Change is the only constant throughout the COVID-19 epidemic.
Sadly, COVID-19 has continued to evolve, and as a result of these genetic alterations, the virus is now better able to evade therapy. In the therapy of COVID-19, monoclonal antibodies (mAbs) that specifically target the spike protein have been demonstrated to be therapeutically effective.
However, if the spike protein mutates too much, these therapies become useless. Any of the existing monoclonal antibody therapies no longer neutralize Omicron and its continuously arising subvariants.
High Risk for Severe COVID-19
The US Food and Drug Administration (FDA) notified at the end of November that the last of the six mAbs that had previously been approved, bebtelovimab, is no longer permitted to treat patients who are at a high risk for developing severe COVID-19 disease progression.
The US Centers for Disease Control and Prevention (CDC) genomic surveillance was utilized by the FDA to support their judgment. Since either the BQ.1.1 or BQ.1 strains were responsible for roughly 68% of new infections, bebtelovimab is predicted to be ineffective against these Omicron subvariants.
Eli Lilly, the company that developed bebtelovimab, and its authorized distributors have been instructed by the FDA to temporarily halt commercial distribution. If COVID-19 mutations sensitive to bebtelovimab start to circulate once more, the mAb product may be kept.
There have been six monoclonal antibody therapies approved by the FDA for emergency use since the start of the epidemic (EUA). The FDA has, however, steadily altered each of these interim EUAs because it believes they are ineffective against new varieties.
The FDA emphasized the value of COVID-19 immunization and mentioned the other COVID-19 therapies that are still accessible, as is the case with their previous reversals of mAb EUAs. These include convalescent plasma, Lagevrio, Veklury, and Paxlovid.
However, sometime in the next year, the US government intends to discontinue paying for Paxlovid. The Pfizer oral medication has been used by over 6 million Americans to stop the serious or deadly development of COVID-19. Midway through 2023, when Paxlovid is anticipated to enter the private market, the Department of Health and Human Services will discontinue paying for it.
The COVID-19 antiviral will cost far more on the commercial market than Paxlovid; Pfizer has so far declined to disclose the projected price. The US government has previously acquired Paxlovid in large quantities.
The Pfizer-BioNTech COVID-19 vaccine, whose cost is expected to increase fourfold, will likewise no longer be covered by the US government starting in 2019.