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FDA Uses “Omicron” as Excuse to End Emergency Use Authorization for Monoclonal Antibody Treatments

FDA Uses “Omicron” as Excuse to End Emergency Use Authorization for Monoclonal Antibody Treatments

Florida Gov. Ron DeSantis slams FDA. In return, Big Media derides DeSantis.

Legal Insurrection readers who have watched Senator Ron Johnson’s (R-WI) “Second Opinion” panel are now well versed in the many examples of the US Food and Drug Administration (FDA) promoting the use of expensive, novel covid treatments over less pricey or repurposed drugs. The agency’s policies on covid are also almost entirely focused on vaccination rather than early treatments.

The FDA’s actions have created a great deal of mistrust, especially because the pandemic policy has completely failed to stop the spread and the virus is now endemic. It has just added to the level of skepticism and misgiving, as it has just ended the emergency use authorization for monoclonal antibody treatment.

Covid-19 antibody drugs from Regeneron and Eli Lilly should no longer be used because they don’t work against the omicron variant that now accounts for nearly all U.S. infections, U.S. health regulators said Monday.

The Food and Drug Administration said it was revoking emergency authorization for both drugs, which were purchased by the federal government and have been administered to millions of Americans with Covid-19. If the drugs prove effective against future variants, the FDA said it could reauthorize their use.

The regulatory move was expected because both drugmakers had said the infusion drugs are less able to target omicron because of its mutations. Still, the federal action could trigger pushback from some Republican governors who have continued promoting the drugs against the advice of health experts.

There are several problems with this act. The Delta variant is still out there, and Regeneron has been effective against that strain. It can be difficult to distinguish between the two variants, so perhaps it would be wiser to have doctors decide.

And while it may be true that Regeneron isn’t as effective against Omicron, the move has the appearance of being politically motivated due to the fact several red states have had success with monoclonal antibody treatment clinics. Florida Gov. Ron DeSantis railed against the decision.

DeSantis referenced anecdotal cases in which people were helped by the monoclonal antibody treatments and said it was “reckless” to block the drugs.

“People have a right to access these treatments, and to revoke it on this basis is just fundamentally wrong and we’re going to fight back,” DeSantis said at a news conference.

Of course, the American press took this as an opportunity to mock and deride the Florida governor.

Many are frustrated that there are few effective early treatment options. Now one of the few that has success has been pulled.

A new study has pointed to why the antibody treatments have proven ineffective and why there are so many vaccine breakthrough cases with Omicron. The variant has so many mutations it bypasses the antibody defenses.

A team from the University of Minnesota discovered that specific mutations create interference in the surface of the variant, preventing antibodies from binding to it, while others result in a complete loss of interaction between the antibodies and the virus. Therefore, the antibodies won’t work against Omicron.

This suggested that preexisting immunization (whether from vaccination or previous infection) may no longer be able to provide optimal protection against the Omicron variant, allowing it to bypass antibodies and enter the immune system, the study said.

“The purpose of antibodies is to recognize the virus and stop the binding, which prevents infection,” Singh said. “However, we found many of the mutations in the Omicron variant are located right where the antibodies are supposed to bind, so we are showing how the virus continues to evolve in a way that it can potentially escape or evade the existing antibodies and therefore continue to infect so many people.”

It appears that T-cells, which are attainable via natural immunization after recovering from infections, work against Omicron, as a study by South African researchers shows.

“Despite Omicron’s extensive mutations and reduced susceptibility to neutralizing antibodies, the majority of T cell response, induced by vaccination or natural infection, cross-recognizes the variant,” the researchers reported on Tuesday on medRxiv ahead of peer review.

“Well-preserved T cell immunity to Omicron is likely to contribute to protection from severe COVID-19,” which supports what South African doctors had initially suspected when most patients with Omicron infections did not become seriously ill, they said.

The good news: After the Omicron surge, a substantial portion of the American population now has T-cell immunity. And while the SARS-Cov-2 virus that causes covid is now endemic, we are on a trajectory to getting back to pre-covid life.

That is if we can loosen the grip of pandemic-power drunk politicians and bureaucrats who are bitterly clinging to the glory days of a fawning press and the possibility of conducting a response experiment on the global level.

