Moderna approval another bait and switch | Eastern NC Now

The U.S. Food and Drug Administration (FDA) on Monday granted full approval of Moderna’s Spikevax COVID vaccine for people 18 and older.

Similar to the agency’s licensing last year of Pfizer’s Comirnaty vaccine, the approval raised a number of legal questions related to mandates and product availability.

Spikevax is a two-dose primary series, approved also for administration as part of a heterologous (“mix and match”) single booster dose for individuals who previously completed their original series of vaccinations with the Pfizer or Johnson & Johnson COVID vaccines.

According to the FDA, Spikevax “has the same formulation as the [Emergency Use Authorization (EUA)] Moderna COVID-19 Vaccine and … can be used interchangeably with the EUA Moderna COVID-19 Vaccine to provide the COVID-19 vaccination series.”

However, in its approval letter, the FDA said Spikevax is “legally distinct” from the Moderna EUA vaccine:

“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.”

The FDA made the same distinction between the Pfizer-BioNTech EUA vaccine and the Pfizer Comirnaty vaccine, which the agency fully licensed in August, 2021, a move that raised questions about liability and the legality of vaccine mandates.

After Monday’s announcement, media outlets were quick to reassure the public the two Moderna vaccines are the same and that this was just a marketing ploy, where Moderna simply “rebranded” what is otherwise the same vaccine.

No ‘fully licensed’ COVID actually available

While Moderna’s Spikevax vaccine is now fully licensed, the original Moderna vaccine will remain under EUA. Indeed, the FDA on Jan. 7 reissued the EUA.

The FDA has also made it clear the Spikevax vaccine will not be available to the American public, announcing:

“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.”

These claims parallel the chain of events that followed the FDA’s full approval of the Pfizer Comirnaty vaccine in August 2021.

At the time, Pfizer and the FDA claimed Comirnaty was not yet available, as there were sufficient stocks of the Pfizer-BioNTech EUA vaccine still available to be administered.

As of this writing, the FDA states, via its website, that Comirnaty products are “not orderable at this time.”

The FDA has not indicated when, or if, the Spikevax and Comirnaty vaccines will be available for distribution in the U.S.

https://childrenshealthdefense.org/defender/fda-full-approval-moderna-spikevax-covid-vaccine/

Even "approved" have not had full testing for long term side effects.  Normally it takes 10 or more years for all the testing to be finished to even be considered for approval.  Something very fishy is going on with these covid injections approvals, IMO.