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Merck Seeks Emergency Approval for COVID-19 Oral COVID Treatment

Merck Seeks Emergency Approval for COVID-19 Oral COVID Treatment

Merck’s new medication, molnupiravir, works by inhibiting the mechanisms by which the virus replicates.

As I have noted many times before, an effective COVID-19 response plans will include focus in effective and inexpensive treatments.

It appears that a new treatment option may be on its way.

Merck plans to request emergency approval for an experimental oral COVID-19 antiviral drug, molnupiravir, after a late-stage trial indicated an approximate 50% risk reduction for hospitalization or death among patients with mild to moderate COVID-19.

An interim analysis, stemming from the Phase 3 MOVe-OUT trial, indicated 7.3% of patients who received molnupiravir were hospitalized or had died about a month later, compared with 14.1% of patients receiving a placebo. The company also reported no deaths in the treatment group, versus eight deaths in the placebo group.

“Merck plans to submit an application for Emergency Use Authorization (EUA) to the U.S. FDA as soon as possible based on these findings and plans to submit marketing applications to other regulatory bodies worldwide,” the company said Friday.

The new medication was also proven to be consistently effective against all strains of COVID-19, including the Delta variant.

A pill to effectively treat COVID-19 has long been a major goal, and the new results quickly won praise from experts.

“This is a phenomenal result, I mean this is a profound game-changer to have an oral pill that had this kind of effect,” former Food and Drug Administration (FDA) Commissioner Scott Gottlieb said on CNBC.

Every participant in the study was unvaccinated and had at least one underlying health condition that increased their chances of developing a more serious case of COVID-19. Some of the most common health factors among participants included obesity, diabetes, heart disease and being over the age of 60.

The trial was conducted at more than 170 sites in countries including the United States, the United Kingdom, Japan, Taiwan and South Africa.

Merck’s new medication, molnupiravir, works by inhibiting the mechanisms by which the virus replicates.

The company name for molnupiravir is ‘EIDD 2801’ the ‘E’ indicating it was developed at Emory University. Antiviral drugs, and this includes the much-in-demand Remdesivir, work by inhibiting the process by which the virus replicates. In the case of molnupiravir, when tested on cultured cells, it works by altering critical enzymes that are necessary for the virus to begin replicating in the body’s host cells.

A key challenge has been that many such antivirals, following a similar mechanism, are not effective as oral pills. However, the Merck pill reportedly appears to have overcome this barrier and adds to its promise as a ‘game-changing’ pill amid the COVID-19 crisis.

Dean Li, Merck’s head of research and development, told medical news website Statnews that the name molnupiravir was also a tangential reference to the weapon of Thor, who is one of the Avengers and a fictional hero of the Marvel Comics Universe. Thor’s hammer is called Mjolnir. “This is a hammer against SARS-CoV-2 regardless of the variant,” said Li. The suffix ‘-avir’ is a common one used for anti-viral drugs.

The pills offer an alternative to the injection cycles associated with monoclonal antibody treatments, which have been the most effective option so far in treating early-stage COVID-10 infections. They are also less expensive and apparently have minimal side effects.

The federal government is paying about $700 per course of treatment. That is about one-third of the cost of a monoclonal antibody treatment. The plan is to make the pills free for Americans, like the Covid vaccines. Whether there are any out-of-pocket costs is likely to be determined after the pills are authorized for use by regulators.

Merck did not report any serious side effects among volunteers in its clinical trial. Any side effects, which typically involve mild complaints like headaches, can be hard to distinguish from feeling ill from Covid, researchers said.
Are there other antiviral pills on the way?

Pfizer is developing a similar pill, as are Atea Pharmaceuticals and Roche. Results from their clinical trials are expected within the next few months. They are unlikely to be available for use until next year.

However, it must be noted that emergency use authorization application does not necessarily mean approval. A study published in the Journal of Infection Diseases reports that NHC (an initial metabolite of molnupiravir) it mutagenic in mammalian cells.

NHC also displays host mutational activity in an animal cell culture assay, consistent with RNA and DNA precursors sharing a common intermediate of a ribonucleoside diphosphate. These results indicate highly active mutagenic ribonucleosides may hold risk for the host.

