WTF? Biden’s FDA Just Yanked The Emergency-Use Authorization For Monoclonal Antibodies Without Warning

K. WalkerJanuary 25, 2022

33 8 minutes read

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This is beyond appalling. It also raises some pretty big questions…

On Monday, the FDA made the stunning announcement that it was pulling the Emergency-Use Authorization (EUA) on two monoclonal antibody therapies that have been successfully used to treat COVID-19.

Monoclonal antibodies can shorten the severity and duration of illness in those infected by the virus if administered early.

The sudden shift is because two manufacturers of the therapeutic, drug companies Regeneron and Eli Lilly, have stated that their therapies are “ineffective” against the dominant Omicron variant.

Today, the FDA revised the authorizations for two monoclonal antibody treatments to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments. https://t.co/mZS55mEpf5 pic.twitter.com/Qi9S5P4ZgB

— U.S. FDA (@US_FDA) January 24, 2022

The announcement went further saying that if another variant pops up that monoclonal antibodies work on, it “may be authorized” for use in certain geographic regions where that variant is spreading.

In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions.

— U.S. FDA (@US_FDA) January 24, 2022

Monoclonal antibody therapies have been promoted by Florida Governor Ron DeSantis because of his two-pronged approach in promoting vaccination as well as seeking effective treatments.

It was first dismissed as “quackery” but more doctors have come forward and said that the treatment is effective.

So have Joe Rogan and Dana White who both successfully used the treatment.

Over the summer, DeSantis announced that a number of monoclonal antibody clinics would be opened across the state. By September, 25 were up and running and had treated over 100,000 patients by mid-month.

The Biden-Harris administration saw this push for monoclonal antibody treatment as a threat to their national push for universal vaccination and has been battling Florida for months.

In September, the federal government was restricting Florida’s access to monoclonal antibodies in order to be “equitable” for other states which had not set up monoclonal antibody clinics.

Tallahassee Vs D.C.: White House And Florida Clash Over Rationing Of Antibody Treatment

DeSantis circumvented the federal government and secured a contract with GlaxoSmithKline to procure their monoclonal antibody treatment directly from them to account for the sudden shortfall due to new HHS guidelines for “equitable access”.

Then, in early December, the Biden-Harris administration decided to copy DeSantis’s homework and called monoclonal antibodies as part of the federal government’s “Winter COVID Plan.”

Biden Implements Same COVID Strategy He Tried To BLOCK In Florida

Biden then famously said to governors that there is “no federal solution” to COVID.

Biden To Governors ‘There Is No Federal Solution’ To COVID — What Happened To ‘I’m Going To Shut Down The Virus’?

In December, Florida’s new Surgeon General, Joseph Ladapo, said that the Biden-Harris administration had been intentionally preventing the distribution of monoclonal antibody therapy which was undermining Florida’s COVID response.

Ladapo wrote to Health and Human Services Secretary Xavier Becerra that he is concerned that the federal government is “actively preventing the effective distribution of monoclonal antibody treatments.”

Ladapo stated that he knows that “some treatment options may not be as effective against the Omicron variant” but added that federal agencies “should not limit our state’s access to any available treatments for COVID-19. Florida can expand treatment options for patients by distributing therapeutics to providers working in areas with a low prevalence of Omicron or clinics capable of variant screening.”

The letter also states that the federal government limiting access is “actively preventing the effective distribution of monoclonal antibody treatment in the U.S.” which “removes a health care provider’s ability to decide best treatment options for their patients in the state.” Lapado called the move, “shortsighted” because the federal government had initially prevented states from purchasing the treatments directly.

He added that Florida is a large, diverse state that has one of the highest populations of seniors in the United States.

Lapado ended by tossing Biden’s words back at him — “President Biden recently stated that there is no federal solution to COVID-19, and solving this pandemic will happen at the state level. Therefore, as Surgeon General, I respectfully request that you allow states and healthcare practitioners to provide treatment options that best benefit the communities that they know and serve.”

Recently, it was discovered that some jurisdictions are using race as a factor to determine who gets monoclonal antibody treatment.

WATCH: Texas Radio Host Claims He Was Denied Monoclonal Antibody Treatment Because He’s White

“Florida disagrees with the decision that blocks access to any available treatments in the absence of clinical evidence,” wrote the Florida Health Department in a press release. “To date, such evidence has not been provided by the United States Food and Drug Administration (FDA).”

It also cited a study on the NIH website that shows that there have been no definitive clinical conclusions that the monoclonal antibody treatments are ineffective against Omicron. The study states, “despite observing differences in neutralizing activity with certain mAbs, it remains to be determined how this finding translates into effects on clinical protection against B.1.1.529.” (Emphasis Added)

It stated that the FDA’s “abrupt decision to remove the EUAs for two monoclonal antibodies” has resulted that the clinics set up just months ago are now “closed until further notice.”

As a result of the @US_FDA‘s abrupt decision to remove the EUAs for two monoclonal antibodies, monoclonal antibody treatment sites will be closed until further notice. Full press release is below. pic.twitter.com/RGeWTPwxCs

— Florida Dept. of Health (@HealthyFla) January 25, 2022

NewsNation correspondent Brian Entin, noted that the sign on the door blames the Biden administration and says that the decision by the FDA was based on one study.

This is the sign on the door of closed Florida monoclonal antibody sites — blaming the Biden Administration for the sites shutting down.
FDA says the treatments don’t work for omicron.
Gov. DeSantis says they are relying on one study – and the treatment should remain available. pic.twitter.com/yB0FdKTznI

— Brian Entin (@BrianEntin) January 25, 2022

Florida’s Surgeon General pushed back on the FDA’s decision and said that they have not provided any clinical data to support the decision to suspend the authorization of monoclonal antibody therapies.

