Confusion Surrounds Monoclonal Antibodies and Anti-Virals
Cutting through the mess as Omicron Cases increase
There is a great deal of confusion and fear surrounding the therapeutics’ availability with the dramatic increases in Omicron Covid cases (most notably the mAB’s and the anti-virals).
I was in pharma and biotech for 40 years. I was involved with both vaccines in my early days, and mAB’s for oncology patients in my last 20 years. I continue to read the medical information on Covid, I follow doctors and nurses who are actually in the ED’s, the ICU’s, etc.
I will give my best understanding of what I know. Any doctor is welcome to provide further detail or correct anything I’m suggesting.
First folks, this is serious. Omicron is going to stress our healthcare system as we have never seen before. We have heard that Omicron is less “severe” than Delta. Perhaps that is true. But we have to wait for further experience and data to come in. We have a different population than S. Africa.
No matter whether Omicron is less severe, it is the number of patients that Omicron is infecting that will overload the system. Even though many will have mild symptoms and able to manage at home, there will be many, many patients going to hospital for management.
Remember Omicron is more contagious as it is airborne. That also means that our healthcare providers are getting sick as well. That stresses the system even more as we are already dealing with a nursing shortage and healthcare burnout. They have been at this steadily for two years now. There could be places that simply don’t have enough nurses or docs to provide care for such massive numbers of patients.
The best and the most responsible thing to do is get vaccinated. Yes, we are in the midst of Omicron spreading like wildfire. Do what you can with getting booster, and initial vaccination if you haven’t already done so. I would suggest that you not test this virus if you are unvaccinated.
Rapid at home tests are almost impossible to get. Please don’t hoard them. All of us need them as possible infections hit our families. I have just ordered some through Amazon. The label indicates they are FDA approved, but I’m not familiar with the brand name. Check your county. I know that Anne Arundel and Baltimore County are ordering more tests and hopefully will have some to hand out soon. DO NOT HOARD!
Ok, what do we know about therapeutics for early stage disease should you get Covid? We have two classes of therapeutics – the only mAB made by GSK and the two anti-virals (Pfizer and Merck).
The Federal Government has pulled from distribution the two mAB cocktails that were given for Delta, as those two regimens simply are not effective for Omicron. Try to imagine a mAB as a key that fits a lock. With Delta the mAB’s fit nicely into the Delta variant. . .and stop Delta from replicating as it could not enter the cells of the patient. Because Omicron has so many mutations, that mAB key is no longer fitting into the key hole. That is why the Feds stopped the distribution – it would be a waste of time and money. These mAB’s are not inexpensive. They are also extremely difficult to manufacture. Medical practitioners simply will not use a product they know to be of no use.
GSK (Glaxo, Smith, Kline) is manufacturing sotrovimab for use with Omicron variant. Here is the patient fact sheet for the product:
The physicians’ fact sheet: https://www.fda.gov/media/149534/download
If you are a healthy individual with few risk factors, you will not qualify at this point for receiving a mAB. We simply don’t have a supply sufficient to treat everyone. This product is to be used within 3-5 days for a newly diagnosed Covid patient with risk factors before the disease gets to severe disease.
The other group of product are the two anti-virals EUA approved by the FDA (Merck and Pfizer). My preference would be the Pfizer product if available. If not, go with the Merck product (just my opinion – speak to your doctor about it). Again, this therapy has to start within 3 days or so of testing positive or showing symptoms.
I believe (don’t quote me) that the supply of either of these two anti-virals is greater than the mAB, and would be the way to go for the average patient at home. I believe the supply is already in pharmacies, as the wholesaler usually has product in warehouse waiting for FDA approval, and then product is immediately shipped out.
If you are on any other medications and you are seeking the antiviral, please, please tell your doctor everything you are taking. There is something called the Cytochrome P-450 (liver metabolism) that can significantly interfere with the absorption of either the anti-viral, or the anti-viral can cause extreme levels of your other meds. Discuss your meds with your doctor, he knows about this metabolic pathway. Don’t hold back on meds you take and be sure to include any OTC, Herbals, etc. that you might take.
What do you do if you get a positive test? Don’t panic. Call your primary care immediately. Every office might be handling these phone calls differently. Talk with your doctor about the possibility of getting the anti-viral or the mAB. The doctor knows who qualifies for either category of product. Don’t get angry or discouraged if you do not qualify. We are living with a widespread variant across the globe. Unfortunately, not everyone will get (or need) a therapeutic. Your doctor should guide you through how to manage your infection.
I’m going to say something that some will not like, but I’m saying it anyway. If you are not vaccinated, get vaccinated or get your booster if you qualify. While this variant is all around us, you might be able to get some benefit. The unvaccinated are still driving the hospitalizations. The immunocompromised (through no fault of their own) are also in danger of being hospitalized. So, be a good member of society and help through getting vaccinated. There is way too much misinformation and lies surrounding the vaccines. Talk with your doctor if you have concerns.
People, it is time for us to step up to the plate. Our healthcare providers need our help. These are the things that will help:
Vaccinate, primary or booster
Wear masks, (KN95 or N95). It is one of the mitigation recommendations.
Don’t waste tests (if you ever get your hands on some).
STOP gathering in groups for the time being.
Respect our healthcare workers. They are burnt out. Be kind.
I don’t agree with the CDC recent guidelines on the 5 day return to work, etc. There is a lot of discussion amongst HCW that this is not the right thing to do. I’m asking all of you to carefully monitor yourself, and do not endanger anyone by not staying inside until you receive a negative test x 2 days.
I just recently went through this with my grandson and daughter. Grandson got infected before Christmas, daughter (vaccinated with 2, shots, no booster) is now infected and is managing at home. Fortunately I had some at-home kits where they were able to test. My granddaughter is vaccinated and thus far, has shown no infection.
Again, do not play a game of “Dare This Virus, particularly if you are unvaccinated. The virus is more likely to win. And we and our healthcare system are at risk. Be responsible.