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The senator is wrong.
The U.S. Food and Drug Administration approved the Pfizer-BioNTech shots for full use on Aug. 23, 2021.
For those 12 to 15 and for booster shots, it remains under the emergency use authorization — as do other company’s shots.
With COVID-19 still surging in parts of the country and booster shots being rolled out to strengthen immunity against the virus, many are still hesitant to get their first vaccine doses.
A recent report from the Kaiser Family Foundation found that a main motivator for those who recently got vaccinated is concerns about the delta variant, which is driving the third wave of the pandemic.
Into that mix comes U.S. Sen. Ron Johnson, R-Wisconsin, who in an Oct. 4, 2021 appearance on the Tucker Carlson show on Fox News made a series of statements trashing the federal government’s response to COVID, including one that is — at best — flat-out wrong.
"We do not have an approved vaccine in America," Johnson said. "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."
He went on to add: "I wrote a letter to the FDA on August 26th — they have still not given me an answer of why didn't they approve it? Why are they basically lying to the American public? That's a serious question to be asked — as we are destroying our health care system with these mandates."
Of course, the Pfizer vaccine has been approved by the FDA. It is now marketed as Comirnaty. Johnson is wrong on that point.
Carlson did not correct Johnson’s statement, instead offering: "At some point, we’re going to learn the depth of the lies and I think it’s going to be shocking to everyone, even those of us who have a very low opinion of those making these decisions."
Let’s dig in a little bit more.
The FDA approved the Pfizer vaccine in August
The federal U.S. Food and Drug Administration approved the first COVID-19 vaccine — the Pfizer-BioNTech shots — on August 23, 2021.
Before that, each COVID-19 vaccine approved in the U.S. — Pfizer, Moderna and Johnson & Johnson — had received an emergency use authorization (or EUA) from the FDA, following an expedited process because of the public health emergency the pandemic triggered.
Due to the full FDA approval, the Pfizer vaccine is now marketed as Comirnaty; it’s the same vaccine as the Pfizer vaccines that were available under the emergency use authorization. Comirnaty had previously been authorized in the European Union on May 28, 2021, according to Pfizer.
In an email to PolitiFact Wisconsin, Johnson’s staff said the senator wrote a letter to the FDA on Aug. 26 asking for clarification on "extending the EUA for the vaccine used in the U.S. and ... granting the FDA approval of the Comirnaty vaccine used in Europe and other countries."
That’s the letter Johnson referenced in the interview, saying of the FDA "they have still not given me an answer of why didn't they approve it?"
But they had approved it three days earlier.
Johnson’s confusion seems to extend from a footnote in the FDA documentation (one cited by his staff as evidence for the claim):
"Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA."
Thus, the emergency use authorization was extended for those ages 12 to 15, and later for those eligible for booster shots.
To be sure, the Moderna and Johnson & Johnson vaccines have not yet been fully approved and continue to be under the FDA’s emergency use authorization.
But Johnson in his interview said there were no approved vaccines in the U.S. and specifically — and wrongly — said the Pfizer vaccine has not been approved.
The emergency use authorization does not mean manufacturers skipped important steps or blew safety standards. The COVID-19 vaccines are proven safe and effective, evaluated in tens of thousands of participants in clinical trials, according to the U.S. Centers for Disease Control and Prevention. For emergency use authorization, the vaccines had to meet the FDA’s scientific standards for safety, effectiveness and manufacturing quality.
Moderna completed its submission for full FDA approval of its COVID-19 vaccine for ages 18 and older on Aug. 25, the company announced at the time.
In an interview, Johnson claimed: "We do not have an approved (COVID) vaccine in America … the Pfizer vaccine available in the U.S. is not FDA approved."
That is entirely untrue. The Pfizer vaccine was approved for full use on Aug. 23, 2021 by the FDA, even though emergency authorization continues with some subsets of the population.
We rate Johnson’s claim False.
Media Matters, Tucker Carlson video clip, Oct. 4, 2021
PolitiFact, What Ron Johnson gets wrong about the COVID-19 vaccines, April 23, 2021
Kaiser Family Foundation, KFF COVID-19 Vaccine Monitor: September 2021, Sep. 28, 2021
Centers for Disease Control and Prevention, Safety of COVID-19 Vaccines, Sep. 27, 2021
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