With the omicron variant of the coronaviruses poised to affect most covid-19 treatments, the U.S. public health officials are preparing for the variant to affect more treatments.
David Kessler, chief scientific officer of the White House covid-19 response team, said that the decision to pause every other week shipments to states of the treatment was part of a broader strategy to marshal the most effective tools to combat omicron.
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Rochelle Walensky, director of the Centers for Disease Control and Prevention, said Wednesday that Omicron is an estimated 3% of all coronaviruses in the United States. At Houston Methodist, omicron grew from less than 3% of cases to more than 30% in four days. The percent of positive tests doubled in New York in three days.
When omicron becomes dominant, the focus will be on sotrovimab, an IV injection from Vir Biotechnology and Glaxo, which is expected to wipe out or weaken much of the covid-19 medicine cabinet. The treatment will hold up against the new variant. Antiviral pills that have not been authorized are expected to fill in the gaps.
A patient who had recovered from the first severe acute respiratory syndrome virus had an antibody in their blood. George Scangos, chief executive of Vir, said that it was chosen because it blocked the two most common strains of the disease. It was more likely to stand up to future viral variants.
Scangos said that he didn't feel good that the competition got knocked out. In the first year after the drug's authorization, the companies are trying to increase manufacturing capacity, but they did not plan to make 2 million treatments.
Kessler said that the government moved to conserve sotrovimab when it was found that the drug might hold up against the variant. A growing number of studies show that it will work. The supply is limited, with about 50,000 total doses on hand, and an inventory expected to grow to 350,000 by early January, according to Kessler. The U.S. government gave 180,000 doses to the states. The distribution data doesn't show which doses have been used.
As they took sotrovimab offline, officials increased shipments to states of monoclonals from Eli Lilly and Regeneron Pharmaceuticals. The drugs are in greater supply and are highly effective against the delta variant. There were 400,000 treatments given to states.
Scangos said that the strategy of the U.S. government was to ship those now because of the strain. The benefit to patients will still be provided by those antibodies. Sotrovimab will be reserved for early next year because everybody expects omicron to take over. That makes sense.
The treatment tool kit against covid-19 has a central part of theonoclonal antibody drugs that is remarkably effective at keeping people out of the hospital. Three are authorized for treatment and one is authorized for prevention.
The treatments work by recognizing the hallmark spike proteins that stud the outside of the virus, and omicron's heavily mutated spikes are expected to dodge the drugs. A next-generation antibody cocktail that could begin human testing early next year is one of the things that Regeneron said it is working on.
The company's cocktail is likely to lose some of its ability to block the virus because of the omicron mutations, according to Lilly spokeswoman Allison Howell. She said that the company's scientists had always anticipated more monoclonals would be needed.
The long-acting monoclonal antibody that was recently authorized as a treatment to prevent illness is likely to retain its protection against omicron, according to the announcement. A preprint study suggested that omicron could escape the individual components of the cocktail.
The new variant could completely evade the combination if Omicron changes more, according to David R. Martinez, a viral immunologist at the University of North Carolina Gillings School of Global Public Health.
The government will switch to sotrovimab once omicron reaches a high enough level.
Kessler said the hard part was telling him when he would switch over.
Kessler said a team is working on details of when and how to switch. Existing treatments from Lilly and Regeneron will work well in areas dominated by delta. Some areas may be close to a tipping point.
The decision to switch will probably be made based on the prevalence of a variant in the region, not by waiting, said Roy M. Gulick, an infectious-diseases physician at Weill Cornell Medicine and co-chair of the National Institutes of Health's Covid-19 Treatment Guidelines panel
Most of the monoclonal antibodies won't be effective against the infection anymore if it becomes the dominant variant. You will know what's in your community by using the public health approach.
In the spring and summer, the Eli Lilly monoclonal antibody cocktail was paused in some states and regions, and eventually stopped nationwide. It went back into use when the levels dropped.
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