The Food and Drug Administration (FDA) on Monday granted full approval of Moderna’s COVID-19 vaccine — except the vaccine it approved currently does not exist and will not be distributed to anyone in the U.S. for the foreseeable future. (Yes, we’ve seen this before.)
The agency granted full approval to a vaccine called “SPIKEVAX” which it claimed is “interchangeable” but “legally distinct,” from the “Moderna COVID-19” vaccine in an effort to shield the biotech giant from liability for potential harms caused by its product.
“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 press release Monday.
The Moderna COVID-19 vaccine will remain under Emergency Use Authorization (EUA), which was reissued on Jan. 7.
Buried in the small print of its approval letter, the FDA said Spikevax and Moderna’s COVID vaccine currently licensed under EUA are “legally distinct” products, with “certain differences that do not impact safety or effectiveness.”
This was the same disclaimer given when the FDA approved Pfizer’s Comirnaty, which has never seen the light of day in the U.S.
Just like the Pfizer “approval” fiasco, this vaccine will not be available to anyone for an indefinite and unspecified period of time.
“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.”
What this means is that people will be given a product that they think is fully approved, while actually receiving an experimental vaccine only authorized for emergency use, as SPIKEVAX does not physically exist.
Furthermore, the FDA stated SPIKEVAX has not been approved or tested with the Omicron variant — which currently accounts for 99.9% of COVID infections in the U.S. — thus it was approved based on former mutations that longer exist in circulation. The same applies to the version of Moderna’s COVID vaccine that will remain under an EUA that was recently reissued.
Under 21 U.S. Code Sec.360bbb-3(e)(1)(A)(ii)(III), “authorization for medical products for use in emergencies,” it is unlawful to deny someone a job or an education because they refuse to be an experimental subject. Instead, potential recipients have an absolute right to refuse EUA vaccines.”
U.S. laws, however, permit employers and schools to require students and workers to take licensed vaccines.
Comirnaty was approved to allow COVID vaccines to be mandated and Pfizer-BioNTech was kept under EUA to shield the company from liability for harms caused by its product. The same is true for Moderna.
At least for the moment, Moderna’s fully licensed SPIKEVAX has no liability shield. Vials of the branded product, which say “SPIKEVAX” on the label, are subject to the same product liability laws as other U.S. products.
For EUA-approved COVID vaccines, the case is different. Vaccines given EUA have an impressive liability shield under the 2005 Public Readiness and Preparedness Act, which shields vaccine manufacturers, distributors, providers and government planners are immune from liability.
The only way an injured party can sue is if he or she can prove willful misconduct and if the U.S. government has also brought an enforcement action against the party for willful misconduct. No such lawsuit has ever succeeded.
Then there’s the National Childhood Vaccine Injury Act of 1986, which provides a legal liability shield to drug manufacturers if they receive full authorization for all ages.
If Moderna and Pfizer secure full approval of their COVID vaccines for children, they can distribute SPIKEVAX and Comirnaty and escape liability for the harms and deaths caused by their products. This is why you likely will not see any of the fully licensed COVID vaccines distributed in the U.S. until this occurs.
The most recent data from the CDC’s Vaccine Adverse Events Reporting System shows 1,071,856 reports of adverse events from all age groups following COVID vaccines, including 22,607 deaths and 178,994 serious injuries between Dec. 14, 2020, and Jan. 21, 2022.
Historically, VAERS has been shown to report only 1% of actual vaccine adverse events.
Same game, different day for the captured FDA.
You can read Moderna’s approval letter below.