The C-19 pill will be found on the US market. The FDA panel recommended that Merck’s drug MOLNUPIRAVIR will get a EUA.
The FDA voted 13-10 that the drug’s benefits outweigh its risk. If the FDA grants the EUA, this would be the first one that Americans could use at home to treat the C-19 virus.
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It signals a shift towards therapeutics as becoming a more influential tool in the war against the virus.
It also questions the necessity of C-19 vaccine mandates, especially as the federal vaccine mandates continue to fail to stop the variants’ transmission, including delta and omicron, which will question the efficacy and reliability.
Molnupiravir may prove as safe and effective treatment that the vaccines can’t offer. The risk profile for C-19 varies by age and is impacted by factors such as obesity and immunocompromising; the FDA decided to forego the C-19 prophylactic vaccines.
Furthermore, some people think that Molnupiravir and Ivermectin are the same product. However, that would be further examined.
“This Advisory Committee briefing document summarizes the data submitted to support the Emergency Use Authorization (EUA) of molnupiravir (MOV) for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death,” the FDA briefing document states.
“Currently, three antivirals monoclonal antibodies (mAbs) are authorized for the treatment of mild-to-moderate COVID-19 in individuals who are at high risk for progression to severe COVID-19, including hospitalization or death. These products all require intravenous (IV) or subcutaneous (SC) injection for administration. MOV is an oral prodrug with antiviral activity against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2),” the FDA briefing document added.
This is the full FDA document:
Take a look at the video below:
At 59:00 into the FDA meeting, the Senior VP of Global Regulatory Affairs and Clinical Safety for Merck, Dr. Sean Curtis, stated that the clinical data on Molnupiravir showed excellent efficacy and safety.
“Molnupiravir was shown to significantly reduce risk of hospitalization or death by approximately 50%,” Dr. Curtis said. Furthermore, the clinical data showed that “through day 29, no deaths were shown in patients who received Molnupiravir, as compared to 8 deaths in patients who received placebo.”
Dr. Daria Hazuda, Ph.D., detailed the mechanism of action for this drug. Hazuda shared the details of the technical chemistry of the medicament before explaining that the oral treatment has similar efficacy across a broad spectrum of SARS-CoV-2 mutations.
“Note that the antiviral activity is similar across SARS-CoV-2 variants of concern, including alpha, beta, gamma, delta, as well as mu,” Dr. Hazuda said.
The US media has displayed considerable hostility to Ivermectin as a C-19 treatment. Because of that, many people questioned the difference between these two drugs.
Many people think that Ivermectin is a safe drug and a cheap treatment against C-19. The US media didn’t want to cover this narrative because it doesn’t fit in their story with the vaccines.
“Right-wing media pushed a deworming drug to treat Covid-19 that the FDA says is unsafe for humans,” Darcy claimed.
“People are purchasing various highly concentrated animal ivermectin drug formulations such as ‘pour-on,’ injectable, paste and ‘drench’ that are intended for horses, cattle and sheep, and taking these drugs has made some people very sick,” the FDA wrote in a letter to veterinarians. “Even if animal drugs have the same active ingredient as an approved human drug, animal drugs have not been evaluated for safety or effectiveness in humans.”
Furthermore, the CDC emphasized that Ivermectin isn’t approved for C-19 treatment. But, a CDC guideline for refugees from 2019 shares that it is a regular part of the prescribed regimen for preventing parasites from being brought into the US.
“These guidelines are recommendations for the International Organization for Migration (IOM) physicians and other panel physicians who administer overseas pre-departure presumptive treatment for intestinal parasites,” the document reads.
“All African refugees who did not originate from or reside in countries where Loa loa infection is endemic (Box 1), with exceptions noted in this document, should receive presumptive therapy with… Ivermectin, two doses 200 mcg/Kg orally once a day for two days,” the CDC lists as one of the medications.
“Moderate-certainty evidence finds that large reductions in COVID-19 deaths are possible using Ivermectin. Using Ivermectin early in the clinical course may reduce numbers progressing to severe disease,” a study in the American Journal of Therapeutics published in June 2021 concluded. “The apparent safety and low cost suggest that ivermectin is likely to have a significant impact on the SARS-CoV-2 pandemic globally.”
Is Ivermectin somehow different from Molnupiravir? Reuters fact-checked this issue and announced that the chemistry of the two drugs is different!
