Vaccine licensing primer – correcting anti-vaccine misinformation

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This article about vaccine licensing was written by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), who is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy, and the law.

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also a member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease. She is also a member of the Vaccines Working Group on Ethics and Policy.

Anti-vaccine activists want to claim the Pfizer vaccine is still experimental despite FDA licensing.  They base that claim on a footnote in a document reauthorizing Pfizer’s Emergency Use Authorization (EUA).  FDA is clear that the now fully-licensed vaccine is identical to the EUA vaccine (except of course for the labeling: the EUA vaccine still bears its EUA label), and that both can legally be marketed.  The anti-vaccine claim is being made because the full licensure of the Pfizer vaccine renders moot their claim (not yet decided by a court) that you cannot mandate a vaccine licensed under the EUA. 

vaccine text and a person wearing latex glove while holding a syringe on pink background
Photo by Thirdman on Pexels.com

Background

Most people outside the pharmaceutical industry do not realize how tightly regulated vaccines and other products are. Vaccines are regulated carefully, and so is the labeling – there are clear rules on what can and cannot be on the label. The labeling requirements are also different between the EUA and the final product (e.g. they have to say it is a EUA product). It is within this framework that regulators need to work. 

On August 23, 2021, the FDA licensed Pfizer-BioNTech’s mRNA COVID-19 vaccine. This was a blow to anti-vaccine efforts to challenge vaccine mandates because their best claim against those mandates was the claim that you cannot mandate a vaccine under a EUA – an area where there is an open legal question, though not necessarily a winning argument.

On August 24, 2021, anti-vaccine activists Robert F. Kennedy Jr. and Meryl Nass, MD came up with their counter salvo, a way to continue to pretend that there is no licensed vaccine against COVID-19, and therefore they can continue to bring lawsuits pretending that the vaccine is “experimental” (as Dr. David Gorski documented, other extremists picked up the Kennedy-Nass invention and ran with it). 

The Kennedy-Nass argument consisted of two claims, one latching onto two grains of truth but using them to misrepresent reality, and one completely false. 

The first grain of truth is that, legally, the two products are distinct, largely because they have different labels, although the contents of the vials are identical.

The second grain of truth is that there are many vaccines (perhaps millions of doses) with the EUA labeling in the distribution pipeline to be put into arms.

Why would Kennedy and Nass make such a mountain out of a molehill? Because it’s the foundation for their second claim, that the Comirnaty-labeled product has no liability shield. Their article alleged that “EUA-approved COVID vaccines have an extraordinary liability shield under the 2005 Public Readiness and Preparedness Act. … [but] At least for the moment, the Pfizer Comirnaty vaccine has no liability shield.” That second claim is completely false, as I explain in full here.

It’s false, in brief, because the PREP act liability shield also covers fully-licensed COVID-19 vaccines, so Pfizer has no motivation to be marketing EUA-authorized and fully-licensed vaccines at the same time except, as most people should realize, to use its full supply of an expensive vaccine in demand all over the world.  Nor would any reasonable person want those EUA vaccines to be wasted — given that the vaccine is identical in every meaningful way to the licensed one.

The FDA-licensed Pfizer-BioNTech’s Vaccine

Legal interpretation is not a theoretical exercise. Generally, it’s done to achieve a real-world goal. In this case, the anti-vaccine effort to claim that there are two meaningfully different Pfizer-BioNTech COVID-19 vaccines, one licensed and one not, is done for two reasons.

  1. First, to scare people from vaccinating; this is done by saying, falsely, that the vaccine with the EUA label is different from the licensed vaccine and “experimental,” by alleging, falsely, that it causes high rates of serious harms and deaths, and by suggesting there’s a conspiracy to mislead them about this – all things Kennedy and Nass wrote.
  2. Second, it is done to create a legal argument against mandates – based on the (real, but controversial, and in my view unconvincing) claim that you cannot mandate an EUA vaccine.

In spite of the grain of truth about different labeling, the anti-vaccine interpretation should be rejected: it is groundless.

  1. The vaccine that is, allegedly, “experimental” is supported by the same data, from the same trials, as the vaccine Kennedy and Nass say is not. Same formula (as Dr. Gorski explained in detail), same data – saying it’s more experimental than the licensed vaccine does not hold.
  2. The bulk of FDA documents make it clear that the vaccines produced before and after the regulatory approval are fully interchangeable, and latching onto one footnote in one document – not the approval document – to try and claim otherwise is taking things out of context.
  3. The anti-vaccine interpretation would undermine the goals of the EUA provisions by leading to throwing out the still-good EUA-labeled vaccine stocks – and that’s not the Congressional intent. 

The anti-vaccine claim is not drawing on the approval letter, which does not include the language they latched on. Looking at that approval letter, it explains that the vaccine licensing is relying on clinical trials NCT04368728 and NCT04380701. What are these?

  • NCT04368728. This clinical trial was started in April 2020 and is still ongoing. It also has the clinical trial number C4591001 and it is under this number that it served as the basis of granting the vaccine an EUA. This is the large, over 40,000 participants, trial that led to the data used both to grant the EUA and the license. It’s the same trial, of the same vaccine.
  • NCT04380701. This smaller trial was used to determine the best dose.

In other words, we have the same data from the same trial supporting the vaccine, whether it’s called COMIRNATY (the brand name) or whether it’s under a EUA. 

