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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
I wasted my time listening to his “testimony” -time I am sorry Iwill never get back and an event that, if I believed it, would have left me less well informed than before I wasted my time. McCullough NEVER PRODUCED NOR PUBLISHED AN IOTA OF EVIDENCE- his articles in AJM are attempts at providing a therapeutic rational for the drugs he is promoting- there is no data. It isn’t clear he has ever treated a sick COVID patient- he is claiming he has treated outpatients patients with mild or asymptomatic COVID ( and this without any substantiation) most who in reality needed no therapy at all! I won’t even mention that cardiologists do not take care of COVID patients. His drug cocktail has never been proven to work in any randomized controlled study- and many of its constituents have been proven by randomized controlled studies to NOT WORK. His claims are backed by no evidence & he makes multiple incorrect statements in his “testimony”- such as once the vax appeared all research into drug therapy stopped (laughable- what is ACTIV6 or PRINCIPLE?- obviously he has never heard of PF-07321332 nor molnupiravir) he claims there is no asymptomatic spread -https://www.uchicagomedicine.org/forefront/coronavirus-disease-covid-19/asymptomatic-coronavirus-infections-contribute-to-over-50-percent-of-spread
he is to COVID what Charles Ponzi is to investments….
addendum- not to overlook some of the other mistakes in your post- but Dr McCullough isn’t a surgeon and there is a reason every organization formerly associated with him is running away and seeking court action to prevent him claiming affiliation with them.
The rational point you are making, Flicker, that we should be offered oral meds that work across the globe with proven results & also work here in this country for other illnesses – keeps hitting the irrational wall that slams your question to the ground. That wall is the in grained belief that there are no effective remedies.
Some people who are victims of the Rockefeller Institute-slanted medical training simply have been taught a subconscious belief mechanism that informs them that:
1: observation is not adequate for the purpose of understanding a causal situation relating to a med phenomenon, and should be discounted
A: unless the observation occurs inside a lab
B: unless the laboratory observation promotes the result desired by those funding the laboratory study
2: the traditional and primary principle of applying or restricting a new med procedure treatment according to risk-benefit analysis, that principle is considered outmoded. especially since many of the risks occur out in the field, rather than in a laboratory
3: just in case someone comes forward to determine through laboratory methods some statistics based on risk vs benefit analysis, the PTB will outlaw the procedures by which these determinations can be made. This is why so few pathologists are allowed to do post mortem exams of suspected COVID vax fatality victims
Let’s not rely on well proven techniques to advance medical- let’s go back to relying on fraudulent hucksters- like America’s Frontline Doctors- who are ripping off the credulous:
https://time.com/6092368/americas-frontline-doctors-covid-19-misinformation/
https://www.scientificamerican.com/article/fringe-doctors-groups-promote-ivermectin-for-covid-despite-a-lack-of-evidence/
https://theintercept.com/2021/09/28/covid-telehealth-hydroxychloroquine-ivermectin-hacked/
Time Mag is a CIA rag. End of story.
Scientific American became all about Corporate-controlled Science-y-ism, starting around 2003 or so.
I will check out The Intercept – sometimes they have interesting tales to tell.
This is the second paragraph from the Intercept article:
“America’s Frontline Doctors, a right-wing group founded last year to promote pro-Trump doctors during the coronavirus pandemic, is working in tandem with a small network of health care companies to sow distrust in the Covid-19 vaccine, dupe tens of thousands of people into seeking ineffective treatments for the disease, and then sell consultations and millions of dollars’ worth of those medications. The data indicate patients spent at least $15 million — and potentially much more — on consultations and medications combined.”
So, first, these Doctors are called “pro-Trump” as if it were an invective or had anything to do with their medical advice. Then they are accused of sowing distrust in the vaccine by calling it an experimental drug. Isn’t it an experimental drug? If not, then tell me what happens to us ten years after we have been “vaccinated”. No one knows because it is a totally new form of treatment that permanently affects our DNA. Lastly, they complain that the group of physicians has charged for their advice and access and for the medications. I assume they believe that Pfizer, Moderna, and J & J are supplying their shots for free.
Sorry, I didn’t read the other articles.
It is quite possible the average American thinks the vaccines are free, as when you go in for your experimental injection, you pay nothing. And if you shop around, you might get a free hamburger or even a free beer!
However Pfizer is already making a killing on a prescription drug it releases for those injured by blood clots.
All vaccines cost at least 400 bucks – paid by the US government or by a Big Insurer.
A bargain BTW….
Are you channeling Nancy Lieder?
I agree, except the Intercept is not the average American person. They should know better.
Demand for ivermectin has driven cost up greatly, as of a few days ago I priced 35 cash tablets of the 3mg commercially available product and my computer which takes our most recent purchase price into account wants 204 dollars. We have been compounding into a liquid syrup to help with cash paying patients. This has also messed up reimbursements, if I bill your insurance for those 35 tabs they will give me 12 dollars because they are basing their reimbursement on the price from months ago. This is the largest reason why chains like CVS will not fill the scripts. For a pharmacy lagging reimbursements and skyrocketing drug acquisition cost can turn into a limitless loss. Sure CVS can afford it but they won’t take that hit, independent pharmacies though cannot afford to operate at such losses. It is still way cheaper compared to the monoclonal antibody therapies though.