With this in mind, let’s hope the Food and Drug Administration does a proper risk evaluation without undo influence of Big Pharma. After all, we were promised the cure would not be worse than the disease.

One last note: I have seen social media statements indicating molnupiravir is repackaged ivermectin. It is not.

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Comments

UnCivilServant | October 3, 2021 at 12:06 pm

We already have a slew of effective treatments. It seems like the only ones not effective are the ‘vaccines’.

    Albigensian in reply to UnCivilServant. | October 3, 2021 at 6:16 pm

    The vaccines are not perfectly effective. But there’s overwhelming evidence that they greatly reduce the risk of progressing to a life-threatening condition if you are infected.

    And no, my point is not that this drug should not be approved. As with most of medicine, it’s a question of whether the benefits outweigh the risks. And at least for older patients, I’d think it would, as even if it presents a small cancer risk, odds are that cancer, if the drug does, in fact, occasionally cause cancer, would not become life-threatening until long past that elderly person’s life expectancy.

    GusPatriot in reply to UnCivilServant. | October 4, 2021 at 6:15 pm

    There are no recognized off label effective treatments since there is no money to made / received by supporting their use. Additionally, if ANY other non EUA treatment is available, the EUA now has a problem. And that threatens the money train. So HCQ, Ivermectin or any other treatment shown to have any success will be blockaded.

    Stuytown in reply to UnCivilServant. | October 5, 2021 at 4:21 am

    Why are you afraid of the vaccines? I live in a town with a 90% vaccination rate. There are no COVID cases.

Great breakthrough by Merck…I hope it delivers as promised.

If nothing else, we have another antiviral in the arsenal that may work against some viruses.

The only worry with emergency approval is that long-term side effects are not vetted yet, but I imagine the treatment course is short-lived.

    I gave you an up-vote. I’m surprised you got 4 downvotes.

    Those 4 downvotes should volunteer to be the first to take the undertested drug.

    If Fauci comes out in favor of it (rather, if his handlers and payers tell him to come out in favor of it), you know it’s poison.

    Fauci needs to be canned. A puppet or not, he did enough to completely destroy his own credibility by his pathetic vanity.

      Joe-dallas in reply to TheFineReport.com. | October 4, 2021 at 9:16 am

      Its not surprising that Healthguyfsu got down votes. Logical / cohert / reality based comments get down votes here all the time. Look at how many downvotes Milhouse gets.

      the merck drug certainly appears to be substantially more effective than Remdesivir, which was highly touted by Fauci.

      India has had very short Gompertz curve (the time length of a covid wave), generally less . than 40-45 days vs one-half of the time in europe and the USA. Since India has a high usage of ivermectin, that would indicate that covid has a harder time getting a foothold into the body to start an infection/illness. though probably less effective as a treatment once covid gets a start.

    We are reaching the time where the first vaccine babies are being born. I wonder if the media will think it is newsworthy if they start being born without arms like Thalidomide

“…versus eight deaths in the placebo group.”

Sure, doc. Sign me up for a 50/50 death sentence.

BIG PHARMA is EVIL.

    Everything ‘big’ these days is evil, because ‘big’ has becomes stooges of the leftists in government – who protect ‘big’ in exchange for BILLIONS under the table.

    Milhouse in reply to LB1901. | October 3, 2021 at 8:34 pm

    Huh?! There were no deaths in the group that took the pill. So this appears to save you from a possible (but not that likely) death sentence.

      MattMusson in reply to Milhouse. | October 4, 2021 at 7:05 am

      IVERMECTAQUININE!

      Brave Sir Robbin in reply to Milhouse. | October 4, 2021 at 2:16 pm

      This should not be a safety trial. That should have already been completed. If safe, the phase three trial is supposed to prove efficacy and specifically benefit above risk.

      I have no specific opinion on this drug, but thought the “N” of the study was a bit small.

      I would like to see safety and efficacy comparisons between this drug and ivermectin and HQC, both as stand alone treatments and as part of a treatment regimen.

