Bait-and-switch me one more time...
Moderna's COVID-19 Vaccine FDA "approval"
Moderna finally did it! Years of plodding away and billions of dollars of investment paid off. They have their first FDA-approved product on the market in the U.S.
…Or do they?
“Bait and switch is a morally suspect sales tactic that lures customers in with specific claims about the quality or low prices on items that turn out to be unavailable in order to upsell them on a similar, pricier item. It is considered a form of retail sales fraud, though it takes place in other contexts.”1
Keeping this in mind, let’s look a little deeper. From the updated Moderna COVID-19 Vaccine Letter of Authorization2 dated January 31, 2022:
“Condition Related to Export
AA. If the product is exported from the United States, conditions C, D, and P through Z do not apply, but export is permitted only if 1) the regulatory authorities of the country in which the vaccine will be used are fully informed that this vaccine is subject to an EUA and is not approved or licensed by FDA and 2) the intended use of the vaccine will comply in all respects with the laws of the country in which the product will be used. The requirement in this letter that the authorized labeling (i.e., Fact Sheets) be made available to vaccination providers, recipients, and caregivers in condition A will not apply if the authorized labeling (i.e., Fact Sheets) are made available to the regulatory authorities of the country in which the vaccine will be used.
Conditions With Respect to Use of Licensed Product
BB. SPIKEVAX (COVID-19 Vaccine, mRNA) is licensed for individuals 18 years of age and older. There remains, however, a significant amount of Moderna COVID-19 Vaccine that was manufactured and labeled in accordance with this emergency use authorization. This authorization remains in place for Moderna COVID-19 Vaccine for this population.” <emphasis added>
It would seem that our “significant amount” of Moderna EUA vaccine makes us fall into “this population.”
According to Fauci on “Morning in America” as of Dec. 30, 2021 (transcript below or watch the video clip to hear him get defensive):
Bankert: …We had so many people ask about Covaxin.
Fauci: We have enough vaccines, the best vaccines available, in the United States. I’m puzzled by that question. We have more vaccines than we need right now. We just need the people to get vaccinated with the vaccines that we have. The mRNA vaccines are desired by everyone else in the world. So we have what we need; we need to use it.
Bankert: Are you opposed to alternative treatments?
Fauci: What do you mean alternative? It’s not an alternative. It’s another vaccine. We don’t need another vaccine; we have plenty of vaccines, they have not applied to get approved…
Editor’s note – Covaxin was submitted for FDA emergency authorization this fall. After the interview, Dr. Fauci offered this statement: Bharat Biotech, the company that has developed Covaxin, has applied to the FDA for an emergency use authorization (EUA) for their vaccine. The FDA is currently evaluating the data and no decision has been made.”3 <emphasis added>
(Note that he lied in the initial interview when he said they had not applied for approval)
So clearly, our mRNA vax stockpiles are overflowing. And if they weren’t, they clearly state that the product is not approved or licensed by the FDA if it is exported…?!
By keeping the EUA designation, they basically keep the most invincible, near-perfect liability protection under the PREP Act (vs. under the Vaccine Act).4
The acting FDA Commissioner Janet Woodcock, M.D. stated, “While hundreds of millions of doses of Moderna COVID-19 Vaccine have been administered to individuals under emergency use authorization, we understand that for some individuals, FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated.”
The “approval” is for appearances, while really nothing has changed in the vial or the EUA designation. Hiding in plain sight again, but only if you read the fine print. Further in the fine print we see that this “approval” only applies to those 18 and older receiving the 2-dose series. Boosters of any kind are also still EUA.
This is identical to what was done for Pfizer’s approval back on August 23, 2021:
“Conditions With Respect to Use of Licensed Product
AA. COMIRNATY (COVID-19 Vaccine, mRNA) is now licensed for individuals 16 years of age and older. There remains, however, a significant amount of PfizerBioNTech COVID-19 vaccine that was manufactured and labeled in accordance with this emergency use authorization. This authorization thus remains in place with respect to that product for the previously-authorized indication and uses (i.e., for use to prevent COVID-19 in individuals 12 years of age and older with a two-dose regimen, and to provide a third dose to individuals 12 years of age or older who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise).”5 <emphasis added>
Same thing for Pfizer boosters and the younger age groups- all EUA.
And the clock was ticking on the Biologics License Application (BLA) decision. The BLA was submitted Aug. 25, 2021.6 Given that the FDA gave it “Priority review” status,7 the 6 month deadline was right around the corner. Let’s remember a finding from a 2017 study on the safety of FDA-approved products:
“…the FDA approves drugs faster than its counterpart agency in Europe does and that the majority of pivotal trials in drug approvals involved fewer than 1,000 patients and lasted six months or less.
It took a median of 4.2 years after the drugs were approved for these safety concerns to come to light, the study found, and issues were more common among psychiatric drugs, biologic drugs, drugs that were granted "accelerated approval" and drugs that were approved near the regulatory deadline for approval.”8
This would seem “near the regulatory deadline for approval” to me? We’ve already had some safety warnings added (myocarditis and pericarditis, blood clotting9). What further mysteries might unfurl over the next 3 years and beyond?
When you hear “Moderna’s approved!” or “Spikevax is approved,” you’ll know what that really means.
Kind of like “Fact check” translates to opinion.10 And “vaccine” translates to a preparation causing immune response. And “safe and effective” translates to “we won’t know… unless we start giving it.”11
Thanks for instilling that confidence, FDA.
* From page 2 of Facebook’s court filing, regarding use of the label fact check:
“The labels themselves are neither false nor defamatory; to the contrary, they constitute protected opinion.”(9)
** CDC changing the definition of vaccine and vaccination Sept. 2021:
“Before the change, the definition for “vaccination” read, “the act of introducing a vaccine into the body to produce immunity to a specific disease.” Now, the word “immunity” has been switched to “protection.” The term “vaccine” also got a makeover. The CDC’s definition changed from “a product that stimulates a person’s immune system to produce immunity to a specific disease” to the current “a preparation that is used to stimulate the body’s immune response against diseases.”12