FDA Cites Non-Peer Reviewed Study to Revoke Monoclonal Antibody Authorization


As reported Tuesday by The Florida Capital Starthe U.S. Food and Drug Administration (FDA) revoked the Emergency Use Authorization (EUA) for monoclonal antibodies as a treatment for COVID-19, but did not provide the data it cited in making its decision.

Without the help of the FDA, which did not return a follow up comment request Wednesday, The Capital Star was able to locate what appears to be the data used in the decision-making process. It is on the website for the National Institute of Health (NIH), for which Dr. Anthony Fauci works.

The data does show that Bamlanivimab and Etesevimab, a combination of antibodies used to fight COVID-19, is less effective against the Omicron variant than other variants. It shows the same for Regeneron, a combination of two separate antibody treatments. All of those treatments are now illegal to use, the FDA has deemed.

Importantly, the antibody cocktails were not deemed ineffective, only less effective.

But the study used to justify the revocation of the EUA for the antibody drugs is not peer-reviewed, which is a critical step in assessing the validity of a scientific study. It is also unclear who conducted the study, and when queried by The Capital Star, the NIH did not respond.

The Capital Star also asked whether Americans who contract other variants of COVID-19 – against which antibody treatments are more effective – should have access to those treatments, the NIH did not reply.

The revocation of the EUA comes just after a different EUA – one that allows pharmaceutical giants Pfizer and Merck to sell COVID-19 pills as treatment for the virus – took effect. Those pills are expected to become more widely available soon.

Florida’s governor, a champion of the antibody treatments who has used them successfully in his state for months, blasted the FDA’s decision Tuesday.

“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,” Gov. Ron DeSantis (R) said in response to the FDA. “This indefensible edict takes treatment out of the hands of medical professionals and will cost some Americans their lives. There are real-world implications to Biden’s medical authoritarianism – Americans’ access to treatments is now subject to the whims of a failing president.”

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Pete D’Abrosca is a contributor at The Florida Capital Star and The Star News Network. Follow Pete on Twitter. Email tips to [email protected].
Photo “Joe Biden” by The White House.






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