The Road to Comirnaty: FDA, EUA, BLA, OMG!

FDA Approval and Alphabet Soup

Use of the Pfizer-BioNTech COVID‑19 vaccine in individuals ages 16 and up was granted full approval by the U.S. Food and Drug Administration (FDA) on Monday, August 23, 2021. Additionally, use in children ages 12-15 is still authorized under the previously-issued Emergency Use Authorization (EUA). This approval has led to several questions, and has been further confused by the vaccine's name change to Comirnaty (pronounced "co-meer-nit-E").

Important Abbreviations and Definitions

U.S. Food and Drug Administration (FDA): The FDA is the government agency responsible protecting and promoting public health through the regulation and approval of medical interventions such as drugs, vaccines, and medical devices.

FDA Approval: Medical interventions such as drugs, vaccines, and medical devices are required to be evaluated for safety and efficacy and approved by the FDA before they can be marketed, advertised, or sold.

Emergency Use Authorization (EUA): The FDA has the power to issue EUAs during public health crises. As explained in my earlier post, "COVID‑19 Vaccine Q&A," EUAs permit the use of unapproved medical interventions, allowing the "red tape" of getting full approval to be temporarily skipped. When seeking an EUA rather than full approval, manufacturers are permitted to let trial phases overlap rather than having one trial at a time, and they are allowed to begin mass manufacture of the product before being granted approval. The FDA still requires clinical trials and rigorous evidence of a treatment's safety and efficacy before it will grant an EUA, but the trial data review can "skip the line" ahead of any other pending approvals and required minimum times can be bypassed if doing so is deemed appropriate. EUAs do not authorize manufacturers to engage in direct-to-consumer marketing, such as television ads and billboards, nor do they authorize the marketing of products to care providers.

Biologics License Application (BLA): Biologic agents ("biologics") such as vaccines, antibodies, and certain hormones like insulin are regulated by the FDA and are required to undergo testing to ensure that they are safe and effective. Manufacturers of biologic agents must file BLAs and prove the safety and efficacy of their biologics before receiving approval to market, advertise, and/or sell these products.

New Drug Application (NDA): Drugs are regulated by the FDA and are required to undergo testing to ensure that they are safe and effective. Manufacturers of drugs must file NDAs and prove the safety and efficacy of their drugs before receiving approval to market, advertise, and/or sell these products.

Name, please...

Comirnaty is the trade name (aka proprietary or brand name) for the Pfizer-BioNTech COVID‑19 vaccine. It's not that the vaccine's name "changed," rather, it finally has a name. Remember, the COVID‑19 vaccines were initially released using Emergency Use Authorizations, so the "fluff" like coming up with names was originally skipped over. Here's a table showing the relationships between manufactures, generic names, and trade names:

Manufacturer	Class	Generic Name	Trade Name	Colloquial Name
Kimberly-Clark	paper product, disposable	facial tissue	Kleenex
Hostess	pastry, dessert	golden sponge cake with creamy filling	Twinkie
Johnson & Johnson	anti-inflammatory, NSAID	ibuprofen	Motrin
Eli Lilly	insulin, short-acting	insulin human injection	Humulin R	"insulin"
Sanofi Pasteur	vaccine, inactivated virus	influenza virus vaccine, trivalent	Fluzone	"flu shot"
GSK	vaccine, recombinant subunit	zoster vaccine recombinant, adjuvanted	Shingrix	"shingles vaccine"
Pfizer-BioNTech	vaccine, RNA	COVID‑19 vaccine, mRNA¹	Comirnaty	"Pfizer COVID vaccine"
Moderna	vaccine, RNA	COVID‑19 vaccine, mRNA²	Spikevax³	"Moderna COVID vaccine"
Janssen	vaccine, viral vector	COVID‑19 vaccine, adenoviral vector⁴	TBA⁵	"J&J COVID vaccine"
¹ Referred to as BNT162b2 in clinical trials. Also known as tozinameran in other regions of the world. ² Referred to as mRNA-1273 in clinical trials. Also known as elasomeran in other regions of the world. ³ FDA licensure for the Moderna COVID‑19 vaccine is pending and it cannot be marketed as Spikevax until full approval has been granted. ⁴ Referred to as Ad26.COV2.S in clinical trials. ⁵ Johnson & Johnson/Janssen has not yet filed for FDA licensure of their COVID‑19 vaccine, nor have they announced a trade name for marketing.

Comirnaty was co-developed by two companies: American pharmaceutical company Pfizer and German biotechnology company BioNTech. Something that is furthering the confusion is the fact that the EUAs were issued to Pfizer, but the license granting full FDA approval has been issued to BioNTech. BioNTech is a significantly smaller company than Pfizer; BioNTech had the biotechnology experts (including mRNA vaccine pioneer Dr. Katalin Karikó) necessary to develop the vaccine, but Pfizer had more financial assets, manufacturing facilities, and overall staff. Such being the case, BioNTech did most of the scientific development of the vaccine while Pfizer handled most of the manufacturing, distribution, and paperwork. Notice how both companies are shown on the original EUA labeling as well as the newly approved labeling:


Links: Pfizer's EUA Fact Sheet (page 8), Comirnaty Package Insert (page 20)

Pfizer is still doing the manufacturing and BioNTech is still the lead - they're just listed in a different order now that BioNTech's legal team has had enough time to handle the paperwork themselves. Whether you've been calling it "the Pfizer vaccine," "the BioNTech vaccine," or "the Pfizer-BioNTech vaccine," it's all the exact same vaccine which is now being marketed as Comirnaty.

This will Happen Again

I don't expect nearly as much confusion when the Moderna COVID‑19 vaccine is granted FDA approval, as Moderna has handled almost everything "in-house." However, I fully expect that this confusion will repeat when the Johnson & Johnson/Janssen COVID‑19 vaccine gains FDA approval, as it was developed and is manufactured by Janssen, but it is distributed in the United States by Johnson & Johnson. Janssen is a Netherlands-based biotechnology company that is owned by the American company Johnson & Johnson. Oh, the technicalities...