Omicron Variant May Circumvent COVID-19 Antibody Cocktails
A leader in producing monoclonal antibody treatments confirmed today ‘there have been no direct in-clinic data testing against the SARS-CoV-2 virus variant known as Omicron.’
In today’s press release, New York-based Regeneron Inc. stated that the company is evaluating REGEN-COV® against the Omicron (B.1.1.529) variant.
To date, prior in vitro analyses and structural modeling regarding the individual mutations present in the Omicron variant indicate that there may be reduced neutralization activity of monoclonal antibody conveyed immunity, including the current REGEN-COV antibodies.
Further analyses are ongoing to confirm and quantify this potential impact using the actual Omicron variant sequence.
However, current U.S. Food and Drug Administration analyses, including a publication in the journal Cell, affirm that REGEN-COV retains potency against the main variants of concern currently circulating within the U.S., including Delta.
‘It is important that high-risk patients who are diagnosed with COVID-19 are aware of current authorized treatment options and seek out these therapies early in the course of their infection,’ stated Regeneron.
Regeneron says it has one of the largest collections of fully human monoclonal antibodies targeting SARS-CoV-2, including its current REGEN-COV cocktail and multiple additional antibodies.
The first of these additional investigational candidates have already entered into clinical trials, with others nearing clinic readiness.
Preliminary analyses suggest that several of these next-generation antibodies may have the potential to retain activity against the Omicron variant and the other existing variants of concern. Further in vitro data is expected over the next month.
REGEN-COV is a cocktail of two monoclonal antibodies (casirivimab and imdevimab) designed specifically to block the infectivity of SARS-CoV-2, the virus that causes COVID-19.
As of November 30, 2021, REGEN-COV has not been Approved by the FDA but is currently Authorized for emergency use for the treatment and post-exposure prophylaxis in specific high-risk individuals.
In the U.S., REGEN-COV is not authorized as a substitute for vaccination against COVID-19, or for pre-exposure prophylaxis for prevention of COVID-19, or for use in patients who are hospitalized due to COVID-19 or require oxygen therapy, or for people currently using chronic oxygen therapy because of underlying comorbidity that requires an increase in baseline oxygen flow rate due to COVID-19.
In the U.S., REGEN-COV is temporarily available for free to eligible people as part of a U.S. government-funded program. However, there are subcutaneous administration fees.
Real-world data indicates COVID-19 vaccinated people can receive antibody treatments. The U.S. CDC recommends that SARS-CoV-2 vaccination for people who have received anti-SARS-CoV-2 mAbs be deferred until ≥90 days after the therapy is completed.
A Houston, Texas-based clinic, Breathe MD, recently confirmed 44% of its patients receiving monoclonal antibodies for symptomatic COVID-19 in the last two months were fully vaccinated.
Mary Talley Bowden, M.D., board-certified in both Otolaryngology and Sleep Medicine, spoke with Precision Vaccinations on On November 8, 2021, "I have treated 1,346 patients with REGEN-COV since August 2021. Our rate of subsequent hospitalization was 0.3%."
"Furthermore, we have seen no serious or unusual side effects from treatment.”
In September 2021, Regeneron announced a new agreement with the U.S. government to supply an additional 1.4 million 1,200 mg doses of REGEN-COV by January 2022.
The development and manufacturing of REGEN-COV were funded in part with federal funds from the Biomedical Advanced Research and Development Authority, part of the U.S.
Department of Health and Human Services' Office of the Assistant Secretary for Preparedness and Response.
Regeneron is a leading biotechnology company located in Tarrytown, NY, that invents life-transforming medicines for people with serious diseases.
Currently, three anti-SARS-CoV-2 mAb products have received Emergency Use Authorizations from the Food and Drug Administration to treat mild to moderate COVID-19 in nonhospitalized patients with laboratory-confirmed SARS-CoV-2 infection who are at high risk for progressing to severe disease and/or hospitalization.
Additional antibody therapies are listed on this webpage.
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