After @HHSGov avoided communication with @HealthyFla regarding statewide allocations, without any warning, @US_FDA suspended the use of multiple MABs treatments. Such decisions should be made based on clinical data – which the FDA has not provided. pic.twitter.com/zpWl7ZGODQ

— Joseph A. Ladapo, MD, PhD (@FLSurgeonGen) January 24, 2022

Governor Ron DeSantis blasted the decision on Twitter, “Without a shred of clinical data to support its decision, the Biden Administration has revoked the emergency use authorization for lifesaving monoclonal antibody treatments.”

In a second tweet, he wrote that “access to treatment shouldn’t be denied based on the whims of a floundering president.”

Floridians have benefited from the state’s treatment sites and their access to treatment shouldn’t be denied based on the whims of a floundering president. https://t.co/Y5nmAV1LCs

— Ron DeSantis (@GovRonDeSantis) January 25, 2022

Some of the jab-happy souls are criticizing DeSantis because they think that he only promotes therapeutics and not vaccination.

Here’s Ian Sams, spokesperson for HHS suggesting that DeSantis isn’t promoting vaccination.

Why is Gov. DeSantis more interested in promoting medicines that don’t work than urging people to take vaccines that do? https://t.co/qHt9BTKWA6

— Ian Sams (@IanSams) January 25, 2022

Where the hell has he been?

Did he not realize that the faux scandal ginned up by 60 Minutes was about a contract for vaccination sites in Publix stores?

60 Minutes Deceptively Edited A Response By Gov. Ron DeSantis In A Blatant Smear Job — Here’s Proof

DeSantis urges people — especially those at high risk — to get the vaccine. But he opposes government mandates.

Fortunately, Christina Pushaw, spokesperson for Gov. DeSantis, was all over Sams’s stupid take.

Why doesn’t the HHS spokesperson understand that the majority of patients seeking monoclonal antibody treatment, like the majority of Floridians, ARE vaccinated? https://t.co/O7ulSEZbnZ

— Christina Pushaw ? (@ChristinaPushaw) January 25, 2022

She’s right, too. Florida’s vaccination rate is at 79% which is among the highest in the United States… and that’s without mandates.

In a press briefing, White House Press Secretary Jen Psaki defended the move, of course.

But this raises some questions… why is this sudden shift being made based on very little clinical data?

Lawyer and political commentator Mike Cernovich has some thoughts on that.

The FDA is trying to make it so that people in Florida die of Covid. They’ll kill people to harm Republicans. Steel yourselves for the evil that is being unleashed. https://t.co/hP55vngVbh

— Cernovich (@Cernovich) January 25, 2022

How many lives will this decision cost?

Here’s another big question that I’m not surprised to learn didn’t just occur to me when I first caught wind of this… If the FDA is suddenly pulling EUAs because the drug isn’t doing what it says it’s supposed to do, then… what about the “vaccines”?

Oh, the FDA is in the business of removing EUAs now? There’s these two companies out there called Pfizer and Moderna. Maybe the FDA can look into them!

— Jordan Schachtel @ dossier.substack.com (@JordanSchachtel) January 25, 2022

If both the monoclonal antibody treatment AND the vaccinations are not effective against the Omicron variant (per FDA), then why pull the monoclonal Emergency Use Authorization, but not the EUA on the Vaccine? https://t.co/iCcGyzSxwX

— TheLastRefuge (@TheLastRefuge2) January 25, 2022

It’s a real head-scratcher, isn’t it?

Notice that the FDA only seems to oppose the COVID measures that are opposed by Saint Fauci, Peace Be Upon Him. Hydroxychloroquine, Ivermectin, increasing Vitamin D levels, or any other generic or over-the-counter therapeutic, well those are all no-nos. Besides, people are so dumb they’re probably going to confuse medication for people with fish tank cleaner or horse de-wormer!

But the vaccines with waning efficacy, no long-term data, haven’t been tested as carcinogenic or for their affect on male fertility, and produce heart-related side effects in teens and young men? No problemo! Shoot those into children… heck, let’s allow Pfizer to test them on babies.

Look, maybe there’s a good reason that the FDA made this call, but it sure does look political and based on very flimsy evidence.

Especially since we have vaccines that are still being used and we still don’t have access to basic data.

Christina Pushaw tweeted that the federal government is treating vaccination and therapeutics like it’s a “zero-sum game.”

Vaccines (pre-treatment) and monoclonal antibodies (post-treatment) are not mutually exclusive. It’s not a zero sum game. In cutting off monoclonals, Biden has effectively said you can only drink water before you exercise, but you cannot have any afterwards.

— Christina Pushaw ? (@ChristinaPushaw) January 25, 2022

There should be no restricting of therapeutics when the vaccines with no data are still being pushed and are just as ineffective against Omicron. Either the EAUs stay for both or they both go. The FDA can’t have it both ways.

Or… the vax manufacturers can just give access to the data to the experts that can analyze it. Like the folks over at the British Medical Journal.

British Medical Journal Calls For Full And Immediate Transparency From Big Pharma And Public Health Officials

Well, that’s one solution.

Have you had it with the Prevaricating Authoritarian Smurf giving his pronouncements about the pandemic from on high? You’re not alone. Maybe it’s time to tell the diminutive bureaucrat who keeps moving the goalposts exactly what you think of him.