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On August 23, the Food and Drug Administration (FDA) in the US approved the Pfizer BioNTech vaccine, the fastest approval in the agency's history. This means the shot is no longer only in use under the Emergency Use Authorization (EUA) and opens the door for vaccine mandates by employers, universities and the military, and gives doctors flexibility in using vaccinations for "off-label use," like giving booster shots. But the approval has been far from straight forward.

Firstly, the FDA did not allow public discussion or hold a formal advisory committee meeting to discuss the data, despite previously saying they were "committed" to doing so. They simply said, in a statement to The BMJ, that the agency did not believe a meeting was necessary since they had already held numerous meetings themselves.

There is also a great deal of confusion about the product that has actually been approved. Approval was granted to the branded shot 'Comirnaty,' a product they say can be used "interchangeably" with the Pfizer-BioNtech shot. But the previous shot is still under EUA and is not FDA approved. On top of this, Pfizer says there are "insufficient stocks" of the newly licensed Comirnaty vaccine.

What the heck is going on here? Join us on this episode of Objective:Health as we delve into the implications.


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Running Time: 00:24:20

Download: MP3 — 22.3 MB