The approval facts
- Aug. 23, 2021: U.S. Food and Drug Administration (FDA) approved Pfizer’s “Comirnaty”
- It is approved only for adults over age 16.
- It is approved only for the first two doses.
Additional Emergency Use Authorization (EUA)
- For adolescents age 12 through 15
- For a third dose to certain immunocompromised who are 12 years and older
- “for logistical reasons, the EUA will continue to cover the use of the Pfizer-BioNTech COVID 19 Vaccine in individuals 16 years of age and older”
Legal distinction
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-BioNTech COVID-19 Vaccine EUA LOA reissued August 23 2021 (fda.gov)
Note that EUA vaccines
- are designated as experimental or investigational products under U.S. law
- therefore, cannot be mandated
- meaning, you have the right to refuse without consequences
- have a huge liability shield that protects everyone involved with them from being sued. So far a compensation program has approved no claims for COVID vaccine injuries.
Have your (legal) cake and eat it too
- In order to mandate a vaccine, it must be fully approved.
- Once a vaccine graduates from an EUA to a fully approved product, it loses its liability shield.
- Therefore, the FDA could not both mandate a vaccine and retain its liability shield under existing law.
- However, the FDA appears to have it both ways with the two Pfizer-BioNTech vaccines when it gives approval in an indefinitely long EUA circumstance. It does this in a fact sheet required to be given to recipients of either the approved Comirnaty or EUA vaccine.
Fact Sheet Fine Print
This EUA for the Pfizer-BioNTech COVID-19 Vaccine and COMIRNATY will end when the Secretary of HHS determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.
Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for Recipients and Caregivers (fda.gov)
WHAT IF I DECIDE NOT TO GET COMIRNATY (COVID-19 VACCINE, mRNA) OR THE PFIZER-BIONTECH COVID-19 VACCINE? Under the EUA, it is your choice to receive or not receive the vaccine. Should you decide not to receive it, it will not change your standard medical care.
Pfizer-BioNTech COVID-19 Vaccine EUA Fact Sheet for Recipients and Caregivers (fda.gov)
Legality of Mandates
Approved Comirnaty vaccine = EUA product
- This guarantees the approved Comirnaty the same liability shield as the EUA vaccine.
- But, because of the EUA status, Comirnaty cannot be mandated.
This evidence and line of thinking is key to avoid being forced to accept this jab. It is experimental, so cannot be mandated on students or employees or anyone.
- Keep this fact sheet, as it is information directly from the FDA about the legal status of vaccinations and mandates.
- The FDA says it is ‘your choice’
