Fact Checking Claims that the Pfizer Vaccine Is Not Yet Approved

The FDA granted full approval in August.

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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.

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  1. Avatar photo
    Tmcke

    One of the saddest things about Conservatism is that its media outlets from the National Review on down are basically meant to incite not to instruct. Decades ago, I subscribed to the National Review and while it was snarky, was an attempt to provide an intellectual footing. Now almost all conservative sites are meant only to debunk - not even to understand. So it was the the "negative income tax" was once highlighted in NR (this is the idea behind the earned income tax credits). Now all we get is lies and half truths.

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    1. Woody87

      I read NR everyday and would disagree with that characterization. They have been refusing to follow many of the popular conservative narratives, in particular speaking out against the many lies of trumpism. But then, I have to ask - what are your truths?

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        Tmcke

        Sorry, decades ago I was a subscriber and about one a month I take a look and it seems that they are only trying to be the opposite of the left. I don't see much effort to suggest some good ideas. A lot of snark but so what.

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  2. Alex DeLarge

    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/

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    1. Avatar photo
      Jack

      Dislike button, anyone?

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    2. woolardtyler

      https://twitter.com/RWMaloneMD/status/1432325367591809027

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    3. Avatar photostaff-badge-circle
      Alec Dent staff-badge Staff

      The FDA announcement of full approval for those 16 and up literally says they’re the same vaccine. Comirnaty is just the name being used for marketing. https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

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        Kevin C. Smith

        His comment/reply gets zero candy corns. I'm sure most readers sprained one or both eyes when rolling them.

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      2. Alex DeLarge

        To be precise, it does not literally say they are "the same vaccine." It weasel words it a bit by saying "has been known as . . . " Press releases are always verbally manipulated to give the public whatever impression is being peddled. The problem with the TD's fact check is that it failed to recognize that this issue of whether there are two legally distinct vaccines is the issue.

        Actually, the Washington Post seems to have done a good fact check which recognizes the confusion caused by the existence of two separate vaccines/vaccine names, with different legal status:

        "The letters issued by the FDA are obtuse and written in legalese, which make it easy for people to misunderstand them. Skeptics have focused on a footnote on page 2 of the letter to Pfizer: “The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness.”

        According to the WaPo, the legal distinctions refer to certain technical authorizations about where they can be produced, etc. However, they both enjoy the same legal liability protection by statute.
        https://www.washingtonpost.com/politics/2021/08/30/false-claim-that-fully-approved-pfizer-vaccine-lacks-liability-protection/





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          George.Skinner

          This is a good example of the "motte and bailey" type of argument that Jonah and others have referenced. The original blog claim was clearly trying to continue pushing the idea that mRNA COVID vaccines are a dangerous experimental medicine. Now that the claim has been easily discredited with an elementary fact check, we're seeing lengthy rebuttals regarding minor technical details of FDA approval.

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          1. Alex DeLarge

            No. This was supposed to be a fact check of a specific claim about FDA approval. If the TD wants to just do PSAs that say: "Vaccines are great, anyone who questions them is lying," they can do that.

            But if they can't be bothered with details and precision they should get out of the "fact check" biz and just write more opinion pieces telling people what they are supposed to think.

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          Faraday

          So we still don’t trust the vaccine because of legalese used in the announcement/documentation? Do I have that right?

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          1. Alex DeLarge

            No. You are one of the confused people.

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          Kevin C. Smith

          Whew, WaPo is right--proven by your comment/reply--about this statement: "The letters issued by the FDA are obtuse and written in legalese, which make it easy for people to misunderstand them."

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  3. Brett C.

    This "fact-check" ignores the fact that the approved vaccine is Comirnaty and is not expected to be available in the US until late October or early November. Yes, it is the same as the EUA vaccine, but unless your shot comes out of a vial labeled "Comirnaty" you are not getting the FDA approved vaccine and are still subject to the liability immunity associated with the EUA vaccines. So, technically, there is no currently available FDA approved vaccine in the US.

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    1. woolardtyler

      This WaPo article spells out why there is no liability difference between the two "legally distinct" products:
      https://www.washingtonpost.com/politics/2021/08/30/false-claim-that-fully-approved-pfizer-vaccine-lacks-liability-protection/

      It also clarifies that liability immunity is due to the invocation of the PREP act. According to this declaration, it is set to expire on October 1, 2024.
      https://www.federalregister.gov/documents/2021/10/04/2021-21652/declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical-countermeasures

      Someone harmed by a countermeasure (such as a vaccine) can apply for reimbursement through the Countermeasures Injury Compensation Program.
      https://www.hrsa.gov/sites/default/files/hrsa/cicp/cicpfactsheet.pdf

      Would it be better for an injured person to be allowed to sue Pfizer instead? I don't know. Fortunately, though, the vaccines are EXTREMELY SAFE AND EFFECTIVE.

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      1. Alex DeLarge

        Pretty safe and kinda effective would be more accurate. But whatever.

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    2. Avatar photostaff-badge-circle
      Alec Dent staff-badge Staff

      The FDA announcement of full approval for 16 and up says they’re the same vaccine and that emergency approval now applies only for the 12 and up range. Comirnaty is just the name being used for marketing. https://www.fda.gov/news-events/press-announcements/fda-approves-first-covid-19-vaccine

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      1. Brett C.

