Real Reason Monoclonal Antibodies Lost FDA EUA, Associate Drug Fail Safety Trial, LETHAL Side Effect
Updated: Jan 31, 2022
Important military reference source document at end of article......
Last week, the FDA pulled Emergency Use Authorization from two Covid-19 monoclonal antibody drugs. The circus of false excuses coming from the FDA to explain the move, and feigned outrage from self appointed vaccine 'opposition' leadership crowd was a spectacle to watch.
Companion Blogs (important):
Monoclonal Antibodies: Study In Tactics Utilized to Sell Opposition on Next Wave Gates Covid Drugs (Gates funding sources, safety issues, pharmaceutical sales pitch)
WHO Latest Covid-19 Drug Recommendation Issued FDA Severe Warnings, Cancer, Blood Clots, Death (IMPORTANT warning for pregnant/breast feeling mothers on monoclonal therapy agent which remains on market)
Last week, Regeneron & Sanofi withdrew their companies' supplemental Biologics License Application for a cervical cancer monoclonal antibody drug which utilizes the same technology as applied in the Regeneron Covid-19 monoclonal antibody drug treatment:
"Libtayo, which was invented using Regeneron's proprietary VelocImmune® technology, is being jointly developed by Regeneron and Sanofi under a global collaboration agreement".
"REGEN-COV (casirivimab and imdevimab) is a cocktail of two monoclonal antibodies that was designed specifically to block infectivity of SARS-CoV-2, the virus that causes COVID-19, using Regeneron's proprietary VelocImmune® and VelociSuite® technologies".
Regeneron Pharma, Sanofi withdraw of sBLA for Libtayo to treat patients with advanced cervical cancer
"Regeneron Pharmaceuticals, Inc. and Sanofi announced the voluntary withdrawal of the supplemental Biologics License Application (sBLA) for Libtayo (cemiplimab-rwlc) as a second-line treatment for patients with advanced cervical cancer. The decision was made after the companies and the US Food and Drug Administration (FDA) were not able to align on certain post-marketing studies. Discussions with regulatory authorities outside of the US are ongoing"......
Last summer, Libtayo paused its long term safety trial after recommendation to halt the study after based on the recommendation of the Independent Data Monitoring Committee
In true parody, the recommendation to halt study from committee which oversees trial recipients safety was reported as due to the drug demonstrating such DAZZLING results, it didn't even NEED to finish safety trials. Yes, seriously.
Additionally, another Libtayo Regeneron monoclonal antibody drug trial was paused in February after a severe adverse event permanently ended the study:
Regeneron stumbles in PhI Libtayo combo study as safety concerns force suspension
"The company disclosed on clinicaltrials.gov that the suspension is due to a severe adverse event, but didn’t go any further. Enrollment will be halted and while the patients currently in the trial won’t receive additional treatment, they will still be monitored for safety. Endpoints News has reached out to the company for more details"
Basically, last week's announcement was an admission Regeneron could not get Libtayo past FDA safety review (no mean feat as the agency is notorious for granting approval for drugs with 'questionable safety trial data). The company pulled the application for the drug rather than allow an outright rejection which would be devastating to prospects for potential approval in other countries still undergoing review. It would also be incredibly bad PR for the Covid-19 monoclonal antibodies which utilize the same technology as Libtayo antibodies, and arise potential panic (and lawsuits) in recent recipients of the Regeneron antibodies (see below for safety risks/lethal side effects associated with administration of Libtayo monoclonal antibodies which do not always show up right away).
The news of Regeneron's failure to obtain FDA approval for its cervical cancer monoclonal antibody drug came, immediately on the heels, of the FDA announcement the agency was suspending emergency use authorization for two Regeneron & Eli Lily Covid-19 monoclonal antibody drugs:
On January 24, the FDA announced two monoclonal antibody treatments were being pulled under pretense of ineffectiveness' against 'Omnicron' variant:
Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal Antibodies to Treat COVID-19 Due to the Omicron Variant
"....Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time. 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"
This story is utter bullox.
Sars CoV2 is based on computer model simulation of government owned genomic sequences which predate 2020, and detected on tests extensively documented to be unsuitable for the purpose by both government health organization and peer review data.
Omicron is another computer model sequence of Sars CoV2 and the tests don't differentiate between 'variants', (so this rationale makes no logical sense even if one completely vests full faith in the official Covid-19 narrative).
The most plausible reason Regeneron/Eli Lily lost its FDA use status is due to extensive safety issues which the FDA is covering up with the Omicron narrative. Given the extent of severe injuries showing up in trials, and known toxic and lethal side effects of this drug, the real world injury/harm physicians and health professionals on the ground was likely untenable to continue. In this climate, it would take significant and undeniable real world harm and push back from underlings in the FDA and health industry to garner a flat out removal for a drug which the Biden administration invested billions. (This blog has been contacted extensively with stories around real world injury associated with these drugs. This writer can report a neighbor's relative lost her seventh pregnancy after testing positive with Covid-19 antigen test and her physician ordered infusion of monoclonal antibodies (please read companion blog here for warning about monoclonal drug still on market with potential to destroy fetal/newborn humoral immunity.
