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Regional Infusion Center changing screening process after FDA halts use of 2 COVID-19 antibody drugs

The FDA and other federal agencies are withdrawing use authorizations for the Regeneron and Bam/Ete monoclonal antibody therapies.

BEAUMONT, Texas — The screening process will soon become “much more strenuous” at the Regional Infusion Center since federal agencies are no longer permitting the use of two monoclonal antibody therapies, Jefferson County Judge Jeff Branick announced Tuesday.

The judge said he received the notice Tuesday about the FDA and other federal agencies' withdrawing use authorizations for the Regeneron and Bam/Ete monoclonal antibody therapies.

Sotrovimab is now the only monoclonal antibody therapy available at the Regional Infusion Center. It has been supplied to the State of Texas in very limited quantities, the judge said.

“Our anticipated weekly allocation in Southeast Texas will provide us with only enough antibodies to treat approximately 80 to 180 patients per week,” Branick said.

Despite the supply chain issues, Branick said the Regional Infusion Center will likely remain open through this weekend.

Health officials are also planning to modify hours and days of operation based upon available medications.

Branick said the change in the screening process is to “ensure that the individuals most at risk of developing serious disease processes receive the infusion.”

Full news release from Jefferson County Judge Jeff Branick...

Today we received notice that the FDA, working in concert with other federal agencies, has withdrawn the use authorizations for two monoclonal antibody therapies commonly known as Regeneron and Bam/Ete.  This leaves Sotrovimab as the only monoclonal antibody therapy available to our Regional Infusion Center.  Sotrovimab has been supplied to the State of Texas in very limited quantities and our anticipated weekly allocation in Southeast Texas will provide us with only enough antibodies to treat approximately 80 to 180 patients per week. 

The State of Texas has requested that the federal government allow it to purchase approved monoclonals directly from the manufacturers, but such request has not been acted upon by the feds as of yet.  While there are a few other monoclonals or pills which have proven effective, according to the FDA, none of these (Veklury , Paxlovid pill by Pfizer and molnupiravir pill by Merck) have been made available to our Regional Infusion Center or local pharmacies for administration. We are advised that local pharmacies should start receiving the Pfizer and Merck pills within a week or so.  A physician's prescription will be required to get the Merck and Pfizer pills.

Because of these significant supply chain issues the Regional Infusion Center will likely be able to remain open through this weekend at which time a decision will be made about hours and days of operation based upon then available medications., Effective immediately, much more strenuous screening will be initiated to ensure that the individuals most at risk of developing serious disease processes receive the infusion.  We advise all individuals who test positive for Covid to visit a health care provider for information on Covid treatment options. 

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