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Florida monoclonal antibody sites closed after FDA revokes treatment authorization

The sites will be closed until further notice.

TALLAHASSEE, Fla. — The Florida Department of Health has closed all monoclonal antibody treatment sites as a result of the Food and Drug Administration's "abrupt decision" to remove the emergency use authorization for two monoclonal antibodies.

The decision led to nearly 2,000 people in Florida having their appointments canceled abruptly Tuesday.

The revised EUA's do not allow providers to administer these treatments in the United States, FDOH says. The Department adds sites will be closed until further notice. 

“I think this is a good example of the system working,” said Dr. Jill Roberts with USF Public Health.

Dr. Roberts says the FDA revoked its emergency use authorization for two of the most popular monoclonal antibody treatments because data shows the drugs are ineffective against the omicron variant.

“It was a really great treatment option when we had delta,” said Dr. Roberts, “But now that omicron has moved in, there really was no more reason to use it.”

The FDA said it was revoking emergency authorization for both drugs, which were purchased by the federal government and given to millions of Americans with COVID-19 – bamlanivimab and etesevimab, which are given together, and REGEN-COV. 

They remain authorized "only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments," the FDA said. 

If the drugs prove effective against future variants, the FDA said it could reauthorize their use.

The regulatory move was expected because both drugmakers had said the infusion drugs are less able to target omicron due to its mutations. Still, the federal action could trigger pushback from some Republican governors who have continued promoting the drugs against the advice of health experts.

Among those pushing back is Gov. Ron DeSantis who first expressed his displeasure with the decision on Twitter Tuesday before later holding a press conference.

“We’re going to fight back against this,” said DeSantis, “Because this is just wrong.”

Hours following the notification, Gov. DeSantis lashed out at the FDA and Biden administration saying the decision was based on limited information. He also acknowledged the drugs might be less effective than they had been.

“But even with omicron — if it’s half as effective, or even 25% of affective,” said Gov. DeSantis. “That’s better than nothing for people.”

“We don’t want products that they think are going to save their life that aren’t,” said Dr. Roberts. “That’s dangerous. It’s extremely dangerous.”

Gov. DeSantis said he doesn’t believe the Biden Administration has done enough to secure an adequate supply of treatments, “And I think they realize that, and I think it would look very bad to be able to admit that. So instead, they’re saying this is revoked.”

When asked if the state would consider legal action, DeSantis said they would be looking into it.

At the Hillsborough County treatment site on Rome Avenue in Tampa, workers wouldn’t say whether anyone had shown up for the monoclonal antibody treatment only to find out that that appointment had been canceled.

“I was in a house full of six people who had COVID,” said Charra Juhnke, a nurse, who was at the site for a test Tuesday.

Juhnke says the monoclonal antibodies definitely worked for her husband a few months back. But not for her mother, who statistically — more recently — was likely to have contracted the omicron variant.

“So, there may be some truth to the statement it might not work against the omicron variant,” said Juhnke. “But I still believe people should have their own right to choose.”

Tampa General Hospital says it stopped administering Regeneron weeks ago.

“The Regeneron was clearly not the right treatment for this wave of the pandemic. So, we moved away from that,” said TGH’s Chief Medical Officer Peggy Duggan.

The hospital has since pivoted to Sotrovimab, a drug they say has been more effective against omicron.

Unfortunately, doses are in short supply.

“I do know people are working hard to get it to us,” said Duggan. “And so, we just continue to do that work and provide other options for our patients as we go.”

It’s possible, say public health experts, that Regeneron may again be more effective on a future COVID variant.

“But I’d also like them to change their rhetoric at this point and say, OK, that ship has sailed,” said Dr. Roberts. “Let’s talk now about how we can get the monoclonal antibodies that really work to the largest number of people.”

Taking a Deeper Dive: 

There are other treatment options available for Floridians they’re just not as easily accessible as the monoclonal antibody treatments from Regeneron and Eli Lilly.

That third monoclonal antibody treatment call Sotrovimab is one. Multiple studies have shown it does treat those with the omicron variant.

The problem: it’s in short supply. It’s given to the most vulnerable or high-risk patients like those in long-term care facilities.

There are also other drugs available.

The most plentiful is the antiviral drug remdesivir which is delivered through IV.

There are antiviral pills recently authorized by the FDA. Paxlovid is from Pfizer and Molnupiravir is from Merck.

Florida’s Deputy Secretary of Health, Dr. Kenneth Scheppke, says unlike Monoclonal treatments, you have to see a doctor and get a prescription.

"You really have to get into drug-drug interactions, are there any liver issues, are there any kidney issues, you really need far more sophisticated medical decision making before we can prescribe one of those medications, so logistically it's a little harder to get out to the general public," he said.

10 Tampa Bay Anchor Courtney Robinson asked if the federal government would give Florida a larger supply of Sotrovimab would Florida re-open the state supported monoclonal treatment sites.  

"It would be phenomenal if we had it. We saw how successful putting out mass access to monoclonal antibodies were over the delta wave. So yes, if we can get enough Sotrovimab and I know it's in short supply, but if there's anything we can do to increase the supply for Floridians that would be fantastic," Scheppke said.

There’s also a preventative monoclonal antibody treatment that is meant for immunocompromised people or those who’ve had adverse reactions to the COVID-19 vaccine.  It’s meant to be taken before individuals catch COVID-19. It’s called EvuSheld and is from AstraZeneca.

The Florida Department of Health does have a treatment locator on its website. You can click and see which pharmacies have those antivirals available and which hospitals have the approved monoclonals.

The Associated Press contributed to this story.