Another FDA Shell Game: FDA Approves A Moderna Vaccine That Is Not In Production Immediately After Moderna Stock Plummets

Oops, they did it again.

This will come as no surprise to readers of The Conservative New Mexican‘s COVID Counterpunch, because we brought you the story of the Comirnaty vaccine licensure back in August.

On Monday, the U.S. Food and Drug Administration (FDA) once again fully licensed a vaccine that doesn’t exist.

The vaccine, made by Moderna and marketed as Spikevax, is authorized for the “prevention of COVID-19 for individuals 18 years of age and older.”

Spikevax, just like Comirnaty, will not be available for an indefinite period of time. (Not surprisingly, that information is buried in the footnotes.)

“Although SPIKEVAX (COVID-19 Vaccine, mRNA) and Comirnaty (COVID-19 Vaccine, mRNA) are approved to prevent COVID-19 in certain individuals within the scope of the Moderna COVID-19 Vaccine authorization, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA.”

https://www.fda.gov/media/144636/download

But no worries, citizens! Just like last time, the FDA assures us that the products are mostly the same as regular Moderna vaccine, even if “legally distinct.”

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.

https://www.fda.gov/media/144636/download

This legal distinction “with certain differences” is the most important part.

Any vaccine under Emergency Use Authorization (EUA) is immune from liability. You can’t sue the manufacturer if you are injured.

A licensed vaccine carries no such immunity for the manufacturer: they are liable if you are injured by their product.

That is, of course, unless you make them unavailable indefinitely, or at least until they can be put on the regular childhood vaccine schedule.

The National Childhood Vaccine Injury Act, which was passed into law in 1986, provides a legal liability shield to vaccine manufacturers if they receive full authorization by the FDA.

Once a vaccine is placed on the childhood schedule, it is shielded from liability for all ages.

Are Pfizer and Moderna waiting to produce Comirnaty and Spikevax until they receive approval for the childhood schedule?

Right now they enjoy complete immunity under the EUA, so long as the labels on their products don’t say “Comirnaty” and “Spikevax.” 

Why wouldn’t they want to continue making their “approved” products unavailable until they too have immunity from liability?

Maximum profit and no responsibility seems like a great deal. 

A deal that our own government is giving them. Moderna, like Pfizer, can market their vaccines as “approved by the FDA,” making people believe they’re safe even though there is no supply of the FDA-approved versions of these vaccines.

Post script: I’m sure the timing of the Moderna approval had absolutely nothing to do with their cratering stock value.

Source: Dr. Grauci, The Conservative New Mexican