As new cases of COVID-19 continue to rise, restrictions on the use of monoclonal antibody infusions by patients – in the face of limited supply nationwide and growing evidence that some therapies are less effective against the last variant.
Hackensack Meridian Health has stopped scheduling additional appointments for monoclonal therapy at this time, “due to a lack of supply,” according to the Health System’s website. “Most of the previously used monoclonal antibody (mAb) treatments are ineffective against the omicron variant of COVID-19. “
“For now, the criteria for recipients are now limited to people 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 antibodies.
A third hospital operator, Atlantic Health System, now offered treatment with monoclonal antibodies on “prescription only in conjunction with a doctor’s orders,” according to its website.
New Jersey was facing an average of 332 seven-day hospitalizations as of Tuesday.
When the Food and Drug Administration granted emergency use authorization for the first monoclonal antibody therapies in November 2020, the initial demand was far less than the available supply, according to the American Hospital Association.
For example, from February to September 13, hospitals and other healthcare delivery sites were allowed to order monoclonal antibodies directly from the supplier.
Amid a new wave of cases in mid-September, the Department of Health and Human Services Assistant Secretary for Preparedness and Response then reverted to a more regulated system of dispensing monoclonal antibody therapy.
New Jersey faced an average of seven days of hospital admissions on Tuesday, according to the CDC, amid a spike in confirmed and probable cases based on test results in time for the Christmas holidays.
The increase in the number of cases has been complicated by the omicron variant which appears to be more resistant to some of these available antibody treatments.
Omicron: More resistant to antibody therapy
Federal officials announced Thursday that they are suspending further deliveries 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 contracts with the US government totaling approximately $ 1 billion to purchase doses of sotrovimab.
This mark has been “only moderately diminished” by omicron compared to its activity against other COVID variants, as reported by Forbes and Texas Tribune.
Hackensack Meridian Health said his hiatus from scheduling additional appointments for monoclonal therapy was also linked to the current lack of sotrovimab supply.
Shortage felt across the country
Likewise, New York City hospitals are restricting or suspending monoclonal antibody treatments, for the same main reasons, as NBC News reported.
The high demand for antibody infusions has been going on for months in Florida, where Gov. Ron DeSantis has long indicated that the therapy should be used in infected patients over other protocols to stem the initial spread of the virus.
More than 130,000 treatments were given to COVID patients in Florida between August 12 and October 14 alone, DeSantis and the state Surgeon General previously said.
Days before Christmas, a spokesperson for the provider operating 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 is not the same
A newly authorized monoclonal antibody treatment manufactured by AstraZeneca, called Evusheld, has recently been authorized for use in immunocompromised patients or those who have shown an adverse reaction to a dose of COVID vaccination.
The FDA’s emergency use for this treatment is very specific, and pre-exposure treatment with Evusheld is not a substitute for vaccination in people for whom COVID-19 vaccination is recommended.
One dose may be effective in preventing pre-exposure in these patients for six months.
“Vaccines have proven to be the best available defense against COVID-19,” said Dr. Patrizia Cavazzoni, director of the Center for Drug Evaluation and Research at the FDA, in a written statement.
“However, there are some people who are immunocompromised who may not develop an adequate immune response to the COVID-19 vaccination, or those who have a history of serious adverse reactions to a COVID-19 vaccine and therefore cannot receive one and have need an alternative prevention option. “
Contact reporter Erin Vogt at [email protected]
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