FDA approves antibody treatment for COVID-19 exposure

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• Federal regulators have issued an emergency use authorization for antibody therapy for people at high risk of exposure to SARS-CoV-2.
• This treatment works by attaching a monoclonal antibody when the new coronavirus first enters the body, preventing it from invading and replicating new cells.
• Experts note that this treatment is not a substitute for vaccination.

Food and Drug Administration (FDA) staff Approved Monoclonal antibody treatment called REGEN-COV under an emergency use authorization. This treatment is intended for adults and children 12 years and older exposed to SARS-CoV-2, who may be at increased risk of developing severe COVID-19.

“REGEN-COV is reasonably effective for post-exposure prophylaxis with COVID-19 in individuals at high risk of developing severe COVID-19, such as hospitalization or death,” the FDA said. Officials say. Said In a letter to the pharmaceutical company that manufactures the product.

“When used under such conditions, the known potential benefits of REGEN-COV outweigh the known potential risks of such products,” officials added.

Dr. William SchaffnerInfectious disease experts at Vanderbilt University in Tennessee say the use of monoclonal antibodies is an important tool in the fight against COVID-19.

“We’ve been paying a lot of attention to vaccines. Obviously there are a lot of people who get sick or seriously ill with this virus, so it’s really good to see another remedy. I You can use all the help we can get, “he said.

Vanderbilt University is one of many clinics nationwide that uses monoclonal antibodies as a treatment for COVID-19.

“We have set up a special clinic to do that, and the people who run the clinic are absolutely confident that they can prevent the evolution of more serious illnesses,” Schaffner said. I did.

“Once you [have an infection], You will be assessed for certain risk conditions that increase your chances of getting a serious illness. If these categories apply, monoclonal antibodies will be provided. As a reminder, you may have only minor symptoms now, but the important thing is to prevent the evolution into something more serious, “he added.

Individuals who are considered high risk include those who are not completely vaccinated, those who are immunocompromised, and those who live in nursing homes.

Monoclonal antibodies work by attaching to some of the SARS-CoV-2 virus and helping the immune system react to it.

Current, three Monoclonal antibody used under emergency use authorization.

The use of these treatments helps prevent the disease from progressing to a serious illness.

“There are two stages in the development of a serious disease. The first is that the virus leaves the throat and bronchi, exits the lungs, and is carried through the bloodstream to other organ systems,” Schaffner said. Explained. “At that point, the virus itself is infecting the cells of those organs and is starting to cause organ dysfunction. While that is happening, your immune system is warned and the virus is exogenous. Recognizing that, it spins itself to fight the virus and energizes itself. “

However, when rejuvenated, the immune system itself can overreact, causing pneumonia and other lung damage.

“It’s like a bombing campaign in a city. It tries to bomb enemy forces, but at the same time it damages civilians,” Schaffner said.

“These monoclonal antibodies work in Phase 1 of the disease because they attach to the virus and prevent it from invading new cells, multiplying, and spreading the infection,” he said. “These are rifles aimed at the early stages of the disease and are designed to prevent the disease from transitioning to the second stage, thus reversing this excessive immune response.”

In issuing guidance on REGEN-COV FDA says Monoclonal antibodies should not be considered a substitute for vaccination.

Schaffner says it’s important that people continue to be vaccinated and that they don’t think monoclonal antibodies are available when exposed to the virus.

“I always bring people back to Benjamin Franklin, one of the founders of the United States. Benjamin Franklin advised us that an ounce of prevention deserves a pound of treatment. Obviously, the back end. It’s better to prevent illness and infection at the front end than to deal with it, “he said.

“Vaccination is quick, easy, very effective, and safe. Why not?” Schaffner added.

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