What is the difference between the Pfizer BioNTech vaccine that we have been using since last December and the new Comirnaty vaccine that was FDA approved in August?
Brand name – and nothing else.
Because full approval has not yet been granted for the Pfizer-BioNTech vaccine for children any product labeled Comirnaty will have a package insert to be used for age 16 and over. However, The FDA has stated that:
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.”
In other words all persons age 12 and above can receive either the Pfizer-BioNTech labeled product or the newer Comirnaty product.
The manufacturing process of the newly branded Comirnaty vaccine is identical to that of the vaccine prior to approval. In fact it must be by law. Part of the approval process is very detailed review and approval of the manufacturing process to make sure that the product is consistent and free of contaminants. A company could not change that process at the time of approval without FDA approval.
It is very typical in the pharmaceutical world that products don’t get a brand name until full FDA approval. Up until approval most products, vaccines or medications may have a generic name and often an internal name that is used by the company from the onset of development. Those names are often just numbers and letters assigned with no mind toward the external market or marketing in general. In fact, the actual name of the Pfizer product in all EUA materials is BNT162b2. However, in the media, names like this don’t fly so the public just adopts the name of the company as the name of the vaccine. Companies cannot market a product until full FDA approval is granted, in part because part of the full approval is approval of marketing materials as well. Once a drug or vaccine is approved however, then the company wants a brand name that it can market.
Where did Pfizer get the name Comirnaty? Start with its pronunciation. “koe-mer’-na-tee”. It is pronounced like the word community and if you notice the letters mRNA are embedded in the name. It also invokes COVID and sounds a bit like the word immunity. Only marketers would come up with that. I think we can expect aggressive marketing soon, riffing off of the community theme. At some point soon we will also see FDA approval of the Moderna COVID vaccine – Spike-vax, less cutesy and more descriptive of what the mRNA in the vaccine codes for – a facsimile of the COVID spike protein.
Written by: Wouter J. Rietsema MD