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What are monoclonal antibody treatments?

Regeneron, one such treatment, has been a major focus recently in Florida.

TAMPA, Fla. — The Food and Drug Administration has approved just a single drug to treat COVID-19. It's given emergency use authorization to others.

The one drug with full approval is an antiviral drug called Veklury (remdesivir). It's cleared for adults and some pediatric patients who are sick enough to be hospitalized. 

More recently, you've probably been hearing about a different treatment: monoclonal antibody.

The FDA has given emergency approval for some monoclonal antibody treatments. They're for adults and kids (12 and up) who've tested positive for COVID-19 and are at high risk for suffering severe symptoms.

None of these are substitutes for getting vaccinated – which federal health leaders say remains your best defense against COVID.

But what are monoclonal antibodies? They're lab-made molecules that the FDA says act as substitute antibodies in your body. They attach to parts of the virus and mimic your immune system's ability to fight off harmful pathogens.

"They can help your immune system recognize and respond more effectively to the virus, making it more difficult for the virus to reproduce and cause harm," the FDA explains on its website.

Monoclonal antibodies are most effective when given as soon as possible after a person is diagnosed. They should be administered within 10 days of symptoms showing up. They are not meant for people who are already hospitalized.

Perhaps best known is the Regeneron "cocktail" given to then-President Donald Trump when he was infected. Texas Gov. Greg Abbott is also receiving Regeneron's monoclonal antibody treatment.

It's typically administered by IV, though subcutaneous injections are an alternative when infusions aren't possible.

Regeneron's so-called "cocktail" is actually a combination of two monoclonal antibodies. The company announced Friday that demand had been surging, with more than 130,000 doses being ordered weekly in the United States.

Analysis has suggested the cocktail is often effective against the main variants circulating globally, including the delta, gamma and beta variants.

Regeneron says its cocktail is free to eligible people – something Florida Gov. Ron DeSantis' office has echoed as it opens more treatment sites statewide, including in the Tampa Bay region.

The Regeneron treatment can reduce the risk of hospitalization or death by 70 percent in high-risk patients outside the hospital, the company said earlier this year.

GlaxoSmithKline makes another monoclonal antibody treatment with emergency use authorization in the U.S. Called sotrovimab, the company says it has been shown to reduce hospitalizations and deaths by 85 percent in high-risk adults.

Like with Regeneron's cocktail, GlaxoSmithKline says its single-dose monoclonal antibody continues to be effective against COVID-19 variants. It's authorized for children 12 and older, too.

Back in April, the FDA revoked its emergency use authorization for Eli Lilly's monoclonal antibody therapy bamlanivimab. The government determined variants were resistant to bamlanivimab, and the potential risks of administering it by itself no longer outweighed the benefits.

Then, in June, the U.S. Department of Health and Human Services paused distribution of Lilly's monoclonal neutralizing antibody etesevimab and the combined use of bamlanivimab and etesevimab. HHS said those treatments weren't as effective against the beta and gamma variants.

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