https://endpts.com/us-ships-out-all-remaining-supplies-of-the-only-covid-treatment-that-works-against-omicron/
UPDATED: US ships out all remaining supplies of the only Covid mAb treatment that works against Omicron
Zachary Brennan
Senior Editor
Right as the new Omicron variant is poised to increase rapidly across the US, the federal government has effectively run out of the only monoclonal antibody treatment that works against it, and at least one major hospital system is now halting all mAb infusions.
Late last month, the federal government paused shipments of GlaxoSmithKline and Vir's mAb treatment sotrovimab in order to conserve supplies of the only treatment that might work against the Omicron variant. Last week, however, HHS told Endpoints News that the move to hold back sotrovimab was unrelated to Omicron, and due to a surplus of Eli Lilly mAbs, which aren't effective against Omicron.
But late Friday, HHS confirmed to Endpoints that the government was withholding the supplies due to the Omicron variant (and apologized for providing inaccurate information a day earlier).
HHS also simultaneously announced that it's shipping its remaining 55,000 doses of sotrovimab, which will begin arriving in the states on Tuesday until more supplies hopefully become available the week of Jan. 3. The department said in a statement:
Early in vitro data suggests sotrovimab works against the Omicron variant. As such, we are actively preparing approximately 55,000 doses of sotrovimab for immediate allocation to state and territorial health departments. Jurisdictions will begin receiving the product as early as Tuesday, December 21, 2021. Current supply of sotrovimab is limited; however, we expect it to grow to approximately 300,000 additional doses in January.
"The feds had no choice but to forward deploy the limited stockpiles they have of the only antibody we know is likely to be highly potent against omicron," former FDA commissioner Scott Gottlieb said.
But the about-face from HHS on why it was withholding sotrovimab reveals an agency scraping to turn a mAb shortage into a positive story about how it planned ahead.
In reality, very few hospitals nationwide will have adequate supplies of sotrovimab later this week and next week, when cases will likely surge due to holiday travel.
New York, Ohio, Pennsylvania, Michigan and Illinois were the only states to receive more than 3,000 doses of sotrovimab each in the latest shipment.
And HHS is advising states to be cautious with its limited supplies, adding, "Until local prevalence of Omicron is greater than 20%, jurisdictions are encouraged to direct sotrovimab to sites that can provide IV treatment (within 48 hours of collection of a patient sample) to highest risk, eligible individuals diagnosed with a test that may identify a potential case of the Omicron variant."
A spokesperson for GlaxoSmithKline said that GSK and Vir have established a strategic manufacturing network that will enable the manufacture of approximately 2 million doses of sotrovimab to support emergency supply in the first year following EUA.
HHS also said Friday that the two other available mAbs, from Eli Lilly and Regeneron, continue to work against the Delta variant, which remains the dominant strain in the US. But with Omicron now over 70% of Covid-19 cases in the US, use of those two mAbs will likely be paused.
The Mt. Sinai hospital system in New York said late Sunday that it's suspending infusions of the Lilly and Regeneron mAbs due to Omicron.
"Due to the increasing prevalence of the Omicron variant of SARS-CoV-2 and the lack of efficacy of both bamlanivimab/etesevimab and casirivimab/imdevimab, we have suspended offering these two treatments for treatment or for post-exposure prophylaxis," Mt. Sinai said in a statement.
Looking forward, states will have to protect against Omicron without the mAb treatments, which will likely compound problems for those who remain unvaccinated.
UPDATED: US ships out all remaining supplies of the only Covid mAb treatment that works against Omicron
Zachary Brennan
Senior Editor
Right as the new Omicron variant is poised to increase rapidly across the US, the federal government has effectively run out of the only monoclonal antibody treatment that works against it, and at least one major hospital system is now halting all mAb infusions.
Late last month, the federal government paused shipments of GlaxoSmithKline and Vir's mAb treatment sotrovimab in order to conserve supplies of the only treatment that might work against the Omicron variant. Last week, however, HHS told Endpoints News that the move to hold back sotrovimab was unrelated to Omicron, and due to a surplus of Eli Lilly mAbs, which aren't effective against Omicron.
But late Friday, HHS confirmed to Endpoints that the government was withholding the supplies due to the Omicron variant (and apologized for providing inaccurate information a day earlier).
HHS also simultaneously announced that it's shipping its remaining 55,000 doses of sotrovimab, which will begin arriving in the states on Tuesday until more supplies hopefully become available the week of Jan. 3. The department said in a statement:
Early in vitro data suggests sotrovimab works against the Omicron variant. As such, we are actively preparing approximately 55,000 doses of sotrovimab for immediate allocation to state and territorial health departments. Jurisdictions will begin receiving the product as early as Tuesday, December 21, 2021. Current supply of sotrovimab is limited; however, we expect it to grow to approximately 300,000 additional doses in January.
"The feds had no choice but to forward deploy the limited stockpiles they have of the only antibody we know is likely to be highly potent against omicron," former FDA commissioner Scott Gottlieb said.
But the about-face from HHS on why it was withholding sotrovimab reveals an agency scraping to turn a mAb shortage into a positive story about how it planned ahead.
In reality, very few hospitals nationwide will have adequate supplies of sotrovimab later this week and next week, when cases will likely surge due to holiday travel.
New York, Ohio, Pennsylvania, Michigan and Illinois were the only states to receive more than 3,000 doses of sotrovimab each in the latest shipment.
And HHS is advising states to be cautious with its limited supplies, adding, "Until local prevalence of Omicron is greater than 20%, jurisdictions are encouraged to direct sotrovimab to sites that can provide IV treatment (within 48 hours of collection of a patient sample) to highest risk, eligible individuals diagnosed with a test that may identify a potential case of the Omicron variant."
A spokesperson for GlaxoSmithKline said that GSK and Vir have established a strategic manufacturing network that will enable the manufacture of approximately 2 million doses of sotrovimab to support emergency supply in the first year following EUA.
HHS also said Friday that the two other available mAbs, from Eli Lilly and Regeneron, continue to work against the Delta variant, which remains the dominant strain in the US. But with Omicron now over 70% of Covid-19 cases in the US, use of those two mAbs will likely be paused.
The Mt. Sinai hospital system in New York said late Sunday that it's suspending infusions of the Lilly and Regeneron mAbs due to Omicron.
"Due to the increasing prevalence of the Omicron variant of SARS-CoV-2 and the lack of efficacy of both bamlanivimab/etesevimab and casirivimab/imdevimab, we have suspended offering these two treatments for treatment or for post-exposure prophylaxis," Mt. Sinai said in a statement.
Looking forward, states will have to protect against Omicron without the mAb treatments, which will likely compound problems for those who remain unvaccinated.