NJ is Running Out of COVID Antibody Treatments During Omicron Crunch
As new cases of COVID-19 continue to climb, so do restrictions on patient use of monoclonal antibody infusions — faced with limited supply nationwide and growing evidence that some therapies are less effective against the latest variant.
Hackensack Meridian Health has stopped scheduling additional monoclonal therapy appointments at this time, "due to lack of supply," according to the healthcare system's website. "Most previously used monoclonal antibody (mAb) treatments are ineffective against COVID-19's omicron variant."
"At this time, the criteria for recipients is now restricted to individuals who are 65 years of age or older OR are immunocompromised and have cancer or have recently received an organ transplant," according to a written update from RWJBarnabas Health on its website, regarding the use of monoclonal antibody.
A third hospital operator, Atlantic Health System, was now offering monoclonal antibody treatment on a "prescription-only basis in conjunction with a physician’s orders," according to its website.
New Jersey was dealing with a 332 seven-day average of hospital admissions as of Tuesday.
When the Food and Drug Administration granted emergency use authorization to the first monoclonal antibody therapies in November 2020, initial demand was much lower than available supply, according to the American Hospital Association.
So from February until Sept. 13, hospitals and other health care delivery sites were allowed to order monoclonal antibodies directly from the supplier.
Amid a fresh wave of cases in mid-September, the Department of Health and Human Services’ Assistant Secretary for Preparedness and Response then went back to a more regulated system of distributing monoclonal antibody therapies.
New Jersey was dealing with a 332 seven-day average of hospital admissions as of Tuesday, according to the CDC, amid a spike in confirmed and likely cases based on test results in time for the Christmas holiday.
The surge in cases has been complicated by the omicron variant appearing to be more resistant to some of those antibody treatments available.
Omicron: More resistant to antibody therapy
Federal officials announced on Thursday that they were pausing any further shipments of two such therapies (bamlanivimab and etesevimab together, etesevimab alone and REGEN-COV), manufactured by Eli Lilly and Regeneron, respectively, pending updated data from the Centers for Disease Control and Prevention.
An additional 300,000 doses of one of the remaining antibody treatments, sotrovimab, would be available for distribution in January, federal officials said.
Last month, GlaxoSmithKline and Vir Biotechnology announced U.S. government contracts totally roughly $1 billion to purchase doses of sotrovimab.
Hackensack Meridian Health said its pause on scheduling additional monoclonal therapy appointments was also linked to the current lack of supply of sotrovimab.
Shortage felt nationwide
Hospitals in New York similarly are restricting or pausing monoclonal antibody treatments, for the same main reasons, as reported by NBC News.
High demand for antibody infusions has been months-long in Florida, where Gov. Ron DeSantis has long pointed to the therapy for use in infected patients over other protocols to stem initial spread of the virus.
More than 130,000 treatments had been administered to COVID patients in Florida between Aug. 12 and Oct. 14 alone, DeSantis and the state's Surgeon General have previously said.
Days before Christmas, a spokesperson for the vendor running several treatment clinics in Florida told Orlando Sentinel that "all sites have seen unprecedented demand and Florida has requested additional allocations from the federal government."
Pre-exposure antibody treatment not the same
A newly authorized monoclonal antibody treatment made by AstraZeneca, called Evusheld, was recently authorized for use in immunocompromised patients, or those who have shown an adverse reaction to a COVID vaccination dose.
The FDA emergency use for that treatment is very specific, and pre-exposure treatment with Evusheld is not a substitute for vaccination in individuals for whom COVID-19 vaccination is recommended.
One dose may be effective for pre-exposure prevention in those patients for six months.
“Vaccines have proven to be the best defense available against COVID-19,"Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a written statement.
"However, there are certain immune compromised individuals who may not mount an adequate immune response to COVID-19 vaccination, or those who have a history of severe adverse reactions to a COVID-19 vaccine and therefore cannot receive one and need an alternative prevention option.”