Share on PinterestFederal regulators have issued an emergency use authorization of an antibody treatment for people at high risk who have been exposed to SARS-CoV-2.The treatment works by attaching monoclonal antibodies to the novel coronavirus when it first enters the body and preventing it from invading new cells and replicating.Experts note the treatment is not a substitute for getting vaccinated.
Officials at the Food and Drug Administration (FDA) have authorized a monoclonal antibody treatment called REGEN-COV under an emergency use authorization. This treatment is for adults and children over age 12 exposed to SARS-CoV-2 who might be at high risk of developing severe COVID-19.
“It is reasonable to believe that REGEN-COV may be effective for use as post-exposure prophylaxis of COVID-19 in individuals who are at high risk for progression to severe COVID-19, including hospitalization or death,” FDA officials said in a letter to the pharmaceutical company that makes the product.
“When used under such conditions, the known and potential benefits of REGEN-COV outweigh the known and potential risks of such product,” the officials added.
Dr. William Schaffner, an infectious disease expert at Vanderbilt University in Tennessee, says the use of monoclonal antibodies is an important tool in the fight against COVID-19.
“We’ve had so much attention to vaccines, it’s really good to see another therapeutic agent because clearly there are many people falling ill, falling seriously ill, with this virus, and we can use all the help we can get,” he told Healthline.
Vanderbilt University is home to one of many clinics across the country using monoclonal antibodies as a treatment for COVID-19.
“We’ve set up a special clinic to do that and the people who run the clinic are absolutely convinced that they can prevent the evolution into more serious disease,” Schaffner said.
“Once you [have an infection], you are assessed for certain risk conditions that make it more likely you will get severe disease. If you fall within those classifications, you are offered monoclonal antibody. Mind you, you may only have minor symptoms now, but the whole point is to prevent the evolution into something more serious,” he added.
Individuals considered at high risk include those who are not fully vaccinated, those who are immunocompromised, and those who reside in nursing homes.
Attacking the virus early
Monoclonal antibodies work by attaching to parts of the SARS-CoV-2 virus and helping the immune system to better respond to it.
Currently, there are three monoclonal antibodies being used under the emergency use authorization.
The use of these treatments helps to stop the disease from progressing to severe illness.
“The development of serious disease goes through two stages. The first is the virus leaves the throat and the bronchial tubes, gets out into the lungs, and is transported via the bloodstream to other organ systems,” Schaffner explained. “At that point, the virus itself is infecting the cells of those organs and begins to cause organ dysfunction. While that’s happening, your immune system becomes alerted, recognizes that the virus is foreign, and revs itself up, energizes itself, in order to fight the virus.”
In revving up, however, the immune system itself can overreact and cause pneumonia and other damage to the lungs.
“It’s like a bombing campaign in a city. You try to bomb the enemy troops, but you get some civilian damage at the same time,” Schaffner said.
“These monoclonal antibodies work in phase one of the illness because they attach themselves to the virus and inhibit the virus from entering new cells, multiplying, and spreading the infection,” he noted. “They are a rifle that is aimed at the earliest stage of the illness, designed to prevent the illness from moving into stage two, and therefore you evert this overactive immune response.”
Not a vaccine substitute
In issuing guidance on REGEN-COV, the FDA states monoclonal antibodies should not be considered a substitute for vaccination.
Schaffner says it’s crucial that people continue to get vaccinated and not assume a monoclonal antibody will be available to help them if they’re exposed to the virus.
“I always refer people back to one of the founders of the United States, Benjamin Franklin, who advised us that an ounce of prevention is worth a pound of cure. Clearly, it’s better to prevent any illness or infection on the front end rather than have to cope with it on the back end,” he said.
“Vaccination is quick, easy, highly effective, and safe. Why would you not do that?” Schaffner added.
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