Monoclonal Antibody drugs have been awash in safety issues throughout the entire trial program (both for use in cancer/Covid 19 attributed 'therapy') with several pauses in studies due to severe safety events:
Regeneron pauses patient enrollment in lymphoma drug trials
"The U.S. Food and Drugs Administration had placed the trials on partial clinical hold and asked the company to change protocols to reduce the occurrence of an inflammatory response called cytokine release syndrome in patients, according to Regeneron.
The syndrome, caused by a large, rapid release of immune substances called cytokines, may occur after treatment with some types of cancer therapies and can sometimes be severe or fatal. It has different symptoms including fever, headache and troubled breathing, according to the National Cancer Institute".
Regeneron halts trial of COVID-19 antibody drug in sickest hospitalized patients
Regeneron Pharmaceuticals said Friday it has paused a clinical study of its antibody drug to treat some of the sickest COVID-19 patients because of a potential safety concern.
The recommendation from an independent monitoring board marks the second time a clinical trial of an experimental coronavirus antibody drug has been paused because of safety issues"
NIAID halts Lilly COVID-19 antibody study.
Eli Lily monoclonal antibodies FAILED phase III clinical trials in hospitalized patients
Lilly’s monoclonal antibody fails in NIH-sponsored ACTIV-3 trial
"In October, the trial halted new enrolment after an independent Data and Safety Monitoring Board (DSMB) recommended so"
Eli Lily is also the manufacturer of Remdesivir, a drug which has been implicated in inducing severe (and fatal) reactions (drug induces kidney failure) in Covid-19 diagnosed patients.
SEVERE safety Issues associated with monoclonal antibodies are extensively documented (studies going back to 2010)
Adverse cardiac events to monoclonal antibodies used for cancer therapy
The safety and side effects of monoclonal antibodies
Libtayo: SEVERE & LETHAL SAFETY RISKS
A review of the safety data for Regeneron's Libtayo (drug which uses same technology as Covid-monoclonal antibodies), clearly shows this drug is flat out dangerous and it is literal insanity to be utilizing a related drug to ostensibly treat mild/moderate Covid-19 attributed cold symptoms.
HIGHLIGHTS OF PRESCRIBING INFORMATION
"LIBTAYO is a monoclonal antibody that belongs to a class of drugs that binds to the programmed death receptor-1 (PD-1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response with the potential for breaking of peripheral tolerance and induction of immune-mediated adverse reactions. Important immune-mediated adverse reactions listed under Warnings and Precautions may not be inclusive of all possible immune-mediated reactions.
(Regeneron Covid-19 monoclonal antibodies shares the same mechanism of action/delivery, it is the same class of drug, the target monoclonal antibody differs)
Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue.
While immune-mediated adverse reactions usually manifest during treatment with PD-1/PD-L1 blocking antibodies, immune-mediated adverse reactions can also manifest after discontinuation of PD-1/PD-L1 blocking antibodies".
This indicates potential for delayed mid-long term serious side effects for the Regeneron Monoclonal Antibody recipients.
Embryo-Fetal Toxicity Advise females of reproductive potential that LIBTAYO can cause harm to a fetus and to inform their healthcare provider of a known or suspected pregnancy
This is the SHORT list, full side effects and warnings may be viewed HERE>.
Monoclonal antibodies have been sold to the public on the same propaganda sales pitch utilized to manipulate the public into acceptance of inoculation with highly experimental and unsafe mRNA and adenovirus Covid-19 vaccinations.
'Early treatment saves lives' slogan is utterly ridiculous even if one ascribes to the official Covid-19 narrative as up to 86% of people have NO symptoms with a positive PCR test diagnosis of Covid-19 and 99% of attributed cases present as mild/or moderate.
There is NO potential health benefit to the use of monoclonal antibody therapy for attributed Covid-19 infection per the documentation of the EUA, drug trials, and use guidelines. Only severe, extreme, and completely unnecessary RISK.
Nonetheless, there was an immediate outcry from the next phase pharmaceutical Covid drug salesman to sell WHO/Gates next phase Covid-19 long term test and treat 'mitigation plan', led by 2024 Republican Presidential favorite, Ron DeSantis:
Densantis responded to the withdraw of EUA for monoclonal antibodies and the closure of infusion centers in Florida with the following Fauciesque statement:
"Without a shred of clinical data to support its decision, the Biden Administration has revoked the emergency use authorization for lifesaving monoclonal antibody treatments," DeSantis said in a Tweet. "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."