      HQC and Ivermectin dosages need to be correct. The studies that show these drugs as either ineffective of potentially harmful either provided the drug to patients too late or gave them extremely high doses several times more than is recommended and potentially toxic to to some people. Studies with application of correct dose indicate HQC and Ivermectin are effective treatments and are much cheaper.

      I have a feeling people did the high and potentially toxic does level studies of the drugs to sully them and make way this new and more expensive treatment option. I can fathom no reason to give patients such high levels of those drugs during studies. With medications, more is not necessary mean better, because more causes toxicity.

Once again Leslie, I shake my head with your medical knowledge. You say: “One last note: I have seen social media statements indicating molnupiravir is repackaged ivermectin. It is not.” I sure as hell hope you get your medical advice from credible medical experts and nor those from Social Media.

    The Friendly Grizzly in reply to natdj. | October 3, 2021 at 12:55 pm

    Ditto.

      Hey, if so, she’s in good company.

      Dean Li, Merck’s head of research and development, told medical news website Statnews that the name molnupiravir was also a tangential reference to the weapon of Thor, who is one of the Avengers and a fictional hero of the Marvel Comics Universe.

      Absolutely astounding ignorance. Tantamount to describing Michelangelo as “one of the Mutant Ninja Turtles.”

      All I can say is that these big red pills had better come with their own “cereal premium” vax card, or there will be war in heaven shortly.

    Ben Kent in reply to natdj. | October 3, 2021 at 1:44 pm

    It’s atomic structure is very close to Iverectin. It looks like a somewhat improved (or disguised) version of Ivermectin.

    As everyone knows, we have had Ivermectin available through out this pandemic – but the powers that be throw shade on it because it does not serve their poltical aims or the monetary aims of bif-pharma.

    Someday, the truth of all this will come out and reveal this as not just a health disaster but also a wicked mix of villains from Fauci, Eco-Health, pharma, politics, China apologists. This evil mix is worthy of a James Bond novel.

    alaskabob in reply to natdj. | October 3, 2021 at 2:06 pm

    However… a trial of Merck’s drug against IVM/HCQ/ D/ C and Zinc would be most revealing. Since clinical use in India has been successful with IVM… such a trial is worthy. Since Moderna came out it’s stock went from $60s to 400s.

      Ben Kent in reply to alaskabob. | October 4, 2021 at 1:57 pm

      INDIA MIRACLE

      Where is the US media ? India had a Covid disaster 6 months ago. Today, due to Ivermectin, India has had a remarkable turn around. The mortality rate has decreased by 98%.

      if the controlled-media in the US did not censor news that goes against the regime’s narrative – this would be big news.

      But they do not want the story of India to get out because Biden and Fauci would look like the corrupt morons that they are.

    Exiliado in reply to natdj. | October 3, 2021 at 2:15 pm

    This “new” drug is very, very, very different to Ivermectin: Big pharma gets to charge about 700% higher price.

    Other than that, same thing.
    This is evil at work.

      natdj in reply to Exiliado. | October 3, 2021 at 3:15 pm

      My wife who has been in medicine over 35 years says this is Ivermectin rebranded with some minor changes at an inflated price. Yep, Big Pharma will make Trillions.

        henrybowman in reply to natdj. | October 3, 2021 at 7:39 pm

        So all those sexy double carbon rings are probably the Red Dye Number 2 they mixed in to make their slime into a pretty pill?

      bullhubbard in reply to Exiliado. | October 5, 2021 at 9:53 am

      India has been using a cocktail of ivermectin, zinc and doxycycline, called a “Ziverdo Kit,” with great success.

      The sudden serious discussion of a Big Pharma cash cow, the positive (or at least not negative) comments on a pricey version of ivermectin, stinks to high heaven of a sweetheart PR deal.

      the idiotic dismissal of ivermectin as “horse dewormer” or “horse paste” now seems beyond idiotically snide; it’s more sinister, like a program of DISINFORMATION, or mockery of effective medicine to steer $ into the accounts of Merck. I can’t imagine the only motive is to “own the conservatives” or some other insane, politically motivated impulse.

    Dathurtz in reply to natdj. | October 3, 2021 at 3:41 pm

    I am not a biochemist, but I have quite a bit of it in my background and I try to keep up with at least some of the professional literature.

