Did FDA Approve the Pfizer COVID Vaccine?

Yesterday’s FDA news release plainly says that the COVID vaccine that has been known as the Pfizer-BioNTech COVID-19 Vaccine has earned FDA approval and will now be known as COMIRNATY. So why were two letters issued by the FDA yesterday?

The approval letter, addressed to Amit Patel of BioNTech Manufacturing GmbH and delivered to Pfizer Inc. in New York, lists the conditions of approval, which include permission to the label the vaccine with the proprietary name COMIRNATY and permission to use the product to vaccinate individuals 16 years of age and older.  The letter defers approval for use of the vaccine in individuals younger than 16 years of age, and it does not approve the administration of a booster shot.  

On page 2, this letter states, “We did not refer your application to the Vaccines and Related Biological Products Advisory Committee because our review of information submitted in your BLA, including the clinical study design and trial results, did not raise concerns or controversial issues that would have benefited from an advisory committee discussion.”  The letter then continues to outline deadlines for the submission of a list of outstanding items, some of which might be considered controversial.  Here are a few that caught my eye:

• A study to evaluate whether the vaccine can safely and effectively be administered in a lower dose to individuals 12 to 29 years of age, due in 2023.
• A study to evaluate the safety of vaccine in pregnancy, including possible birth defects, due in 2025.
• Various studies to assess myocarditis and pericarditis after administration of vaccine, due between 2022 and 2026.
• A study to assess the safety and effectiveness of the vaccine in children 12-15 years of age (spring 2023), 6 months to <12 years of age (fall 2023), and children <6 months of age (summer 2024).

The approval letter also specifies deadlines for submission of final content of labeling “as soon as possible, but no later than 14 days from the date of this letter,” and proposed advertising and promotional labeling “before initial dissemination.”  

The second letter, addressed to Ms. Elisa Harkins of Pfizer Inc. in Pennsylvania, is a revision of the Emergency Use Authorization for the Pfizer-BioNTech COVID-19 Vaccine.   While this letter acknowledges Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY are biologically equivalent and can be used interchangeably, it creates a legal distinction between them.  This letter authorizes the continued use of Pfizer-BioNTech COVID-19 Vaccine and, when it is available, COMIRNATY in children between 12 and 15 years of age.  It also authorizes administration of either vaccine in a third dose (“booster”) to certain immunocompromised individuals.  It further permits Pfizer to continue to provide Pfizer-BioNTech COVID-19 Vaccine (but not COMIRNATY) to individuals 16 years and older under emergency use authorization until Pfizer’s inventory is consumed.  All product labeled Pfizer-BioNTech COVID-19 Vaccine will “clearly and conspicuously state that it has not been approved or licensed by FDA.”  Even though the vaccines are the same, if you get one labeled “Pfizer-BioNTech COVID-19 Vaccine”, you are not getting an approved vaccine; if you get the one labeled “COMIRNATY”, you may be, as long as you’re at least 16 years old and getting your first or second shot.

Yesterday I said that if the FDA short-circuited its rigorous approval process, the results would be deadly.  I am not accusing the FDA of doing so; I am not an expert in FDA procedures.  But I think we can agree that this approval is complicated, that some information we would all like to see is missing, and that much of that missing information won’t be available any time soon.