Monoclonal antibodies – a layman’s perspective - plus Paxlovid price shenanigans

Let’s start with a table taken from the excellent site

COVID-19 early treatment: real-time analysis of 3,443 studies (c19early.org)

Those names in the right hand column ending in “..mab” are monoclonal antibody treatments. You can also spot a few other notorious treatments – Paxlovid and Remdesivir. More on Paxlovid later, but that Remdesivir stuff not only has the nickname “run death is near” it is also one of the most expensive treatments around.

Maybe we could include the cost to save one life for the C19 mRNA injections. We know that it takes 600-900 treatments to prevent a single hospitalization, whilst causing dozens of hospitalizations from the injections themselves. We could do some analysis on the number of C19 mRNA injections at 20 bucks a pop at the outset, then 100 bucks a pop for the bivalent and now around 200 bucks a pop for the new monovalent – and even the clinical trials showed ZERO reduction of any significance in mortality.

Maybe the treatments in the left hand column could be nuanced into prophylactic and early treatment. Perhaps the mAb’s are so specific as to warrant their use – despite any side effects.

The table does not adjust for severe (life altering) serious (life threatening) or fatalities.

.We are all aware of the poor manufacturing involved in the C19 mRNA injections that cause all sorts od deadly diseases and conditions. Let’s leave aside the quality controls present or absent in the production and administration into arms of those being “treated” and zoom in on the theory, rather than the practice for now.

Ok, dictionary definition:

monoclonal antibodies (plural noun)

1. an antibody produced by a single clone of cells or cell line and consisting of identical antibody molecules.

Here’s an image for Cancer treatment using mAb’s

From here: Monoclonal Antibodies: Definition & How Treatment Works (clevelandclinic.org)

“Monoclonal Antibodies

Monoclonal antibodies are proteins made in a laboratory meant to stimulate your immune system. Monoclonal antibodies treatments are given mainly as IV solutions, often in an infusion center.”

There is a lot of information on mAb’s including this:

Understanding How Monoclonal Antibodies Work - StatPearls - NCBI Bookshelf (nih.gov)

Here’s an interesting one mentioning IgG’s

Monoclonal antibody therapies against SARS-CoV-2 - PMC (nih.gov)

From the Introduction:

“The first monoclonal antibody (mAb) for clinical use (muromonab-CD3) was approved by the US Food and Drug Administration (FDA) in 1986.

1 Since then, about ten new mAbs have been approved each year (mostly IgG1), with an estimated global yearly sale of US$75 billion in 2021.

2 Most of these mAbs have been licensed for non-infectious disease indications. However, successful efforts have been made in the COVID-19 pandemic to research and develop mAbs against SARS-CoV-2. At the beginning of the COVID-19 pandemic, IgG mAbs against the spike protein of SARS-CoV-2, either as single agents or mAb cocktails (i.e., a combination of two or more mAbs), were announced and advertised by many authorities as the most effective antibody therapeutic solution for COVID-19.

3 As of March 4, 2022, the Coronavirus Antibody Database (CoV-AbDab) contains 5210 antibodies and nanobodies against SARS-CoV, MERS-CoV, and SARS-CoV-2.”

Remember the hoo-ha earlier in 2023 about the dominance of IgG4 post infection/injection and the subordination of IgG1 and IgG3? Seems like injecting mAb’s of IgG1 have not had much success or attention.

(100) Shifting Immunoglobulins (IgG) proportions – low IgG3 and high IgG4 responsible for increased child RSV infections (and others) from C19 mRNA BOOSTED PARENTS (substack.com)

And Dr Jessica Rose piece from August 2023

(100) IgG4, CD4s and why the LNP/mRNA platform should be prohibited (substack.com)

Moving on to known adverse events for mAbs:

From here, 13 years ago:

(100) IgG4, CD4s and why the LNP/mRNA platform should be prohibited (substack.com)

“... However, administration of mAbs carries the risk of immune reactions such as acute anaphylaxis, serum sickness and the generation of antibodies. In addition, there are numerous adverse effects of mAbs that are related to their specific targets, including infections and cancer, autoimmune disease, and organ-specific adverse events such as cardiotoxicity. ... Here, we review some of the adverse effects encountered with mAb therapies, and discuss advances in preclinical testing and antibody technology aimed at minimizing the risk of these events.”

Well, that was 13 years ago. Advances must have been made to make mAb’s safer?