    They look like two very different molecules with very different modes of action to me. What, exaxtly, is the similarity that is making y’all say they are the same medicine?

      natdj in reply to Dathurtz. | October 3, 2021 at 4:27 pm

      Well, my wife has been reading the medical journals and talking with other medical providers and the thinking is that Ivermectin, which is cheap and has been through the appropriate vetting process through the FDA (unlike the vaxx) should not be castigated as a poison simply because the media says so. I believe there is a growing minority of medical professionals who will tell you that this is no longer about medicine but control and who has the best lobbyists. Could this drug be a lifesaver? Who knows, but the vaxx is not cutting it.

        Dathurtz in reply to natdj. | October 3, 2021 at 4:42 pm

        With ya 100% on that. I just don’t see much similarity between the two medicines in their structure or function.

The Friendly Grizzly | October 3, 2021 at 12:52 pm

I’m just a cynical old codger, and I am seeing this as nothing more than Merck wanting its share of the take on this national panic.

I sincerely hope I am wrong.

Let’s be honest, if they use the same risk assessment used to approve the vaccines then this thing is a shoe in for approval 🤣🤣

You know what though? For a [Chinese] virus so utterly fucking dangerous there sure do seem to be a lot of cost effective/cheap medicines that The Man ™ has worked hard to quash from getting used widely by those most effected by the Chinese Virus (HCQ, Ivermectin, this, monoclonal stuff Democrats laughed at and then attempted to take over control of and so on).

    alohahola in reply to mailman. | October 3, 2021 at 1:00 pm

    There also seems to be a lot of people alive and kicking around.

    I certainly am not seeing and hearing any bring-out-your-dead carts rolling down the street.

      JHogan in reply to alohahola. | October 3, 2021 at 2:24 pm

      Local so-called ‘news’ outlets of the Dem-media propaganda complex in major metro areas dutifully cover every single kid that dies from Covid.

      While ignoring all of the other kids dying from all of the other things kids die from and all related statistics.

      Milhouse in reply to alohahola. | October 3, 2021 at 8:40 pm

      We had that here in NYC for about a month. That was a terrible month. My community was hit hard; if we had been allowed to attend funerals I’d have been going to one almost every other day. But it’s over. By mid-May last year we all realized that it was over, and we came out of our bunkers and resumed life. And we promptly got accused of infecting everyone who never lost anyone but found they liked cowering in bunkers and didn’t want to stop.

    The Friendly Grizzly in reply to mailman. | October 3, 2021 at 1:33 pm

    The Covid has had an interesting bright side: no one seems to be getting the flu!

      On the flu-Covid Ven diagram the flu circle is almost completely inside the Covid circle.

      No school, work from home, and much more adherence to clean hands might have something to do with that too!

      I got this year’s flu shot, but I asked the guy giving it how they had figured out which strain to develop the vaccine for, since there hadn’t been a flu season last year. Normally they look at what China got last winter, and what Australia got in the Southern winter, and bet that that’s what will be heading for us next winter, so they vaccinate us against it. But this year they didn’t have that information, so how did they know what to do.

      He agreed with me and said they must have just guessed. So it’s anyone’s guess whether it will do any good. Still, flu shots are well-researched and tested, and we know how safe they are, so it seems to me to make sense to take it just in case. Unlike the Wuhan vaccine, which is a whole lot of unknown.

        The_Mew_Cat in reply to Milhouse. | October 4, 2021 at 12:47 pm

        I am not getting a flu shot this year because they are using the same strains as last year, and there is no flu circulating with all the restrictions on international travel.

So I should trust the FDA, CDC, and big Pharma with their trail of fraud, corruption, and totalitarian behavior? Could it be that this is the new money maker as the toxic ingredients of the shots are becoming known? They wouldn’t lie about these numbers or data or ingredients would they? They won’t silence people who ask questions about these pills will they?

It’s another -vir drug, an antiviral. Okay.

I would still stick with an antiparasitic that has been repurposed as an antiviral and has already been proven to be effective: ivermectin.

