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Explaining Monoclonal Antibody Treatments for Covid
Following any infection, your immune system will create antibodies to defend itself and store these blueprints for later in case they are needed again. Many of our vaccines attempt to replicate this response without the detrimental effects of actually contracting the virus. Inactivated vaccines, like the quadrivalent flu shot, take bits and pieces of virus particles that are grown in eggs (that is why they always ask if you have an egg allergy) and these stimulate the immune response.
The MRNA covid vaccines exploit this same principle but instead of inactivated virus particles, it contains small bits of RNA that are taken up by our own cells. Then much like how the virus itself replicates, our cellular machinery copies the code and makes the virus spike particle which causes the immune response. All this just to aid our bodies in learning how to fight off the infection.
What if we just had Covid-19 antibodies that we could give as an effective therapeutic? Turns out we do and they are called monoclonal antibodies. We know what covid antibodies look like that is how we test for them after all so we can most certainly just make them in a lab. While it is not quite that simple, it is possible and Regeneron has accomplished this feat.
Initially referred to as the Regeneron Cocktail, a 50/50 mix of casirivimab and imdevimab (brand name REGEN-COV) has proven to be very effective, likely saving the previous president’s life to the pleasure and dismay simultaneously of half the country. It does carry a hefty price tag at around $1,250 a dose but the government has already put it on their tab so it will be no cost to the patient for the drug. That does not include administration fees and other associated costs that come with IV or Subcutaneous infusion the patient may be liable for. Competitors have also entered the playing field with Glaxo Smith Kline and Vir agreeing to distribute their drug sotrovimab under the brand name Xevudy in Australia where it has approval for almost $2,000 a dose. They obtained emergency use authorization from the FDA as well in May. Eli Lilly also has received FDA emergency use approval for two of its antibody drugs, bamlanivimab and etesevimab.
REGEN-COV has been available in the United States under an emergency use authorization since last November. Recently though, it has been back in the news as use has spiked in certain states. In response, on September 3, HHS made changes to the ordering and distribution process. In what they are calling “A temporary change” to “promote optimal and equitable use of the available supply”. In the same statement, they also say “It remains the goal of the federal government to ensure the continued availability of these drugs for current and future patients.” The following actions were taken to achieve these goals.
- Limiting immediate orders and shipment only to administration sites with HHSProtect accounts and current utilization reporting
- Reviewing all orders for alignment with utilization, currently estimated at 70% of orders
In order to ensure the continued availability of this life-saving product, the government has put a halt to some orders and shipments and placed additional roadblocks in the way of obtaining the medication. Direct ordering of the product because you need it will no longer occur and how much you get will be decided by the HHS in coordination with state and local officials. You can check your state’s allocation here: State/Territory-Coordinated Distribution of COVID-19 Monoclonal Antibody Therapeutics (September 21, 2021) (phe.gov)
The idea of having some strategic stockpile for whatever reason has never made much sense to me. We can make more of the medication and if we used every dose to potentially save a life, why should that be frowned upon? What good does it do to have some extra doses sitting on a shelf until they expire? Meanwhile on the ground, these actions can have real consequences as local restrictions may result in fewer patients obtaining therapy. As a workaround, Florida has announced its intention to purchase the GSK product sotrovimab to help offset its reduced availability of REGEN-COV thanks to their new allocation.
Jacob Hyatt, Pharm D.
Father of three, Pharmacist, Realtor, Landlord, Independent Health and Medicine Reporter
https://substack.com/discover/pharmacoconuts
Further Reading and References:
https://www.phe.gov/emergency/events/COVID19/investigation-MCM/cas_imd/Pages/default.aspx
https://www.phe.gov/Preparedness/legal/prepact/Pages/PREPact-NinethAmendment.aspx
https://secure.medicalletter.org/w1614a
An EUA for casirivimab and imdevimab for COVID-19. Med Lett Drugs Ther. 2020 Dec 28;62(1614):201-202. PMID: 33451174.
https://www.phe.gov/emergency/events/COVID19/investigation-MCM/Pages/FAQs-mAB.aspx
https://www.phe.gov/emergency/events/COVID19/investigation-MCM/Documents/USG-COVID19-Tx-Playbook.pdf
https://www.youtube.com/watch?v=DCk7LyMslxo
Published in Healthcare
Is there a best time for taking these therapies? For example, if someone tests positive for COVID-19 and waits a week before getting therapy, is that worse than just taking it as soon as testing positive? What about taking them to ward off any potential infection?
