FACT CHECK (Context Needed): Claim that the FDA granted BLA Approval for a Different COVID-19 Vaccine That You Cannot Get

Nothing unusual here - FDA Documents Confirm EUA vaccine and BLA vaccines are completely interchangable with the same formulation

The a bunch of people shared with me this video claiming the BLA approval was a scam. Here is the exact quote from the video:

“The little trick that they have done here is that 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 am sorry to say that, I know its a shock to this viewership. But, the product that is licensed is the BioNTech product which is substantially similar but not necessarily identical. It’s called COMIRNATY. I think that is how its pronounced. And, its not yet available. They haven’t started manufacturing it or labeling it. And, that’s the one the liability waive will no longer apply to. So the one that’s actually licensed is not yet available, and when it does become available, it will not longer have the liability shield. In the interim, the one that does have the liability shield is the Pfizer product and that’s what is currently available and its still under Emergency Use Authorization. So, that’s no change. The press has just not done their work and figured out what is going on here.”

The reality is, this appears to be much ado about nothing if you understand how the FDA works, except for maybe people getting by with a technicality for a few more days or weeks regarding forced vaccines due to the availability of a repackaged product.

First of all, Pfizer is BioNTech’s partner on this vaccine. Pfizer filed the EUA for the drug on behalf of BioNTech, while BioNTech filed the BLA itself. That is what he is referring to on the “Pfizer vaccine” versus the “BioNTech vaccine.” But the reality is both companies are still collaborating on the BLA as you can see from the last page of the BLA label the drug is “manufactured by Pfizer” for BioNTech:

Source: COMIRNATY Package Insert, page 20

Here is the thing you need to understand. Pfizer could not market the product at all under an Emergency Use Authorization (EUA). Physicians could use it at their own patients’ peril, but they did not need to be part of some approved investigational study trial to do so. But Pfizer could not go out and prospectively try to get physicians to get the product. You need a Biological License Application (BLA) approved to do that.

When you have an approved product you can then use a trade name to promote it. In this case that is COMIRNATY. It is standard all for pharmaceutical companies to reveal their trade name after approval and it be on the label. That does not mean it is a separate product in terms of the formulation. It does have to have a separate label with the new trade name and with the physician prescribing information dictated by the FDA under terms of the BLA. And for that reason, it is legally a separate product.

For example, the EUA continues to exist for populations not addressed specifically in the BLA. Pfizer cannot market a drug to physicians targeting that age group. Likewise the prescribing information will be completely different; they are not going to get the BLA label as it does not even address that age group, and the warnings and precautions are different.

So you have to have separate products with different packaging for the two different patient populations even what is in the bottom is the exact same thing. And it is stated on the authorization letter to Pfizer in the letter it self and in footnote 8 that the formulation is the same:

“COMIRNATY (COVID-19 Vaccine, mRNA) is the same formulation as the Pfizer-BioNTech COVID-19 Vaccine and can be used interchangeably with the Pfizer-BioNTech COVID-19 Vaccine to provide the COVID-19 vaccination series

“ 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.”

Source: Letter of Authorization Addressed to Pfizer, page 2

So the products are literally the “same formulation” and the FDA is literally saying you can use them interchangably. It is not like they are making any changes in substance. The meaningful difference is the packaging which makes sense given the need for differnt labels.

Now I did not see the whole clip, and am thus not sure exactly what he is referring to as the “liability shield.” In terms of product liability, all vaccine manufacturers basically have substantial immunity to lawsuits under the National Childhood Vaccine Injury Act of 1986. So I am assuming he is referring to some sort of employer liability for attempting to mandate an experimental vaccine, implying that until doctors get stock of the new BLA labeled vaccines they cannot force you to take the EUA packaged vaccines. Maybe that is a legal technicality, but I doubt it will last long as I assume Pfizer has been gearing up for this BLA launch for months. As soon as they can print those labels, those package will be out the door. If there is a loophole here, it will not last long. Given the fact that the FDA is even saying you can use the two products interchangeably in their own letter, I am not even sure an employer or judge would take such an argument seriously. If the formulations are the same, then all that really matters in substance is what the FDA authorizes them to do with it.

To me, this is not a big deal at all. This is exactly what you would expect on approval if you asked anyone who knows the industry 6 months ago. There is not one new vaccine that is a different formulation from the EUA one. “Once again the mainstream media has lied to you” was stated above. What “exactly” is the lie? What is the “TRICK/CON about FDA ‘Approval’” referenced in the title of the video? That the media reported a BLA approval that was actually granted?

