WASHINGTON – As U.S. hospitals under pressure prepare for a new wave of COVID-19 cases caused by the fast-spreading omicron variant, doctors warn of another challenge: the two standard drugs they used to fighting infections likely won’t work the new strain.
For more than a year, antibody drugs from Regeneron and Eli Lilly have been the treatments of choice for the onset of COVID-19, thanks to their ability to prevent serious illness and keep patients out of hospital.
But the two drugmakers recently warned that lab tests suggested their therapies would be much less potent against omicron, which contains dozens of mutations that make it harder for antibodies to attack the virus. And while the companies say they can quickly develop new antibodies targeting omicron, these shouldn’t be launched for at least several months.
âI think there is going to be a shortage,â said Dr Jonathan Li, director of Harvard / Brigham Virology Specialty Laboratory. âWe only have one FDA-cleared monoclonal antibody leftâ with omicron due to the reduced efficacy of Regeneron and Lilly’s drugs.
The delta variant still accounts for more than 95% of estimated cases in the United States, according to the Centers for Disease Control and Prevention. But agency executives say omicron is spreading faster than any previous variant and will become the dominant strain nationwide within weeks.
Provided by injection or infusion, antibodies are laboratory-made versions of human proteins that help the immune system fight viruses and other infections.
Glaxo’s drug, developed with Vir Biotechnology, has been specifically formulated to bind to a part of the virus that is less likely to mutate, according to the companies. Early lab-simulated omicron studies by drugmakers and outside researchers show promising results.
The supply of the drug is “extremely limited and additional doses of the product will not be available until the week of January 3,” the US Department of Health and Human Services said in a statement posted online.
The agency said it distributes the drug to states based on their levels of infections and hospitalizations.
The HHS recommends that states keep the drug for the most-at-risk patients who are most likely to have omicron infections, either based on lab tests that can identify the variant or high levels of spread of it. omicron in local communities, identified as 20% and above.
High-risk patients include the elderly and those with serious health problems, such as obesity, heart disease, diabetes, and immune system disorders.
Prior to the halt in shipments, Glaxo’s drug accounted for about 10% of the 1.8 million doses of antibodies distributed to state health officials between mid-September and the end of November, according to federal figures.
London-based Glaxo said it is on track to produce 2 million doses by May, under contracts with the United States, Canada, United Kingdom, Japan and several other countries. . The company is working to increase its manufacturing capacity next year.
The loss of two leading antibody therapies puts even more emphasis on a pair of long-awaited antiviral pills that U.S. regulators are expected to clear soon.
Drugs from Pfizer and Merck are said to be the first treatments Americans can take at home to prevent serious illness. Pfizer’s drug in particular has shown a potent effect, reducing hospitalizations and deaths by nearly 90% in high-risk patients.
“If deployed effectively, it has huge potential,” to offset antibody treatments, said Andrew Pekosz, virologist at Johns Hopkins University. “This is an immediate place where these antivirals could minimize the impact of omicron.”
However, initial supplies of both drugs are expected to be limited.
The increasingly shrinking treatment toolbox is a painful reminder that the virus still has the upper hand in the United States, even with more than 200 million Americans fully vaccinated.
Scientists around the world are rushing to understand the omicron, especially if it causes more or less severe disease and how easily it evades protection from previous infections, vaccination, and antibody-based drugs.
âWe’re definitely going to see more hospitalizations,â said Dr. James Cutrell of the University of Texas Southwestern Medical Center. “If we run out of antibodies, it will definitely contribute to a lot more patients needing to be hospitalized.”
AP medical writer Laura Ungar contributed to this story.
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