Mask Up, Get Vaxxed, and Antibody Treatment is on the Way

mask up get vaxed
It feels like we have come full circle and are back to Square One with the Coronavirus. Twelve short months or long – more long than short – months ago schools were shuttering in many states and going remote for the school year and zoom became the new boardroom. Dust collected in office cubicles and life changed for better or worse for the planet. The lives lost still burn a hole in the collective memory of families and strangers alike and the lines were drawn as to whether the virus was a hoax or real and something as simple as a mask became a point of contention, shame, and political division. 

Then came the vaccine and that became an issue as well. “To vax or not to not vax” became more famous than Hamlet’s “to be or not to be” – although to be or not to be considerate of the next person is the question. To mask or not to mask was an issue so how could anyone force anyone to vaccinate? A simple mask! But this is not an opinion piece on consideration for others or self. I personally am torn and have too many people close to me who have suffered with Covid and possibly died as a result of covid. I have too many people close to me struggling with getting vaxxed. I am vaxxed but was concerned because I’ve had anaphylaxis. Masks are a no brainer. Shame on anyone who squabbles about wearing a mask. Do you wear your seatbelt? Do you stop at a red light? Now with breakthrough covid cases everyone is at risk: the unvaccinated and the vaccinated alike and it’s about time we all pitched in and looked out for one another. 

But as I said this is not an opinion piece, this is a piece about help. The kind of help if you happen to get covid that you might want to be aware of regardless of your vaccination status. There are drugs that many people do not know about that can help in specific cases. And that is what this piece is about – bringing awareness about two such drugs: Regen-cov ( more commonly known as regeneron) and one that is still in the clinical trial period -Allocetra. Regeneron is a monoclonal antibody treatment. 

What are monoclonal antibodies?

“Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful antigens such as viruses. Sotrovimab is a monoclonal antibody that is specifically directed against the spike protein of SARS-CoV-2 and is designed to block the virus’ attachment and entry into human cells.”

What is a monoclonal antibody “cocktail”?

“Monoclonal antibody ‘cocktails’ contain two antibodies and trials will investigate whether the therapy can improve the outcomes for COVID-19 patients”

“The cocktails will also be tested as a preventive therapy in those who are healthy but at high risk of getting sick because they work in a healthcare setting or have been exposed to an infected person.”

What do health experts feel about monoclonal antibody treatment? 

“While authorized vaccines have proven safe and effective in holding the line against COVID-19, they are not 100% effective. Reports of uncommon breakthrough cases among fully vaccinated Americans, coupled with the delta variant tearing through the country, threaten to undermine the fiercely fought wins against the pandemic.”

“For the fully vaccinated who do test positive, if you are at high risk for severe infection, health experts are now turning to Food and Drug Administration authorized, virus-fighting monoclonal antibodies in some cases. They are saying it’s safe and beneficial for those who have been vaccinated, but get infected with COVID-19 nonetheless.”

“Receiving antibody treatments in a timely manner could be the difference of ending up in the hospital or getting over COVID (quickly),” Dr. Shmuel Shoham, infectious disease physician at Johns Hopkins University School of Medicine, told ABC News.”

What is Regeneron?

“Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.”

What is Regen-cov?

Regen-cov is the company’s “Monoclonal antibody cocktail developed to bind and neutralize the SARS-CoV-2 virus”. 

“REGEN-COV comprises casirivimab with imdevimab and is authorised for the treatment of mild-to-moderate COVID-19 in adults and paediatric patients with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalisation;”

On 20 July 2021, Japan became the first country to grant full approval for the use of Regeneron’s casirivimab and imdevimab antibody cocktail to treat patients with mild to moderate COVID-19.”

Does it work? Seems so. 

RECOVERY trial results suggest that REGEN-COV reduces the risk of death and the length of hospital stay for seronegative (patients who had not mounted their own immune response) hospitalised patients with severe COVID-19 (16 June 2021)”

Results from a phase III trial of recently infected asymptomatic COVID-19 patients found that REGEN-COV (casirivimab with imdevimab) decreased the overall risk of patients progressing to symptomatic COVID-19 by 31%; the trial’s primary endpoint. It also decreased the overall risk of progression by 76% after the third day, decreased the duration of symptoms and significantly reduced viral levels (12 April 2021);”

Topline results from a phase III outcomes trial suggest that investigational REGEN-COV (casirivimab with imdevimab) significantly reduced the risk of hospitalisation or death by 70% (1,200 mg intravenous [IV]) and 71% (2,400 mg IV) compared to placebo. It also met all secondary endpoints, including the ability to reduce symptom duration (23 March 2021)”

