an experimental gene therapy that, in the FDA's words, "is subject to an EUA and is not approved or licensed by FDA" and "legally distinct" from the vaccine approved in August 2021.
Let that sink in.