Pfizer’s FDA Approval – What Does it Really Mean?

As you have likely heard, the FDA formally approved Pfizer’s COVID-19 vaccine this week. This allowed Pfizer to rebrand its product. The new vaccine is called “Comirnaty,” which is an unwieldly amalgamation of COVID, community, immunity, and mRNA.

According to media reports, the rebranded vaccine is identical in every way to the original vaccine. This is not true.

The FDA fact sheet on the Pfizer/Comirnaty vaccine alerts recipients that these are two separate products: “You are being offered either COMIRNATY (COVID-19 Vaccine, mRNA) or the Pfizer-BioNTech COVID-19 Vaccine to prevent Coronavirus Disease 2019 (COVID-19) caused by SARS-CoV-2.” The fact sheet notes that “The products are legally distinct with certain differences that do not impact safety or effectiveness.”

Hmmm. What does “legally distinct” mean?

First, the Pfizer brand vaccine is still being distributed under the FDA’s Emergency Use Authority (EUA), which means people have a right of refusal. The federal law states that recipients of an unapproved emergency use product (i.e., a product distributed under the EUA), “individuals to whom the product is administered [must be] informed of the option to accept or refuse administration of the product.” (21 U.S. Code § 360bbb)

This right of refusal is essential, as, according to the CDC, “Since April 2021, there have been more than a thousand reports to the Vaccine Adverse Event Reporting System (VAERS) of cases of inflammation of the heart—called myocarditis and pericarditis—happening after mRNA COVID-19 vaccination (i.e., Pfizer-BioNTech, Moderna) in the United States.” Moreover, nearly 7,000 deaths following the administration of a COVID-19 vaccine have been reported to CDC’s Vaccine Adverse Event Reporting System (VAERS) since December 2020.

Second, vaccines under the EUA are shielded from liability. If you suffer a serious adverse event as a result of the vaccine, as over 1.2 million people in the U.S. have, you have no legal recourse. All you can do is apply to the Countermeasures Injury Compensation Program, which has historically denied compensation to 96% of applicants.

On the other hand, there is no statutory opt out right for Comirnaty. Religious exemptions and accommodations are still available, but we anticipate they will be more difficult to receive and some jurisdictions may prohibit them entirely, as has happened with school-age vaccine requirements in some states.

In addition, Comirnaty is not shielded from legal liability. If you are going to get the vaccine, you may wish to specifically request Comirnaty for this reason.

While the formulation of the Pfizer and Comirnaty vaccines is identical, these are two different products.

Please contact us if you have questions about the pro-life implications of vaccines and vaccine mandates.

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