There is no emergency (other than Dr Faucenstein warning us again that Xmas is in doubt) but we need emergency approval of another vaccine? It’s time to end this madness. Arrest that fool!

Lucifer Morningstar | October 3, 2021 at 1:15 pm

Good luck to Merck. They’re oral treatment for The Covid™ will never be approved or given an EUA at this point. The Biden regime has too much invested (literally) in the Pfizer/BioNTech vaccine to admit there are effective treatments at this point.

    My bet is molnupiravir stays in extended EUA status. Once the mRNA vaccines get full approval the existence of a treatment doesn’t eliminate them, so then molnupiravir can be safely approved.

      “Emergency Use” generally means “And we can’t get sued” so there’s no downside to producing and administering as much as they can. If it turns out that Mol is indeed a “Take this pill if you have Covid and your chance of death drops to zero” then I’ll happily do backflips on the public square. Imagine all the power-greedy tyrants who no longer can use their favorite club to beat us.

      “Wear your mask or we’re all going to die!! What do you mean, Covid death rates just hit zero? It must be an Evil Pill!”

Covid Treatment Rules in the US Rules (by government decree, proclamation, and order) —

1) All ‘vaccines’ and new medications will be outrageously expensive and patented. Approval will be rushed. Short term side effects will be ignored. Potential long term effects will be first ignored and later discounted. Vaccination will be mandated wherever and whenever possible. Boosters will be required.

2) ‘Natural immunity’ will be ignored and/or discounted. Only newly developed medications will be allowed. Any decades old existing inexpensive medications shown to be empirically effective and with widespread successful use in poorer nations will be outlawed for use in the US. Doctors and pharmacists will be subject to loss of license to practice for attempting to prescribe/provide such medications. Doctors will be threatened with loss of license to practice for even discussing such medications with patients.

Your Ruling Class has spoken. So be it.

For further insights see ‘fascism’ and ‘thalidomide’.

Remember the massive covid outbreak in India over the summer? One Indian state, with 200+ million residents, implemented a test-and-treat-at-home protocol using Ivermectin as one element. They saw a massive collapse in their case and death rate.

Here is a great write-up: https://www.thedesertreview.com/opinion/columnists/indias-ivermectin-blackout—part-v-the-secret-revealed/article_9a37d9a8-1fb2-11ec-a94b-47343582647b.html

    jb4 in reply to Paul. | October 3, 2021 at 9:04 pm

    The writeup for India was fascinating, but note this posted comment, “Thank you for this article, and I’m following India’s progress with interest. However, the India Council of Medical Research recently dropped ivermectin from its treatment protocol. It seems they see the data differently. Can you shed some light on this decision?”

      henrybowman in reply to jb4. | October 4, 2021 at 12:34 am

      Light? I’m bringin’ the heat.

      Dr Soumya Swaminathan, Director-General of the Council of Medical Research, is being sued for causing the deaths of Indian citizens by misleading them about Ivermectin. The brief accused Swaminathan of misconduct by using her position as a health authority to further the agenda of special interests to maintain an EUA for the lucrative vaccine industry. Punishment under section 302 of the Indian Penal Code is death penalty or life imprisonment.

      Deseret Review: “The entire world witnessed the effectiveness of Ivermectin against India’s deadly second surge as the locations that adopted it saw their outbreaks quickly extinguished in stark contrast to those states that did not.

      Among the most prominent examples include the Ivermectin areas of Delhi, Uttar Pradesh, Uttarakhand, and Goa where cases dropped 98%, 97%, 94%, and 86%, respectively. By contrast, Tamil Nadu opted out of Ivermectin [due at least in part to Swaminathan’s recommendation]. As a result, their cases skyrocketed and rose to the highest in India. Tamil Nadu deaths increased ten-fold.”

Ivermercktin they wish.

Ivermectin saved Uttar Pradesh. If Ivermercktin does 1/10th as much it will get 10x the credit.

Early combination therapy with hydroxychloroquine and azithromycin reduces mortality in 10,429 COVID-19 outpatients

Early ambulatory treatment of COVID-19 with HCQ+AZ as a standard of care is associated with very low mortality, and HCQ+AZ improve COVID-19 survival compared to other regimens.

