The Food and Drug Administration’s (FDA) move banned, at least for now, the use of monoclonals produced by Regeneron and Eli Lilly.
The regulator said the most recent information and data showed the treatments are “highly unlikely” to work against the Omicron variant of the CCP (Chinese Communist Party) virus and the drugs can only be used on patients who are likely to have been infected or exposed to a different variant. Because Omicron is dominant nationwide, the antibodies cannot be used anywhere in the United States at this time.
The FDA did not provide citations for the data in a press release, updated fact sheets for health care providers, or letters to the companies. An agency spokesperson did not respond to requests for comment and a call went straight to a voice mailbox that was full.
The agency in its release pointed to a National Institutes of Health panel recommendation against the two monoclonal antibodies (mAbs) that cited two studies, one of which wasn’t peer reviewed, that indicated they weren’t as effective against Omicron.
The Florida Department of Health said that the “abrupt decision” means all state-run monoclonal antibody treatment sites will be closed until further notice.
“Florida disagrees with the decision that blocks access to any available treatments in the absence of clinical evidence,” the agency said. “To date, such clinical evidence has not been provided by” the FDA.
Florida officials called for President Joe Biden’s administration to reverse the decision.
“Without a shred of clinical data to support this action, Biden has forced trained medical professionals to choose between treating their patients or breaking the law,” Florida Gov. Ron DeSantis, a Republican, said in a statement.
“In our field of medicine, when someone comes to you seeking a treatment that could save their life, it is essential to have treatment options to ensure health care providers can make the best decisions for their patients,” Florida Surgeon General Dr. Joseph Ladapo added. “The Federal Government has failed to adequately provide the United States with adequate outpatient treatment options for COVID-19. Now, they are scrambling to cover up a failure to deliver on a promise to ‘shut down the virus.’”
Officials pointed to a different study in which researchers said that “despite observing differences in neutralizing activity with certain mAbs, it remains to be determined how this finding translates into effects on clinical protection against B.1.1.529,” or Omicron.
Monoclonal antibodies are laboratory-created antibodies designed to protect recipients against the CCP virus, which causes COVID-19.
According to earlier studies, they are one of the most effective COVID-19 treatments.
Florida has heavily promoted monoclonals since they became available in 2020.
Monoclonal antibodies made by GlaxoSmithKline are still authorized for use in the United States, and U.S. health officials recommend the treatment as well as Gilead Sciences’ antiviral remdesivir, and separate antiviral pills made by Pfizer and Merck.
A spokesperson for Eli Lilly told The Epoch Times in an email that “Lilly and the FDA agree that it is not medically appropriate, at this time, to treat patients with mild to moderate COVID-19 with bamlanivimab and etesevimab together in the U.S.”
“Evaluation of both pseudovirus and authentic virus confirm that they are not effective at treating the currently predominant Omicron variant. Authorization status will change as needed, depending on prevalence and trends of variants of concern,” it said.
Analysis of a separate antibody therapy shows it is potentially effective against all known CCP virus variants of concern, including Omicron, and Eli Lilly is working with the FDA to get that treatment, bebtelovimab, emergency clearance, the spokesperson added.
Regeneron said in a statement that the company “continues to progress next generation antibodies that are active against Omicron, Delta (B.1.617.2) and other variants of concern” and is “working urgently and collaboratively with the FDA to determine how to bring additional safe and effective monoclonal antibody treatments to patients as quickly as possible.”
The new therapeutics could be available in the coming months, pending regulatory clearance, the company added.
From The Epoch Times