Covid-19 monoclonal antibody treatments: Effectivity and Shortages ...
... not to mention Cost since vaccinated US taxpayers are paying for these expensive treatments even as several southern governors have attacked Biden over his attempts to boost the vaccination rate and tamp down caseloads.
Right-twisting Whining-Wingnuts who don't follow the news ask: "Why is the Biden admin shutting down the spigot on proven methods for treating covid?
>> U.S. Pauses Distribution Of Monoclonal Antibody Treatments That Proved Ineffective Against Omicron
Zachary Snowdon Smith & Forbes Staff
Forbes
December 23, 2021
forbes.com
Topline | The U.S. government has paused distribution of Covid-19 monoclonal antibody treatments made by Regeneron Pharmaceuticals and Eli Lilly, saying those treatments are probably ineffective against the omicron variant, while some hospitals struggle with limited supply of GlaxoSmithKline and Vir Biotechnology’s more effective treatment.
Key Facts
Thursday, the U.S. Department of Health and Human Services announced it would pause distribution of Regeneron’s REGEN-COV treatment and Eli Lilly’s bamlanivimab and etesevimab treatment.
Regeneron and Eli Lilly’s treatments, while effective against previous coronavirus variants, are likely not effective against omicron, whereas GlaxoSmithKline’s sotrovimab treatment appears to still be effective, according to U.S. Food and Drug Administration fact sheets updated Thursday.
The pause on Regeneron and Eli Lilly’s treatments will continue until new data on their effectiveness is received from the Centers for Disease Control and Prevention, HHS said.
Use of these treatments may still be appropriate in places where omicron is less common and there is a limited supply of alternative treatment options, HHS said.
Mutations in the spike proteins of coronavirus particles have prevented Regeneron and Eli Lilly’s antibodies from attaching to them, whereas the area of the protein targeted by GlaxoSmithKline’s sotrovimab remains unaffected by omicron’s mutations, Prevention reported.
Key Background
When effective, monoclonal antibody treatments can prevent serious illness or hospitalization among high-risk coronavirus patients. However, Tuesday, some New York area hospitals reported they had run out of sotrovimab just as the omicron variant was establishing its dominance in the U.S. Delivery of 55,000 doses of sotrovimab began earlier in the week, with an additional 300,000 doses expected to be available by January 3, according to an HHS release. The most recent shipment of sotrovimab was distributed to the U.S. states and territories according to factors including infection and hospitalization rates, with allocations ranging from just 66 doses for Alaska to 4,242 for New York.
Tangent
Delivered through an IV needle, monoclonal antibodies are lab-grown antibodies that help reinforce the body’s natural immune system as it develops its own antibodies to the virus. However, the treatment doesn’t replace a need for vaccination, HHS said. <<
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The potential shortage is not new. This from mid-September ...
>> Biden's team tightens grip on state use of Covid antibody treatments
Federal health officials plan to allocate specific amounts to each state under the new approach.
Adam Cancryn
Politico
September 19th
politico.com
The Biden administration is imposing new limits on states’ ability to access to Covid-19 antibody treatments amid rising demand from GOP governors who have relied on the drug as a primary weapon against the virus.
Federal health officials plan to allocate specific amounts to each state under the new approach, in an effort to more evenly distribute the 150,000 doses that the government makes available each week.
The approach is likely to cut into shipments to GOP-led states in the Southeast that have made the pricey antibody drug a central part of their pandemic strategy, while simultaneously spurning mask mandates and other restrictions. That threatens to heighten tensions between the Biden administration and governors like Florida’s Ron DeSantis, who have emerged as vocal opponents of the federal Covid-19 response.
President Joe Biden has sharply criticized DeSantis and others for resisting efforts to encourage mask wearing and ramp up vaccinations, vowing in a speech last week that if “governors won’t help us beat the pandemic, I’ll use my power as president to get them out of the way.”
Still, until recently, the administration had shipped the antibody treatments to states on an as-needed basis — with top health officials in early August going as far as encouraging those battling the Delta surge to seek even more supply.
But demand from a handful of southern states has exploded since then, state and federal officials said, raising concerns they were consuming a disproportionate amount of the national supply. Seven states — Texas, Florida, Mississippi, Tennessee, Georgia, Louisiana and Alabama — accounted for 70 percent of all orders in early September.
The imbalance prompted an effort to rein in control of supplies, over concerns that the government wouldn’t have enough on hand to respond to Covid-19 surges elsewhere in the country.
Earlier this month, HHS officials told states that they would more closely scrutinize how much of the treatments were actually being used — but that the department was not going to throttle states’ supply.
“The answer is no, we have not transitioned back to an allocation process,” John Redd, chief medical officer for HHS emergency preparedness and response office, said at the time.
That changed just days later, when the department informed states it indeed planned to take back control over where doses were sent, with allocations made based on case levels and usage of the antibody drugs.
“HHS will determine the amount of product each state and territory receives on a weekly basis,” an HHS spokesperson said. “State and territorial health departments will subsequently identify sites that will receive product and how much.”
The decision prompted criticism from Alabama’s state medical association, which warned that it would limit access to the treatment for hospitals already grappling with a rise in Covid-19 patients.
In Tennessee, health department spokesperson Sarah Tanksley told POLITICO the additional scrutiny of state orders was already resulting in delays getting the drugs to providers.
Yet administration officials have bristled in recent weeks over the southern states’ reliance on expensive treatments paid for by the federal government — even as several governors have attacked Biden over his attempts to boost the vaccination rate and tamp down caseloads.
States such as Tennessee and Alabama that have relied heavily on the drugs are also among those with the lowest levels of vaccination against Covid-19.
“It’s where the surges are,” said Marcus Plescia, chief medical officer of the Association for State and Territorial Health Officials, of the rising demand for monoclonal antibody drugs. “And where they haven’t been successful with the other mitigation efforts.”
The new HHS policy represents a return to the early days of the pandemic response, when the states had few other options for combating Covid-19 and demand was high for any treatment that could help keep people out of the hospital.
Once the Covid-19 vaccines rolled out across the nation and caseloads fell, demand for monoclonal antibody drugs dropped, allowing the government to more freely dole them out as needed.
Yet as Delta fueled a resurgence throughout the Southeast, Republican governors latched onto the treatments as a preferred alternative to reimposing public health restrictions. In Texas, Gov. Greg Abbott has opened a series of antibody infusion centers, even as he’s sought to ban mask requirements in schools.
DeSantis has similarly touted efforts to make the treatment widely available, while downplaying the virus’ threat and criticizing the Biden administration’s support for vaccine mandates and school mask mandates.
“Floridians who are getting this treatment, they’re people who need it,” DeSantis’ spokesperson, Christina Pushaw, said. “We’re proud of this rollout and proud of Gov. DeSantis for leading on it and raising the profile of this treatment throughout the country.”
In the face of that rising demand, the Biden administration has also scrambled to accelerate manufacturing of the drugs; already, the government has upped its overall weekly shipment to 150,000 doses from 100,000.
Even so, it will likely take several weeks to expand the pipeline for the treatments, with state officials saying they expect the new limits to remain in place at through at least October.
“Nobody was really using monoclonal antibodies until a few weeks ago. Then there was just this surge of use,” Plescia said. “There is now clearly a shortage.”
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- Eric L - |
