FDA Quietly Authorizes Antibody Treatment for COVID-19 Exposure: Here’s How It Works

• Federal 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.