WASHINGTON, D.C. – There are currently no fully FDA-approved licensed COVID shots available. All COVID shots remain under federal Emergency Use Authorization, meaning individuals have the “option to accept or refuse” the product.
On September 22, 2021, the Food and Drug Administration (FDA) sent a follow-up letter to the original approval to Pfizer pharmaceutical company that stated, “having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 23, 2021 letter of authorization in its entirety with revisions incorporated to authorize for emergency use the administration of a single booster dose of COMIRNATY.”
On page 6, footnote 12 of that letter the FDA clearly states, “Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA. Additionally, there are no products that are approved to prevent COVID-19 in individuals age 12 through 15, or to provide: an additional dose to the immunocompromised population, or a booster dose to the authorized population described in this EUA” (emphasis added).