Approved, just not available. So how can there be a mandate?

Aside from a host of other reasons, it appears there is no legal basis for a mandate at this time. According to the Letter of Authorization (Reissued) from the FDA to Pfizer Inc., there is not an available vaccine that is APPROVED for use. The product that was approved is labeled Comirnaty, which is stated to be the original Pfizer BioNTech product being re-labeled/remarketed “for legal reasons.” The FDA granted continued EUA (emergency use authorization) for the Pfizer BioNTech label, and approval for the Comirnaty label. However, on Page 5, in footnote 9 it states,

“Although COMIRNATY (COVID-19 Vaccine, mRNA) is approved to prevent COVID-19 in individuals 16 years of age and older, there is notsufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of the EUA. Additionally, there are no products that are approved to prevent COVID-19 in the individuals age 12 through 15, or that are approved to provide an additional dose to the immunocompromised population described in the EUA.”

So… no approved vaccine available for distribution to this population (16 and older) in its entirety at the time of this reissuance. As most of us know, you cannot mandate anything that is under EUA. Additionally, there is no one liable or accountable in the event any person receiving this EUA product suffers from any adverse effects, no matter how minimal or severe. While a pharmaceutical company can be sued for damages from FDA approved drug, such is not the case for a vaccination. Why? Because Congress passed a law in 1986 that protects vaccine manufacturers from being sued in civil personal injury and wrongful death lawsuits resulting from vaccine injuries.

However, there is another way. It’s called the Vaccination Injury Compensation Program. This is a no-fault based program whereby people claiming vaccine injuries do not have to prove that the vaccine actually caused the injury. Instead, they only have to show that the injury occurred immediately after the vaccine was given. Since the inception of the program (late 1980s), it has paid out more than $4 billion to those who said they were harmed by vaccines. 

I’m no lawyer but this seems pretty black and white to me. How can this be mandated when it is not available? Did they really think we wouldn’t read the fine print? I encourage everyone to read this letter for themselves, including the fine print, and comment if your interpretation is any different.

Another interesting read is the Approval Letter, although much of it has been redacted.


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