Tag: monoclonal antibodies

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

Peter D'Abrosca

As reported Tuesday by The Florida Capital Star, the 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 is cited in making its decision. 

Without the help of the FDA, which did not return a follow up comment request Wednesday, The 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), which is headed by Dr. Anthony Fauci. 

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FDA Pulls Authorization for Antibody Treatment, Refuses to Answer Questions

Peter D'Abrosca
SAN DIEGO (Jan 26, 2020) Lt. Cmdr. Raben Talvo, Naval Medical Center San Diego's (NMCSD) Office of Clinical Quality department head, administers the hospital’s first monoclonal antibody (mAb) treatment to a COVID-19-positive patient Jan. 26. Bamlanivimab, the mAb treatment, is administered under emergency use authorization (EUA) guidance from the U.S. Food and Drug Administration (FDA) to treat mild to moderate COVID-19 symptoms in some adult and pediatric patients who are at high risk for progressing to severe COVID-19 symptoms. NMCSD's mission is to prepare service members to deploy in support of operational forces, deliver high quality healthcare services, and shape the future of military medicine through education, training, and research. NMCSD employs more than 6,000 active duty military personnel, civilians, and contractors in Southern California to provide patients withworld-class care anytime, anywhere. (U.S. Navy photo by Mass Communication Specialist 3rd Class Harley K. Sarmiento)

The U.S. Food and Drug Administration (FDA) Monday unexpectedly pulled its Emergency Use Authorization (EUA) for monoclonal antibody treatments for COVID-19, dealing a blow to states like Florida which have been using the treatment effectively for months. 

“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’s decree. “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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DeSantis Administration Slams Biden over Reduced Monoclonal Treatments

Grant Holcomb

The administration for Florida Gov. Ron DeSantis has blasted President Joe Biden for capping the amount of monoclonal antibody treatments states like Florida can receive. The U.S. Department of Health and Human Services (HHS) has taken over the national distribution of the treatments.

The HHS says their leadership will provide “equitable distribution” and “with consistent, fairly distributed supply over the coming weeks.” However, DeSantis’ press secretary, Christina Pushaw, said the move by the Biden administration was “regrettable.”

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Florida Surgeon General Scott Rivkees Leaving Florida Department of Health

Grant Holcomb
Scott A Rivkees

Florida Surgeon General Scott Rivkees is leaving his post at the Florida Department of Health (FDOH). Rivkees has been with Gov. Ron DeSantis’ administration since 2019 and led the FDOH since the COVID pandemic began in Florida in March 2020.

“We thank Dr. Rivkees for his meaningful work during the most challenging pandemic of our lifetime. We appreciate his service to the people of Florida and wish him the best in his future endeavors,” said DeSantis’ press secretary Christina Pushaw to Florida Politics.

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Hospital CEOs, DeSantis Discuss Rise in COVID Cases

Grant Holcomb

Florida Governor Ron DeSantis held a roundtable discussion with the CEOs of some of Florida’s largest hospitals, and they said fewer people are being hospitalized or dying from COVID.

While they are definitely seeing increased cases, the CEOs said the delta variant is making its way through a younger population, who they said are more suited to deal with the effects of and recover from the virus.

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Governor Mike DeWine Warns Ohioans to Watch Hospital Capacity as Health Director Mulls Outpatient Treatments for COVID-19

Jack Windsor

During the Thursday COVID briefing, Ohio Governor Mike DeWine said that he “took an oath to do everything to protect the lives and wellbeing of fellow Ohioans” and that the next three weeks will be the most critical in battling COVID.

DeWine then stressed the importance of Ohioans understanding and keeping an eye on hospital capacity in their respective communities.

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Ohio Governor and Chief Medical Advisor Asked About Speeding Up Delivery of Therapies to COVID Patients

Jack Windsor

The Ohio Star reported that Ohio Governor Mike DeWine called a special press conference on Monday, November 23 alongside the Ohio Hospital Association leaders to address the state’s COVID hospitalization rise.

As reported, during the briefing doctors who lead each of Ohio’s three zones (the state is segmented into three areas) disclosed staffing shortages due to COVID quarantine orders, which had further depleted caregiving capacity already run thin by upticks in COVID hospital cases around the state.

The Star has received inquiries from readers describing their situations.  One woman told the story of her husband who was alerted that he had been exposed to COVID and within days began exhibiting symptoms. When he called his doctor seeking preventative therapies, he was denied.  The man was later admitted to a hospital for days, where he received therapeutic treatments that aided his recovery.

Consequently, The Star took the opportunity during Governor DeWine’s twice-weekly COVID presser on Tuesday to ask the following question:

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