The last available COVID-19 monoclonal antibody, bebtelovimab, is now no longer authorized due to suspected inability to neutralize the most dominant COVID-19 variants, Omicron BQ.1.1 and BQ.1.
The only constant in the COVID-19 pandemic is change.
COVID-19 has continued to mutate, and unfortunately these changes to its genetic code have made the virus more adept at eluding treatment. Monoclonal antibodies (mAbs) target the spike protein and have been shown to be clinically beneficial in the treatment of COVID-19.
However, these treatments are rendered ineffective if the spike protein mutates too much. Omicron and its continually emerging subvariants can no longer be neutralized by any of the available monoclonal antibody treatments.
In a statement at the end of November, the US Food and Drug Administration (FDA) announced that the last of the 6 previously authorized mAbs, bebtelovimab, is now no longer authorized to treat individuals at high risk for severe COVID-19 disease progression.
The FDA cited US Centers for Disease Control and Prevention (CDC) genomic surveillance in their decision; nearly 68% of new infections were caused by either the BQ.1.1 or BQ.1 strains, and bebtelovimab is expected to be ineffective against these Omicron subvariants.
With this FDA announcement, bebtelovimab developer Eli Lilly and its authorized distributors are ordered to pause commercial distribution for the time being. The mAb product may be retained, in the event that COVID-19 variants susceptible to bebtelovimab begin to circulate once again.
Since the beginning of the pandemic, there were 6 monoclonal antibody treatments available under FDA Emergency Use Authorization (EUA). However, the FDA has gradually revised all of these temporary EUAs due to believed inefficacy against emerging variants.
As is their other reversals of mAb EUAs, the FDA stressed the importance of COVID-19 vaccination and noted the other COVID-19 treatments still available. These include Lagevrio, Veklury, and Paxlovid, as well as convalescent plasma.
However, the US government plans to stop covering the cost of Paxlovid sometime next year. Nearly 6 million Americans have taken the Pfizer oral pill to prevent severe or fatal COVID-19 progression. Paxlovid is expected to hit private markets in mid-2023, at which point the Department of Health and Human Services stops paying for the treatment.
The US government had previously purchased Paxlovid in bulk, but the COVID-19 antiviral will cost much more on the private market; Pfizer has thus far declined to share the anticipated price.
Next year, the US will also stop paying for the Pfizer-BioNTech COVID-19 vaccine, which will likely quadruple in price.