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Supplies Limited For More Than One Year Since Monoclonal Antibodies Authorized For Treating C-19!

The only authorized outpatient medical therapy for preventing the worsening of C-19 symptoms in high-risk patients, but there isn’t any steady supply of monoclonal antibodies from the fed government one year after its approval for the use of medical regulators.

Released at the same month as the coronavirus shots, monoclonal antibody therapies don’t have the attention as the vaccines. Today President Biden grasps the entire focus on vaccinating children, giving boosters to the adults, and increasing testing, representing part of the new actions to fight the C-19 pandemic.

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Dr. Marc Siegel is a practicing internist and a professor of medicine at NYU’s Langone Medical Center. He stated that the shots could not bring America out of the pandemic. More breakthrough cases happened with the Delta and Omicron variants and hospitalizations, and the numbers are rising this winter.

Over 206 million Americans are fully vaccinated, and 72 million got the booster dose. People are considered fully vaccinated after getting two doses of the shot.

Siegel stated that the Biden admin couldn’t discover therapeutics for early treatment of people with mild C-19 because of the admin’s “obsessive focus on the vaccines to the exclusion of all else.”

“When it comes to therapeutics, the Biden team’s results are even more anemic,” Siegel wrote in an op-ed in USA Today. “Paxlovid, Pfizer’s new protease inhibitor wonder drug, has been approved but is scarce.”

“Ditto monoclonal antibodies, the synthetic neutralizing antibodies that have been so helpful in patients at high risk of complications or hospitalizations. Omicron is most susceptible to sotrovimab, made by GlaxoSmithKline, but in most states, it is almost impossible to find,” he added.

The US HHS delivered more than 197,000 courses of monoclonal antibody treatment.

Lack Of Public Messaging!

The monoclonal antibody therapy was effective in preventing serious disease and hospitalization. These are somehow different than the convalescent plasma from a recovered C-19 patient. There the antibodies are “created [in a lab] to specifically target an essential part of the infectious process.’’

From December 16, 2021, the NIH doesn’t suggest convalescent plasma for hospitalized patients without impaired immunity. These monoclonal antibody treatments got EUA in November 2020, but the media didn’t want to cover that because it would lower the vaccination rate.

The lack of media coverage, this treatment resulted in individuals unaware of the short timeframe to get this effective therapy. It caused low demand for this treatment right at the time when it was needed the most.

Dr. Peter McCullough is an internist, cardiologist, and epidemiologist. He said that he was frapped by‘’ the lack of fanfare on the monoclonal antibodies, there was almost no uptake.”

“We heard reports that over 80 percent of the supply was sitting on the shelves. Nursing homes weren’t informed, urgent care wasn’t supplied, hospitals weren’t in supply. There wasn’t any messaging.”

The Epoch Times talked to the CDC for comment about the lack of interest worldwide and was told to contact the FDA, who didn’t comment on this issue.

The HHS allowed authorized health care providers to order the therapies from the supplier from February 2021 to September 13, 2021.

The Delta’s emergence and the vaccine ‘’effectiveness’’ saw increased demand for the therapies, leading the HHS to share that it would revert back to control the distribution.

The number of monoclonal antibodies allocated to every state and territory would be based on case numbers, hospitalizations, and utilizations, a system that is used until today.

On September 13, the HHS stated that the Delta variant created the surge in monoclonal antibody therapy used “particularly in areas of the country with low vaccination rates,” without further clarification.

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Epoch Times Photo

Omicron mutation added to the confusion on whether specific antibody therapies should continue to be used and if they are effective clinically, especially when the HHS banned the allocation of the therapy two days before Christmas.

Regeneron shared a December 16 press release, stating, “While Regeneron’s currently authorized REGEN-COV antibodies have diminished potency against Omicron, they are active against Delta, which currently is the most prevalent variant in the U.S.”

Efficacy With Omicron!

Florida’s State Surgeon General, Dr. Joseph A. Lapado, stated that the data of one study doesn’t have the same outcome in humans.

“So the laboratory evidence was indicating the affinity of the antibodies, such as the Regeneron antibodies for the Omicron variant were diminished … but that’s not the same thing as concluding that the Regeneron monoclonal antibodies will not work in a patient with Omicron,” Lapado said

“So, there’s a difference between laboratory data and clinical data. And they decided to withhold medication based on laboratory data, but we care about clinical outcomes. The decisions should be based, obviously, on clinical data, which is why they’ve reversed [the pause].” He added.

The decision was also “in light of recent National Institutes of Health (NIH) clinical guidelines published on December 30, 2021, and the significant variability in the prevalence of the Omicron Variant of Concern (VOC),” it added.

The NIH suggested a 3-day-course of intravenous remdesivir as a treatment option for not-hospitalized patients with mild C-19.

The FDA approves Remdesivir for patients requiring hospitalization.

Source
The Epoch Times

Addison Wilson

A passionate teacher in English Language and Literature ready to give her best! Developing and implementing diverse curriculums covering a wide range of subjects. With my problem-solving skills, every job will be easily completed, so punctuation is my strength. Highly skilled at motivating students through positive encouragement and reinforcement of concepts via interactive classroom instruction and observation. My working style fits every personality type, so it makes me a great team player. I have completed numerous journalistic projects successfully, so digging for further information is my field. Fighter for freedom of speech! The truth must be revealed!

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