Fact Checking Claims that the Pfizer Vaccine Is Not Yet Approved
The FDA granted full approval in August.
A widely shared article from Red Voice America, which describes itself as being owned by “patriots” and fighting “false narratives against conservatives,” claims that “Biden BUSTED As Pfizer ADMITS There’s No Vaccine Approved By FDA In The U.S. In Recorded Call.” The article claims to have a phone call recording of a Pfizer employee who allegedly “admits” that the Pfizer vaccine has not been approved by the FDA.
In an email to The Dispatch Fact Check, a spokesperson for Pfizer confirmed that the Pfizer COVID-19, which has been available for use under an Emergency Use Authorization (EUA) since December 11, 2020, has been granted FDA approval. The approval was noted at the time by many major media outlets, including the Washington Post, NPR, the New York Times, CNN, and the Associated Press, among others.
On August 23, the FDA released a press release announcing FDA approval of the Pfizer-BioNTech COVID-19 vaccine: “Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.”
Pfizer also announced FDA approval of the Pfizer-BioNTech COVID-19 vaccine on August 23: “Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) approved the Biologics License Application (BLA) for COMIRNATY® (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 16 years of age and older. COMIRNATY is the first COVID-19 vaccine to be granted approval by the FDA.”
If you have a claim you would like to see us fact check, please send us an email at factcheck@thedispatch.com. If you would like to suggest a correction to this piece or any other Dispatch article, please email corrections@thedispatch.com.
Republicans took all of about 15 minutes after Colin Powell died to use it as proof that vaccines don't work and are dangerous. The truth has nothing to do with this.
As usual, the problem with these hacky Zuckerberg-compliant fact checks is that they do not use terms precisely and change the meanings of the checked terms mid-way through the fact-check. In this case, it is the term "the vaccine" that you play shell games with.
You say the "Pfizer-BioNTech COVID-19 vaccine" has been approved. This is actually incorrect. As your own sources explain: "**COMIRNATY** is the first COVID-19 vaccine to be granted approval by the FDA." The question is whether these are the same vaccines for purposes of FDA approval. Your reliance on an ambiguous Pfizer press release aside, it appears they are not the same, at least for FDA approval purposes.
The original vaccine is still only approved for emergency use and it the one being given to people. This thing called COMIRNATY is the one that has been given final approval. But it is not the one actually being shot into people's arms.
Pfizer is apparently deliberately using the original emergency vaccine because the emergency use authorization includes a liability shield for Pfizer. Whereas if it were to actually use the finally approved vaccine, it would not get the liability shield. Pfizer is thus claiming they are the same, but yet somehow different legally. A real journalist would figure out how that can be.
Here's Dr. Robert Mallone's take, which is the statement that should be fact checked (if Zuckerberg will allow you to):
"Dr. Robert Malone: It’s absolutely not available. So, the little trick that they’ve done here is they have issued two separate letters for two separate vaccines. The Pfizer vaccine which is what is currently available is still under emergency use authorization and it still has the liability shield. Once again the mainstream media has lied to you. I’m sorry to say that, I know it’s a shock to this viewership, but the product that’s license is the BioNtech product, which is substantially similar but not necessarily identical. It’s called Comirnaty, I think that’s how it’s pronounced, and it’s not yet available. They haven’t started manufacturing it or labeling it and that’s the one that the liability waiver will no longer apply to. So the one that’s actually license is not yet available and when it does become available it will no longer have the liability shield. In the interim, the one that does have the liability shield is the Pfizer product and that’s what’s currently available and it’s still under emergency use authorization, so that’s no change.
The press has just not done their work and figured out what’s actually going on here."
https://www.thethinkingconservative.com/dr-malone-sounds-alarm-on-liability-coverage-of-pfizer-vaccine/