It seems that Florida was effectively using Regeneron ( or whatever they call it) by making the infusions readily and quite publicly available. Do you think it could be possible that the Biden administration has prohibited a freely flowing distribution of monoclonal anti-bodies for political reasons? Gee, I wonder. Naw…they couldn’t be so inhumane, could they?
You want to start it as soon as possible after diagnosis. Must be within 5 days of onset of symptoms to have much benefit.
Stockpiling, along with rationing, stops Florida from demonstrating the effectiveness of the infusions and attempts to harm DeSantis at the same time. It won’t work very well but it may harm a lot of people. Perhaps that’s another purpose.
Regeneron is made using human embryonic stem cell lines from “low quality” embryos from IVF procedures. As reported by CNN,
Abortion and research using cells from aborted babies to create “humanized” mice for a vaccine or cure a made from IVF “leftovers” are woven throughout this Covid nightmare. You reap what you sow.
But don’t talk about the nobel-prize-winning discovery from nature that has shown remarkable potential and efficacy in a certain South Asian nation. They’ll call you a nut case conspiracy theorist.
Just because Democrat governors could shoot off their mouths and accuse Trump of playing partisan politics with the distribution of vaccines doesn’t mean mere citizens can blame Biden for doing the same with monoclonal antibodies.
That’s nothing compared to the treatment you get if you ask to see the data supporting the claim that ivernectin was efficacious in India. It’ll be as if you walked into a Democrat caucus and announced that all lives matter.
What are you looking for? What data have you not seen that is so important to you? And why can’t you look for it yourself?
I’m looking for the data that convinced other people that ivermectin has been efficacious in India. I presume they aren’t just making that claim because their ChiCom handlers told them to say it, or because some sweet-talking YouTube dude whispered it in their ears. I have looked for it myself and all I’ve come up with is vaccination rates in an Indian province, data on the trajectory of covid cases in a province in India, and a vague statement that “they used ivermectin,” whatever that means. That didn’t convince anybody of anything, and I want to find out what did.
That convinced a lot of people. It just didn’t convince you. I don’t know how to find anymore than what Deseret News has reported. But I don’t see why I should distrust those numbers anymore than you distrust the CDC numbers. In fact, I strongly suspect I should be highly skeptical of CDC numbers.
Then I don’t understand how their minds work, if that convinced anybody of anything. I haven’t been given any reason to distrust any of the numbers I read about, so that’s not the issue. But we use ivermectin here in the U.S., too, so why not use the same reasoning to blame it for the latest surge?
The people using ivermectin right now are largely doing it independently of the health care system. Pharmacies stopped filling the prescriptions in a lot of places. I don’t think people are being treated by the medical establishment as a whole with ivermectin. What makes you think they are?
You sneer at it, but there really is a difference between big picture thinkers that look at overall trends vs detail thinkers that look at details. You seem to be the detailed thinker. There are some here that are trend thinkers. We can complement each other, but right now, I feel like you are deliberately roadblocking people who you think are stupid or lazy or something.
The data from the CDC is not transparent and lacks a lot of information such as how many unvaccinated have had a shot or two shots but haven’t met the criteria for “fully vaccinated”? How many of those unvaccinated are actually suffering an adverse reaction to the shot? How many of the unvaccinated in the hospital really are victims of their own doubts? As opposed to in the process of joining the vaccinated?
But you seem to want to ignore the big picture questions.
The Indian province said they started treating patients with ivermectin. What am I supposed to do? Disbelieve it? Why not believe it until I’ve seen data that suggests otherwise? I have no reason to doubt their experience given the rend they are seeing.
I wish I had data to convince you, but most of our lives and world history have been conducted without data and instead with trends. When pharmacists are advertising they won’t fulfill ivermectin prescriptions, I am under the impression the number of people being treated with it are low. If you find data that suggests otherwise, than I am wrong. But why would you assume the opposite with no data and the public, government dogma against it?
The statement that “they used ivermectin” covers a lot of ground. It can mean almost anything. If people want to get specific about what that term means in India, that would be wonderful. It would probably be a huge step toward answering the questions that people seem to be offended at my asking.
