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Tennessee limiting monoclonal antibody treatment to unvaccinated residents

"Clinically, it makes sense," a top Tennessee health official said.
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In Tennessee, the patients first in line for the monoclonal antibody Covid-19 treatment are likely to be the ones who landed in the emergency room because they did not get vaccinated.

Extraordinary demand coupled with the federal government’s need to cap shipments of these scarce drugs has forced Tennessee health officials to recommend limiting the treatment to unvaccinated patients with the worst cases of Covid-19.

But doing so raises ethical questions, public health experts said, about who should get this treatment and who shouldn’t.

“For example, if a patient who had a heart transplant had received the vaccine but is still at risk of severe Covid-19 infection was denied access to antibody treatment that could have reduced the severity of their infection, how is this fair?” asked Dr. Sadiya Khan, an epidemiologist at the Northwestern University Feinberg School of Medicine.

Dr. Lisa Piercey, Tennessee’s top health official, agreed that the state’s “logical” decision is not likely to be popular.

“Clinically, it makes sense,” Piercey said Friday, The Tennessean reported. “But the doctor in me thinks about all these ‘what ifs?’ What if there is a super-high-risk older person, but they are not technically considered immunocompromised? Do they not get it but a 22-year-old unvaccinated person with asthma – they get it?”

Under the Tennessee recommendations, vaccinated people who are immunocompromised will also be eligible for the treatment, Piercey said.

Tennessee, which is following the guidance of the National Institutes of Health, appears to be the first state to recommend limiting monoclonal antibody treatment to Covid-19 patients who are unvaccinated or vaccinated but immunocompromised.

“What the state is doing is putting the highest risk patients first in line,” Dr. Karen Bloch of Vanderbilt University Medical Center said. “And not having a vaccine does place one at a higher risk of dying from Covid. So identifying those most at risk makes sense.”

Monoclonal antibody treatment lessens the severity of Covid-19 symptoms, and with more cases of the highly infectious delta variant, the demand for it has soared.

But in recent months, 70 percent of the country’s supply has gone to seven Southern states: Alabama, Florida, Texas, Mississippi, Tennessee, Georgia and Louisiana.

All but Louisiana are led by Republicans who have opposed mandating Covid-19 vaccinations. And all but Florida have below average Covid-19 vaccination rates.

“The recent increase in COVID-19 cases has caused a substantial rise in the utilization of monoclonal antibody drugs, particularly in areas of the country with low vaccination rates,” Dr. Daniel Skovronsky, Eli Lilly and Company’s chief scientific and medical officer, said in a recent statement.

Tennessee’s vaccination rate is 44.1 percent, which is one of the worst in the country, according to the latest Mayo Clinic statistics.

Last week the Biden administration ordered more doses from the two main suppliers, Regeneron and Eli Lilly and Company, and informed state officials it would start capping the shipments of the drug to make sure there’s enough for the rest of the country.

“Our supply is not unlimited,” White House spokeswoman Jen Psaki said. “And we believe it should be equitable across states across the country.”

That move drew immediate criticism from the Republican governors of Florida, Mississippi and Texas (Ron DeSantis, Tate Reeves and Greg Abbott).

DeSantis, in particular, has touted expensive monoclonal antibody treatments (about $2,100 a dose) but has refused to mandate the far-cheaper vaccines (between $10 and $20 a dose) or proven safety measures like wearing masks.