Monoclonal Antibody Infusions: an alternative to vaccination? In some situations probably yes.
Specifically, they are probably most useful for "positive Covid infected" PWP who are 1) NOT vaccinated or have not been vaccinated with last 90-120 days, 2) who are > 65 years old, 3) who have 1 or more comorbidities, 4) who have serious symptoms probably requiring hospitalization, and 5) who have hospital/physician willing to use this modality.
Currently the MA IV infusion modalities are FDA "emergency use authorized" only, so not every state's medical centers/hospitals have them available for use.
(Monoclonal antibodies are laboratory-made synthetic versions of proteins naturally produced by the human immune system in response to invading viruses such as SARS-Cov-2)
Even though the mortality rate resulting from infection from Sars-CoV-2 remains very low globally (126 million cases with 2.7 million recorded deaths or an OS of .0214% as of 3/25/2021), constant efforts have been tried to reduce this number once an individual becomes infected, particularly if admitted to a hospital.
Variants will probably become more and more of a problem for any current vaccine. We see that a recent, very small study found that the Pfizer-BioNTech mRNA vaccine had limited efficacy in identifying mutated receptor-binding domains (RBDs) of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein similar to the B.1.351 and P.1 variants.
Chang X, et al. BNT162b2 mRNA COVID-19 vaccine induces antibodies of broader cross-reactivity than natural infection but recognition of mutant viruses is up to 10-fold reduced.
One such modality that might help the shortcoming of vaccines is an old modality (dating back to the late 1970s) called MONOCLONAL ANTIBODY IV INFUSION. By 2015, 50 or so MA products (Humira, Enbrel, Avastin, etc.) were available with a market value of > $100 billion USD. Unfortunately, this modality has had mixed results in treating cancers and diseases such as MS, RA, TB and STDs.
So is the MA IV modality (mABs) just a big pharma widely produced treatment repurposed for Covid or is it truly valuable in reducing deaths of “Covidinfected” people?
Question#1: Any real clinical trials? Yes.
Regeneron (Trump used REGN-2) and Lilly (both via US NAIAD funding) have proceeded with two very good Phase III, randomized, 2,000+ participants each, placebo-controlled, double-blind clinical trials to test whether their proprietary experimental monoclonal antibodies (mAbs) can prevent infection by SARS-CoV-2 coronavirus.
In a press release of 3/23/2021 re their phase III, Regeneron claims:
REGEN-COV™ (CASIRIVIMAB WITH IMDEVIMAB) ANTIBODY COCKTAIL REDUCED HOSPITALIZATION OR DEATH BY 70% IN NON-HOSPITALIZED COVID-19 PATIENTS (n= 4,567)
1) Therefore this combo reduced hospital stays on average from 14 days to 10.
2) This combo also reduced deaths by a factor of 3.5(!) through day 29 (hypothetically only 100 deaths vs 350 on the placebo)
3) All doses (8,000 mg, 2,400 mg and 1,200 mg) had similar efficacy across all endpoints.
4) All patients in this analysis had at least one risk factor
Question #2: what “common and frequently prescribed” MA treatment is currently available in the US?
Lilly’s combination of Bamlanivimab and Etesevimab administered together (authorized dosage of 700 milligrams bamlanivimab and 1400 milligrams etesevimab) is allowed and available for the treatment of mild to moderate COVID-19 in adults and pediatric patients who test positive for SARS-CoV-2 and who are at high risk due to “comorbidities” for progressing to severe COVID-19.
The justification for this approval was based on a single, relevant, but with a sample size lacking statistical relevance, CT. 518 participants received a single infusion of bamlanivimab 2,800 milligrams and etesevimab 2,800 milligrams together, and 517 received the placebo. The primary endpoint was COVID-19 related hospitalizations or death by any cause during 29 days (1 months) of follow-up. Hospitalization or death occurred in 36 patients who received placebo compared to only 11 patients treated with bamlanivimab 2,800 milligrams and etesevimab 2,800 milligrams administered together, a 70% reduction. All 10 deaths (2%) deaths occurred in the placebo group. Thus, all-cause death was significantly lower in the bamlanivimab 2,800-milligram and etesevimab 2,800-milligram group than the placebo group.
Medicare/Medicaid guidelines require that as with ALL other monoclonal antibody infusion treatments, bamlanivimab and etesevimab may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary.
Question #3: if MA IV infusion is so great, why aren’t every VA, SNF and hospital facility using it when appropriate?
The answer is obvious. AEs are not rare, and if they do occur they require expertise and EMS resources. Plus, infusion requires equipment, a tech to set up and 1 hour to complete per person. A vaccination shot can be given by almost anyone with minimal training and only takes seconds.
Do the math.
Sharon