In essence, the anti-vaccine claim is that this same vaccine, which now has more data from the same trial, is “experimental” when it has the older label, and not experimental once a new label is put on it. That does not make sense. Drug manufacturers have always, and legally, marketed quantities that were produced while the drug was still in IND status (prior to final approval).  In fact, the FDA has a guidance document on how to do that. The fact that the particular batch was manufactured prior to approval does not make it forever “experimental.”   This is just semantic shell-games. 

Further, the claim is problematic in other ways. The claim draws on a footnote in a letter the FDA sent to continue the emergency use authorization for Pfizer-BioNTech’s vaccine for certain uses. (This is a later version, not the one issued the day of the licensure – but it’s the one the anti-vaccine article links to, and much of it is identical).

The letter was issued to allow continued use of the vaccine, including for uses the vaccine was not licensed for (e.g., vaccinating 12-15-year-olds, and for the later letter, allowing certain boosters). This is not the licensure letter, and it focuses on whether the vaccine can be given a EUA.

Thus when the anti-vaccine article linked to it from the word “approved” in this sentence: “Monday, the U.S. Food and Drug Administration (FDA) approved a biologics license application for the Pfizer Comirnaty vaccine,” it was inaccurate. But that’s the small part of the problem. The larger part is that the antivaccine claim both misrepresents what the FDA says in this document and ignores what it said in all the other documents. 

In the text leading to the footnote that the anti-vaccine activists misuse, the FDA says:

COMIRNATY (COVID-19 Vaccine, mRNA) is the same formulation as the Pfizer-BioNTech COVID-19 Vaccine and can be used interchangeably with [it].

This text is repeated in the footnote, which says:

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.

This is how Kennedy and Nass describe this footnote:

The FDA decrees that the Pfizer-BioNTech vaccine under the EUA should remain unlicensed but can be used “interchangeably” (page 2, footnote 8) [the page numbers changed in the later document] with the newly licensed Comirnaty product.

Second, the FDA pointed out that the licensed Pfizer Comirnaty vaccine and the existing, [sic] EUA Pfizer vaccine are “legally distinct,” but proclaims that their differences do not “impact safety or effectiveness.”

I’m intentionally leaving their hyperlinks. The FDA’s footnote does not say the Pfizer-BioNTech vaccine will remain “unlicensed.” It is acknowledging that some of the stock precedes licensing but points out, in the text, that the vaccines have the same formula and can be used “interchangeably.”

How are they legally distinct? Well, p. 8 requires the vaccines to have “labels and carton labels” “clearly marked for ‘Emergency Use Authorization.” And the vaccine “is authorized to be distributed, stored, further redistributed, and administered by emergency response stakeholder when packaged in the authorized manufacturer packaging (i.e., vials and cartons) despite the fact that the vial and carton labels may not contain information that otherwise would be required under the FD&C Act.”

Basically, the Food, Drug, and Cosmetics Act prohibits the selling of mislabeled drugs. This authorization letter allows selling the vaccine even though it does not have the full license label. But label or not, it is the same vaccine. And that vaccine is now licensed, even if some stock with a different label remains. 

FDA’s press release makes it clear that “[t]he vaccine .. known as the Pfizer-BioNTech COVID-19 Vaccine … will now be marketed as Comirnaty” – it’s the same vaccine. The basis for regulatory approval talks of “COMIRNATY (also referred to as BNT162b2 in this document)” – and BNT162b2 is the EUA vaccine. The same document makes it clear that the EUA was a step on the way to approval of the same vaccine.

Given this, when the anti-vaccine article claims that “While the media has trumpeted that the FDA has approved COVID vaccines, the FDA has not approved the Pfizer BioNTech vaccines,” it is incorrect, intentionally or not. 

Finally, accepting the anti-vaccine interpretation – that once a vaccine that was under a EUA was licensed, the previous stock remains “experimental” and cannot be used the way a licensed vaccine can – is problematic given the purpose of the EUA provisions.

The EUA provisions – initially the Project Bioshield Act of 2004 – were created to allow the use of products faster during an emergency. They balance speed and thoroughness of review, but their entire goal was to allow products to be available without delays during an emergency where the time of a full FDA review is considered too costly (in lives and harms).

An interpretation that suggests that licensing a EUA vaccine means the use of previous stock provided under a EUA is more limited would incentivize throwing out EUA stock – having less of a product, when the entire goal of the EUA provisions was to make products available in a crisis. Licensing a EUA vaccine means that the product now – since it was licensed – meets the high bar of safety and effectiveness vaccines are held to. It suggests the EUA vaccine is very safe and should be used. The anti-vaccine interpretation would undermine that.

Photo by Priscilla Du Preez on Unsplash

Vaccine licensing conclusion

The anti-vaccine interpretation that the vaccine currently used is not licensed cannot stand. It is, at its core, disinformation aiming to mislead people into not vaccinating, and trying to provide a way for the anti-vaccine activists to keep alive cases based on the legal claim that licensing a EUA vaccine is rendered moot. It should be rejected. 


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Dorit Rubinstein Reiss
This article is by Dorit Rubinstein Reiss, Professor of Law at the University of California Hastings College of the Law (San Francisco, CA), is a frequent contributor to this and many other blogs, providing in-depth, and intellectually stimulating, articles about vaccines, medical issues, social policy and the law. 

Professor Reiss writes extensively in law journals about the social and legal policies of vaccination. Additionally, Reiss is also member of the Parent Advisory Board of Voices for Vaccines, a parent-led organization that supports and advocates for on-time vaccination and the reduction of vaccine-preventable disease.