Scratch that Ron. The actual EVIDENCE shows EXTENSIVE & SEVERE safety risks with package insert warning documenting the use of theses drugs resulted in clinical WORSENING & side effects which required hospitalization in trials (so much for 'early treatment saves lives')
Worse, trusted outlets such as Natural News joined in efforts to falsely frame monoclonal antibody EUA withdrawal, as a political and RACIAL issue, instead of exposing extreme danger to public health and demanding an end to ALL EUA for this 'therapy':
This was the same tactic applied by Tucker Carlson:
Many of the doctors featured in Ron Johnson 'doctors that heal' hearing are eager (and paid pharmaceutical advocates) for this potentially lethal treatment,
See companion articles:
Bill Gates, History of Pesticides as Medicine in Africa, & Red Flag Ivermectin Nanoparticle Study
Peter McCoullough has received significant pharmaceutical consultation fees from Covid-19 vaccine developers and monoclonal therapy manufacturer including Regeneron.
Dr Robert Malone went on Joe Rogan where he stated false information and pondered whether authorities were 'brain dead' in removing EUA for monoclonal antibodies:
''I have been hearing from frontline docs, is those older Regeneron monoclonal antibodies are still very effective in their hospitalized populations and yet they are no longer able to get it....." -
FDA NEVER APPROVED COVID-19 Monoclonal IN HOSPITALS:
Joe Rogan & Dr Malone went onto to lament the banning of 'effective' medicine (i.e. Gates developed drug which may induce lethal side effects/cancer to treat mild cold symptoms)....and muse whether money may be driving the decision to halt the drugs - .watch the exchange HERE:
Rogan's claim Biden is making this about money is farcical as the Biden administration's Department of Defense paid these companies nearly 3 billion dollars last fall,(pharmaceutical manufacturers got the money UP FRONT):
Biden Administration Buys More Monoclonal Antibody Treatments to Ward Off Shortage
"The United States is paying Regeneron $2,100 per dose, which the government is then providing to patients at no cost. Regeneron will be paid $2.94 billion for the additional doses, according to the U.S. Department of Defense
A second manufacturer, Eli Lilly and Company, said the United States bought 388,000 doses of its monoclonal antibody treatment etesevimab. The United States had previously purchased the company's bamlanivimab".
It is important to note the Department of Defense in Operation Warp Speed as Covid-19 has been an extensively funded/planned/simulated exercise with the military actively funding development of new technology vaccines and drugs introduced through Operation Warp Speed for over a decade:
Remdesivir (army funded 50 million to develop drug)
mRNA vaccine technology (moderna & Pfizer, DARPA)
Monoclonal Antibody Therapy: 45 Million Department of Defense/2015
DARPA and JPEO-CBRND award $37.6M to The Wistar Institute and collaborators
The drugs/vaccine rolled out under the guise of treating Covid-19 represent a sphere of biotechnological agents which have been actively studied and financed for use in potential biowarfare for decades. It is imperative citizens start paying attention to the funding, military language, and military departments involved in coordinating Covid-19 response.
This is not coincidental and it is not benign.
Ending this article with a summary from The Militarily Critical Technologies List Part II: WEAPONS OF MASS DESTRUCTION TECHNOLOGIES - it is a list of all the technology and drugs now being introduced through Operation Warp Speed under the pretense of pandemic protection. Monoclonal antibodies are on this list.
The Militarily Critical Technologies List Part II: WEAPONS OF MASS DESTRUCTION TECHNOLOGIES
SECTION III BIOLOGICAL WEAPONS TECHNOLOGY
"The introduction of modern biotechnology during the past 25 years has markedly changed the qualitative and quantitative impact that biological warfare, or the threat of such warfare, can have on military forces and urban communities. This new technology provides the potential capability of (
1) developing biological agents that have increased virulence and stability after deployment;
(2) targeting the delivery of organisms to populations;
(3) protecting personnel against biological agents;
(4) producing, by genetic modification, pathogenic organisms from non-pathogenic strains to complicate detection of a biological agent;
(5) modifying the immune response system of the target population to increase or decrease susceptibility to pathogens; and
(6) producing sensors based on the detection of unique signature molecules on the surface of biological agents or on the interaction of the genetic materials in such organisms with gene probes.
The specific technologies used in realizing these capabilities include
(1) cell culture or fermentation;
(2) organism selection;
(3) encapsulation and coating with straight or crosslinked biopolymers
; (4) genetic engineering;
(5) active or passive immunization or treatment with biological response modifiers;
(6) monoclonal antibody production;
(7) genome data bases, polymerase chain reaction equipment, DNA sequencers, and the rapid production of gene probes; and (8) the capability of linking gene probes and monoclonal antibodies on addressable sites in a reproducible manner.
Remember, NEVER AGAIN IS NOW.
Operation Warp Speed Using CIA-Linked Contractor to Keep COVID-19 Vaccine Contracts Secret
Pfizer /Moderna Military Funding For Vaccines, Decade of Headlines In Lead Up to Covid-19 Vaccines
Military Being Deployed to Reinstitute Disastrous Covid-19 Government Protocols, History Repeating