As Omicron Surges, consider that the First Authorized COVID-19 Therapies Were Not Drugs or Vaccines

December 17, 2021

On March 24, 2020, the U.S. Department of Health and Human Services (HHS) declared that the emergence of COVID-19 justified the Emergency-Use Authorization (EUA) of drugs, biological products, and medical devices to combat the pandemic.

Within a month of the HHS declaration, The U.S. Food and Drug Administration (FDA) awarded an EUA to industry colleagues at Terumo BCT, ExThera Medical Corporation, CytoSorbents, Inc., and Baxter Healthcare Corporation.  The therapeutic products from these organizations were not drug or biological agents, they were blood purification technologies.

In connection with these EUA awards, FDA published a statement that blood purification devices may be effective at treating certain patients with confirmed COVID-19 by reducing various pathogens, cytokines, and other inflammatory mediators from the bloodstream. 

 Consistent with FDA’s statement, we have been advancing Sigyn Therapy, a dual-function blood purification technology that we created to address pathogen sources of life-threatening inflammation in concert with the broad-spectrum elimination of cytokines and other inflammatory mediators. 

 Beginning in December of 2020, we have reported results from a series of in vitro blood purification studies that validated the ability of Sigyn Therapy to extract a broad-spectrum of viral pathogens (including COVID-19), gram-negative and gram-positive bacterial toxins, hepatic toxins, cytovesicles and pro-inflammatory cytokines from human blood plasma.

Concurrent with our intent to participate in the emerging blood purification industry, COVID-19 has revealed the strengths and weaknesses of government preparedness initiatives that were in place at the outset of the pandemic. 

In this regard, the development, clinical testing, market clearance, and global delivery of multiple vaccines that protect against severe COVID-19 infection is unprecedented.  Less than one year after the HHS mandate, vaccines from Janssen, Moderna, and Pfizer-BioNTech were cleared under Emergency Use Authorization.  Beyond the ongoing need to protect against COVID-19, the business environment for protective vaccines should continue to be robust as a confluence of global warming, urban crowding and intercontinental travel are likely to fuel a continuance of future pandemics.

Inversely, 5.3 million COVID-19 deaths and the shutdown of global economies have exposed the futility of aligning post-exposure antiviral drugs with emerging pandemic threats.  Especially if preventive messenger RNA (mRNA) vaccines can be delivered to the marketplace at a pace that precedes the development of a post-exposure antiviral drug.  Between the EUA clearance of the blood purification and vaccine technologies referenced above, Remdesivir (Gilead Sciences, Inc.), a drug repurposed from the Ebola 2014 outbreak, was the sole antiviral to be cleared under EUA.

As a result, an increasing emphasis should be placed on blood purification technologies as post-exposure countermeasures to treat hospitalized patients with severe infections.  In closing, consider that a properly designed blood purification device can perform functions that are beyond the reach of drugs and will have broad commercial applications beyond the treatment of pandemic viruses.

Have a Happy Holiday Season, Jim