Well the sooner the better if therapy is necessary. These are IV or subcutaneous infusion so not as easy as popping a pill and would be normally reserved for patients with severe cases. Using something like these prophylactically while probably effective and the emergency use authorization has wording to allow for it is kind of like shooting a mosquito with a 12 gauge bit of overkill for general population prophylaxis.
What is the cost of the Regeneron product?
Although it is interesting to realize this therapy for COV 19 exists, the fact remains that HCQ is 20 bucks a month and ivermectin is equally cheap.
If these two cheap products were made available, it would be far less likely that serious cases of COV would come about.
If REGEN-COV can replace remdesivir as a solution for severe COV 19 patients, that would be a godsend.
Our nation and its acceptance and approval of Dr Fauci and his cult of “Gold standard” cures has kept the cheapest and perhaps most effective methods of prophylactically dealing with COV 19 and remedying cases of it once people are infected is both an outrage and a tragedy.
Plus with the release this summer of information on how remdesivir has a tendency to blow out a patient’s kidneys which leads to pulmonary edema but is often mistaken for and treated as pneumonia so the patient ends up dying from total organ failure, the terrific fatality count of COV patients is both an outrage and a tragedy.
I hope I love to see heads roll, because as far as Fauci goes, he has no excuse.
None whatsoever. His 2005 paper on the efficacy of HCQ in the treatment of corona viruses deprives him of a legal remedy of saying he didn’t know that by preventing HCQ from having a role in stopping COVID last year.
There is though a simple explanation for why he did this: to make his buddies at Big Pharma happy:
The health agency of the district approved of and endorsed an ivermectin protocol? As opposed to our country that did not.
It stands to reason that, in the absence of data to prove otherwise, we can determine that the protocol was used more liberally there than it is here.
I see no qualms with drawing those conclusions in the absence of data. If you find data disproving it, I will reconsider. I will take them at their word on the issue. I have no reason not to.
$3,120 for a 5-day course.
Ivermectin, $1.80 for a 5-day course.
I’ve read that in India the dose is 0.3mg/kg @ day-1 and again in 72 hours, and repeat monthly. Whatever the dosage that was used most recently, I’m sure it was medically reviewed and approved. The Indians aren’t ignorant of how to prescribe and distribute pharmaceuticals.
I bought two five day treatments of HCQ, Z pak, and Zinc for less than $20. The Zinc was the most expensive part.
But monoclonal antibodies are just a plot by Big Pharma to get profits while hiding the effectiveness of HCQ & ivermectin! it will probably alter your DNA! It will lead to everyone dying by 2024! It won’t work b/c Dr Mercola can’t profit off of it! TIC
Nothing in there that messes with dna or rna. It is a therapeutic being made available to treat. Which is good since even the vaccinated are still getting sick. Clearly, therapeutics are going to be necessary.
Its like you ignore most of us at least took bio 101 and know that RNA makes copies of our DNA to read into cell proteins. We might be getting some stuff wrong, but the suspicion is born in the most widely accessible science knowledge to the population. We also know that antibodies fight off illness, so putting manufactured antibodies in our bodies is a little less weird that putting in foreign instruction manuals for our cells to make foreign proteins.
If you can’t figure out how to persuade people based on information they already have without treating them like complete idiots, you kinda deserve to lose the argument.
I do notice that only the most expensive therapeutics are being used, but at least it’s something besides “vaccine! Vaccine! VACCINE!!!”
Ah, MiMac. Good to see you. Maybe you can answer these questions, that no other proponents of the government’s medical regime seem willing or able to answer. Would you please?
Why does everyone, 100% of all the populace, (Biden now says only 98%, which necessarily includes children to the age of 5, but that keeps creeping upwards) have to take the vaccine? Especially, even those with natural immunity?
And second, Why are doctors prohibited upon loss of jobs, licensure and professional certification, from administering any oral medicines that are safe and may defeat the SARS-CoV-2 virus and prevent severe illness? Added: Or even speaking out about or questioning the vaccine’s efficacy or its safety?
Additionally, why is the standard of medical care being written without years of practical and empirical data, written apart for historic procedure and precedent, and being enforced as if law?
