SEN. RON JOHNSON: We do not have an FDA–approved vaccine being administered in the U.S. The FDA played a bait and switch. They approved the Comirnaty version of Pfizer drugs. It’s not available in the U.S. They even admit it. I sent them a letter three days later going ‘What are you doing?’
“What they did is they extended the emergency use authorization for the Pfizer drug vaccine that’s available in the U.S., here that’s more than 30 days later, they haven’t asked that very simple question. If you’re saying that the Pfizer drug is the same as the Comirnaty, why didn’t you provide FDA approval on that? So, there’s not an FDA-approved drug and, of course, they announced it so they could push through these mandates so that people actually think, ‘Oh, OK now these things are FDA approved.’ They are not and again, maybe they should be, but the FDA isn’t telling me why.”
JayGalt wrote: ““What they did is they extended the emergency use authorization for the Pfizer drug vaccine that’s available in the U.S., here that’s more than 30 days later, they haven’t asked that very simple question. If you’re saying that the Pfizer drug is the same as the Comirnaty, why didn’t you provide FDA approval on that? So, there’s not an FDA-approved drug and, of course, they announced it so they could push through these mandates so that people actually think, ‘Oh, OK now these things are FDA approved.’ They are not and again, maybe they should be, but the FDA isn’t telling me why.””
They extended the EUA for those under sixteen while approving the vaccine for almost everyone older than sixteen.
Many anti-vaxxers have used the fact that the EUA is still in effect for those under sixteen to justify a claim that the vaccines have not been fully approve which is hogwash.
The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series. An individual may be offered either COMIRNATY® (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2.
Here is the FDA approval letter:
https://www.fda.gov/media/151710/download