US restricts use of two monoclonal antibodies that don't work against Omicron
Two monoclonal antibody combos from Eli Lilly and Regeneron are no longer authorized in the US, and shipments to states have ceased because HHS said they are “highly unlikely” to work against the sweeping new variant Omicron.
The move by the FDA comes as states like Florida have become insistent that the mAbs need to be independently evaluated, although the federal Department of Health and Human Services, which has shipped hundreds of thousands of these two mAbs to states in recent weeks, did not ship any this week.
“Jurisdictions, providers and patients should be aware that we have more treatments that do work against Omicron available than ever before, including oral and IV antivirals in addition to the GSK/Vir monoclonal antibody,” HHS said.
Still, all of the treatments remain scarce with about 200,000 Covid cases per day in the US, according to the CDC. HHS each week only ships about 50,000 courses of GSK’s sotrovimab, 75,000 of AstraZeneca’s Evusheld, and every two weeks about 100,000 courses of Pfizer’s pill Paxlovid and another 400,000 courses of Merck’s pill molnupiravir.
The decision to update the Lilly and Regeneron EUAs follows the NIH’s decision to update its clinical guidelines to recommend against both treatments at this time. Lab studies have repeatedly shown that both antibody combos have virtually no activity against Omicron, the variant that now accounts for nearly all coronavirus cases in the US.
And unlike with Lilly’s former mAb bamlanivimab, which had its EUA revoked last April, FDA opted to revise, rather than revoke, these two mAb emergency use authorizations, while noting that, “In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions.”
Some remain unconvinced, although their opinions seem more centered on their political stance against Biden’s FDA than anything related to the data. Taking a swipe at the FDA, Florida’s surgeon general Joseph Ladapo told a local TV station that Florida will not rely on “what other people, or people that the media labels ‘experts’ say.”
Florida’s health department also released a statement calling the FDA move “abrupt,” saying all of its mAb sites will close, and urging citizens to call the FDA “on why this decision was made.” But Regeneron and Lilly both made clear last month the mAbs don’t work against Omicron.
Florida Gov. Ron Desantis released his own statement, similarly making a fuss about the move by FDA, falsely calling it “abrupt and unilateral,” even as there’s broad agreement that the mAbs don’t work against Omicron.
EXCLUSIVE: Florida Surgeon General balks at FDA's decision to limit use of Regeneron and Eli Lilly monoclonals because they're ineffective against Omicron.
Says he wants more clinical data to back up decision.
Here's a portion of our interview. More to come. pic.twitter.com/qUmC1bEchJ
— Jay O'Brien (@jayobtv) January 25, 2022
According to Kaiser Health News, Florida was among the top two states administering these two mAbs from Jan. 5 through Jan. 18.
While Florida may end up following the data (neither Lilly nor Regeneron has raised any issues with the decision from FDA or HHS), Ladapo highlights the way in which the FDA and other federal health agencies have been undermined throughout the pandemic, and have continued to lose the trust of the American people.
