Today, 23 August 2021, the Pfizer/BioNTech COVID-19 mRNA vaccine received full FDA approval for individuals 16 years and older. This should stop the claim by anti-vaxxers claimed that these vaccines were “experimental,” because they had an Emergency Use Authorization (EUA) in the USA and other countries, despite the fact that the EUAs required just as rigorous analysis as a typical New Drug Application.
Let’s examine what this Pfizer COVID-19 vaccine FDA approval means practically.
The Pfizer COVID vaccine FDA approval
According to the FDA,
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. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
As I mentioned in the introduction, this vaccine is approved for those 16 years of age and older. However, for those individuals between 12 and 15 years, the EUA is still in effect.
FDA-approved vaccines undergo a standard process for reviewing the quality, safety, and effectiveness of medical products, which I described in detail previously. For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a Biologics License Application (BLA). A BLA is a comprehensive document that is submitted to the agency providing very specific requirements.
For the Pfizer COVID-19 vaccine, the BLA submission to the FDA builds on the extensive data and information previously submitted that supported the EUA, such as preclinical and clinical data and information, as well as details of the manufacturing, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made.
The FDA conducts its own analyses of the information in the BLA to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.
The Pfizer vaccine contains messenger RNA (mRNA) which is used by the body to produce the S-proteins in the SARS-CoV-2 virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will attack the virus and prevent COVID-19. The mRNA in this vaccine is only present in the body for a short time and is not incorporated into – nor does it alter – an individual’s genetic material.
As you might be aware, the EUA was used as a legal argument to block mandates, although it found little success in Federal courts. Basically, these people attempted to use the EUA as an argument that the vaccines were “experimental,” so mandating them is both unethical and illegal.
Regardless of these ridiculous arguments, the Pfizer COVID-19 vaccine received as thorough of a review during the EUA process as it did during the recent FDA review for full approval. In other words, the EUA was not some sped-up, cursory review, it was thorough with dozens of vaccine scientists involved in reviewing the data.
But now, there is no excuse, the Pfizer COVID-19 vaccine has full FDA approval. And in an article by Professor Dorit Rubinstein Reiss and Arthur L Caplan, this approval “demolishes” one of the last remaining arguments against a mandate.
According to Reiss and Caplan:
Several states have moved to mandate vaccines, as have some employers. But others hesitated, in part because there is legal uncertainty around whether it is legal to mandate vaccines under an EUA. We believe—and the only court to address this so far agreed—that it is legal to mandate vaccines under an EUA. But that’s no longer relevant. With FDA licensure, that question is moot.
The vast majority of current lawsuits challenging vaccines mandates focused on the EUA status of these vaccines. Well, they are no longer all under EUA. Claims against university and employer mandates for licensed vaccines are few. Most of them are focused on whether a denial of a specific exemption was legitimate, rather than on the legality of the entire mandate. In some places, unions may be able to challenge vaccines mandates not negotiated with them, but not in all. Ultimately, licensure removes the strongest argument mandate opponents had.
It is time to move. Delta is raging. People are dying. Vaccines are not the only tool we need to use, but are a key part of our arsenal. We need to use them. We need vaccines mandates for every profession working with a vulnerable population—nursing homes, prisoners, hospitals, children in school, the disabled and daycares. If any of those workers are not willing to vaccinate, they should not be allowed to interact with their vulnerable charges. Political barriers are not a good reason to allow staff to infect their charges. We applaud the federal government’s and several states’ move to require vaccines for their employees. We hope more states will follow. Public servants should not allow themselves to be disease vectors because of misinformation. Covid-19 vaccines are safe, effective, and now licensed. We should quickly deploy them to support other measures and stop Covid-19 once and for all.
So, this pretty much destroys this argument used by anti-vaxxers. And because the Moderna vaccine is so similar to the Pfizer one, we can expect a similar full approval.
Even a number of US soldiers filed a lawsuit to prevent mandatory COVID-19 vaccinations. If you didn’t know, US soldiers, almost at the first step after joining, are given every vaccine you could imagine, including ones for diseases like anthrax that aren’t available to us civilians. And there are no religious or personal belief exemptions. And there are no medical exemptions because any medical exemption would probably be a reason to discharge the soldier, sailor, or Marine from the service.
I told a discussion with someone who didn’t want to get vaccines after he had joined the Army. He wanted to argue with the Army that the vaccines were dangerous and useless, typical anti-vaxxer nonsense. I explained to him that this wasn’t a choice – if he didn’t get the vaccines, he would be discharged from the US Army. The Army wants smart, healthy young adults, and someone who had no logical evidence that vaccines were neither safe nor effective, would not be the type of soldier that they wanted.
At any rate, the US Secretary of Defense has stated that all servicemen and women would be vaccinated with the Pfizer COVID-19 vaccine since it now has full FDA approval. These are orders from the top, and not following those orders is a violation of the law. Again, the military wants healthy soldiers and sailors, not ones that are in danger of COVID-19.
This is great news for the battle against COVID-19. There are lots of people who were legitimately on the fence until the vaccine received full approval. For most of us, of course, the EUA was just as valid as a full FDA approval for the Pfizer COVID-19 vaccine, but if you aren’t into the weeds about regulations regarding vaccines, it may have seemed that the EUA was something a lot less than full FDA approval.
For now, this empowers employers and governments to move full steam ahead with mandated vaccines. And that’s good news.
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