The below is not intended as medical counsel, only as information to be considered in researching treatments.
By Nancy Thorner –
A monoclonal antibody is a laboratory-produced protein that functions like the antibodies made by the immune system in response to infection.By binding to a specific molecule on a virus or bacteria — known as an antigen — a monoclonal antibody can enhance or restore the immune response against these pathogens and can help prevent the virus from infecting human cellsMost of the monoclonal antibodies being developed to treat COVID-19 target the spike protein, which the coronavirus (SARS-CoV-2) uses to enter the host cells.
Monoclonal antibody treatment has been used and testedTrusted Source for the Ebola virus and respiratory syncytial virus (RSV), as well as chronic illnesses such as rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, and more.Scientists are also developing monoclonal antibodies that target cancer cells.Research suggests that certain monoclonal antibodies can reduce the risk of hospitalization and death in people with asymptomatic or mild COVID-19.Scientists are also looking at whether this treatment can reduce the risk of someone with COVID-19 transmitting the virus to others in their household.
Monoclonal antibody treatments
Several monoclonal antibodies have received emergency approval Trusted Source from the FDA:
- REGEN-COV. This drug cocktail contains two monoclonal antibodies, casirivimab and imdevimabTrusted Source. It’s approved for people over age 12.
- Sotrovimab. This drug is authorized for adults and kids over 12 years old.
- Bamlanivimab/etesevimab. In June, the U.S. government paused distribution of these two monoclonal antibodies because tests showed that they did not work against the Beta and Gamma variants of the coronavirus. The FDA recommends that health professionals use other monoclonal antibodies instead.
On November 21, 2020, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for casirivimab and imdevimab to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct SARS-CoV-2 viral testing and who are at high risk for progressing to severe COVID-19. This includes those who are 65 years of age or older or who have certain chronic medical conditions.
Here is Regeneron's EU authorization for casirivimab and imdevimab. The FDA is an agency within the U.S. Department of Health and Human Service.
In a clinical trial of patients with COVID-19, casirivimab and imdevimab, which must be administered together by intravenus (IV) infusion, was shown to reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression within 28 days after treatment when compared to placebo.
Under the EUA, fact sheets that provide important information about using casirivimab and imdevimab administered together in treating COVID-19 must be made available to health care providers and to patients and caregivers.
These fact sheets include dosing instructions, potential side effects and drug interactions. Possible side effects of casirivimab and imdevimab include anaphylaxis and infusion-related reactions, fever, chills, hives, itching and flushing.
Regeneron’s antibody cocktail also has emergency approval for use in people at high risk of severe COVID-19 who were exposed to the coronavirus but haven’t yet tested positive or developed symptoms. This is useful in situations where an unvaccinated person is exposed to COVID-19. With the two-dose mRNA vaccines, full protection doesn’t occur until 2 weeks after receiving the second dose. By then, people might already be severely ill. Shortly after exposure to the virus, “the vaccine’s probably not going to do someone any good. It won’t take effect soon enough for the person to be protected,” said Carnahan. “Whereas with antibodies, the protection is available within minutes to hours.”
Biden’s rationing of monoclonal antibody treatments, called “Equity”
Watch here. In states that traditionally votes Republican, such as Florida, Texas, Mississippi, Georgia, Louisiana and others, Biden is cutting the amount of life-saving monoclonal antibody treatments to those states by over 50%–All in the name of “equity.” It doesn’t matter if the people in those states need the treatment more than other states.
It appears to be a political strategy of the Left to punish the unvaccinated, conservatives and Christians—votes they will never receive, and people they can do without.
The federal government’s sudden rationing of monoclonal antibody treatments, which are keeping Americans who get COVID-19 out of hospitals, is hitting Alabama hard, with some sites already running out of or projected to run out of supply soon.
Sen. Rand Paul addresses Florida’s shortage
Sen. Rand Paul (R-KY), when appearing on the Friday, September 17, 2021 broadcast of “Hannity” on the Fox News Network, addressed the problems surrounding the White House’s policy regarding the distribution of monoclonal antibody treatments.
“Paul said that Democrats running the country from Washington, D.C. are making decisions about distributing the life-saving treatments according to “socialist thinking,” rather than based on the fundamental principles of supply and demand.”
"The senator told Hannity that the current policy demonstrates the difference between socialized medicine and capitalism. When demand goes up, as is the case currently in Florida, supply should be increased to match it, as happens with capitalism."
DeSantis said that the Biden administration’s new policy for “equitable” distribution of monoclonal antibody treatments was a “major curveball,” with a “really huge cut.”
Florida Acquires Monoclonal Antibodies from GlaxoSmithKline
Gov. Ron DeSantis announced on Sept. 23: “The state of Florida obtained thousands of monoclonal antibody treatments to treat COVID-19 from a UK-based company after the Biden administration's abrupt rationing of federally acquired doses. Florida went to GlaxoSmithKline, which produces monoclonals that haven't yet been bought up by the federal government. They reached an agreement on about 3,000 doses.”
"That's showing that we're going to leave no stone unturned. And, if there's somebody that needs a monoclonal antibody treatment, we're going to work hard to get it to them."
Said DeSantis, "Monoclonal Antibody Brought Florida COVID ER Visits Down 70 Percent", as he locked horns with the Biden administration.
Since Florida opened monoclonal antibody treatment sites in August:
+100,000 Floridians have received treatments
COVID hospital admissions have fallen by over 60%
COVID hospital census has declined for 28 consecutive days
ER visits for COVID have declined by over 70%
Cost a factor in monoclonal antibody treatments
The cost of Regeneron’s two-drug cocktail is $1,250 per infusion, according to Kaiser Health News. The federal government currently covers this.
Compare this to the cost of a single dose of the COVID-19 vaccine — about $20 — which is also covered right now by the federal government.
The cost of GSK’s (GlaxoSmithKline used in Florida) and Vir’s monoclonal antibody costs about $2,100 per infusion. This is covered by a combination of government payments, reimbursements, and GSK’s copay program, reports USA Today.
However, some infusion centers may charge treatment fees. “These are covered by Medicare, Medicaid, and most private health insurances, although some plans may charge a copay.”
“In order to receive monoclonal antibody treatment, you must have tested positive for COVID-19 within the last 10 days. You will also need a referral from a healthcare professional.”
"Monoclonal antibody treatment is being offered at outpatient locations, hospitals, urgent care centers, and some physician’s offices throughout the country. The U.S. Department of Health and Human Services has an infusion location finder on its website.”
“Although many infusion centers are ramping up around the country, experts emphasize that monoclonal antibody treatment is not a substitute for COVID-19 vaccination.”
