Did the USA Under-Forecast Monoclonal Antibody Treatment Demand?

Florida Governor Ron D. DeSantis Tweeted late on September 20, 2021, 'Since Florida opened monoclonal antibody (mAbs) treatment sites in August, 100,000 Floridians have received treatments and COVID-19 hospital admissions have fallen by over 60%.'

And, 'COVID hospital census has declined for 28 consecutive days, with COVID-19 related ER visits declining by over 70%.'

However, the 46th Governor of Florida continued Tweeting by stating, 'Florida’s treatments (have recently been) cut by more than 50%.'

This reduction is counter to Florida's Board of Medicine decision to support mAbs treatments on August 5, 2021.

Governor DeSantis's concerns are related to the U.S. Department of Health and Human Services' (HHS) decision to issue a Public Health Emergency update of September 13, 2021, announcing a revised State/territory-coordinated distribution system for Monoclonal Antibody Therapeutics.

Monoclonal antibodies that target the spike protein have shown clinical benefits in treating SARS-CoV-2 coronavirus infection.

HHS stated 'it had transitioned away from a direct ordering process products from AmerisourceBergen. And transitioning to a state/territory-coordinated distribution system gives health departments maximum flexibility to get these critical drugs where they are needed most.'

In the future, 'HHS will determine the weekly amount of mAb products each state and territory receives based on COVID-19 case burden and mAb utilization.'

HHS published mABS distributions for the week of September 13, 2021, at this link.

To address potential mAbs treatment access issues, the following investigational monoclonal antibody therapies are now available under U.S. FDA emergency use authorization (EUA):

• Casirivimab and imdevimab, administered together (EUA issued November 21, 2020, latest update July 30, 2021)
• Bamlanivimab and etesevimab, administered together (EUA issued February 9, 2021)
• Sotrovimab (EUA issued May 26, 2021)
• Tocilizumab (EUA issued June 24, 2021)

The FDA's EUA authorized the use of these mAbs therapies to treat mild-to-moderate COVID-19 in adults and pediatric patients when both of these apply: the patient has a positive COVID-19 test result, or the patient is at high risk for progressing to severe COVID-19, hospitalization, or both.'

Furthermore, the U.S. CDC published information from state and local health authorities regarding reports of viral variants of importance in their region to guide treatment decisions.

The Miami Herald reported on September 20th, Tampa General Hospital CEO John Couris said he’s not happy with the decision to ship Florida fewer doses of mAbs treatments than the state has requested.

“I don’t know why they did it, because the supply chain was working perfectly the way it was,” Couris said before the Florida House Pandemics and Public Emergencies Committee.

“This change is going to hurt people in Florida."

"It’s already starting to make us, for example, think about how we are going to have to limit the hours of operations associated with our ability to provide this life-saving therapy.”

Note: The UK's Medicines and Healthcare products Regulatory Agency Approved the REGEN-COV treatment in August 2021. And the European Medicines Agency began its rolling review onmAbs in January 2021.