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Comments

“The regulatory move was expected because both drugmakers had said the infusion drugs are less able to target omicron because of its mutations.”

“Less able” does not mean “unable.” Florida has sustained very low death numbers for months now, and it’s embarrassing to the Biden Administration, so they had to do something to boost those deaths to take out DeSantis before he becomes a threat.

    JHogan in reply to Evil Otto. | January 26, 2022 at 8:20 am

    A few more dead Floridians is a small price to pay to reassert Biden’s and Fauci’s dictatorial power over nationwide Covid treatment — while sticking it to DeSantis.

    The Biden Regime is evil.

    FJB. And Fauci belongs in prison.

    Idonttweet in reply to Evil Otto. | January 26, 2022 at 9:46 am

    Has anyone asked the FDA when they expect to rescind the EUA for the so-called vaccines since they don’t work against omicron either? I do believe there are multiple studies that reach that conclusion. Studies not funded by companies with competing products recently being pimped as the more expensive replacement for the monoclonal antibody treatments.

    It is now even more evident that the FDA does the bidding of the pharmaceutical companies to maximize their profits and not to maximize the public health.

caseoftheblues | January 26, 2022 at 7:13 am

The FDA letter was vague citing injection site irritation(oh my!!) as one of the possible bad side effects their pulling the monoclonal would help stop….weird tho…they are not pulling any of the EUAs for the vaccines…and thats 100% of what is being used in US despite the fact they do not stop the catching of it, spreading of it or even at this point hospitilizations…and they have caused 10’s of thousands of deaths and hundreds of thousands of serious side effects many permanent. At this point they don’t even care how blatent their corruption is. They KNOW they will never face any consequences for the mass death they have actively caused.

nordic_prince | January 26, 2022 at 7:16 am

Get rid of ALL 3-letter agencies.

IRS, FDA, FBI, EPA are a good place to start.

If the Government quit paying Hospitals $3000 for each prescription for Remdisivir they would quit using that in a minute. The last reports I saw showed that 75% of patients given Remdisivir are taken off before completing the course because of Liver and Kidney damage.

The drug is literally killing people and hospitals are incentivized to administer it.

Historians will study this time period with the question of genocide and conclude it was suicide.

Of you LISTEN to Gov DeSantis the study you are quoting in your biased article, which could have been written by the Administration, is very flawed and has no review
I have Covid and I was to get monoclonals and had 2 appointments and they were both canceled here in Texas.

I am so angry , BIDEN IS MURDERING US and only ONE Gov gives a shit!

JOE BIDEN: How can I really stick it to Ron DeSantis and the people who voted for him?

FDA: We got this, boss.

And while the SARS-Cov-2 virus that causes covid is now endemic, we are on a trajectory to getting back to pre-covid life.

I doubt things will ever go completely back to normal. At least not for a couple of generations.

We have a generation of kids who have spent two years forced to wear masks on their faces for at least 7-9 hours a day due to irrational fear of a germ. Many will now live a life of hypochondria and germaphobia. Politicians will exploit this.

And just the other day I saw one of their grandparents outside in 10 degree weather with a snowblower. Clearing the driveway and sidewalks. While wearing a mask.

Tens of millions of weak and/or impressionable American minds have been poisoned and permanently damaged.

    scooterjay in reply to JHogan. | January 26, 2022 at 8:26 am

    You are correct. Let us hope the rest of the world figures out we are on a path to enslavement of Biblical proportions and says no. I started yesterday. I confronted a Biden supporter that was pumping gasoline in her ic-engine powered car. She didn’t like what I had to say….I used sarcasm by saying I was proud of her for still displaying the Biden/Harris sticker in the face of the high price of that environmentally-harmful gasoline you are putting into your carbon-spewing device that the sticker resides upon. She didn’t like that at all, and I grinned and said “I don’t like you at all”.
    Make. Them. Uncomfortable.

When the vaccines fail to stop a variant, they tell you to get another vaccine.

The experts strike again

“It appears that T-cells, which are attainable via natural immunization after recovering from infections, work against Omicron, as a study by South African researchers shows.”

