This week, most sources rushed to announce the approval of the Pfizer vaccine. However, it appears that due to a bit of a bait and switch and lack of digging, what we all understood was approved may not have been. But nobody has chosen to correct the narrative on mainstream media.
So, what came out on Monday? In reading the FDA press release with fresh eyes, we can see that the approval was issued to Pfizer’s partner BioNTech Manufacturing GmbH.1 The formulation that has been known commonly as the Pfizer BioNTech vaccine will now be marketed as Comirnaty by BioNTech.1 The current vaccines available in pharmacies are still the same ones that are authorized under EUA (emergency use authorization). The newly approved Comirnaty hasn’t been produced yet. In fact, the license grants BioNTech the authorization to manufacture the vaccine that their partner, Pfizer, had manufactured previously.2 In a letter to Pfizer, the FDA said that Comirnaty and the previous vaccine, still available under EUA, can be used interchangeably. However, there are consequences.3
In a letter to Pfizer from the FDA on the date of approval:
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.2
Vaccines under EUA have a liability shield, protecting the manufacturer from lawsuits due to injury or death. With licensure, the liability shield is no longer relevant. In reality, what’s been commonly known as the Pfizer vaccine can be used in the place of a licensed product, while remaining under the liability shield. Once the vaccine is added to the childhood vaccination schedule, it, again, would receive a protective status.
Approved, Yet Without Data to Prove Safety
While which vaccine has been approved has been portrayed in a questionable way, we also know that the process and data used was also questionable. In fact, according to the approval letter:
The review of this product was associated with the following National Clinical Trial (NCT) numbers: NCT043687284 and NCT043807015.
No data has been reported to the clinical trial set yet. Estimated study completion dates are estimated to be completed in May and April of 2023 respectively.4,5
The Licensure also requires further testing in specific groups. Final research data will be due between 2021-2026.2 There are three studies related to pediatrics that must be, but are yet to be, completed:
- Pediatrics aged 12-15 to be completed May of 2023. Reports to be submitted October 31, 2023.2
- Pediatrics 6 months <12 years to be completed November of 2023. Reports to be submitted May 31, 2024.2
- Pediatrics <6 months to be completed July of 2024. Reports to be submitted October 31, 2024.2
There are six studies regarding myocarditis and pericarditis that will proceed from current through 2026.2 One study relating to pregnancy and infant outcomes runs through June of 2025 with reports submitted by December 31, of 2025.2
The approval and licensure on the Comirnaty product is for people aged 16 years and over. The EUA on the Pfizer BioNTech remains in effect for those 12-15 years and as a booster for those with compromised immune systems.1,2