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Reason: None provided.

"and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA."

Do not be confused with the language. The EUA will remain in effect for those uses not spelled out in the "approved" BLA. Does the acceptance of a BLA mean full approval? Yes. The BLA is a full FDA approval folks. The EUA would have to be examined for those specific uses not spelled out in the BLA - those uses have extended EUA.

A company receiving a BLA for their product can introduce the now named product into interstate commerce and market it for its approved uses. A BLA also has no defined end date — assuming no significant problems emerge, the product can stay on the market indefinitely. Isn't that a joke? EUAs are time sensitive and have expiration dates. Full approval means it can be prescribed also for off label use. Just what they need - more ways to poison people. In short order, this move will eliminate the competition trying to apply for EUAs of their own inoculations. Gee, who stands to benefit? The remaining players on the EUA field at the moment are also applying for BLAs and we should start seeing those rolling out in the next several months.

The bottom line is that this is not an extended EUA, but indeed a politically and financially motivated full FDA approval. We will see if it has the desired effect that they were hoping for - to get those waiting on the sidelines to roll up their sleeves and get the clot shot.

3 years ago
2 score