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Same as COVID-19 vaccines, antibody treatments are only authorized for emergency use by the FDA

Similar to state-run vaccine sites set up throughout Florida, Gov. DeSantis recently expanded efforts to open monoclonal antibody treatment sites across the state.

WASHINGTON, D.C., USA — Monoclonal antibody treatment. Regeneron. You've probably heard those words thrown around a lot for the past few weeks.

It's a treatment for people diagnosed with COVID-19. Most notably perhaps, it was given to former President Donald Trump when he contracted the virus last year. 

Recently, the drug therapy has been championed by many health experts and national and state leaders, including Gov. Ron DeSantis. 

This month, DeSantis announced plans to expand the COVID-19 antibody treatment, calling it "the best thing we can do to reduce the number of people that require hospitalization." 

The push for getting the word out about the drug therapy comes as much of the nation is facing a surge of COVID-19 cases and hospitalizations fueled by the delta variant.

However, it is important to note that the treatment, like COVID-19 vaccines, only has Emergency Use Authorization (EUA) from the FDA. 

This means that it's not "better" than the vaccine, in terms of its approval status. And, it's not a replacement or substitute. The therapy can only be given once you've tested positive, or for a select few people who are immunocompromised and were exposed to someone who tested positive. 

The treatment is most effective within the first week of diagnosis or development of symptoms. 

Health experts and national, state and local leaders agree that vaccines are the best option for preventing COVID-19. And, even if you test positive for the virus, it is the best option for preventing severe illness, hospitalization and/or death.

The first monoclonal antibody treatment given the green light was manufactured by Eli Lilly on Nov. 9, 2020. In March 2021, Eli Lilly announced it would stop distributing its therapy bamlanivimab for use on its own after the FDA said it might not be effective against COVID-19 variants.

On Nov. 21, 2020, Regeneron's therapy was given EUA as well. This therapy uses a combination of casirivimab and imdevimab. 

When the treatments were authorized, COVID-19 vaccines were undergoing trials and had not yet been given emergency authorization themselves. That happened on Dec. 11, 2020, when Pfizer's two-shot vaccine was given the emergency go-ahead. Moderna followed about a week later and the one-shot Johnson and Johnson was authorized in February 2021.

What is the difference between emergency use authorization and licensure (approval) by the FDA?

According to the American Academy of Family Physicians: "Emergency use authorization (EUA) is a process by which the FDA can authorize use of a medication or vaccine with less data if the benefit of the vaccine has been shown to outweigh the risk. EUAs can be issued only during a declared emergency, such as the COVID-19 pandemic. Vaccines issued an EUA will continue to be studied, and have additional safety monitoring and informed consent and education associated with them." 

A survey in June from the Kaiser Family Foundation found that 3 in 10 unvaccinated adults would be more likely to get the shots if one of the vaccines received FDA approval. 

RELATED: 'The picture really doesn't do it justice': Man who took picture of patients at monoclonal treatment center talks about experience

RELATED: Where to receive COVID-19 antibody treatments across Tampa Bay


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