The European Medicines Agency’s Committee for Medicinal Products for Human Use concludes that REGN-COV2 can be used for the treatment of confirmed COVID-19 in patients who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19”

“In an interim analysis, the REGN-COV2 antibody cocktail was found to reduce viral load, with a greater effect in patients whose immune response had not yet been initiated or who had a high viral load at baseline. Safety outcomes were similar in the combined REGN-COV2 dose groups and the placebo group (Weinreich et al. 17 December 2020)”

Regeneron Pharmaceuticals, Inc. announces positive, prospective results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing its investigational antibody cocktail, REGN-COV2, met the primary and key secondary endpoints. REGN-COV2 significantly reduced viral load and patient medical visits (28 October 2020)”

Is it FDA approved? For Emergency Use Authorization. 

“Following the June update that allowed for a lower dose of Regeneron’s antibody cocktail to treat COVID-19, the FDA has again expanded emergency use authorization, this time allowing for its use as post-exposure prophylaxis.”

“According to a press release from Regeneron, the update enables individuals who have already been exposed to SARS-CoV-2, along with those who are at high risk of being exposed due to residing in an institutional setting (eg, nursing homes or prisons), to receive the cocktail.”

“Today’s FDA authorization enables certain people at high risk of developing severe COVID-19 infection to access REGEN-COV if they have been exposed to the virus — the first time an antibody treatment has been authorized for this purpose,” George D. Yancopoulos, MD, PhD, president and chief scientific officer of Regeneron, said in the release. “With this authorization, the FDA specifically highlights the needs of immunocompromised people, including those taking immunosuppressive medicines, who may not mount an adequate response to vaccination, who are exposed to a person with COVID-19 or are in an institutional setting and are at high risk of exposure because of infection occurring in the same setting.”

“The release further noted that the cocktail, a combination of casirivimab and imdevimab known as REGEN-COV, can now also be administered monthly for individuals 12 years of age and older who require repeat dosing for ongoing exposure.”

“REGEN-COV is not intended to be used as a substitute for vaccination against COVID-19 and is not authorized for pre-exposure prophylaxis to prevent COVID-19, according to the release.”

Additionally, In November of 2020 Eli Lilly was granted FDA emergency approval for their antibody treatment for covid-19. 

“INDIANAPOLIS, Nov. 9, 2020 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) today granted Emergency Use Authorization (EUA) for Eli Lilly and Company’s (NYSE: LLY) investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg. Bamlanivimab is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. Bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset. The authorization allows for the distribution and emergency use of bamlanivimab, which is administered via a single intravenous infusion.”

If you live in Los Angeles and are in need of antibody therapy the following is a non-exhaustive list of links of where you might go to inquire about receiving this life saving therapy:

Regeneron’s hotline is 844-734-6643

Eli Lilly hotline 855-LillyC19

Now a word about Allocetra. 

“Enlivex Therapeutics Ltd is an Israel-based clinical stage macrophage reprogramming immunotherapy company developing Allocetra, off-the-shelf cell therapy designed to reprogram macrophages into their homeostatic state. AllocetraTM is a therapy designed to reprogram macrophages into their homeostatic state. Diseases such as solid cancers, sepsis, COVID-19 and many others reprogram macrophages out of their homeostatic state. These non-homeostatic macrophages contribute significantly to the severity of the respective diseases. By restoring macrophage homeostasis, AllocetraTM has the potential to provide immunotherapeutic mechanism of action for life-threatening clinical indications that are defined as unmet medical needs, as a stand-alone therapy or in combination with therapeutic agents.”

“Nes Ziona, Israel, July 12, 2021 (GLOBE NEWSWIRE) — Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), a clinical-stage macrophage reprogramming immunotherapy company, today announced that it has initiated the design and construction process for a new wholly owned manufacturing plant in Israel. Upon completion, this cGMP plant will provide additional manufacturing capacity for AllocetraTM, the Company’s immunotherapy product candidate.”

If you or anyone you know is showing symptoms of Covid-19 please get tested as soon as possible and remember to wear a mask at all times when in public spaces or indoor gatherings with people outside of your own family. Covid is real and people do die. Stay safe.

Author: Sherri Margolin (Dark Matters)

Disclaimer: Absolutely nothing you read in here should be taken as investment advice. The discussion of securities and ideas is never to be considered a recommendation to buy or sell any.  Always do your own due diligence.

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