The Sconi

Sen. Ron Johnson (R-WI) wrote a letter to the acting FDA commissioner concerning Pfizer's vaccine and then incorrectly stated on Fox News that there isn't an approved COVID-19 vaccine in the U.S.

“These mandates are driven by the bait-and-switch of the FDA that we now have an approved vaccine,” Johnson told Fox News host Tucker Carlson on Oct. 4. “We do not have an approved vaccine in America. They did it for the Comirnaty – it’s available, I guess, in Europe, but the Pfizer vaccine available in the U.S. is not FDA-approved – it’s got an emergency use authorization (EUA).”

Pfizer's COVID-19 vaccine was approved by the FDA in August for people ages 16 and older and the vaccine which was known as Pfizer-BioNTech COVID-19 is marketed as Comirnaty, according to the FDA. The Pfizer vaccine is the same one that the FDA had previously authorized for emergency use authorization with the European Union authorizing Comirnaty in May, according to Politifact.

Johnson’s letter was intended for acting commissioner of the FDA Janet Woodcock.

“In the letter that reissued the EUA for the Pfizer-BioNTech COVID-19 vaccine, the FDA stated that Comirnaty and the Pfizer-BioNTech COVID-19 vaccines are 'legally distinct with certain differences that do not impact safety or effectiveness,'" Johnson wrote. "That statement, together with the fact that the FDA issued two distinct letters – one extending the EUA for the vaccine used in the U.S. and the other granting the FDA approval of the Comirnaty vaccine used in Europe and other countries – has caused a great deal of confusion. There is no doubt that the FDA’s action will lead to more vaccine mandates and increased pressure on those currently choosing not to get vaccinated.”

Newsweek reported that the FDA did expand an existing EUA for the Pfizer vaccine for ages 12 to 15; while the formulation of the EUA version and Comirnaty are the same, they are legally distinct. Before FDA approval, the vaccine could not be marketed in the U.S. as Comirnaty. Before FDA approval, the vaccine could not be marketed in the U.S. as Comirnaty.

“Of the nearly 80 million eligible Americans who have not gotten vaccinated, many said they were waiting for approval from the FDA," President Joe Biden said last month. "Well, last month, the FDA granted that approval.