For someone who realizes the mainstream media often exaggerates, I just do not see something here to criticize.

Update (8/30/21):

It came to my attention that perhaps the liability provided under the National Childhood Vaccine Injury Act of 1986 might be quite as watertight as I thought, and that is one of the motivations behind bringing up the issue of the liability shield under the EUA versus a full BLA. I even saw someone imply that a drug had to be on the childhood recommended schedule to qualify for that exemption. That may or may not be true, I just cannot confirm it as of yet. Here is the section of the Act which looks pretty broad to me with few exceptions:

Source: 42 U.S. Code § 300aa–22 - Standards of responsibility

I know the US Code has plenty of contradictions in it, so maybe there are some other loopholes. What I have found is that despite the passage of the Act, there have been civil court ruling for vaccine manufacturers since its passage under a legal doctrine that claims a manufacturer has a “duty to warn.” You can read more about that issue in the below excerpt of a very good summary of the vaccine liability question:

Source: Vaccine Supply and Innovation, 6 Liability for the Production and Sale of Vaccines

I do not necessarily see issuing a BLA concurrently with an EUA being a very persuasive argument. Maybe there is a technicality there, but the reality is that the FDA is saying both products are literally the same formulation and you can use an EUA product for a BLA indication, and vice versa.

The product packaging should not matter. The treatment of the BLA patient populations with COMIRNATY or the exact same formulation with EUA packaging is an FDA approved application of the drug. That is the actual substance of the situation. If the courts were looking at this honestly, the approved indications are what should matter. But we all know courts in the U.S. these days are far from unbiased. So who knows…

I have also heard further statements over the last couple of days claiming there was no approval of a BLA. Again, that is not true, and it really is making anti-vaxxers look like they are tin-foil hatters when there are provable scientifically valid reasons for not taking the vaccines.

To explain this more clearly, there were two separate applications submitted. Pfizer submitted the EUA on behalf of BioNTech late last year. An VRPAC panel meeting was conveyed to advise on the approval of that EUA on December 10, 2021. They did not advise on the approval of the BLA which was not even submitted at that time (some people are claiming that the FDA lied when they said there was no panel for the BLA citing the December 10th meeting which was not for the purpose of deciding on the BLA).

BioNTech, not Pfizer, submitted the BLA in 2021. That was the BLA that was approved on Monday of last week. There was no VRPAC panel meeting consulted on this BLA, something that was highly unusual. Here is the exact wording of this letter of the relevant section of the letter

Source: BioNTech BLA Letter

You can read more about the PHS Act and BLAs authorized under it here. In order to receive a BLA the FDA must determine the “safety, purity and potency of the product.”

Source: Frequently Asked Questions About Therapeutic Biological Products

You can see the product has been issued a BLA with a BLA number which means the FDA deems it as safe and effective. That is about as clear as it can get. Of course the same agency said Vioxx and a bunch of other faulty drugs were “safe and effective” as well, so that does not exactly mean much.

What is confusing people is the fact two letters went out and you have an EUA and BLA in existence at the same time. The letter that was sent to Pfizer, which I referenced earlier in the piece, was in reference to their submission of the EUA and regarded the extension of that EUA. It spoke about the BLA issued to BioNTech but also references the extension of the EUA so that COMIRNATY could be used for patients under the EUA (i.e. not “on label”) and the Pfizer EUA product with the same formulation and different packaging could be used for patients who were under the BLA label. Every word on that letter is consistent with that interpretation and through that lens.

There is nothing unreasonable about that. It is literally the same formluation with different packaging by the FDA’s own words (see above) so when you have a limited supply you do not have to artificially match the packaging to the use (i.e a 12 year old has to only get the EUA packaging and a 30 year old has to get the BLA packaging). The physicians are presumably adult enough to be able to pull up the different labels as necessary (well…).

In the real world, you have physicians prescribing drugs off label all the time. Many of you on statins are likley “off label” recipients. The only thing you might question is why the EUA had to continue anyway given that physicians can now prescribe the BLA off label as they have in the past, i.e. the EUA is no longer necessary. And certainly there is an argument for that. The thing is the FDA has never really been in the position to endorse an “off label” use before like this, at least not that I am aware of. If it revoked the EUA in persons from 12 to 16, then technically it could be argued that is what they are doing, and I am not sure they want to set that precedent. Or maybe there is some arcane legal argument that says as long as it is in force, Pfizer cannot be sued.

I have a feeling no matter what happened, courts are going to prevent Pfizer some being sued unless there is an unexpected change in the judiciary or the government itself. Justice, or should I say injustice can be bought in the US, unfortunately.