Anyone following the money sees why it was so important for our CDC and NIAID officials to prevent early treatment.
Those officials did this through a two step tango:
There is not a spot in hell hot enough to assign to such officials.
@cm
And it strikes me as odd that people will faithfully follow the Reuters-assembled data that shows the seriously high numbers of new COVID cases and deaths here in the USA, but then stick to the tired old line of “we simply can’t trust the numbers coming out of India, Japan, Turkey, etc.”
@flicker
Here’s a thought: why don’t you take some time out of yr busy schedule denouncing the supporters of actual remedies and listen to this one excellent presentation by Dr Peter McCullough. (Flicker put together the relevant topic.)
Dr McCullough is a board certified cardiologist and surgeon who has testified under oath to Congress as to the efficacy of the ivermectin protocol he used for his COVID patients.
Like a few others here, you keep wanting citations, and then more citations, but when such are offered in a comprehensive manner, your name is always missing from those reviewing the videos offering the citations!
Take some time to absorb the needed info, or if you don’t want to spend that time, at least then admit the matter is really not important enough for you to spend the time. Then leave those who have heard the info alone from yr continual specious attacks.
https://ricochet.com/1057889/dr-peter-mccollough-on-the-international-approach-to-covid-and-vaccine-development/
1) Why would I defend Biden? The man is, at best, a hack with a failing memory. I am trying to be charitable here- b/c if his memory isn’t failing then he is bald faced liar (no one recommended keeping troops in Afghanistan).
2) what are the effective oral meds for COVID? The data isn’t there for HCQ nor ivermectin.
3) MDs should face discipline for making outrageous claims-preferably by their specialty boards- but I would include Dr Oz on the list with Mercola, McCullough, Blaylock etc.
As usual you didn’t answer one single question of mine. I was not asking your opinion of Biden, or whether oral meds are 100% or 50% or 0% effective. You cannot answer the questions because there is no rational answer other than that they want everyone to get inoculated against something, for some purpose other than saving lives.
Not true-1)- I can’t explain Biden policies since I do not support them and they aren’t based on any data. Why would I be expected to defend them.
2) there are no effective oral meds so MDs can’t prescribe them-no reason to bemoan the prohibition of the impossible.
3)you asked why MDs are being disciplined- I answered they should be.
4) if any standards lack data etc it is the use of HCQ & ivermectin for COVID. Vaccines have a long history.
You are increasingly becoming irrelevant.
Six months ago, it might be possible for someone who has been overly influenced by Rockefeller Institute-style of medical school teaching to truly be unaware of the efficacy of HCQ and ivermectin, but now that is impossible.
I offer, from Johns Hopkins the graph of the stats on India as proof of decency of ivermectin working at bottom of my remarks.
Also it simply is not possible for the med profession and those health agencies guiding that profession to have it both ways.
Either doctors were fooled by the CDC & FDA over the past 5 decades in their willingness to follow those agencies’ guidelines regarding prescribing chloroquine and its newer derivatives: first for travelers going off to malaria-infested regions, plus US service people who were infected with malaria, and then HCQ’s ability to be prescribed for lupus and rheumatoid arthritis, and due to allowing use of risky awful HCQ, the health agencies should face a major lawsuit for their recklessness in allowing the remedy’s usage.
Or, conversely the doctors who stood by accepting the agencies’ guidelines & avoided prescribing HCQ for COVID, together with the FDA & CDC officials themselves should face huge lawsuits for Not Allowing Prescription COVID Use of HCQ, and causing for the murders of all patients deprived of this remedy.
One or the other. Take your pick.
The whole scenario is as if we were told flying in a modern jet would cause our demise if we fly to Chicago in said jetliner, but not if we fly to Minneapolis.
No, that’s not right. I didn’t ask for procedures, or even an explanation of the propriety of the procedures of disciplining professionals.
I asked why can’t doctors — by government decree with state boards and certification boards in agreement — say that for THESE MEDS, FOR THIS ILLNESS — MDs can’t prescribe off-label medicines — in contradiction to historical practice? (Saying they’re unproven is a misdirection, because everything is unproven until it’s tried — and the vaccines were certainly unproven before they were administered — and this is an “emergency”.)
And why must 98% of Americans receive a vaccine — and even if they have natural immunity.