The shell game continues: Moderna’s 'FDA approved' vax is not available to Americans, and it's not scrutinized for Omicron

Omicron accounts for 99.9% of sequenced cases

Two FDA “approvals,” two shell games.

On Monday, the FDA “approved” Moderna’s Spikevax COVID-19 vaccine for all US customers. Just like the Pfizer “approval” episode, this vaccine will not be able for anyone for an indefinite period of time. And according to the FDA, the shot was approved without being tested for Omicron, which accounts for 99.9% of current U.S. COVID cases.

“Today, the U.S. Food and Drug Administration approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for the prevention of COVID-19 in individuals 18 years of age and older,” the FDA said in a widely-celebrated press release Monday.

The FDA noted in the small print of its approval letter that Spikevax and Moderna’s emergency use authorization shot are “legally distinct” products, adding that there are “certain differences that do not impact safety or effectiveness.” The same disclaimer was made when the FDA approved Pfizer’s Comirnaty, which has never seen the light of day in the United States.

Moreover, the FDA said that Spikevax will not be available for an indefinite period of time.

The FDA stated:

“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.”

Phil Kerpen @kerpen

Same old song

Ben M. @USMortality

They are also changing the name, just like Pfizer did: - EUA: "Moderna COVID-19 Vaccine, mRNA" - FDA approved: "Spikevax" "The vaccine has been known as the Moderna COVID-19 Vaccine, and will now be marketed as Spikevax" Guess, when the FDA approved will be available? https://t.co/h9DRsKtZ9K

And recent history tells us that the best guess for Spikevax’s availability is… probably never.

As of this writing, it has been 161 days since the FDA approved the Pfizer shot Comirnaty. When Comirnaty was approved, government health authorities and Pfizer claimed that Comirnaty was not available due to emergency use authorization shots still being in stock at pharmacies and doctor’s offices. 

Since then, nothing has changed.

Almost six months after its “full approval,” the CDC website continues to state that Comirnaty “is not orderable at this time” in the United States. 

Shell Game? There remains no FDA approved COVID vaccine in the United States

Now back to Moderna’s Spikevax for a moment.

The FDA makes it clear that Spikevax has not been approved or tested for the Omicron variant, and that it was approved for former mutations that no longer exist in circulation. This extension also applies to the EUA version of the Moderna shot.

So not only is the FDA approving what amounts to a ghost shot, they’re acknowledging that this injection may only stand to allegedly combat a strain that no longer exists. According to the most recent data, Omicron now accounts for 99.9% of sequenced cases.

CDC variant tracker website

Paradoxically, the FDA just last week cited Omicron as a reason to pull its emergency use authorization for monoclonal antibody products. With mounting evidence that the shots seemingly have zero ability to prevent COVID-19 in the Omicron era, the FDA seems to have decided to carve out a special place for Moderna and Pfizer in its regulatory scrutiny processes.

So why aren’t these FDA approved shots making their way to US customers. The answer may lie in the legal status of the shots. As I explained in The Dossier last month:

“Due to a law passed during the Reagan Administration, in order for drug makers to be granted more robust legal liability protection for their vaccines, they must first secure full approval for the children’s version of their shot.

The National Childhood Vaccine Injury Act (NCVIA), which was passed into law in 1986, provides a legal liability shield to drug manufacturers if they receive full authorization for all ages.”

Are Pfizer and Moderna waiting for full authorization for children’s shots to distribute Comirnaty and Spikevax to the masses? There’s plenty of litigators who have suggested that this is exactly what is going on in Big Pharma world.

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