“Dr. Stephen Griffin, virologist and associate professor at the University of Leeds (here), told Reuters that molnupiravir is not repackaged ivermectin.”
“The two drugs have ‘dissimilar chemistry,’” he said. “There is no way that Merck is doing this,” he said.
“Molnupiravir is a derivative of a nucleotide that, predictably, interferes with the RNA replication of the virus. While Ivermectin does also have a defined mechanism of action, BUT it’s against ion channels found in parasites,” Griffin said.
“Information profiles are viewable on Drugs.com for molnupiravir (here) and ivermectin (www.drugs.com/ivermectin.html),” Reuters notes.
“Paul Auwaerter, the Clinical Director of the Division of Infectious Diseases (here) at Johns Hopkins Medicine told Reuters via email that the only similarity the two drugs have is that they ‘have been brought to the FDA for market approval by the Merck Company,’” the report adds.
“The professor pointed to structural differences between the two drugs, which can be explored in papers here and here and drug class differences,” the report notes.
“Ivermectin is classified as a macrocyclic lactone. It is derived from Streptomyces avermitilis which is a bacterium,” Dr. Auwaerter said. Molnupiravir, instead, is classified as a ‘nucleoside analog’ (like some HIV medications) and ‘works as an antiviral,’ he added.
Dr. John Campbell, Master of Science in health science from the University of Bolton, and a PhD. in nursing education from the same university shared something on the popular YouTube Channel. Take a look at what he said:
He discussed the scientific literature on Ivermectin that supports the claims that Ivermectin is a safe and effective drug against the C-19 virus.
Dr. Ajayi compared the two popular drugs, Ivermectin and Molnupiravir, in an illuminating passage.
“Molnupiravir is a pro-drug of the novel active antiviral nucleoside analogue β-d-N4-hydroxycytidine (NHC, EIDD1931),” he states, technically. “It’s a broad-spectrum antiviral agent against SARS-CoV-2, SARS CoV, seasonal or pandemic influenza and MERS coronavirus….”
“Ivermectin is an FDA-approved, WHO essential drug used as broad-spectrum antiparasitic, antibiotic and RNA viruses, including HIV, Zika, MERS coronavirus. It is being repurposed as a therapeutic agent for COVID-19 after in vitro studies in Vero/hSLAM cells showed that it caused a 5000-fold inhibition of SARS-CoV-2 (99.98% at 48 hours) with an IC50 of 2.8µM. The corresponding in vitro IC50 of molnupiravir for SARS-CoV-2 is 0.3µM in Vero cells and 0.08µM in Calu-3 Cells.”
“The IC50 of Molnupiravir shows it to be a more potent anti-SARS-CoV-2 agent, compared to Ivermectin in vitro,” Dr. Ajayi adds.
The critical point is that these two medicaments could be complementary in their action on the virus.
“Pharmacodynamically, the mechanisms of anti-SARS-CoV-2 action, both of molnupiravir and ivermectin are overlapping and complementary,” he states while referring to Table 1. “Molnupiravir active metabolite (NHC-5’ Triphosphate), acts as a competitive alternative substrate for the viral RNA dependent RNA polymerase (RdRp), causing viral mutagenesis or transition mutations, which leads to viral error catastrophe
and extinction of replication,” he points out.
“There is some concern about the safety of NHC -nucleoside triphosphate, which is also mutagenic to mammalian cells,” he adds. “Ivermectin exhibits multifarious actions, ranging from binding to SARS-CoV-2 spike protein S, reducing cell entry via human ACE2 receptors, inhibition of the nuclear transport of viral proteins, which prevents interference with replication, to binding to RdRP, reducing the activity of the viral transcription -replication complex,” he continued.
“Ivermectin has additional effects on Signal Transduction Activation of Transcription (STAT-3) and inhibition of cytokine production and inflammation, which has not yet been shown for molnupiravir,” he added.
“As most but not all double-blind studies, and meta-analyses, have shown benefits of ivermectin in COVID19 including 56% mortality reduction, and given the complimentary pharmacokinetics and pharmacodynamics of the drugs, direct head-to-head comparison of molnupiravir and ivermectin, in blinded randomized clinical trials are needed,” Dr. Ajayi argues. “A combination of molnupiravir with ivermectin putatively, maybe at least additive or synergistic in effects on RdRP or cytokine release.”
“This should be further investigated in anti-SARSCoV-2 antiviral combination therapy,” Dr. Ajayi concludes.