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Tennessee- no antibodiy treatment for Vaxxed

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    Posted: September 21 2021 at 6:20am

This story was behind a paywall at the but posted USAToday.

Tennessee recommends vaccinated residents lose access to monoclonal antibody treatment for COVID

7:58 am EDT Sep. 21, 2021

NASHVILLE — The Tennessee state government now recommends nearly all vaccinated residents be denied access to monoclonal antibody treatment in a new effort to preserve a limited supply of antibody drugs for those who remain most vulnerable to the virus, largely by their own choice.

The federal government began capping shipments of these drugs last week because the majority of the national supply is being used by a small number of poorly vaccinated southern states, including Tennessee. State officials say restricting eligibility to the treatment will reserve the now-limited

supply of drugs for those unvaccinated residents most likely to suffer severe complications from a coronavirus infection. But the recommendation is certain to frustrate many vaccinated Tennesseans, who took commonsense steps to help stop the pandemic and, as a result, may now lose access to one of the most effective treatments for the virus.

About 44% of Tennesseans are fully vaccinated. Under the state's new recommendation, only vaccinated people who are immunocompromised still will be eligible for monoclonal antibody treatment.

Tennessee’s top health official, Health Commissioner Dr. Lisa Piercey said Friday the new eligibility recommendation was “logical” but certain to be unpopular. Piercey said the change also creates thorny hypothetical questions about who gets the treatment and who does not.

“Clinically, it makes sense,” Piercey said. “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?”

Tennessee: State may run low on monoclonal antibodies that treat COVID-19 as feds cap shipments to protect supply

Despite the questions, the Tennessee Department of Health will move forward with the recommendation based on guidance from the National Institutes of Health. The NIH issued guidelines recommending in times of shortage that medical providers prioritize unvaccinated people and partially vaccinated people over those who are fully vaccinated, and therefore more likely to fight off the virus on their own.

Piercey on Friday described the change to antibody treatment as an eligibility criteria that would be invoked by the state, not unlike other mandatory regulations created by the federal government. On Monday, health department spokesperson Sarah Tanksley clarified the change was merely a recommendation — not a requirement — and the decision is “ultimately” left to individual medical providers.

Dr. Karen Bloch, medical director of the antibody infusion clinic at Vanderbilt University Medical Center, said limiting antibody treatment to unvaccinated people was a hard choice made necessary by the desire to do the most good with limited supplies.

Giving antibody drugs to vaccinated people, who are much less likely to get severely ill, is of "limited benefit," she said.

"If we had enough to give this to every single person at risk of hospitalization, that would be ideal. But with this limited resource, identifying those at most risk makes sense," Bloch said. "Taking out the politics, the unvaccinated fit into that category."

Monoclonal antibodies: A COVID-19 defense second only to vaccination

Monoclonal antibody treatment uses an infusion or injection of synthetic antibodies, cloned in a lab, to create a temporary defense to the coronavirus in a patient's bloodstream.

It is one of the most successful tools for preventing severe illness from the virus, largely seen as second only to the vaccines themselves, albeit at one thousand times the cost to the federal government.

Antibody drugs cost taxpayers about $2,100 per dose.

The vaccines cost about $20.

Antibody treatment is currently available at more than 200 Tennessee locations, many of which opened in recent months as demand rose during the delta surge. As of Monday afternoon, the health department had not made clear how medical providers at these locations will distinguish between vaccinated and unvaccinated Tennesseans.

The treatment is believed to be about 70% successful at keeping a COVID-19 patient out of the hospital if administered within a 10-day window after symptoms arise. That means many patients must receive antibody drugs before they feel especially sick to reduce their chances of becoming severely ill later.

Since about 90% of recent COVID-19 infections in Tennessee occur among unvaccinated populations, this antibody treatment already is being used primarily on unvaccinated residents. But, until now, vaccinated residents were offered equal access to the treatment.

Under the state’s revised eligibility recommendations, Tennesseans will qualify for monoclonal antibody treatment if they meet all of these criteria:

Have tested positive for coronavirus and not hospitalized; 

Have mild to moderate symptoms that started fewer than 10 days ago; 

Are age 65 of age or older, or have a medical condition that makes them more vulnerable to the virus: obesity, pregnancy, diabetes, immunosuppression, chronic kidney disease, hypertension, sickle cell disease or chronic diseases of the lung or heart; 

And are either unvaccinated or vaccinated and immunocompromised. 

Only that last rule is new, and most of the others are not as restrictive as 

they first appear. Tennessee is leading the nation in recent COVID-19 

infections, adjusted for population, and the state reports very high rates of obesity, hypertension and many of the other qualifying conditions.

Piercey said eligibility criteria were set by the Food and Drug Administration when it issued an emergency use authorization for treating COVID-19 with monoclonal antibodies in November. This month, as supplies of antibody drugs began to run low, state governments were encouraged to develop more restrictive guidelines or adopt the recommendations from the National Institute of Health.

Tennessee chose to follow the NIH, at least for now, Piercey said.

“The (emergency use authorization) is only for people with these conditions, and that’s been the same since day one,” Piercey said. “The new thing is the NIH criteria of, well, even if you have those conditions, but you’re vaccinated, you don’t get it now.”

Monoclonal antibody supplies are 'not unlimited,' but Tennessee is getting more than its share

Monoclonal antibodies became available to treat the coronavirus last fall. But because of the limitations of the drugs and poor public awareness, the treatment did not see high demand until the delta surge.

Now, federal officials say that demand is draining the nationwide supply.

The federal government informed state officials last week it would begin capping shipments of antibody drugs to individual states in an effort to ensure there were enough to go around. About 70% of the national supply of these drugs was being used by seven southern states with raging outbreaks, including Tennessee. All of the seven states except Florida have below average vaccination rates.

"Our supply is not unlimited," White House spokesperson said Jen Psaki last week, "and we believe it should be equitable across states across the country."

Under the new federal rules, Tennessee will receive a weekly allotment of antibody drugs that could change week to week. While these new caps will reduce the drugs available to Tennessee, it appears the state is still getting more than its share.

The Biden Administration is dispersing an average of 150,000 doses of the drugs per week, according to the White House. Tennessee got about 7,700 doses last week, which is about double what it would receive if supply was divided evenly by population. 

The shortage of antibody drugs is likely to exacerbate a growing wedge between vaccinated and unvaccinated Americans and the politicians vying for their votes.

Some conservative leaders, including Florida Gov. Ron DeSantis and Mississippi Gov. Tate Reeves, now accuse the Biden administration of withholding life-saving drugs from southern states in need. Democratic critics are quick to point out these same politicians have hamstrung policies on masks or vaccines that would have slowed the virus and lessened the South’s need for monoclonal antibodies.

Tennessee Gov. Bill Lee, who similarly opposes mask and vaccination mandates and also promoted antibody treatments, had not publicly criticized Biden on the issue as of Monday afternoon.

Lee said Friday the supply caps were "very concerning" and he would explore "alternative delivery streams" for antibody drugs. Casey Black, a spokesperson for Lee, declined to provide any details about the governor's statements on Monday.

The USA TODAY Network contributed to this report.

Follow Brett Kelman on Twitter at @brettkelman.

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