Of all of the great statements made by this panel, that is the biggest thing I came away with and gave it a lot of thought. I seems to me that nature is a lot better at identifying the problem and coming up with a solution than an army of “scientists” in the employ of greedy to the point of evil corporations spending millions of dollars to make billions but can’t seem to stay ahead of nature.

Pretty much describes how the game works. The globalists are plotting to control us by impeding nature long enough with bureaucracy and politics to allow them to jump in with their expensive, mandatory but dubious “magical” cures. This is how we are losing our liberties and our civilization on our way to becoming obedient proles in Karenistan.

Leslie Eastman: The agency’s policies on covid are also almost entirely focused on vaccination rather than early treatments.

“An ounce of prevention is worth a pound of cure.” — Benjamin Franklin, 1736

Leslie Eastman: The Delta variant is still out there, and Regeneron has been effective against that strain.

Whole genome sequencing has determined that nearly all cases of COVID are due to the Omicron variant.

Leslie Eastman: And while it may be true that Regeneron isn’t as effective against Omicron, the move has the appearance of being politically motivated

“Political appearance” doesn’t change the scientific findings. Vaccination remains the best way to prevent infection, hospitalization, and death.

idonttweet: Has anyone asked the FDA when they expect to rescind the EUA for the so-called vaccines since they don’t work against omicron either?

That is incorrect. People who are vaccinated are much less likely to be hospitalized or die from COVID.

“COVID-19 vaccination protected against SARS-CoV-2 infection, even as the Omicron variant became predominant.”
https://www.cdc.gov/mmwr/volumes/71/wr/mm7104e2.htm

It doesn’t work very well against Omicron so we need to stop using it.

Why doesn’t this same reasoning apply to the vaccine?

The booster itself is, at best, only 70% effective against Omicron…and lets not shit ourselves here. Omicron is the most mild version of the Chinese Death Kooties that we have seen to date bordering on as inconvenient as the common cold.

Funny how the fucking Chinese Virus vaccine which itself isnt particularly effective at stopping the spread of the Chinese virus hasn’t been pulled. Why its almost as if this is a political thing eh?!?

One of my sons lives in FL Just tested positive for the dreaded covid. His doctor’s office follows I-Mask protocol. He got a script for ivermectin and the local pharmacy filled it- something that can’t happen here in the Peoples Republic of NY under Dictator Hochul.

Even worse in the Peoples Republic of Maine, where following on in the great traditions of the Union of Soviet Socialist Republics, Doctor Meryl Nass had her medical license suspended and was sent for a mental evaluation for prescribing ivermectin.

Ummm, it’s as if they were protecting their vested intrests by pushing out all other competitors…

Wait a minute, there’s some truth here.

Monoclonal therapy using the COVID alpha will not work well against omicron. Monoclonal antibodies are actually known to be very specific and picky. Another type of globulin serum carrying polyclonal antibodies tends to be less potent but more versatile.

Therefore, the move should be to develop either monoclonal therapies raised specifically against omicron or develop a polyclonal therapy (if it will work…I’m not sure it would be as effective as the former option).

    Dr.Dave in reply to healthguyfsu. | January 27, 2022 at 9:28 am

    You are correct but why does our government only enact all or nothing approaches. The other strains are still out there. They could have changed it so the emergency order only pertained to the varrients where it is effective. Wait….I’m sorry. This approach would actually give doctors the discretion….really cant do that!

we are on a trajectory to getting back to pre-covid life

Not that I can see. Masks are still mandatory in hospitals, doctor’s offices, airplanes, airports, and most forms of public transportation, despite their demonstrable worthlessness in combating respiratory viruses. Employers are still free to impose vaccine mandates, and many do. International travel by the unvaccinated is essentially impossible. Cruise lines forbid unvaccinated passengers, and doing the same for domestic travel by air is being floated.

The real problem here is that the federal government has any involvement at all. As I see it, the Constitution gives them no legitimate authority to either prohibit, or force on the public, any sort of medical treatment — or the great majority of other things government is now doing. We no longer have a Constitution — there is no limit to the powers of government.