Quote:
Originally Posted by drducat
What I am seeing is the original Pfizer is still EUA only and the BioNTech is fully approved. My understanding the BioNTech is not yet available and the pfizer is.
Pfizer is still not liable and BioNTech will be once on market. The FDA sent out 2 different letters, one for each product.
Nothing about swapping labels which is not legal is it?
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Of course swapping labels is not legal which is why the extra language exists and, if you are being sincere, why you are confused.
Product shipped prior to FDA approval was labeled for the EUA use. Much of that product was shipped and is now waiting for arms. Product produced now that the approval has been granted will be labeled accordingly. A short name, Comirnaty, has been chosen (and most likely licensed) for the product and will appear on the new label. Nothing has changed in the product itself but the labeling needed to be changed to reflect the new status with the FDA.
Note that since the approval was for 16 and over it was necessary to state that the product with the new name is covered by the EUA for 12-15 year olds and for third shot boosters. Otherwise, when the product with the old labeling was gone there would be no vaccine available for the 12-15 range.
I did not see separate letters for the two names or separate FAQ sheets for the two names or anything at all that implied there were two separate vaccines. All I found was clarification that the formulation was the same and that despite the name difference, each could be used under the EUA for the 12-15 range and "boosters" and each could be used for the 16 and over range.
The following sections from the revised EUA LOA may help explain things:
8. The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.
AA. COMIRNATY (COVID-19 Vaccine, mRNA) is now licensed for individuals 16 years of age and older. There remains, however, a significant amount of Pfizer-BioNTech COVID-19 vaccine that was manufactured and labeled in accordance with this emergency use authorization. This authorization thus remains in place with respect to that product for the previously-authorized indication and uses (i.e., for use to prevent COVID-19 in individuals 12 years of age and older with a two-dose regimen, and to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise).
BB. This authorization also covers the use of the licensed COMIRNATY (COVID-19 Vaccine, mRNA) product when used to provide a two-dose regimen for individuals aged 12 through 15 years, or to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. Conditions A through W in this letter apply when COMIRNATY (COVID-19 Vaccine, mRNA) is provided for the uses described in this subsection III.BB, except that product manufactured and labeled in accordance with the approved BLA is deemed to satisfy the manufacturing, labeling, and distribution requirements of this authorization.