FDA Halts Use Of 2 Monoclonal Antibody Treatments Shown To Struggle Against Omicron
By: Erika Stanish/KDKA-TV
PITTSBURGH (KDKA) - The Food and Drug Administration announced Monday the removal of two monoclonal antibody treatments after evidence showed they're less effective against the Omicron variant.
In a news release, the FDA said the Omicron variant makes up 99% of COVID-19 cases in the United States.
"Therefore, it's highly unlikely that COVID-19 patients seeking care in the U.S. at this time are infected with a variant other than Omicron, and these treatments are not authorized to be used at this time. This avoids exposing patients to side effects, such as injection site reactions or allergic reactions, which can be potentially serious, from specific treatment agents that are not expected to provide benefit to patients who have been infected with or exposed to the Omicron variant," said Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research.
Regeneron and Eli Lilly infusions have been halted, according to the FDA, leaving Sotrovimab as the last remaining monoclonal infusion.
"We're limited currently to one out of the three monoclonals that are available, drastically reducing the number of folks that we can take care of," Olympus Infusions owner Adam Rice said.
A sign on the door of Olympus Infusions Tuesday said only 52 doses of Sotrovimab remain in stock and will only be available for those with an appointment. Monoclonal antibody infusions are a treatment that can help patients recover from COVID-19 without going to the hospital.
Rice told KDKA that the treatment center ran out of supply and was going to be forced to shut down Wednesday before he was able to find more doses.
"We just got a delivery in today of a number of doses so we will run one more full day tomorrow and take it as a comes," Rice said.
Even before the FDA's announcement, the state health department said demand for monoclonal antibodies was outpacing supply from the federal government. Last week, the department of health said Pennsylvania was allocated approximately 1,800 doses of monoclonal antibodies.
"This is not unexpected, and the department is committed to working closely with the provider community to meet their evolving needs," Health Department deputy communications director Ryan Eldredge said.
With a severely limited supply, the state Department of Health said it's critical for Pennsylvanians to step up and do their part to slow the spread of COVID-19.
KDKA reached out to Allegheny Health Network to ask how the changes could affect hospitals.
"According to Dr. Thomas Walsh, AHN Infectious Disease specialist, only one of the monoclonal antibodies has been proven effective against the Omicron variant, and that is Sotrovimab. The others are not effective, and with Omicron representing nearly 100 percent of current Covid cases, they have no use, and the FDA made a sound judgment call in halting their use and distribution," AHN spokesperson JoAnne Clobus said. "Physicians at AHN continue to administer Sotrovimab to those patients who are at the highest risk of developing complications from the virus."
Clobus said AHN is continuously monitoring its supply to determine which patients need it most.
UPMC said for about a month, it has been using Sorovimab exclusively for eligible patients infected with COVID-19.
"At that time, the Omicron variant of SARS-CoV-2 became dominant in all the communities we serve. Sotrovimab remains an effective monoclonal antibody treatment for eligible patients. UPMC was the first health system in the country to administer this treatment after federal authorization and we have a great deal of experience with it," said Rick Pietzak, a spokesperson for UPMC.
"Supply of Sotrovimab is limited nationwide, so UPMC maximizes the effect of our allotment by giving it to the patients who our research shows are most likely to become severely ill without it. Eligibility criteria is available at www.upmc.com/antibodytreatment."
Pietzak said patients should not count on monoclonal antibodies as their COVID protection.
"The best approach is to get vaccinated now and get a booster when you are eligible. Find out where by visiting www.upmc.com/coronavirus/covid-vaccine or calling 844-876-2822. Also, wear a mask indoors or in crowds and avoid large gatherings. Finally, stay home if you are sick and get tested. Find testing options at www.upmc.com/coronavirus/testing-centers," Pietzak said.
