> On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.
Approving the biologics license application _is_ the formal approval. The reason the media is reporting that the FDA gave formal approval is because the FDA did in fact do that.
The letter goes on to say:
> On August 23, 2021, 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 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA.
So as well as granting formal approval, they _also_ extended the EUA.
Why did they do both?:
The extension of the EUA covers the existing vials of vaccine in the field and the supply chain which don’t have the approved labelling. Drug and biologic products are approved for sale under conditions that include specific labelling (the brand, in this case “Comirnaty” and the prescriber/patient instructions) and for specific indications.
The stock in the supply chain doesn’t meet those requirements, but it would be wasteful to recall it. Additionally, the EUA authorises more indications than the full BLA: kids 12-16, for one. The old stock, and now the new Cominarty-labelled stock, are authorised for these populations under the extended EUA.