The Comirnaty vaccine just received full FDA approval, but many people online are pointing out that small print found in FDA documents describes the Pfizer-BioNTech COVID-19 vaccine as “legally distinct” from the Comirnaty vaccine. A representative from Pfizer talked to Heavy about the “legally distinct” wording.
A Pfizer Representative Said the 2 Vaccines Have the Same Ingredients
Heavy reached out to Pfizer after news began circulating that the FDA has pointed out that the Comirnaty vaccine, which received FDA approval, and the Pfizer-BioNTech COVID-19 Vaccine, which has emergency use approval, are listed as being “legally distinct.”
A Pfizer representative told Heavy:
In terms of its ingredients and how it is made, the vaccine being approved for those 16 years and older is no different from the vaccine that has been administered to millions of Americans to date under the EUA.
The representative also told Heavy that the manufacturing process is the same. The products with the EUA authorized label will still be used until their expiration date, if storage conditions are followed.
The representative wrote to Heavy:
The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the EUA authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series. The Pfizer-BioNTech COVID-19 EUA labeled product will still be shipped and usable until its expiry date, as long as authorized frozen storage conditions have been maintained.
The manufacturing process does not change – and as such, we foresee no delays in shipments as a result of this approval.
When Comirnaty received full FDA approval, the FDA noted in a press release: “The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty… 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.”
Under the FDA’s Vaccine Information Fact Sheet for Recipients and Caregivers, which covers both Comirnaty and the Pfizer-BioNTech COVID-19 Vaccine, the FDA notes: “The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under Emergency Use Authorization (EUA) have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.”
However, a footnote at the bottom of the fact sheet, issued on August 23, does note: “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.”
Pfizer confirmed with Heavy that those differences do not involve vaccine ingredients or how the vaccines are made. Heavy asked for confirmation that the “certain differences” only involve labeling.
Pfizer responded and reiterated to Heavy that in terms of being “legally distinct with certain differences,” the FDA-approved Comirnaty vaccine and the EUA-authorized Pfizer-BioNTech COVID-19 vaccine have the same ingredients and are made using the same processes. Safety and effectiveness are the same, Pfizer noted.
The phrase “legally distinct with certain differences,” the representative said, simply refers to differences in the documentation included in the separate regulatory submissions for emergency use authorization and full approval. For example, the submissions may have indicated different manufacturing locations or different approved materials suppliers. They emphasized that an FDA review found the EUA-authorized and FDA-approved products are equivalent. The Pfizer representative noted that this is all actually common for licensed vaccines.
The FDA did not respond to Heavy’s inquiry for comment.
‘Comirnaty’ Was a Name Created by a Branding Agency
According to the FDA, “Comirnaty” is pronounced “koe-mir’-na-tee.” It was created by a branding agency, CNN reported, and is a combination of “COVID-19 immunity” and “mRNA,” intending to remind people of the word “community.”
The name’s actually been around for a while, just not in the United States. A December 2020 article by Fierce Pharma noted that Comirnaty was approved by Swiss and European regulators, and was created by the naming agency Brand Institute.
Scott Piergrossi, Brand Institute president of operations and communications, told Fierce Pharma: “The name is coined from Covid-19 immunity, and then embeds the mRNA in the middle, which is the platform technology, and as a whole the name is meant to evoke the word community.”
The companies had also considered the names Covuity, RnaxCovi, and Kovimerna, along with RNXtract. Those names were filed with the U.S. Patent and Trademark Office.
Approval for the vaccine came after the FDA followed about 12,000 clinical trial participants for at least six months.
Pfizer will continue studying rare myocarditis side effects along with pregnancy and infant outcomes, the FDA noted in its press release.