Antihistamines and azithromycin as a treatment for COVID-19 on primary health care – A retrospective observational study in elderly patients

Between March and April 2020, 84 elderly patients with suspected COVID-19 living in two nursing homes of Yepes, Toledo (Spain) were treated early with antihistamines (dexchlorpheniramine, cetirizine or loratadine), adding azithromycin in the 25 symptomatic cases. The outcomes are retrospectively reported. The primary endpoint is the fatality rate of COVID-19. The secondary endpoints are the hospital and ICU admission rates. Endpoints were compared with the official Spanish rates for the elderly. The mean age of our population was 85 and 48% were over 80 years old. No hospital admissions, deaths, nor adverse drug effects were reported in our patient population. By the end of June, 100% of the residents had positive serology for COVID-19

The plasmablast response to SARS-CoV-2 mRNA vaccination is dominated by non-neutralizing antibodies and targets both the NTD and the RBD
via Crap…. (OAS and OC43)*

Polyclonal antibody responses in vaccinees were robust and comparable to or exceeded those seen after natural infection. However, the ratio of binding to neutralizing antibodies after vaccination was greater than that after natural infection and, at the monoclonal level, we found that the majority of vaccine-induced antibodies did not have neutralizing activity.

A risky proposition, an indecent proposal. And silent spread.

“Emergency” use is predicated on there not being another pill already out there which works, which means, if it is granted, it will be another case of massive fraud. The discussion of whether this pill is similar to Ivermectin or not misses the larger point, namely that it is inferior to Ivermectin, which has multiple mechanisms of action and already known to be safe. We’re supposed to be thrilled that a $700 pill has 50% efficacy with unproven safety when Ivermectin is that good or better, has been around several decades, safer than aspirin?

This article came out early on, after Merck issued their phony warning about the safety of Ivermectin: joyce-kamen dot medium.com/merck-its-truth-telling-time-4496d9af9ca1#_=_

I read Legal Insurrection because Professor Jacobson has a good understanding of the law.

I read the In the Pipeline blog because Dr. Derek Lowe has a good understanding of medicinal chemistry.

See his post at https://www.science.org/content/blog-post/molnupiravir-thor-s-hammer-delivers

As a Ph.D. chemist I can say without hesitation or doubt that molnupiravir and ivermectin are very different molecules. In the med chem space they are not even close.

    Exiliado in reply to Cache. | October 4, 2021 at 10:04 pm

    Well, I am no “Ph.D. chemist” but I can also say without hesitation that Aspirin, Ibuprofen, Acetaminophen and Naproxen are “very different molecules”. But they all share the same or similar mechanisms of action, by inhibiting certain enzymes that cause inflammation or other adverse conditions.
    We could say the same about sugar vs. corn syrup. Aren’t they also “very different molecules”?

    It is evil to deny people access to known, safe and effective medication in order to impose new, experimental, 700% more expensive drugs. It is also an insult to anyone’s intelligence to go around justifying these evil actions with the “very different molecules” argument.

    IverMercktin and Pfizervectine are evil attempts to profit from human suffering. Shame!

Ivermectin, in its approved on-label use, kills parasites by activating glutamate-gated ion channels. Other mechanisms are hypothetical at this point. The folks at Monash University who discovered that ivermectin kills COVID-19 viruses in cell cultures, state “Do NOT self-medicate with Ivermectin and do NOT use Ivermectin intended for animals.”
https://www.monash.edu/discovery-institute/news-and-events/news/2020-articles/Lab-experiments-show-anti-parasitic-drug,-Ivermectin,-eliminates-SARS-CoV-2-in-cells-in-48-hours

See also https://www.fda.gov/consumers/consumer-updates/why-you-should-not-use-ivermectin-treat-or-prevent-covid-19

https://www.aha.org/news/headline/2021-08-27-cdc-alerts-clinicians-surge-ivermectin-poisoning-during-pandemic

Molnupiravir works by pushing RNA replication into making so many errors that the virus can’t effectively produce. This is a totally different mechanism and has been studied for years. https://www.science.org/content/blog-post/molnupiravir-last-small-molecule-coronavirus-hopes

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