FDA Pulls Authorization for Evusheld As Ineffective Against New Covid Strains
Evusheld has become the latest COVID-19 antibody drug to lose federal authorization after it was deemed ineffective against the dominant versions of the virus
The U.S. Food and Drug Administration (FDA) on January 26th withdrew its emergency use authorization for Evusheld, a two-dose cocktail of monoclonal antibodies meant to provide protection to those who have a compromised immune system that makes them more vulnerable to severe COVID-19 infection than others.
Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses, the FDA explained in the announcement of the changes. This means that as viruses mutate over time, antibody treatments may be rendered useless by the mutations the virus has picked up.
The decision is not surprising, as the FDA warned health care professionals and patients in October 2022 about the “increased risk” of Evusheld not being able to neutralize emerging new COVID variants.
Earlier this month, the agency made it clear that it wasn’t expecting Evusheld to be effective against the XBB.1.5 subvariant, which at that time was estimated to account for nearly 30 percent of circulating variants across the nation.
With that said, the FDA nonetheless has decided to wait for additional data to verify their concerns. Citing the data from the U.S. Centers for Disease Control and Prevention (CDC), the FDA indicated that Evusheld is indeed not active against XBB.1.5, which is now responsible for about half of all new COVID cases nationwide.
Specifically, the FDA reported (pdf) that Evusheld doesn’t neutralize Omicron subvariants BQ.1, BQ.1.1, BF.7, BF.11, BA.5.2.6, BA.4.6, BA.2.75.2, XBB and XBB.1.5.1. These variants collectively account for 90 percent of all U.S. infections.
The move to limit the use of Evusheld also has to do with the medication’s side effects, such as allergic reactions, which can be potentially serious, according to the FDA.
AstraZeneca, the British-Swedish pharmaceutical giant that developed the drug, declared that it has started trials of another antibody, called LAAB, which so far has been able to neutralize all variants in lab settings.
“AstraZeneca is aiming to make the new LAAB available in the second half of 2023, subject to trial readouts and regulatory reviews,” the company said in a statement after the FDA pulled Evusheld authorization.
Evusheld currently remains authorized in many other countries, including Japan and those of the European Union, the company noted.
With Evusheld knocked out, there is no FDA-authorized monoclonal antibody left for immune-compromised patients who wanted a pre-exposure treatment. The last of its kind, Bebtelovimab developed by AbCellera and Eli Lilly, lost its emergency use authorization in November 2022.
See more here theepochtimes.com
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VOWG
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They are still playing the game.
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just Me
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VOWG,
It isn’t a game it is a scam. The scum made sure that they demonized/banned any effective early treatment.
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aaron
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covid is a disease of the mind, does not exist outside of a computer model
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Jerr
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From reading the FDA EUA linked release, two things come to mind.
First in the Evushield trials was its effectiveness of assessed separately for the vaccinated and unvaccinated populations given this monoclonal?
Second, why was this monoclonal antibody not allowed to be used for post Covid infection prophylaxis in the unvaccinated population like the other monoclonals were permitted during the early phase of the pandemic?
It seems FDA may be excluding monoclonal treatments that are effective for the unvaccinated population because they are not effective for the vaccinated population.
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Saeed Qureshi
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@ “This means that as viruses mutate over time, antibody treatments may be rendered useless by the mutations the virus has picked up.”
It is proving the point (reality) again and again, i.e., there is no virus, and there can’t be any treatment (vaccines or otherwise).
It was known from the start, e.g.:
“… it is impossible to develop a proper vaccine because, as noted, one cannot monitor the virus or disease and then how the vaccine’s effectiveness will be established. It cannot be! Therefore, a fake vaccine will most likely be developed to satisfy the regulatory wish and calm down the created public hysteria and fear. Unfortunately, such vaccines, if developed and administered, will undoubtedly create potentially dangerous side effects, without any presumed benefits, by interfering with the body’s immune system and other related physiological processes.”
https://bioanalyticx.com/science-for-the-pandemic-at-the-authorities-false-in-fact-fraudulent-requires-urgent-action/
We are in the pandemic’s second (next) phase, i.e., to protect the virology and medical/pharmaceutical pseudoscience. However, these (fake science) professions are doomed.
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Doug Harrison
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If I had your level of expertise on this matter Saeed, I would have said the same so thank you again for your deep understanding and your ability to express your knowledge so well.
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Saeed Qureshi
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Doug Harrison:
Thank you for your kind words. Greatly appreciated.
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Jakie
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Seems that there are now proven cures… treatments for Colds & Influenza…and perhaps other formerly incurable maladies.
The question though, is that of another newer idea generated by this massive murderous scam…are Colds and Flus a natural cyclic bodily process to rid itself of toxins and etc?
If so…then should we all just suffer through them, or should folks take curative meds, such as Ivermectin?
Seems to also be emerging cures for Cancers…these same antiparasitics. The year before the c19 terror campaign…it was announced that Another antiparasitic has shown high effectiveness as an anti cancer agent…Fenbendazole. What was that dose rate?
Dr Royal Rife claimed that he observed a Pleomorphic micro organism Shanghai cells energy engines & converted the cells to cancer cells. He destroyed the bugs with a resonating frequency…the cells returned to normal. This was sometime circa 1920-30s….he sold his machines and diagnostic microscopes far and wide…he was attacked and reputation & work destroyed by the same perps behind the c19 scam & mass genocide.
Has anyone seen any modern evidence/ research along these lines?
There is a community. using reinvented frequency generators & associated apparatus…but rediscovery of the frequencies used to destroy pathogens is hit or miss.
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