Why Were Americans Not Informed of the Difference Between FDA-Approved and Emergency Use Authorization?

Some internet trolls highlight the fact that Donald Trump signed the Operation Warp Speed bill that authorized the development of COVID “vaccines.”  While that is true, the rest of the story that they conveniently ignore is truly illuminating.

To fully understand the dynamics of the COVID response from the White House, you have to begin with the Right to Try Act that President Trump signed into law on May 30, 2018.  

The Right to Try act “authorize[s] the use of unapproved medical products by patients diagnosed with a terminal illness….”  This indicates, and the subsequent text makes clear, that this act does not apply to drugs which are already on the market for any indication, as these would no longer be “investigational” or “unapproved,” and that patients with a potentially curable condition would not be eligible patients for consideration of treatment under this act.

From a National Institute of Health article:

Cancer patients who have exhausted standard treatments often seek access to investigational drugs.  Often, however, such access is unavailable, due to either the unavailability of a trial, lack of an open recruiting spot on the trial, even when the trial itself is open, or the inability of the patient to meet one or more trial eligibility criteria.  In such settings patients often seek access to investigational agents outside of a trial.  The federal ‘Right to Try’ legislation was passed to create an additional avenue, different from the FDA’s Expanded Access, or ‘Compassionate Use’ Program, through which patients might obtain access to investigational drugs.

From the FDA website:

The FDA uses its Emergency Use Authorization (EUA) authority, under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), to allow the use of unapproved medical products, or unapproved uses of approved medical products, to diagnose, treat, or prevent serious or life-threatening diseases when certain criteria are met, including that there are no adequate, approved, and available alternatives.

What the internet trolls and the corrupt left never tell you is that the unapproved medical products, under the Right to Try Act, only received EUA, and just like Operation Warp Speed, COVID 19 “vaccines” were only authorized for use (i.e., not FDA-approved) under the FDA’s Emergency Use Authorization authority.

Terminal patients were allowed access to experimental drugs, which received EUA, under Right to Try; after COVID-19 appeared, all were allowed access to experimental drugs (mislabeled, but marketed as a “vaccine”), which received EUA, under Operation Warp Speed.  Of course, one could not sue the pharmaceutical companies if the EUA drugs (COVID 19 vaccines) failed.

With Dr. Fauci as the White House’s primary spokesperson, the message to everyone was the salvation of the COVID shot. Remember: “Get the jab!”

So what is the difference between FDA approval and Emergency Use Authorization?

FDA Approval … is an independent, scientifically reviewed approval for medical products, drugs and vaccines.  Approval is based on substantial clinical data and evidence, the product is deemed safe, effective and able to be produced within federal quality standards.

…

Emergency Use Authorization (EUA) is a mechanism used by the FDA to facilitate making products available quickly during a public health emergency, when there is no other adequate and approved medical product available.

In my American Thinker article, It Was Anthony Fauci’s Fault, I provide the documented references to the development timelines for potential vaccines against what was then widely referred to as the “novel coronavirus.”

A January 22, 2020 Newsweek article on SARS-CoV2 finds Dr. Fauci quoted: “NIAID was partnering with Moderna to develop an mRNA vaccine.”

On January 31, 2020, President Trump Declares Coronavirus A Public Health Emergency And Restricts Travel From China.  

Per an LA Times article, Robert F. Kennedy, Jr. said this to Joe Rogan:

Because there’s a federal law, the emergency use authorization statute, says you cannot issue an emergency use authorization to a vaccine if there’s an existing medication that has been approved for any purpose that is demonstrated effective against the target illness.  So, they had to destroy ivermectin and hydroxychloroquine.”

(This is a declaration Kennedy has repeated on multiple occasions.)

And once that tidbit of news was injected into the corrupt media, outlets went into overdrive to destroy Kennedy; he was a “dangerous” disinformation king.

So why did the FDA suddenly proscribe and prohibit the use of proven coronavirus therapeutics and prophylaxes immediately after President Trump extolled the virtues of off-label medicines like hydroxychloroquine—see Fauci’s 2005 paper—and before any EUA “vaccines” became available?

Didn’t the left go into disinformation overdrive when it was learned that there were Texas doctors with COVID patients—some of whom were on their deathbed—and that they were being cured by, or responded to FDA-approved therapeutics after Trump asked about hydroxychloroquine?  The FDA went nuts; Fauci was apoplectic.  The “Nobel prize-honored” ivermectin became “horse paste.”

When the “vaccines” became available, immediately after Trump left office, a timely political statement, wasn’t it supposed to be Joe Biden’s leadership and mandate that would save the world?

Didn’t Trump only become the “pandemic” bad guy (he signed Operation Warp Speed) when the untested, unproven, experimental, and often mandated “vaccines” were found to be an unmitigated failure?

Didn’t Trump take the recommendations of his staff and authorize the funds to Big Pharma to develop COVID “vaccines” under Operation Warp Speed?  Yes, COVID “vaccines” would be made available, just like terminal patients seeking experimental drugs under Right to Try.

“Coronavirus,” defined in medical dictionaries (prior to 2020) as a head cold or flu, largely “escap[ed] neutralization by vaccine-induced humoral immunity”; that is, coronavirus is not a vaccine-preventable illness. (Technical jargon for a virus that mutates and degrades over 2–3 years; see SARS and MERS.)

So what happened? The sheep on the left and other oblivious masses lined up for the jab and assumed Emergency Use Authorization was the same as FDA Approval.

Real vaccines go through rigorous testing, including multiple phases of clinical trials to determine their safety and efficacy, before being reviewed and authorized by regulators.  The U.S. Food and Drug Administration must license (approve) a vaccine before it can be used in the United States and FDA regulations for the development of vaccines (ostensibly) ensure their safety, purity, potency, and effectiveness.

Fauci himself even told Trump it takes five years or more to develop a tested vaccine—but given Fauci’s true allegiances and political power, we can imagine he exploited Trump’s trust in him, selling mRNA experiments as “safe.”

EUA “vaccines” could have been anything, and hysterical people made crazy by the left’s propaganda got an armful of experimental something; millions against their will.  One day we might know if the EUA concoctions were Wuhan wet market sewer water or something else.

I think the record reflects that Donald Trump did what a president is supposed to do—make a strategic decision based on the advice of his staff.  I think the record also reflects now that Fauci was a deep state asset for the Democrat party who had the knowledge, training, and experience to make the correct decision on how to respond to a pandemic.  But he didn’t, and his decision to slip mRNA technology into the pandemic response equation before any consideration to use FDA-approved therapeutics was grossly wrong; if/when Congress finally gets their act together, Fauci’s actions before, during, and after Operation Warp Speed should land him in jail.

image, Pixabay license, no attribution required.

American Thinker