        I acknowledged that it is the same formulation. Legally, however, it is not the same because the immunity attaches to the EUA vaccine, but the immunity goes away with Comirnaty. Until Comirnaty is available, Pfizer-BioNtech still has legal immunity from liability. Comirnaty is not currently available in the US. If I put two beverages in front of you and told you they were the same, but that you could sue for any ill reaction to the first, but not the second, would you take the second? I seriously doubt it.

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        1. Avatar photostaff-badge-circle
          Alec Dent staff-badge Staff

          This is a point that's addressed on the FDA's website page about Comirnaty. The EUA no longer applies for those 16 and up, but "The EUA remains in effect for the two dose primary series in individuals 12 years of age and older and as a third primary dose for individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise. Additionally, the FDA authorized the vaccine for emergency use to allow for a single booster dose administered at least 6 months after completion of the vaccination primary series in certain populations." https://www.fda.gov/vaccines-blood-biologics/qa-comirnaty-covid-19-vaccine-mrna

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          1. Brett C.

            So, here is an honest question for the fact-checkers that I think gets to the heart of the issue (or at least my issue) because it is my understanding that an EUA cannot coexist with a licensed vaccine. Is that true? The way I read the FDA announcement you cite to is that they amended the EUA to include authorization for ages 12-15, but the wording is that the EUA is now "12 years of age and older." They did not state, as you say, that the EUA no longer applies for those 16 and up. My understanding is that an EUA is in effect until it is revoked or the pandemic (i.e., emergency) ends. I have seen no revocation of the original EUAs and, again, my understanding is that once a licensed vaccine is widely available then all EUAs have to be revoked for the scope of that approval/licensure because an EUA cannot be authorized when there is a licensed treatment available. So, once Comirnaty becomes "widely available" then they will have to revoke all prior EUAs for whatever is covered under the Comirnaty license (i.e., initial 2-shot regimen). It is currently only approved for those 16 and older under the 2-shot regimen, so EUAs will still be authorized for those under 16 as well as for boosters of Pfizer, Moderna, and J&J even if the original EUA is revoked, but Comirnaty will be the only available option for those 16 and older (unless Moderna and/or J&J get approved). I have seen no revocation of the original EUA and my understanding is that it is still in effect until such time as it is revoked. I honestly would like to know if it is true that an EUA cannot coexist with a licensed treatment. The formulations may be the same, but the legal ramifications are different under an EUA and an approval and I see no evidence that the EUA has been revoked.

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    Pat Riot

    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.

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    1. Woody87

      So every republican, right? Every republican ran out and said this? Just like you might take umbrage when somebody uses a label that includes you, but its okay when you apply it to others?

      The problem in this country is our fascination in drawing tribal lines. Oh but liberals aren't like that. They are enlightened. They just hate anti-vaxing ignorant right wingers, who probably deserve to die anyway.

      And so hate feeds on hate. Let's start by not focusing on labels and instead focus on the fact that we are all Americans, and we all capable of rational but different thought. When we start respecting each other instead of dehumanizing each other we can start to work towards common solutions.

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        Pat Riot

        No, just the leadership. What the followers do is of no consequence to anybody. It's like saying that not everybody who worked for Bin Laden was a bad person like Bin Laden. That might be true but who cares?

        The GOP is Trump's political party. Everybody who supports that party supports Trump.

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      2. Alex DeLarge

        Pat appears to be a full-time employee of the DNC, whose main job duty is to insert anti-Republican talking points into every thread. We shouldn't criticize, it's a tough job market out there.

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    2. Alex DeLarge

      If he died of Covid, then the vaccine didn't work. But like pretty much all "covid deaths" he actually died of something else -- in this case, cancer.

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        Pat Riot

        He died because he probably came in contact with some Republicans who didn't give a shit about anybody else in the world besides themselves and didn't vax and/or mask.

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        1. Alex DeLarge

          Probably black Democrats gave it to him. They have the lowest vax rates.

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            Tmcke

            You really can't see the difference? Sorry, African American vaxx rates have improved to be about the same a whites/ Maybe to point out that it wss probably a Republican bothers you - but when I see the maps of disease I think Trump voter, so about the same.

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          2. Patrick E

            FFS, I joined The Dispatch to get away from garbage like this in comments sections.

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            Tmcke

            What are you, the house troll? The Dispatch is meant for civil debate.

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            Pat Riot

            No, they don't.

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        John M.

        He died of COVID because his cancer was of the blood that limited his bodies ability to fight infections and viruses.

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        1. Alex DeLarge

          It's that way with a lot of diseases. They weaken you or destroy your immune system so you die of whatever is the last bacteria or virus you come into contact with. If someone with AIDS dies of an opportunistic fungus infection we wouldn't normally say they died "of fungus."

          But whatever. Causation in individual cases is hard to apportion. The gross excess death numbers are probably the only good guess at how many covid is really killing. The media never seems to track those, however. They like the useless up and down charts of "cases" instead.

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            Patrick

            I used to think this too. But the gross excess deaths are being tracked, and they are even higher than the deaths attributed to COVID. It doesn’t really matter what we label a specific death as, but we are counting the total bodies. Covid is killing us.

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          John M.

          This has already been seen in immuno-compromised individuals and cancer patients. The vaccine is not as effective as most because of their bodies weakened immune system. That is why a third dose is suggested.

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