FDA’s move to halt use of two COVID-19 antibody drugs was based on data
CLAIM: The Food and Drug Administration revoked its emergency authorization for two monoclonal antibody treatments even though they are highly effective in treating COVID-19.
AP’S ASSESSMENT: Missing context. The antibody treatments from Regeneron and Eli Lilly helped patients infected with previous variants of the coronavirus, but they don’t work against omicron, according to several independent studies that the FDA used to make its decision. The FDA noted that omicron infections account for more than 99% of U.S. COVID-19 cases, making it “highly unlikely” the antibodies would help people currently seeking treatment.
THE FACTS: The FDA’s decision on Monday to halt for now the use of two COVID-19 antibody drugs led to immediate outcry on social media and by Florida Gov. Ron DeSantis, who has heavily promoted antibody drugs as a signature part of his administration’s COVID-19 response.
DeSantis called the move “reckless” and “fundamentally wrong” in a news conference on Tuesday. Meanwhile, social media users seized on the news to falsely suggest the FDA made its decision without evidence, or blocked the drugs because it wanted to kill people.
“I just saw that the FDA has withdrawn emergency approval for the Regeneron and Eli Lilly monoclonal antibodies,” read one tweet shared thousands of times. “What are they doing? Trying to kill us?”
“Every single person has been raving about the monoclonal antibodies as an effective treatment to Covid. It has quite literally been saving lives,” read another widely shared tweet. “So naturally, the drug cartel over at the @US_FDA bans it.”
These reactions lack key context: Though the treatments did save the lives of patients infected with the delta variant, they don’t work against omicron, which now accounts for almost all COVID-19 cases in the U.S.
In addition, alternate therapies to battle early COVID-19 cases, including two antiviral pills and a monoclonal antibody treatment from GlaxoSmithKline, remain effective against the omicron variant, though supplies of those drugs are limited.
Federal officials said the FDA decision was supported by several independent studies, including a peer-reviewed paper published in the journal Nature last month. In that study, a consortium of European researchers tested the ability of several antibody drugs to neutralize a live sample of the virus, concluding that Lilly and Regeneron’s antibodies “were inactive against omicron.”
The American Medical Association, the nation’s largest physician group, said it agreed with the FDA decision, issuing a statement that read: “Limiting the use of these treatments will help ensure patients receive the best available therapy.”
Asked about DeSantis’ opposition to the FDA decision, White House press secretary Jen Psaki said, “Let’s just take a step back here to realize how crazy this is.”
“They are still advocating for treatments that don’t work,” she said of DeSantis.
Health officials continue to urge vaccination as the best and safest way to protect yourself against the coronavirus. Three studies released earlier this month provided more evidence that COVID-19 vaccines are helping prevent hospitalization and death from the omicron variant, at least among people who received booster shots.
The FDA announcement on Monday was expected, as both Regeneron and Eli Lilly have said for weeks that their treatments are less able to target omicron because of its mutations. In updated drug labeling released Monday, the FDA said omicron appears 1,000-fold less vulnerable to Regeneron’s drug and nearly 3,000-fold less vulnerable to Lilly’s drug.
The FDA has said that if the drugs prove effective against future variants, it could reauthorize their use.
Dr. Craig Spencer, director of global health in emergency medicine at New York-Presbyterian/Columbia University Medical Center, told The Associated Press in a phone interview Wednesday that his hospital stopped using the Regeneron and Lilly treatments weeks ago because of their ineffectiveness against omicron.
He said state leaders should encourage the alternate therapies that have been shown to work against omicron. He decried false claims that the FDA’s move was not based on evidence, calling the misinformation “disheartening and so dispiriting.”
“That has an impact,” he said. “It is going to mean that people will continue to misunderstand how to best treat themselves, how to treat their family members, what to do if they get sick. It further undermines our ability to cohesively respond to this pandemic.”
This is part of AP’s effort to address widely shared misinformation, including work with outside companies and organizations to add factual context to misleading content that is circulating online. Learn more about fact-checking at AP.