From here:

Benefits and Risks of Administering Monoclonal Antibody Therapy for Coronavirus (COVID-19) - StatPearls - NCBI Bookshelf (nih.gov)

“.. Many monoclonal antibodies received emergency use authorizations for this purpose; however, as the virus evolved, many antibodies became ineffective. This activity outlines the indications, actions, contraindications, and adverse events for monoclonal antibody therapy used as a valuable treatment for outpatient COVID-19 infections.”

“Monoclonal antibody therapy is not indicated in severe COVID-19 illnesses requiring hospitalization.[22][23][24] It has been proposed that monoclonal antibodies may be associated with worse outcomes for patients requiring high-flow oxygen or mechanical ventilation. Even when they were in use, monoclonal antibodies were never authorized for use in these patients due to this potential for harm.”

From here:

Monoclonal Antibodies: How They Work, Uses, Side Effects (verywellhealth.com)

“As valuable as monoclonal antibodies are for the treatment of cancer and other diseases, they can cause sometimes significant side effects. The side effects can vary from one drug to the next and tend to be more profound when delivered intravenously (due in large part to the size of the dose).”

Ok, so what about clinical trials for mAbs. Here’s a pre-C19 link referencing a bunch of clinical trials:

Monoclonal Antibodies in Cancer Therapy - PMC (nih.gov)

Here’s a link to the UK’s approval of Sotrovimab:

MHRA approves Xevudy (sotrovimab), a COVID-19 treatment found to cut hospitalisation and death by 79% - GOV.UK (www.gov.uk)

“This monoclonal antibody – the second to be authorised by the Medicines and Healthcare products Regulatory Agency – is for people with mild to moderate COVID-19 who are at high risk of developing severe disease.”

79% reduction in hospitalization and death (remember the cost per life saved in the table at the top was 352,800 bucks.

From here:

Sotrovimab: COVID-19 Uses, Side Effects, Dosage (medicinenet.com)

From the “Warnings” section:

“Clinical worsening of COVID-19 symptoms has occurred, including events requiring hospitalization, in some patients treated with sotrovimab. It is not clear if these were due to progression of COVID-19 or treatment-related.

Use of monoclonal antibodies, including sotrovimab, can worsen the condition if administered to hospitalized patients with COVID-19 who require oxygen or mechanical ventilation.

Sotrovimab is not authorized for treatment of mild-to-moderate COVID-19 when infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to these drugs and regional variant frequency.”

So, the FDA says “Sotrovimab is not authorized for treatment of mild-to-moderate COVID-19 when infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant” whilst the UK says “– is for people with mild to moderate COVID-19 who are at high risk of developing severe disease.”

By the way “In 2021, the United States government agreed to purchase 1.5 million doses of the drug at $2,100 per dose.” - the odd 3.15 billion dollars,

Confused? You won’t be if you turn into next week’s episode!

It may be that the use of Sotrovimab has been discontinued because of the emergence of new variants. One does wonder what the interaction of this drug is with the different mRNA and viral vector injections (and all the other treatments for heart disease, diabetes, depression, etc).

Re monoclonal antibodies still in use? Maybe new ones to handle new variants? Is the use of mAb’s to rebalance IIgG1 and 3  levels relative to IhH4 a dead issue?

Perhaps more importantly – are ANY mAb adverse events being reported to VAERS?

Lastly, Paxlovid was in the headlines last month as the US Government returned the odd 7.8 million doses and Pfizer jacked its price from 530 bucks to 1,440 bucks – not a bad deal if Pfizer can sell them! The table at the top indicates that it costs around 140,000 bucks to save one life using Paxlovid.

From 17 October 2023:

Government Reduces Paxlovid Stockpile, Returns Millions of Doses (webmd.com)

“The move is widely expected to raise the price of the treatment, but the government and Pfizer agreed on measures to reduce out-of-pocket costs through the year 2028. The government’s price per course of the treatment was $530, and one analyst told CNN that the price could rise to as much as $2,500 on the private market. The result may be a copay for people who have private insurance.

The return is worth $4.2 billion..”

From 19 October 2023:

Pfizer hikes price of COVID antiviral Paxlovid from $530 to nearly $1,400 | Ars Technica

“Pfizer on Wednesday revealed that it raised the list price of a course of Paxlovid—its lifesaving antiviral drug used to reduce the risk of severe COVID-19 in those most vulnerable—to nearly $1,400, more than double the roughly $530 the US government has paid for the treatment in the emergency phase of the pandemic.

Pfizer has all sorts of ways to get the taxpayer to cover the hike, via Medicare and Medicaid – concealing the  costs via accounting “devices”.

Onwards!

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