Many vaccinated Tennesseans could be denied access to monoclonal antibodies in favor of unvaccinated people as new recommendations aim to conserve the life-saving treatment for those at highest risk of COVID-19 hospitalization.
The development comes amid high nationwide demand for the drugs.
Tennessee Department of Health spokesperson Bill Christian said in an email that the U.S. Department of Health and Human Services "recently informed states of disruptions to the federal supply chain for monoclonal antibody products."
Monoclonal antibodies, such as the treatment made by Regeneron, are laboratory-made proteins that work by mimicking the antibodies that target the coronavirus to help speed recovery for people with mild to moderate COVID-19 symptoms that began less than 10 days earlier.
People who are 65 and older and those with weakened immune systems or chronic conditions such as obesity, diabetes and heart disease are good candidates for the treatment.
As of last week, seven states with high levels of COVID-19 and low vaccination rates — including Tennessee, Georgia and Alabama — accounted for 70% of the nation's monoclonal antibody orders, a White House spokesperson said during a Sept. 16 news briefing, noting that "our supply is not unlimited."
As a result, the federal government changed how it allocates the drugs to the states.
Providers are no longer able to order the treatments directly, and the federal government instead will determine each state's weekly allocation of drugs based on usage and case levels, according to a news release from the Georgia Department of Public Health.
Christian said that if monoclonal antibody providers across Tennessee need to prioritize distribution of the treatment, the state recommends they follow the National Institutes of Health guidelines.
Those guidelines say people who are not fully vaccinated and at high risk of progressing to severe COVID-19 should get the treatment before people who are at high risk and fully vaccinated — with the exception of those with weakened immune responses, such as organ transplant recipients and patients undergoing chemotherapy.
"Ultimately, this comes down to providers' clinical judgment to ensure those most at risk are receiving this treatment. Providers across the state continue to receive [supplies] of the treatment; however, we do not have an update on allocation for this week," Christian said.
Although unvaccinated people are much more likely to become hospitalized or die due to COVID-19, it's still possible for the fully vaccinated to become seriously ill or succumb to the disease.
Those so-called "breakthrough" cases have become more common in recent months, which experts attribute to a variety of possible factors, including new coronavirus variants, high levels of community spread, possible waning immunity for some vaccinated people and a larger pool of vaccinated people overall.
Older adults and people with underlying conditions are also the groups with the highest vaccination rates, because they're at higher risk for serious COVID-19 illness and death regardless of vaccination status.
Dr. Mark Anderson, an infectious disease specialist at CHI Memorial Hospital, said monoclonal antibodies are one of the best evidence-based treatments available when it comes to keeping high-risk COVID-19 positive people out of the hospital.
Given the delta-variant-fueled summer surge and the region's low vaccination rate, Anderson said CHI Memorial's monoclonal antibody clinics have been using "a lot" of the treatments.
"We are trying to give the majority of it to unvaccinated [people], because they're at the highest risk," Anderson said. "If we have a vaccinated person who has really advanced heart or lung disease, or they've had a transplant, or they're on chemotherapy for cancer — those are the kind of things we would still prioritize."
Anderson said he believes the state and federal recommendations are on target given how effective the vaccines are at preventing serious illness.
"With the exception of those immunosuppressed and elderly, the majority of people who have been vaccinated who are getting infected are not getting sick enough to be in the hospital or dying. The exceptions are very small, and that's still holding true," he said. "Even with this ferocious delta variant, these vaccines are still performing very well."
Anderson also emphasized that monoclonal antibodies are not a replacement for vaccines and that vaccination is by far the safest and most effective tool to avoid the worst effects of the coronavirus.
"People should not use [monoclonal antibodies] as their main strategy. That's very poor planning. That's like saying you won't wear a seat belt, because we have good hospitals and a trauma center in Chattanooga," Anderson said. "You really need to get the vaccine, don't rely on this. But if you do get infected while you're still thinking about [vaccination] and have some of those medical conditions, you should call your primary care doctor as fast as possible."
There are more than 200 sites providing monoclonal antibodies in Tennessee in the state, including at least three in Hamilton County. Locations can be found on the department of health website, covid19.tn.gov.
Contact Elizabeth Fite at firstname.lastname@example.org or follow her on Twitter @ecfite.