COVID mortality continues to rise across the United States, mainly among unvaccinated populations, prompting renewed interest in newly developed treatments.
Monoclonal antibody (mAb) therapy is one of the most successful treatments available.
Patients are given high doses of antibodies specifically tailored to attack SARS-CoV-2, the virus that causes COVID, as part of this treatment.
These therapies have proven particularly popular in locations like Florida, where there are a large number of unvaccinated persons and a severe outbreak of the Delta form has been ongoing since August.
Governor Ron DeSantis has praised mAbs, saying them “the best thing we can do to lessen the number of people who require hospitalization,” yet dismissing COVID vaccinations as a personal choice with no societal benefit.
Vaccination, according to health professionals, is a superior method to prevent the need for these treatments in the first place.
When administered early in an infection, however, mAbs are quite effective.
More than 20 nonclinical infusion centers, including libraries, theatres, and churches, have been set up in Florida to deliver mAbs to persons who have COVID or have just been exposed to someone who does.
Despite this, public health officials have struggled to keep up with demand; one viral photo from late August shows a woman suffering from COVID sleeping on the floor of the Jacksonville Library, waiting for a mAb injection.
As of September 16, more than 90,000 people had received the treatment, according to DeSantis.
Scientific American spoke with several scientists regarding the role of mAbs in the fight against COVID.
What exactly are monoclonal antibodies and how do they function?
MAbs have long been used to treat diseases like cancer and autoimmune disorders, with approximately 100 medicines licensed by the US Food and Drug Administration since 1994.
To make them, scientists inject a protein into a mouse—for example, a piece of SARS-CoV-2—and then harvest some of the mouse’s immune cells, which produce antibodies against the protein.
These cells are then joined with human cancer cells and allowed to proliferate, allowing for the mass production of particular antibodies that can be injected into patients.
Many COVID mAbs appear to operate well in combination with other antibodies that target other regions of the virus.
The licensed COVID mAbs appear to be most effective when administered shortly after symptoms appear.
Brandon Webb, an infectious disease physician at Intermountain Healthcare in Utah, explains, “That’s the time window in which the virus itself is playing a significant role before it generates the inflammatory complications.”
When a patient’s immune system overreacts to an infection and necessitates mechanical breathing due to inflammatory damage to the lungs, the antibodies appear to be far less effective—and possibly even detrimental.
What antibodies are there to choose from?
Three monoclonal antibodies (mAbs) that target SARS-CoV-2 are now accessible under an FDA emergency use authorization (EUA), which allows a medication to be used in specific persons but does not grant full approval.
GlaxoSmithKline and Vir’s sotrovimab antibody appears to minimize the probability of those infected with COVID being hospitalized for more than a day or dying by 79 percent.
Casirivimab/imdevimab, a two-antibody combination from Regeneron, looks to be similarly beneficial, lowering the risk of hospitalization and mortality by 70%.
The FDA approved a third cocktail, Eli Lilly’s bamlanivimab/etesevimab, in 2020, but the agency advised against using it early this year after it looked ineffective against emerging viral strains like Delta.
The combination is back on the market as of August 27 after a two-month break, but only in states where less than 5% of COVID infections are caused by drug-resistant strains like Delta.
For those already hospitalized with COVID, the FDA approved a fourth cocktail, Genentech’s tocilizumab, in June.
Tocilizumab targets a signaling molecule that might cause the immune system to overreact and produce severe amounts of inflammation, unlike the other medicines that target SARS-CoV-2 itself.
Tocilizumab was authorized by the FDA in 2010 for the treatment of rheumatoid arthritis.
However, it is only marginally effective against COVID: studies reveal that 12% of patients who received the mAb required ventilation or died, compared to 19% of those who received a placebo.
Who is eligible for mAbs?
Eli Lilly, Regeneron, GlaxoSmithKline, and Vir antibodies are approved for children and people aged 12 and up who have not been hospitalized, whereas Genentech antibodies are for children and adults who are on ventilators.
However, the medicines are not yet available to everyone: the EUAs state that patients must be at high risk of COVID problems to get them.
This covers adults aged 65 and up, as well as those suffering from obesity, diabetes, or cardiovascular disease.
The FDA approved Regeneron’s mAb in August for persons who fulfill these risk criteria and have been exposed to COVID but have not yet tested positive for the virus.
What is the nature of the treatment?
In a clinical environment, mAbs are given as an intravenous infusion that lasts around 20 minutes, comparable to chemotherapy treatment.
Under the skin, the Regeneron mixture can also be injected. According to Susanne Doblecki-Lewis, an infectious disease physician at the University of Miami, this is the ideal option for pop-up locations and nonclinical settings where intravenous infusions are difficult.
Four shots are delivered concurrently in the injection procedure, often two in the arms and two in the stomach.
Clinics evaluate patients for one hour after providing the mAb therapy for rare allergic responses.
Hypersensitivity, rashes, and diarrhea are some of the other negative effects.
While the mAb cocktail is free, some clinics charge for the infusion, which needs qualified health care staff and specialized equipment to administer.
Is the use of mAb therapies a viable alternative to vaccination?
Both Webb and Doblecki-Lewis emphasize that mAb therapy is not a replacement for immunization.
“Unfortunately, because of the way monoclonal antibodies are being advertised, some people would prefer monoclonal antibodies,” Doblecki-Lewis explains.
The vaccines, on the other hand, have fewer adverse effects, are less expensive and more readily available, and are much easier to use.
“It’s just so evident that the vaccine is a better first step,” she says.
If they meet the EUA criteria, vaccinated patients with breakthrough COVID infections can get mAb therapies.
This includes immunocompromised persons who are unlikely to have had a significant immunological response to the immunization.
However, some research suggests that receiving mAb therapy before receiving the vaccination reduces the vaccine’s capacity to elicit an immune response since the body already has high levels of antibodies against SARS-CoV-2.
As a result, the US Centers for Disease Control and Prevention advises unvaccinated patients getting mAb treatment to wait 90 days before obtaining their first immunization.
Vaccination, however, is still recommended, according to Webb. He says, “It’s absurd to expect we’ll be able to treat our way out of this pandemic.”
THE AUTHOR IS: Sara Reardon is a freelance journalist based in Bozeman, Mont. She is a former staff reporter at Nature, New Scientist and Science and has a master’s degree in molecular biology.
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